Condition category
Mental and Behavioural Disorders
Date applied
31/03/2018
Date assigned
26/04/2018
Last edited
26/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Simon Forstmeier

ORCID ID

http://orcid.org/0000-0003-0580-1512

Contact details

University of Siegen
Faculty II – Dept. of Education Studies & Psychology
Developmental Psychology
Adolf-Reichwein-Str. 2a
Siegen
57068
Germany

Type

Public

Additional contact

Dr Elisheva van der Hal-van Raalte

ORCID ID

Contact details

AMCHA
23
Hillel Str.
P.O. Box 2930
Jerusalem
91029
Israel

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DFG: FO 308/2-1

Study information

Scientific title

Life Review Therapy for Holocaust Survivors (LRT-HS): A randomised controlled trial

Acronym

LRT-HS

Study hypothesis

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

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

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

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/04/2017

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Probable dementia (MMSE < 26),
2. Acute psychotic disorder
3. Acute suicidality

Recruitment start date

01/12/2017

Recruitment end date

31/05/2020

Locations

Countries of recruitment

Israel

Trial participating centre

Amcha
23, Hillel Str. P.O. Box 2930
Jerusalem
91029
Israel

Sponsor information

Organisation

University of Siegen

Sponsor details

Adolf-Reichwein-Str. 2a
Siegen
57068
Germany

Sponsor type

University/education

Website

http://www.uni-siegen.de/

Organisation

Herzog Hospital

Sponsor details

A Teaching Hospital affiliated with the
Medical School of the
Hebrew University of Jerusalem
Givat Shaul St.
Jerusalem
9103702
Israel

Sponsor type

Hospital/treatment centre

Website

http://traumaweb.org/our-team/

Organisation

Amcha

Sponsor details

23
Hillel Str.
P.O. Box 2930
Jerusalem
91029
Israel

Sponsor type

Other

Website

https://www.amcha.org/english

Funders

Funder type

Not defined

Funder name

Deutsche Forschungsgemeinschaft

Alternative name(s)

German Research Foundation, DFG

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Funder name

Claims Conference

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results will be published in peer-reviewed scientific journals.

Intention to publish date

31/03/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes