Life Review Therapy for Holocaust Survivors: A study to evaluate the efficacy of a treatment
| ISRCTN | ISRCTN12823306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12823306 |
| Secondary identifying numbers | DFG: FO 308/2-1 |
- Submission date
- 31/03/2018
- Registration date
- 26/04/2018
- Last edited
- 16/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The Holocaust was one of the most traumatic catastrophes ever. Survivors seeking
psychotherapeutic treatment today, now in their seventies and older, show the burden of the past becoming less endurable. They may exhibit a depressed or anxious mood as a result of an underlying posttraumatic stress disorder (PTSD). Established psychological treatments for PTSD (e.g., cognitive behaviour therapy, psychodynamic therapies) have been evaluated mainly with young and middle-aged adults, only very few studies have investigated them in old age. No controlled study exists applying those treatments to the special sample of Holocaust survivors. Moreover, there is a need for an age-specific treatment of PTSD and other stress-related mental disorders. A narrative approach including life-review and narrative exposure seems to meet very well the natural need of older people to review their lives and is highly effective. However, most studies on the efficacy of live review therapy (LRT) focus on late-life depression. There is a lack of efficacy studies evaluating the effect of LRT on PTSD symptoms in older individuals that have experienced traumatic events during their lives.
Thus, the main goal of this study is to evaluate the effect of LRT for Holocaust survivors on
symptoms of PTSD and related mental health problems (depression, anxiety, prolonged grief), compared to a supportive control group. A secondary goal is to identify features of participants who seem to benefit from the intervention.
Who can participate?
Jewish adults that survived the Holocaust, i.e., were born 1945 or earlier in Europe and having experienced persecution, concentration camp, witnessing torture or death, or having to survive in hiding and/or other traumatic events by the Nazi regime during World War II. They must have one or more of the following mental conditions: Post traumatic-stress disorder (PTSD), complex PTSD, depressive disorder, anxiety disorder, prolonged grief disorder.
What does the study involve?
Participants are allocated to one of two groups. Those in the first group receive life-review therapy (LRT), in addition to attending the social club. Those in the second group attend only the social club (control group). The social club at Amcha centers is a meeting place which answers the need to relate to others. It provides activities like films, lectures, courses in art, music, memory improvement, gymnastics, languages (English, Yiddish), visits to interesting places, birthday celebrations, discussions of relevant issues, etc. There are no trauma-focussed interventions in the supportive group. LRT treatment consists of 20 sessions over 6 months. It includes six modules: Introduction and motivation; Structured life review; Narrative exposition; Examining stuck points; Recapturing life; Closing of therapy.
What are the possible benefits and risks of participating?
All participants attend the social club that helps them to relate to others and perform pleasant activities. Participants who are randomized to the LRT group will receive an additional psychotherapy program that aims to reduce symptoms of post-traumatic stress, depression, anxiety, and grief. Participants who are randomized to the control group may receive the same psychotherapy program after the end of this study. By taking part in this study there are no risks of physical injury or harm. Elevated levels of stress may be experienced during some psychotherapy sessions, but this may decrease in the same session.
Where is the study run from?
Amcha (Israel)
When is study starting and how long is it expected to run for?
April 2017 to December 2020 (updated 16/03/2021, previously: March 2021.)
Who is funding the study?
1. German Research Foundation (Germany)
2. Claims Conference (USA)
Who are the main contacts?
1. Simon Forstmeier
simon.forstmeier@uni-siegen.de
2. Elisheva van der Hal-van Raalte
eliavhal@netvision.net.il
Contact information
Scientific
University of Siegen
Faculty II – Dept. of Education Studies & Psychology
Developmental Psychology
Adolf-Reichwein-Str. 2a
Siegen
57068
Germany
 ORCID ID |
0000-0003-0580-1512 |
|---|
Public
AMCHA
23, Hillel Str.
P.O. Box 2930
Jerusalem
91029
Israel
Study information
| Study design | Interventional study design; Randomised controlled trial; one intervention arm (50%), one control arm (50%); single-centred |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | https://www.bildung.uni-siegen.de/mitarbeiter/forstmeier/projekt1.html |
| Scientific title | Life Review Therapy for Holocaust Survivors (LRT-HS): A randomised controlled trial |
| Study acronym | LRT-HS |
| Study objectives | Does the life-review therapy as short-term treatment for Holocaust survivors (in addition to attending the “social club”) reduce the symptoms of PTSD and related mental health problems (depression, anxiety, prolonged grief) more than a supportive control group (attending the “social club” only)? |
| Ethics approval(s) | Ethics committee of the German Association of Psychology (DGPs),11/01/2016, ref: SF_112015 Ethics committee of the Hebrew University of Jerusalem, School of Social Work, 15/05/2017 |
| Health condition(s) or problem(s) studied | Post-traumatic stress disorder (PTSD), depression, anxiety disorder, prolonged grief. At least one of these conditions must be present at study intake, either at syndromal (DSM-5 diagnoses) or subsyndromal level. |
| Intervention | Participants’ symptoms of PTSD, depression, anxiety, and grief are assessed and they are randomised at a 1:1 ratio to either: 1. Life-review therapy, in addition to social club (LRT) 2. Supportive control group, i.e., social club only (control) LRT-HS: includes six modules: Introduction and motivation; Structured life review; Narrative exposition; Examining stuck points; Recapturing life; Closing of therapy. 20 sessions. In addition to attending the social club at Amcha. Control: "Social club" at Amcha centers; is a meeting place which answers the need to relate to others. It provides activities like films, lectures, courses in art, music, memory improvement, gymnastics, languages (English, Yiddish), visits to interesting places, birthday celebrations, discussions of relevant issues, etc. There are no trauma-focussed interventions in the supportive group. Randomization: Block randomization, stratified for number of syndromal vs. subsyndromal diagnoses Outcome variables were assessed at three time points (baseline, end of treatment, follow-up at 6 months after end of treatment). |
| Intervention type | Behavioural |
| Primary outcome measure | Primary endpoints are PTSD and depressive symptoms, assessed at baseline, end of treatment, follow-up at 6 months: 1. PTSD symptoms assessed using PTSD Checklist for DSM-5 (PCL-5) 2. Depressive symptoms assessed using Patient Health Questionnaire (PHQ-9) and Geriatric Depression Scale (GDS) |
| Secondary outcome measures | Secondary outcome measures are assessed at baseline, end of treatment, follow-up at 6 months: 1. Other symptom measures - Complex PTSD symptoms: The complex PTSD part of the ICD-11 Trauma Questionnaire - Anxiety symptoms: The Depression Anxiety Stress Scale-21 (DASS-21) - Grief symptoms: The ICD-11 Symptom-Diagnostic Test for Prolonged Grief Disorder (PG-ICD-11) 2. Process measures - Dysfunctional thoughts: The Posttraumatic Cognitions Inventory (PTCI) - Reminiscence style: The Reminiscence Functions Scale (RFS) - Positive well-being: The Life Satisfaction Index (LSI) - Posttraumatic growth: The Posttraumatic Growth Inventory (PTGI) 3.Furthermore, sociodemographic characteristics (age, gender, educational level) and cognitive status (Mini Mental Status Examination, MMSE) are assessed at baseline. |
| Overall study start date | 01/04/2017 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Being a Holocaust survivor, i.e., born 1945 or earlier in Europe and having experienced persecution, concentration camp, witnessing torture or death, or having to survive in hiding and/or other traumatic events by the Nazi regime during World War II. 2. Diagnosis of one or more of the following conditions: PTSD, complex PTSD, depressive disorder (Major, minor depression), anxiety disorder, prolonged grief disorder. Patients with a subsyndromal form of the mentioned disorders can also be admitted to the study. 3. Participants do not receive any psychotherapy treatment during the time of the study (except for LRT in the intervention condition). 4. Participants must have been informed about the study and must have given written informed consent. This includes that he/she is willing to be randomized to one of the study conditions. |
| Key exclusion criteria | 1. Probable dementia (MMSE < 26), 2. Acute psychotic disorder 3. Acute suicidality |
| Date of first enrolment | 01/12/2017 |
| Date of final enrolment | 31/05/2020 |
Locations
Countries of recruitment
- Israel
Study participating centre
P.O. Box 2930
Jerusalem
91029
Israel
Sponsor information
University/education
Adolf-Reichwein-Str. 2a
Siegen
57068
Germany
| Website | http://www.uni-siegen.de/ |
|---|
Hospital/treatment centre
A Teaching Hospital affiliated with the
Medical School of the
Hebrew University of Jerusalem
Givat Shaul St.
Jerusalem
9103702
Israel
| Website | http://traumaweb.org/our-team/ |
|---|
Other
23, Hillel Str.
P.O. Box 2930
Jerusalem
91029
Israel
| Website | https://www.amcha.org/english |
|---|
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be published in peer-reviewed scientific journals. |
| IPD sharing plan | The datasets generated during and analysed during the current study are/will be available upon reasonable request from Simon Forstmeier (simon.forstmeier@uni-siegen.de). Consent from participants was obtained. The data is anonymous. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/04/2020 | 27/04/2020 | Yes | No |
| Results article | 08/05/2023 | 15/06/2023 | Yes | No |
Editorial Notes
16/06/2023: IPD sharing statement added.
15/06/2023: Publication reference added.
01/02/2022: Contact details updated.
31/01/2022: The intention to publish date has been changed from 31/03/2022 to 31/12/2022.
16/03/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2021 to 31/12/2020.
2. The plain English summary was updated to reflect these changes.
3. The trial website was added.
02/06/2020: The following changes were made to the trial record:
1. Recruitment ended on 31/05/2020
2. The total final enrolment was added.
01/05/2020: Due to current public health guidance, recruitment for this study has been paused.
27/04/2020: Publication reference added.
