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Article history:
Received 26 March 2014
Received in revised form
20 May 2014
Accepted 22 May 2014
Available online 2 June 2014
Background: Abnormal forms of grief, currently referred to as complicated grief or prolonged grief
disorder, have been discussed extensively in recent years. While the diagnostic criteria are still debated,
there is no doubt that prolonged grief is disabling and may require treatment. To date, few interventions
have demonstrated efcacy.
Methods: We investigated whether outpatients suffering from prolonged grief disorder (PGD) benet
from a newly developed integrative cognitive behavioural therapy for prolonged grief (PG-CBT). A total of
51 patients were randomized into two groups, stratied by the type of death and their relationship to the
deceased; 24 patients composed the treatment group and 27 patients composed the wait list control
group (WG). Treatment consisted of 2025 sessions. Main outcome was change in grief severity;
secondary outcomes were reductions in general psychological distress and in comorbidity.
Results: Patients on average had 2.5 comorbid diagnoses in addition to PGD. Between group effect sizes
were large for the improvement of grief symptoms in treatment completers (Cohen's d1.61) and in the
intent-to-treat analysis (d 1.32). Comorbid depressive symptoms also improved in PG-CBT compared to
WG. The completion rate was 79% in PG-CBT and 89% in WG.
Limitations: The major limitations of this study were a small sample size and that PG-CBT took longer
than the waiting time.
Conclusions: PG-CBT was found to be effective with an acceptable dropout rate. Given the number of
bereaved people who suffer from PGD, the results are of high clinical relevance.
& 2014 Elsevier B.V. All rights reserved.
Keywords:
Bereavement
Prolonged grief disorder
Complicated grief
Persistent complex bereavement-related
disorder
Randomized controlled trial
Psychotherapy
1. Introduction
Prolonged grief disorder is being proposed as part of the stress
related disorders category in the ICD-11; in the DSM-5, persistent
complex bereavement disorder is classied as a condition for
further study (American Psychiatric Association, 2013). Despite
this discrepancy, many papers on severely impairing forms of
abnormal grief have been published in the last few decades. The
term complicated grief was coined by Horowitz and his colleagues (Horowitz et al., 1997; Prigerson et al., 1995), while traumatic grief was used by Prigerson and her colleagues (Jacobs,
1999; Prigerson et al., 1997; Shear et al., 2001). As the concepts
evolved, the criteria and denitions for grief varied (for an overview and a comparison of the terminology, see Shear et al. (2011)).
However, core symptoms overlap between denitions: for example, intense yearning and preoccupation with the loss, reactive
n
Corresponding author at: Catholic University Eichstaett-Ingolstadt, Ostenstr. 25,
D-85071 Eichsttt, Germany. Tel.: 49 8421 93 1581; fax: 49 8421 93 2033.
E-mail address: rita.rosner@ku.de (R. Rosner).
1
MK and MH are no longer afliated with the Ludwig-Maximilian-University
http://dx.doi.org/10.1016/j.jad.2014.05.035
0165-0327/& 2014 Elsevier B.V. All rights reserved.
57
2. Methods
2.1. Procedure
The study was approved by the university's ethics committee
and has been registered with Clinical Trials (Identier:
NCT01433653). Pilot patients were seen in 2005. Randomization
began in October 2006. The last patient nished therapy in June
2011. The study design is a stratied randomized controlled trial.
We stratied our sample according to the patient's relationship to
the deceased, namely, a child or other form of kinship, and
according to the type of death, namely, a natural or non-natural
death. A stratied randomization list was electronically produced
and provided by the university's Department of Statistics; then it
was transferred into four groups of envelopes (according to type of
death type of kinship) that contained group allocation. Allocation was not disclosed to patients or project workers before the
end of baseline assessment.
The control condition was a wait list. The waiting period was
set at four months or longer. This shortest possible waiting period
of four months was chosen for ethical reasons to avoid unnecessary suffering on the patients' part as well as for practical purposes
to ensure treatment adherence. Once a month during the waiting
period, patients met with the diagnostician, who had assessed the
patients' baseline, for ethical and safety reasons. These interim
sessions did not include any treatment; rather, these sessions
consisted of informal safety check-ups, such as inquiring about
possible intentions of self-injurious behaviour or suicidal ideations. None of the participants had to be excluded from wait list
because of respective clinical reasons. Treatment was offered as
soon as a therapist was available, but not before the minimum
waiting period of four months. On average, patients in the wait list
control group were re-assessed by their respective diagnostician
after six months of waiting (M 6.04; SD 1.36). Patients in the
treatment group were assessed at baseline by a diagnostician,
while later assessment was conducted by their respective therapist. During the treatment, but not during the wait list period,
symptom questionnaires (PG-13 and SCL-90-R, see Measures
section below) were administered three times (along with additional process measures): (1) between sessions 5 and 7,
58
Excluded (n = 56)
Not meeting inclusion criteria (n = 36)
- No PGD diagnosis (n = 27)
- Insufficient language skills (n = 3)
- Currently in psychotherapy (n = 2)
- Acute substance dependence (n = 3)
- Acute psychosis (n = 1)
Declined to participate (n = 20)
Enrollment
Allocation
Allocated to PG-CBT (n = 24)
Started treatment (n = 22)
Post-treatment
assessment
Lost to post assessment (n = 1)
Analysis
Analyzed in ITT sample (n = 24)
Excluded from ITT-analysis (n = 0)
Fig. 1. Participant ow. Note. PG-CBT integrative cognitive behavioural therapy for prolonged grief; ITT intent-to-treat.
59
3. Results
3.1. Completion and baseline differences
Three out of the 27 participants dropped out of WG (11%)
immediately after allocation; another participant completed the
waiting time, but parts of the data at post-treatment assessment
are missing. Five out of the 24 allocated participants in PG-CBT
dropped out during treatment (21%): two did not start treatment,
60
Table 1
Demographic and clinical characteristics of the intent-to-treat sample.
Total sample
(N 51)
Female gender
Age in years, M (SD)
44 (86%)
47.53 (14.72)
PG-CBT
(n 24)
20 (83%)
43.0 (13.0)
Table 2
Intent-to-treat analyses: means (SD) at pre- and post-treatment for PG-CBT (n 24)
and wait list (n 27), controlled comparison.
WG
(n27)
24 (89%)
51.56
(15.22)
Marital status
Single
Married/partnered
Divorced/separated
Widowed
17 (33%)
17 (33%)
7 (14%)
10 (20%)
10 (42%)
8 (33%)
4 (17%)
2 (8%)
7 (26%)
9 (33%)
3 (11%)
8 (30%)
15 (29%)
36 (71%)
7 (29%)
17 (71%)
8 (30%)
19 (70%)
31 (61%)
20 (39%)
4.93 (7.08)
17 (71%)
7 (29%)
7.10 (9.43)
14 (52%)
13 (48%)
3.01
(3.10)
Type of death
Natural
Non-natural
Years since loss, M (SD)
Comorbid disorders a
At least one other disorder
Number of comorbid disorders,
M (SD)
Major depressive disorder
Posttraumatic stress disorder
Generalized anxiety disorder
Panic disorder
Somatoform disorders
86%
2.52 (1.73)
31 (62%)
11 (22%)
7 (14%)
12 (24%)
27 (54%)
83%
2.54 (1.89)
15
6
5
8
12
(62%)
(25%)
(21%)
(33%)
(50%)
88%
2.50
(1.61)
16 (62%)
5 (19%)
2 (8%)
4 (15%)
15 (58%)
Note. Comorbid disorders are 12-months prevalences. PG-CBT Integrative cognitive behavioural therapy for prolonged grief; WG wait list group;
a
n 50 in the total sample and n 26 in WG (one person in WG was not
assessed formally for comorbid disorders).
one completed only one session, and two dropped out after seven
respectively nine sessions. Two patients did not complete posttreatment assessment, but were still considered completers: one
patient nished after 18 treatment sessions, and the other completed the full 25 sessions. Of the other treatment completers, one
patient nished after 22 sessions, and one nished after 24; all
others received 25 sessions. Therefore, on average, treatment
completers received 24.42 sessions (SD 1.71). Treatment completers and drop-outs were compared on all variables reported in
Table 1 as well as on the baseline data of the PG-13 and SCL-90-R.
The 19 completers and 5 drop-outs differed in only one variable;
much more time had passed between the loss and study intake in
completers (M8.67 years, SD 10.06) than in drop outs (M 1.17
years; SD 0.85), t(18.93) 3.21, p 0.005 (unequal variances
assumed). However, this might have been due to a large range in
completers (6 months to 36 years vs. 6 months to 2.5 years in
drop outs).
Concerning outcome measures there were no differences in
baseline scores according to group neither in the original ITT
sample nor the completer sample.
3.2. Main outcomes
For the ITT analysis, the univariate ANCOVA yielded a signicant and large effect (d 1.32) of PG-CBT in comparison with WG
on the primary outcome measure, grief assessed with the PG-13
(see Table 2). The same is true for the completer analysis (d 1.61,
see Table 3). In addition to the results provided in Tables 2 and 3,
we computed simple pre- to post-treatment comparisons. In PGCBT, results were highly signicant and showed large effects,
t(23) 5.22, p o0.001, d 1.26, for the ITT analysis and t(18)
6.35, p o0.001, d 1.65, for the completer analysis. PG-13 scores in
WG did not change signicantly, t(26) 0.65, p 0.520, d 0.10, for
PG-13
Pre
Post
PG-CBT
WG
Group time
Between
group ES
M (SD)
M (SD))
23.60
0.33
1.32
2.84
0.06
0.33
0.23
0.01
0.09
7.79nn
0.14
0.73
1.32
0.03
0.23
1.43
0.03
0.46
nnn
41.17 (5.75)
30.71 (10.19)
42.63 (5.05)
42.07 (6.58)
SCL-90-R
Global severity
index
Pre
Post
1.24 (0.60)
0.86 (0.58)
1.23 (0.77)
1.08 (0.75)
Somatization
Pre
Post
1.26 (0.75)
0.93 (0.73)
1.24 (0.97)
1.00 (0.86)
Depression
Pre
Post
1.68 (0.85)
1.18 (0.76)
1.89 (0.85)
1.78 (0.88)
Anxiety
Pre
Post
1.16 (0.69)
0.78 (0.77)
1.15 (1.00)
0.96 (0.78)
Phobic anxiety
Pre
Post
0.65 (0.70)
0.39 (0.52)
0.91 (0.96)
0.75 (0.97)
p o 0.01.
po 0.001.
nnn
the ITT analysis and t(22) 0.65, p 0.522, d 0.12, for the completer analysis.
61
Table 3
Completer analyses: Means (SD) at pre- and post-treatment for PG-CBT (n 19) and
waitlist (n 23), controlled comparison.
PG-13
Pre
Post
SCL-90-R
PG-CBT
WG
M (SD)
M (SD)
0.47
1.61
3.63
0.09
0.33
0.42
0.01
0.13
7.44nn
0.16
0.60
1.26
0.03
0.29
1.06
0.03
0.33
34.03
41.21 (6.03)
28.05 (9.51)
nnn
41.78 (4.63)
41.13 (6.42)
Global
severity
index
Pre
Post
1.28 (0.64)
0.85 (0.63)
1.21 (0.81)
1.08 (0.75)
Somatization
Pre
Post
1.32 (0.74)
0.90 (0.71)
1.29 (1.02)
1.01 (0.91)
Depression
Pre
Post
1.74 (0.89)
1.15 (0.84)
1.80 (0.83)
1.66 (0.86)
Anxiety
Pre
Post
1.16 (0.71)
0.76 (0.79)
1.21 (1.02)
0.99 (0.78)
Phobic
anxiety
Pre
Post
0.76 (0.75)
0.44 (0.58)
0.91 (0.99)
0.71 (0.99)
4. Discussion
The present ndings suggest that our treatment for PGD is
highly effective in terms of reducing grief severity. The controlled
ES for grief symptom improvement in PG-CBT completers is
d 1.61; compared with the ES values reported in meta-analyses
62
for an average of six months. Therefore, one could argue that the
PG-CBT completers improved signicantly more than waiting list
participants only because they had more time to improve. However, given the rather long duration of time since loss, and
therefore the chronicity of their symptoms, such an argument
seems rather unlikely. Second, post-treatment assessment was not
blinded; for practical reasons, it was performed by the respective
therapist. Finally, we computed no power analysis in advance and
the sample size was small; furthermore only a few male patients
were treated. Therefore, these results should be regarded as being
preliminary.
4.2. Clinical implications and conclusions
We reported on a broader range of comorbid diagnoses than in
previous treatment trials; our results show that PGD patients have
a high degree of comorbidity. Although results on comorbidity are
not directly comparable between studies because the diagnostic
procedures varied, studies performed to date appear to show a
high comorbidity with depression and anxiety disorders as well as
with PTSD; for the latter diagnosis, we found a markedly lower
prevalence than Shear et al. (2005). In our study, somatoform
disorders were surprisingly prevalent. Somatization symptoms
should be assessed in future studies.
PG-CBT showed less pronounced improvement in comorbid
symptoms than the treatments in the study by Boelen et al.
(2007); this may be due to specic sample characteristics, such
as other comorbidity patterns. However, PG-CBT proved to be as
effective as other treatments in the designated target syndrome,
prolonged grief. Together with the results of Rosner et al. (2011b),
where this approach was evaluated in a very different setting
(group format with inpatients), these ndings are encouraging
enough to warrant further study. On a broader scope, this trial
once again showed that PGD is a useful diagnostic entity that can
be specically targeted, supporting the validity of PGD. Consequently, our results suggest that it is useful to screen for PGD and
provide a specic grief treatment protocol in clinical settings
where patients are admitted for various disorders.
Role of funding source
The actual therapy hours were compensated through the health insurance
system. The study itself has not been funded.
Conict of interest
None of the authors has any conict of interest.
Acknowledgement
None.
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