Arch Womens Ment Health (2011) 14:465477
DOI 10.1007/s00737-011-0240-4
ORIGINAL ARTICLE
Efficacy of cognitive behavioral internet-based therapy
in parents after the loss of a child during pregnancy:
pilot data from a randomized controlled trial
Anette Kersting & Kristin Kroker & Sarah Schlicht &
Katja Baust & Birgit Wagner
Received: 24 February 2011 / Accepted: 25 September 2011 / Published online: 18 October 2011
# Springer-Verlag 2011
Abstract The loss of a child during pregnancy can be a
traumatic event associated with long-lasting grief and
psychological distress. This study examined the efficacy
of an internet-based cognitive behavioral therapy program
for mothers after pregnancy loss. In a randomized con-
trolled trial with a waiting list control group, 83 participants
who had lost a child during pregnancy were randomly
allocated either to 5 weeks of internet therapy or to a 5-
week waiting condition. Within a manualized cognitive
behavioral treatment program, participants wrote ten essays
on loss-specific topics. Posttraumatic stress, grief, and
general psychopathology, especially depression, were
assessed pretreatment, posttreatment, and at 3-month
follow-up. Intention-to-treat analyses and completer analy-
ses were performed. Relative to controls, participants in the
treatment group showed significant improvements in
posttraumatic stress, grief, depression, and overall mental
health, but not in anxiety or somatization. Medium to large
effect sizes were observed, and the improvement was
maintained at 3-month follow-up. This internet-based
cognitive behavioral therapy program represents an effec-
tive treatment approach with stable effects for women after
pregnancy loss. Implementation of the program can thus
Anette Kersting and Kristin Kroker contributed equally to this work
and should both be considered first author.
A. Kersting (*) : B. Wagner
Department of Psychosomatic Medicine, University of Leipzig,
Semmelweisstr 10,
04103 Leipzig, Germany
e-mail: anette.kersting@medizin.uni-leipzig.de
K. Kroker : S. Schlicht : K. Baust
Department of Psychiatry, University of Muenster,
Albert-Schweitzer Str 11,
48145 Muenster, Germany
help to improve the health care provision for mothers in this
traumatic loss situation.
Keywords Pregnancy loss . Posttraumatic stress .
Depression . Therapy . Randomized controlled trial
Introduction
Although often not openly discussed, the loss of a child
during pregnancy is a relatively common experience.
Various adverse pregnancy outcomes can lead to miscar-
riage in early or later pregnancy to termination of
pregnancy due to fetal anomalies or to stillbirth. An
estimated 15% of clinically recognized pregnancies and
up to 50% of all pregnancies end in miscarriage (Geller
et al. 2010; Gold et al. 2007), and stillbirth occurs in up to
1% of all births (Gold et al. 2007). Prenatal diagnosis of
multiple fetal anomalies often results in the termination of
pregnancy (Kramer et al. 1998; Mansfield et al. 1999).
Many women experience severe psychological distress
following pregnancy loss (Berth et al. 2008). Studies have
shown that the loss of a child during pregnancy or shortly
after birth can lead to long-lasting grief (Brier 2008;
Kersting et al. 2007) and manifest psychiatric disorders
(Kersting et al. 2007; Klier et al. 2000; Neugebauer et al.
1997). Women have an increased risk of an affective
disorder in the first 6 months after miscarriage (Klier et al.
2000; Neugebauer et al. 1997). In particular, women who
have experienced a late miscarriage are at higher risk for a
depressive disorder than women with healthy children, even
years later (Cougle et al. 2003). Post-loss depression is
often higher in mothers than in fathers (Klier et al. 2002),
with fathers showing less intense reactions (Badenhorst
et al. 2006; Vance et al. 1995). In terms of anxiety
466
disorders, the risk of posttraumatic stress disorder (PTSD)
is particularly elevated in women after pregnancy loss
(Engelhard et al. 2001; Kersting et al. 2007); these women
show a high degree of traumatic symptoms, comparable
with those who experienced after other severe traumatic
events (Kersting et al. 2009a; Korenromp et al. 2007) and,
in some cases, persisting even years later (Kersting et al.
2005; Korenromp et al. 2009). General symptoms of
anxiety are also known to increase after pregnancy loss
(Brier 2004; Geller et al. 2004).
Furthermore, the experience of pregnancy loss may
affect subsequent pregnancies: in a prospective study,
Bergner et al. (2008) found that early miscarriage was
associated with increased anxiety and depressive symptoms
in the subsequent pregnancy. Another study showed that
29% of women developed a posttraumatic stress disorder in
the pregnancy following a stillbirth (Turton et al. 2001).
Despite the increasing recognition that many women
experience serious and lasting psychological problems after
pregnancy loss, womens dissatisfaction with aspects of the
health care received in this situation is less recognized. In
their recent review, Geller et al. (2010) focused on
satisfaction with pregnancy loss aftercare, especially in
women after early miscarriage. They found that the typical
treatment does not include specific psychosocial aftercare
and that many women reported insufficient emotional
acknowledgment of their loss, provision of information,
and involvement in treatment decisionsall factors that are
associated with higher levels of satisfaction with aftercare
(Geller et al. 2010).
To date, there have been few controlled studies of
psychological support and counseling services targeting
parents after pregnancy loss. In a randomized controlled trial,
Nikcevic et al. (2007) investigated the influence of medical
and psychological interventions on womens distress after
miscarriage and found psychological counseling to have
beneficial effects on grief and worry over and above medical
investigations and consultations. Swanson et al. (2009)
examined couples-focused interventions in a randomized
controlled trial. They compared the effects of three counsel-
ing sessions with a nurse, self-caring, a combination of nurse
and self-caring, and a control condition with no intervention.
The nurse caring condition proved more effective than any
other condition in accelerating womens resolution of
depression. Interestingly, the nurse caring condition and the
no treatment condition proved more effective than the other
conditions in resolving mens depression. Neugebauer et al.
(2007) investigated telephone-administered interpersonal
counseling for women with subsyndromal depression after
miscarriage; in this small open trial, they observed a decrease
in depressive symptoms.
Hence, pregnancy loss is a neglected health care area in
which psychosocial support is often lacking. In recent
A. Kersting et al.
years, however, the internet has emerged as a useful source of
information and support for parents in this situation
especially when guided search functions are available (Geller
et al. 2006). A wealth of internet-based mental health services
now exist, ranging from pure information sites to virtual self-
help groups, automatized self-help programs, counseling,
and even psychotherapy for all kinds of mental health
problems (Kersting et al. 2009b). In particular, internet-based
treatments for depression (Andersson and Cuijpers 2009) and
anxiety disorders (Andersson 2009) such as posttraumatic
stress disorder (Lange et al. 2000b, 2003; Litz et al. 2007)
have been investigated in randomized controlled studies and
proved effective, with moderate to large effect sizes.
In view of findings demonstrating the efficacy of an internet-
based treatment program for PTSD (Knaevelsrud and
Maercker 2007; Lange et al. 2003), Wagner et al. (2006)
adapted a cognitive behavioral therapy program for compli-
cated grief for the internet and evaluated its efficacy. Results
showed that participants benefited from the intervention, with
significant decreases (of large effect sizes) in traumatic stress
response and grief as well as in depressive symptoms and
anxiety. A recent evaluation of a brief internet-based self-help
writing intervention for bereaved people without therapist
responses (van der Houwen et al. 2010) showed decreased
feelings of emotional loneliness and increased positive mood,
but no effects on grief or depressive symptoms.
Given the success of the internet-based cognitive behavioral
treatment approaches for posttraumatic stress disorder (Lange
et al. 2000b) and complicated grief (Wagner et al. 2005,
2006), the treatment protocol for complicated grief (Wagner
et al. 2006) was adapted for mothers after pregnancy loss,
which specifically addressed problems and needs of this
population. To evaluate its efficacy, we assessed a broad
range of symptoms: posttraumatic stress, grief, depression,
and general psychopathology in terms of overall mental
health, anxiety, and somatization. Our hypotheses were that
mean posttraumatic stress, grief, depression, and overall
mental health scores would (1) show a significantly greater
decrease from pre- to posttest in the treatment group (TG) than
in the waiting list control group (WLC) and (2) remain stable
from posttreatment to 3-month follow-up in the TG.
Method
Participants
The internet-based cognitive behavioral therapy was directed
at mothers who had lost a child during pregnancy through
miscarriage, termination of pregnancy due to fetal anomaly, or
stillbirth. All participants were self-referrals. Further inclusion
criteria for participating were: living in a German-speaking
country, being a German native speaker, having access to the
Internetbased-therapy after pregnancy loss 467

internet, and signing informed consent. We implemented an
extensive screening procedure using validated instruments to
rule out serious mental health problems: applicants with
severely depressed mood and suicidal tendencies (BSI,
subscale depression of the Brief Symptom Inventory; Derogatis
1993), dissociative tendencies (Somatoform Dissociation
Questionnaire; Nijenhuis et al. 1997), risk of psychosis
(SDPD, German translation of the Dutch Screening Device
for psychotic disorder; Lange et al. 2000a), and substance
abuse and dependence (questions about consuming behavior
on alcohol and other drugs) were contacted via telephone and
excluded when severity of symptoms was confirmed in the
relevant section of the Structured Clinical Interview for
DSM-IV (First et al. 1997) interview. These applicants were
advised on appropriate treatment and given help to find
treatment, if requested. Further exclusion criteria were
pregnancy at treatment allocation, psychotherapy at treatment
allocation, and age under 18 years. Between October 2007
and July 2008, 159 women completed our screening ques-
tionnaires. Of these, 48 were excluded: 19 (25%) had serious
mental health problems (severely depressed mood, dissocia-
tive tendencies, and risk of psychosis) and 29 (38%) met the
other exclusion criteria (current pregnancy, in psychotherapy,
age under 18 years, lost the child after birth, and not living in
a German-speaking country). A further 28 women (37%)
declined participation without giving specific reasons or were
nonresponsive. From the excluded applicants, seven received
psychopharmacological medication (five antidepressants and
two benzodiazepines), whereas only one participant of the
study received benzodiazepines. A total of 83 women eligible
for participation gave their informed consent and were
included in the study. The study protocol was approved by
the respective local ethical committees and was conducted in
accordance with the Declaration of Helsinki ethical standards
(Ethik-Kommission der rztekammer Westfalen-Lippe und
der Medizinischen Fakultt der Westflischen Wilhelms
Universitt Mnster: http://www.campus.uni muenster.de/
ethikkommission.html).
Design
The 83 participants were randomly allocated to either the
treatment condition (TG) or the WLC (for demographic and
obstetric characteristics see Table 1). Outcome measures

Table 1 Demographic and obstetric details of the study sample with test statistics

Study sample Internet therapy TG WLC Test statistic p value

(N=78) (N=45) (N=33)

Mean age in years, M (SD) 34.3 (5.34) 34.1 (5.34) 34.5 (5.42) 0.270a 0.788, n.s.
Married/cohabiting, N (%) 75 (96.2) 43 (96) 32 (97) 0.103b 0.748, n.s.
Education, N (%) 2.821c 0.244, n.s.
Low 7 (9.0) 6 (13.3) 1 (3)
Medium 35 (44.9) 18 (40.0) 51.417 (51.5)
High 36 (46.2) 21 (46.7) 15 (45.5)
Years of education, M (SD) 16.3 (2.86) 16.0 (2.95) 16.8 (2.71) 1.111a 0.270, n.s.
Obstetric data
Kind of loss, N (%) 0.355d 0.949, n.s.
Early miscarriage 40 (51.3) 23 (51.1) 17 (51.5)
Late miscarriage 13 (16.7) 8 (17.8) 5 (15.1)
TOP due to fetal anomaly 10 (12.8) 5 (11.1) 5 (15.2)
Stillbirth 15 (19.2) 9 (20.0) 6 (18.2)
Gestational week, M (SD), [range] 17.8 (9.66), [240] 18.7 (9.80), [740] 16.7 (9.49), [238] 608.00e 0.312, n.s.
Time since loss in months, M (SD), [range] 15.4 (27.40), [1144] 9.6 (12.68), [160] 23.5 (38.84), [1144] 531.50e 0.103, n.s.
Miscarriage before, N (%) 26 (33.3) 14 (31.1) 12 (36.4) 0.236b 0.627, n.s.
TOP before, N (%) 4 (5.1) 2 (4.4) 2 (6.1) 0.102b 0.749, n.s.
Stillbirth before, N (%) 2 (2.6) 1 (2.2) 1 (3.0) 0.050b 0.823, n.s.
Having living children, N (%) 45 (57.7) 28 (62.2) 17 (51.5) 0.894b 0.344, n.s.

TOP termination of pregnancy, WLC waiting list control group, TG treatment group
a
Two-tailed t test
b
Pearson chi-square, 22 table, df=1
c
Pearson chi-square, 32 table, df=2
d
Pearson chi-square, 42 table, df=3
e
MannWhitney U test
468
were posttraumatic stress, grief, overall mental health,
depressive and anxious symptoms, and somatization. Data
were collected pre- and posttreatment and 3 months after
completion of the internet-based therapy. Subjects in the
waiting list condition were subsequently invited to participate
in the internet-based intervention.
Measures
The demographic and obstetric data collected included age,
marital status, education, kind of loss, gestational week,
time since loss, previous pregnancy outcomes, and having
living children. Posttraumatic stress reactions were assessed
using the Impact of Event Scale (IES; Horowitz et al.
1979). This instrument is widely used to assess two
categories of responses to major life events: intrusive
experiences and avoidance of thoughts and images associated
with the event. The scales 15 items assess frequency of
symptoms over the past 7 days on a four-point measurement
scale (Horowitz et al. 1979). The IES is a reliable index that
indicates the degree of subjective distress associated with a
specific trauma and has good psychometric properties
(Sundin and Horowitz 2002). In the present study,
participants were instructed to relate the IES items specifi-
cally to the loss of their child. Internal consistency in our
sample was good (=0.87).
The extent of grief was assessed using the Inventory of
Complicated Grief (ICG; Prigerson et al. 1995). This scale
is designed to assess a wide range of cognitions, emotions,
and behaviors describing a grief reaction. Participants
responded to the 15 items on a five-point measurement
scale. The ICG has been shown to have good psychometric
properties (Cronbachs =0.94, testretest reliability=0.80,
Prigerson et al. 1995). Internal consistency in our sample
was good (=0.89).
General psychopathology and depression were measured
using the well-validated BSI (Derogatis 1993), a psycho-
logical self-report symptom scale. The 53-item scale
records the experience of physical and psychological
symptoms over the past 7 days. The BSI provides several
indices, including the Global Severity Index of overall
mental health and indices for the subscales of depression,
anxiety, and somatization. The internal consistency in our
sample was excellent (=0.94).
Intervention
Interventions involving cognitive behavioral components in
bereavement interventions have shown treatment efficacy
(Boelen et al. 2007; Shear et al. 2005; Wittouck et al.
2011). In parallel, the effectiveness of cognitive behavioral
therapy for PTSD has been well documented (Bradley et al.
2005). Confrontation with difficult memories of the
A. Kersting et al.
traumatic event has proven to be an important element of
effective psychotherapy for PTSD. Confrontation has been
found to significantly reduce avoidance behavior. Given the
similarity of some symptoms of complicated grief disorder
to those of PTSD, it is conceivable that cognitive
behavioral treatments designed for PTSD (Foa and Jaycox
1999) might show similar symptom reductions among
individuals with complicated grief. Based on this rationale,
an internet-based cognitive behavioral treatment program
for complicated grief (Wagner et al. 2005, 2006) was
specifically adapted to the needs of mothers after loss of a
child during pregnancy (see Kersting et al. 2011 for further
details of the treatment protocol.)
The program comprised three phases, in which participants
wrote a total of ten assignments. In the first phase of self-
confrontation, they wrote four assignments describing the
traumatic loss and its circumstances. In the second phase of
cognitive restructuring, they wrote a further four assign-
ments, framed as a supportive letter to a hypothetical friend
with the aim of providing new perspectives on the loss. The
third and final phase of social sharing focused on a symbolic
farewell letter (two assignments) that participants could
address to themselves, to a person connected with the loss,
or to a loved one. Each writing assignment lasted 45 min and
took place at regular and scheduled times. Twice in each
phase, the therapist providedwithin one working day
individual written feedback along with instructions on the
next writing assignment.
Procedure
Participants were informed through newspaper articles
about the program, information posted on related
internet pages, and information published on our own
website. Information flyers on the program were
distributed in five cooperating centers and in associated
clinics and medical surgeries. The first contact was
initiated by applicants via our website or email contact;
hence, all participants were self-referrals. The applicants
were first asked to complete the screening question-
naires, which assessed demographic and obstetric data
as well as information about the exclusion criteria.
Applicants excluded for mental health reasons were
advised to attend psychiatric and/or psychotherapeutic
face-to-face treatment in their local region and were
delivered with information how and where to find
treatment. Women who were currently pregnant were
encouraged to contact the treatment team for specific
advice. Applicants eligible for the program were
informed about the therapy concept and the study
protocol. An informed consent was given prior to
inclusion in the study. The participants were then
allocated to the TG or the WLC by means of block
Internetbased-therapy after pregnancy loss
randomization using a random number table retrieved
from http://ts.nist.gov/WeightsAndMeasures/Publications/
upload/h133_appenb.pdf.
Participants then completed the baseline (pretreatment)
questionnaires. The duration of both the treatment and the
waiting list condition was 5 weeks. All participants (TG
and WLC) completed the posttreatment questionnaire, and
participants in the TG additionally completed a 3-month
follow-up assessment. The participants in the WL condition
were invited to begin the internet-based writing therapy
immediately after the posttest.
Data analysis
We tested for group differences in demographic and
obstetric information using Chi-square tests, t tests, or
nonparametric tests as appropriate. On the variables mean
posttraumatic stress, grief, depression, anxiety, somatization
and overall mental health (BSI sum score), we performed
2 2 repeated measures analysis of variances (RM-
ANOVAs) with the within-subjects factor time (pre- vs.
posttest) and the between-subjects factor treatment (therapy
vs. waiting list). The focus of this analysis was on the
interaction effect treatment time. Stability of mean
posttraumatic stress, grief, depression, anxiety, somatiza-
tion, and overall mental health (BSI sum score) from
posttest to 3-month follow-up in the TG was tested with
planned pairwise t tests.
A priori power calculations performed with G*Power
3.0.10 (Buchner et al. 1997) indicated that a sample size
of 34 participants per group would provide a power of
0.85 to detect a moderate improvement of 0.5 in mean
scores of posttraumatic stress after treatment at a signif-
icance level of 0.05. Taking an intention-to-treat (ITT)
approach, we conducted RM-ANOVAs and paired t tests
for all initial participants on the basis of the last
observation carried forward principle; in case of non-
completers, pretreatment scores were carried forward to
replace the missing values (TG, n=45; WL, n=33). In
addition, we performed a per protocol (PP) analysis,
conducting the same analyses on only those participants
who completed the therapy program (TG, n=33; WL,
n=26). All analyses were conducted using SPSS (version
17.0.0 for Windows) with a significance level of 0.05.
Effect sizes were calculated as Cohens d (Cohen 1992)
considering dependent and independent group relations.
We present effect sizes for changes within each group as
well as effect sizes between the two groups, which reflect
the additive effect of the internet therapy relative to
waiting (Cohen 1992; Dunlap et al. 1996). Guidelines for
interpreting effect magnitude are as follows: 0.20 = small
effect, 0.50 = medium effect, and 0.80 = large effect
(Cohen 1992).
469
Results
Attrition
Of the 83 participants initially randomized, 5 had to be
excluded from the intervention after randomization4
because they became pregnant and 1 because of serious
illness. Of the remaining 78 participants, 59 (76%)
completed the intervention and posttreatment assessment.
The response rates in the control group (WLC, 79%; n=26)
and the intervention group (TG, 72%; n=33) did not differ
significantly, chi(1) = 0.307, p = 0.579. Of those who
dropped out (n=19), 12 (63%) were nonresponsive, 2
(11%) withdrew because they no longer needed support, 2
(11%) did not have enough time, 2 (11%) described writing
as the wrong approach, and 1 (5%) no longer had internet
access. Of the treatment group, nine participants dropped
out in the first phase of treatment and three in the second
phase. The participants who dropped out did not differ from
participants who completed the intervention and posttreat-
ment assessment on any of the demographic or obstetric
variables except time since loss, which was significantly
longer for those who dropped out (M=33.2 months, SD=
44.05) than for completers (M=10.1 months, SD=17.59),
U(76) = 285.00, p= 0.008. In particular, no significant
differences were found between completers and drop outs
in any of the baseline measures: posttraumatic stress,
t(73)=0.604, p=0.548; grief, t(74)=0.111, p=0.912; over-
all mental health, t(75) = 0.394, p = 0.695; depression,
t(75) = 0.332, p = 0.741; somatization, t(75) = 0.386,
p=0.701; and anxiety, t(75)=0.678, p=0.500. Figure 1
summarizes the study enrollment flow.
Demographic and obstetric data
Following randomization, there were no significant
differences between the two groups in any of the
demographic or obstetric data obtained (Table 1). In
particular, no significant baseline differences were found
between TG and WLC in any of the symptom categories
(Table 2, p values ranging from 0.324 to 0.765).
Efficacy of treatment
To evaluate the efficacy of the internet-based therapy
program, we ran RM-ANOVAs on both an ITT dataset
and a PP dataset. Data on symptom levels are given in
Table 2. Figure 2 illustrates findings for posttraumatic stress
across time. Time had a significant main effect on all
symptom categories (in the following, we report the ITT
analyses): posttraumatic stress, F(1, 76)=28.084, p<0.001;
grief, F(1, 76)=22.330, p<0.001; and overall mental health
(BSI sum score), F(1, 76)=20.152, p<0.001. Moreover,
470 A. Kersting et al.

Fig. 1 Study enrolment flow

159 potential participants
assessed for eligibility

76 excluded
19 mental health problems
29 met exclusion criteria
17 declined
11 non-responsive

83 Randomized

48 Randomized to receive 35 Randomized to receive

internet treatment (TG) waiting-list-control (WLC)
3 excluded because of pregnancy 1 excluded because of pregnancy
1 excluded because of serious
illness
45 started intervention 33 started intervention

12 Drop outs 7 Drop outs

9 non-responsive 3 non-responsive
1 no more time 2 no support needed
1 no internet-access 1 no more time
1 writing not adequate 1 writing not adequate

33 Completed 26 Completed
postassessment postassessment

4 Lost to
follow-up

29 Completed
3 months follow-up

time had a significant effect on all BSI subscales: depression,
F(1, 76)=15.502, p<0.001; somatization, F(1, 76)=6.181, p
=0.015; and anxiety, F(1, 76)=6.203, p=0.015. In contrast,
group did not have a significant main effect on any of the
symptom categories or subscales: posttraumatic stress,
F(1, 76)=2.781, p=0.099; grief, F(1, 76)=3.133, p=0.081,
overall mental health, F(1, 76)=0.344, p=0.559; depression,
F(1, 76)=0.284, p=0.596, somatization F(1, 76)=0.577, p=
0.450; and anxiety, F(1, 76)=0.042, p=0.839. In the
following, the interaction effects group time are presented
separately for all variables.
Posttraumatic stress The results of the group time
interaction effects of the RM-ANOVAs for both datasets
are given in Table 3. A significant group time interaction
effect emerged for posttraumatic stress, indicating that
improvement from pretest to posttest was significantly
higher in the treatment group than in the waiting list control
group, F(1, 76)=6.682, p=0.012. Only posttraumatic stress
changed in the WLC group over the waiting period.
Although the change failed to reach significance in the
ITT analysis, it was significant in the PP analysis, as shown
by planned post hoc t tests (see Table 4). Nevertheless,
changes in the treatment group were significantly higher
than in the waiting list control group, as indicated by the
significant group time interaction effect in the
RM-ANOVA and a medium effect size between the groups
of dbetween =0.56.
Internetbased-therapy after pregnancy loss 471

Table 2 Means and standard

deviations on symptom levels Score range Pretreatment Posttreatment 3 months follow-up
(pre- and posttreatment and
3 months follow-up) Mean SD Mean SD Mean SD

Traumatic stress. 075

Therapy 33.1 13.21 17.9 12.36 19.1 14.54
Waiting 34.6 11.39 27.9 10.92
Grief 1575
Therapy 39.5 9.89 30.1 8.78 30.5 11.52
Waiting 38.2 9.30 36.5 9.30
Mental health 04
Therapy 0.99 0.59 0.44 0.40 0.39 0.40
Waiting 0.88 0.58 0.75 0.53
Depression 04
Therapy 1.28 0.85 0.47 0.49 0.52 0.74
Waiting 1.00 0.74 0.99 0.85
Somatization 04
Therapy 0.52 0.57 0.24 0.32 0.17 0.22
Waiting 0.71 0.93 0.53 0.59
Anxiety 04
Therapy 0.92 0.79 0.53 0.82 0.40 0.56
Waiting 0.92 0.90 0.70 0.63

Grief The reduction in grief was significantly higher in the
treatment group than in the waiting list control group, as
indicated by the significant group time interaction effect
on grief, F(1, 76)=11.329, p=0.001, dbetween =0.68. There
was no significant change in grief in the waiting list
condition (see Table 4).
General psychopathology There were significant group
time interaction effects on overall mental health (BSI sum
score), F(1, 76)=8.635, p=0.004, dbetween =0.46, which is
attributable to a significant interaction effect on the BSI
subscale depression, F(1, 76)=16.621, p<0.001, dbetween =
0.53, with the treatment group showing a significant
improvement from pre- to posttreatment and significantly
higher changes than those observed in the waiting list
control group. Although the treatment group showed
Traumatic stress
50
significant improvements in anxiety and somatization
(see Table 4), these changes did not differ significantly
from those seen in the WLC group, as reflected by the
nonsignificant group time interaction effects: anxiety,
F(1, 76)=0.834, p=0.364 and somatization, F(1, 76)=
0.570, p=0.453. The analyses of the PP dataset revealed an
identical pattern of results and almost identical outcomes
for all symptom categories (see Table 3).
Covariates
Of the demographic and obstetric variables, time since loss
was the only variable that differed substantially, though not
significantly, across the two groups (TG and WLC). Hence,
the time since loss was included as a covariate in the
RM-ANOVA. All interaction effects on all symptom catego-
TG
ries in both analyses (ITT and PP) remained significant when
WLC
time since loss was controlled (see Table 3).

40 Reliable change

30
The reliable change index (Jacobson and Truax 1991) was
calculated to statistically determine a reliable change in
20
response to the internet-based intervention. Compared to
the waiting list, the treatment group showed a reliable
10
improvement on the outcome measures posttraumatic stress
pre post follow-up
and the subscale depression of the BSI (ITT and PP) and on
Fig. 2 Psychopatholocial symptoms across time grief and overall mental health (PP only, see Table 5).
472 A. Kersting et al.

Table 3 Test statistics of interaction effects of group time (pre- and posttreatment) and estimated between-groups effect sizes on all symptom
categories

ITT RM-ANOVAa PP RM-ANOVAb ITT RM-ANCOVA PP RM-ANCOVA

F(1, 76) p value dbetweenc F(1, 57) p value dbetweenc F p value F p value

Traumatic stress 6.682 0.012* 0.56 6.472 0.014* 0.86 4.275 0.042* 5.751 0.020*
Grief 11.329 0.001** 0.69 13.020 0.001** 0.71 8.320 0.005** 11.287 0.001**
Mental health 8.635 0.004** 0.46 10.698 0.002** 0.66 6.202 0.015* 8.620 0.005**
Depression 16.621 <0.001** 0.53 20.727 <0.001** 0.75 13.396 <0.001** 17.752 <0.001**
Somatization 0.570 0.453, n.s. 0.416 0.520, n.s. 0.171 0.680, n.s. 0.196 0.660, n.s.
Anxiety 0.834 0.364, n.s. 0.664 0.419, n.s. 0.388 0.536, n.s. 0.420 0.520, n.s.

ITT intention-to-treat, PP per protocol, RM-ANOVA repeated measures analysis of variance, ANCOVA analysis of covariance
*p<0.05, **p<0.01, significance of change
a
Test statistic for interaction of time condition in the RM-ANOVAs on ITT data set
b
Test statistic for interaction of time condition in the RM-ANOVAs on the PP data set
c
Effect size dbetween for between groups (Dunlap et al. 1996)

Three-month follow-up symptoms of posttraumatic stress and grief were signifi-

Planned paired t tests showed that improvements persisted
at 3-month follow-up: posttraumatic stress, t(44)=0.564,
p=0.576; grief, t(44)=0.241, p=0.811; overall mental
health, t(44)=0.760, p=0.451; depression, t(44)=0.723,
p=0.473; anxiety t(44)=1.141, p=0.260; and somatization,
t(44)=0.942, p=0.351. The analyses of the PP dataset
revealed an identical pattern of results and almost identical
outcomes for all symptom categories. Details are given in
Table 4.
Effect sizes
In the treatment group, pre-/posttreatment effect sizes
(Cohens d) for the core symptoms ranged from d=0.66
to d=0.84 in the ITT dataset, indicating medium to high
effects, and from d=0.93 to d=1.15 in the PP dataset
(Table 4), indicating high effects. In the WLC group, only
posttraumatic stress showed a medium effect size of d=0.32
in the ITT dataset (PP, d=0.59). We calculated additive
effect sizes of internet treatment relative to waiting that
ranged from d=0.66 to d=0.86 for the core symptoms,
indicating medium to large effects. The details are given in
Tables 3 and 4.
Discussion and conclusion
In this pilot study, we investigated the efficacy of an
internet-based cognitive behavioral therapy program for
mothers after the loss of a child during pregnancy. We
found significant improvements in posttraumatic stress and
grief as the main outcomes after treatment. Self-reported
cantly lower after 5 weeks of internet-based therapy,
intraindividually compared with pretreatment symptoms
and interindividually compared with a waiting list condi-
tion. Furthermore, overall mental health and depression
were significantly improved after the treatment. The
symptom categories of posttraumatic stress, grief, and
depression can be directly related to the experience of the
loss and are thus labeled core loss-related symptoms. As
significantly higher improvements in all of these symptoms
were observed in the treatment group than in the waiting
list control group, these effects can evidently not be
explained by spontaneous remission, but reflect treatment-
related effects. This finding is in line with prior studies,
which have repeatedly found that these symptoms may
improve over time, but do not vanish completely without
treatment. On the contrary, numerous studies have shown
high persistence and clinical relevance of the symptoms of
traumatic stress (Engelhard et al. 2001; Kersting et al. 2005;
Korenromp et al. 2009), grief (Brier 2008; Kersting et al.
2009a), depression, and anxiety (Brier 2004; Carter et al.
2007; Klier et al. 2002).
For the more general, not loss-related symptom categories,
such as anxiety and somatization, there was no additive effect
of the treatment relative to waiting. Hence, the improvements
observed in core loss-related symptoms do not reflect general
treatment effects on psychological well-being, but can be
interpreted as a differential effect of this cognitive behavioral
intervention program. The only symptom level that changed
significantly over the waiting time of 5 weeks was traumatic
stress; this result was in line with prior findings (Carter et al.
2007; Engelhard et al. 2001).
The improvements observed in core symptoms remained
stable at 3-month follow-up, indicating at least short-term
Table 4 Planned post hoc tests on ITT sample and on PP sample pre- to posttreatment and posttreatment to follow-up and within-groups effect sizes

ITT pre- to posttreatmenta PP pre- to posttreatmentb ITT posttreatment to 3-months follow-up PP posttreatment to FU
Internetbased-therapy after pregnancy loss

t p value dwithinc t p value dwithinc t p value dwithinc t p value dwithinc

Traumatic stress Therapy 5.734 <0.001** 0.84 6.691 <0.001** 1.15 0.564 0.576, n.s. 0.05 0.561 0.580, n.s. 0.10
Waiting 1.951 0.06, n.s. 0.34 2.980 0.007** 0.59
Grief Therapy 5.253 <0.001** 0.72 5.954 <0.001** 0.95 0.241 0.811, n.s. 0.02 0.239 0.813, n.s. 0.05
Waiting 1.529 0.137, n.s. 0.11 1.704 0.103, n.s. 0.18
Mental health Therapy 5.410 <0.001** 0.64 6.201 <0.001** 0.93 0.760 0.451, n.s. 0.05 0.758 0.455, n.s. 0.12
Waiting 1.123 0.270, n.s. 0.07 1.308 0.203, n.s. 0.22
Depression Therapy 5.622 <0.001** 0.68 6.514 <0.001** 0.95 0.723 0.473, n.s. 0.05 0.721 0.477, n.s. 0.10
Waiting 0.111 0.913, n.s. 0.05 0.056 0.956, n.s. 0.01
Somatization Therapy 3.291 0.002* 0.25 3.435 0.002** 0.49 0.942 0.351, n.s. 0.04 0.942 0.354, n.s. 0.22
Waiting 0.901 0.375, n.s. 0.08 1.174 0.252, n.s. 0.19
Anxiety Therapy 2.402 0.021* 0.32 2.451 0.020* 0.49 1.141 0.260, n.s. 0.11 1.143 0.263, n.s. 0.16
Waiting 1.222 0.231, n.s. 0.10 1.697 0.103, n.s. 0.24

ITT Intention to treat, PP per protocol, FU follow-up

*p<0.05, **p<0.01, significance of change
a
Test statistic for planned post hoc t test on ITT data set
b
Test statistic for planned post hoc t test on the PP data set
c
Effect size dwithin for within groups (Cohen 1992)
473
474
Table 5 Percentage of participants showing reliable change (RC) at posttest on all symptom categories
ITT
Therapy Waiting
Traumatic stress 62 36
Grief 53 36
Mental health 51 30
Depression 51 24
Somatization 24 24
Anxiety 31 27
RC computed using the formula (x2 x1)/SDiff (Jacobson and Truax 1991)
ITT intention-to-treat, PP per protocol
*p<0.05, **p<0.01, significance of change
stability of treatment effects, although there was no further
therapeutic support apart from the follow-up assessment.
This finding is in line with previous results showing that
grief-related symptom reduction was maintained at 1.5-year
follow-up (Wagner and Maercker 2007). Hence, the
intervention program proved to be effective in decreasing
symptoms and normalizing distress, and the short-term
stability of treatment effects indicates that this approach
may help to prevent the subsyndromal states that occur after
pregnancy loss from developing into complicated grief or
other psychiatric disorders, as has been reported in several
studies (Engelhard et al. 2001; Kersting et al. 2007;
Neugebauer et al. 1997). Hence, the significant and stable
decreases observed in core loss-related symptoms relative
to the waiting list condition reflect differential, additive,
and direct treatment effects of this internet-based cognitive
behavioral treatment program.
The efficacy of this program to support women after
pregnancy loss is emphasized by the large effect sizes (see
Cohen 1992) observed for traumatic stress (d=0.84 in the
ITT dataset; d=1.15 in the PP dataset) in the treatment
group from the within-groups perspective. The online
treatment approach evidently has great practical signifi-
cance for women in this difficult situation. The effect sizes
found in our pilot study are comparable with those reported
in studies of similar internet-based approaches for patients
with posttraumatic stress following traumatic events such as
interpersonal violence, the sudden or violent death of a
close person, or traffic accidents (Knaevelsrud and
Maercker 2007; Lange et al. 2000b; Wagner et al. 2006).
Thus, there is converging evidence for the efficacy of
cognitive behavioral writing therapy with intensive thera-
peutic feedback. Between-group effect sizes, which reflect
the additive effect of the treatment relative to waiting alone
(Dunlap et al. 1996), ranged from 0.53 to 0.69 (ITT, and
0.66 to 0.86 in PP), further corroborating the efficacy of the
treatment.
A. Kersting et al.
PP
Chi Therapy Waiting Chi
5.096* 82 42 9.903**
2.206 67 39 10.470**
2.656 70 39 5.756*
5.739* 70 31 8.838**
0.0 39 27 1.009
0.034 42 31 0.845
Note that the target population of women after pregnancy
loss does not share a diagnosis of a specific psychiatric
disorder, but is a homogenous group of women across a rather
broad age range with one shared experience: a traumatic
pregnancy loss. As described in the Introduction section,
many of these women experience severe psychological
distress (Kersting et al. 2009a; Klier et al. 2002; Korenromp
et al. 2007, 2009) and are at increased risk of psychiatric
disorders (Engelhard et al. 2001; Kersting et al. 2007;
Neugebauer et al. 1997). The impact of the traumatic loss
event in our sample was comparable to the values observed
in other study samples being confronted with an extraordi-
nary traumatic life events, for instance sexual abuse, violence
and assault, or natural disaster (Sundin and Horowitz 2002).
According to Neal et al. (1994), the level of posttraumatic
stress in our sample can be interpreted as ranging between
subclinical and clinical symptoms. The need for specific
treatment after pregnancy loss is unquestioned in the
literature. However, aftercare typically does not involve
therapeutic support and the treatment received is rarely
experienced as satisfying (Geller et al. 2010). Hence, it is
important to provide these young women with specific
treatment options and to lower the utilization threshold.
Within a graded treatment approach, this effective and well-
accepted internet-based approach could be a first-line
treatment option. Our findings suggest that its implementa-
tion would enhance satisfaction with care, prevent longer-
term emotional maladaption to the loss in at least some
women, and lower the threshold for treatment seeking in
those with persistent symptoms.
Another advantage of this internet-based approach is its
geographical and temporal independence, which proved to
be especially important for our target group of young
women after pregnancy loss. In our outpatient clinic, we
experienced that the inhibition threshold for these women
to use regular outpatient psychological services was high.
Because our clinic serves a large region, it proved difficult
Internetbased-therapy after pregnancy loss
for women to make time for regular appointments,
particularly when young children had to be looked after. It
was often difficult to provide these women with decentral-
ized therapeutic support because of lack of specialization or
lack of awareness of the need for psychotherapeutic
support. As acceptance of electronic communication is
high in this age group, internet-based therapy options can
provide geographically and temporally independent and
specific supportand thus lower the treatment utilization
threshold.
Finally, from a methodological perspective, it is a further
strength of this internet-based manualized treatment ap-
proach that the therapeutic input is revisable and closely
connected to the manual.
Limitations
The dropout rate of 24% is higher than reported for
comparable internet-based programs for complicated grief
(8%; Wagner et al. 2006), PTSD (17%, Knaevelsrud and
Maercker 2007), and prevention of complicated grief (20%;
Wagner and Maercker 2008), which must be considered in
terms of generalization of the results. Apart from time since
loss, which was significantly longer for those who dropped
out, no direct relationship was found between dropout and
other characteristics. Based on our clinical experience, we
can speculate that the higher dropout rates may be related to
short-term change in the needs of this group of women.
Women who have lost an unborn child but still want to
have children often experience intense inner conflict
between mourning the loss of the child and going on with
the next pregnancy. This conflict situation may in turn
contribute to this raised dropout rate; however, to the best
of our knowledge, empirical data in support of this
explanation have yet to be published.
The present study design with a waiting list control
group does not allow us to identify the specific mechanisms
underlying the treatment effects observed. It would have
been unethical to deny treatment to those patients originally
randomized to the waiting list for 3 months. Consequently,
there was no control group against which the outcomes of
the treated sample could be compared. Future studies
should test the internet-based cognitive behavioral approach
against a placebo treatment condition or even against face-
to-face cognitive behavioral therapy based on the same
principles. It would also be worth examining which
components of the therapy program (confrontation phase,
restructuring phase, or social sharing phase) contribute
most to the improvement of symptoms.
Although they were explicitly addressed, no men took
part in our study. Thus, we cannot draw any conclusions
about treatment effects in men. Although research has
shown that mens emotional experience of miscarriage
475
differs from women, fathers also experience strong negative
emotional reactions (Puddifoot and Johnson 1997) and
develop various coping strategies after pregnancy loss
(Johnson and Baker 2004). Future research may therefore
benefit from using alternative recruitment methods to enroll
male participants.
Treatment outcomes were assessed exclusively by self-
report instruments delivered via the internet. Structured inter-
views would have increased the validity of these measures and
provided further information on the diagnosis of disorders.
Future research
Future studies should monitor outcomes across a longer
follow-up period. Apart from examining the long-term
stability of symptom improvement, it is important for research
designs to cover anniversary dates of the pregnancy loss or the
estimated delivery date. In our next project phase, we will
therefore collect data 12 months after the end of the treatment.
It would also be valuable for future research to evaluate the
efficacy of this internet-based intervention across different
loss situations: miscarriage, stillbirth, or termination of
pregnancy due to fetal anomalies. Further studies should
identify patients specific needs in these different situations.
Future studies could also benefit from assessing treatment
outcomes other than symptom reduction (e.g., integration of
the loss into the patients life) and from monitoring the therapy
process to evaluate specific treatment process variables.
Our results add to the accumulating body of evidence
demonstrating that internet-based approaches represent an
effective therapeutic option for a variety of psychiatric
disorders. Especially as part of a graded treatment approach,
internet-based interventions offer a low-threshold first-line
treatment. Given the general lack of psychotherapeutic
support in place for women after pregnancy loss, this
internet-based interventionwhich proved to be both effec-
tive and accepted in the present sampleseems a promising
and necessary approach. At the same time, it is important to
enhance awareness of existing services and capacity to cater
for this population.
Acknowledgments We are grateful to all the women who partici-
pated in this study. This project was fully funded by the German
Federal Ministry for Family Affairs, Senior Citizens, Women, and
Youth.
Conflict of interest The authors declare that they have no conflict of
interest.
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