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Trial registered on ANZCTR

Registration number

ACTRN12608000259347

Ethics application status

Approved

Date submitted

15/05/2008

Date registered

22/05/2008

Date last updated

14/10/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of a cognitive-behavioral writing therapy (Integrative testimonial therapy –ITT) of traumatised war children of the II. World War: A randomized trial

Scientific title

The efficacy of Integrative Testimonial Therapy for traumatised war children of the II. World War suffering from PTSD

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Quality of life

Post Traumatic Stress Disorder (PTSD)

posttraumatic growth

self-efficacy

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The treatment manual consists of 11 writing sessions of 45 minutes within 6 weeks. During a first diagnostic phase, an overview about the psychological and physical health status of the patient is provided.
The treatment manual includes 3 components. The first component includes the reconstruction of the biography of the patient (7 writing sessions). In each session the patient is urged to describe a defined period of his/her life, therefore a consistent biography is generated at the end of the therapy.
2 writing sessions concerning the traumatic event of the patient during the II. WW or right after it are combined with the biographic component. In these 2 writing sessions the patient is requested to write about the trauma in detail.
This narrative exposition allows the patient to integrate the fragmented memories into a more consistent biography.
During the last component of the treatment (cognitive reappraisal, 2 writing sessions) the patient should write down his/her point of view on the traumatic experience and his/her life from the current perspective.
The communication between patient and therapist takes place via internet or letter.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Individuals assigned to the waiting-list receive the same treatment after being reassessed after a period of 6 weeks.

Control group

Active

Outcomes

Primary outcome [1]

Posttraumatic stress scale (PDS)

Timepoint [1]

At pre-treatment, post-treatment, 3-months-follow-up, 6 months-follow-up, 12 months-follow-up

Secondary outcome [1]

Depression - Brief Symptom Inventory (BSI)

Timepoint [1]

At pre-treatment, post-treatment, 3-months-follow-up, 6 months-follow-up, 12 months-follow-up

Secondary outcome [2]

Quality of Life - EUROHIS-Quality of Life 8-item index (EUROHIS-QOL)

Timepoint [2]

At pre-treatment, post-treatment, 3-months-follow-up, 6 months-follow-up, 12 months-follow-up

Secondary outcome [3]

Anxiety - Brief Symptom Inventory (BSI)

Timepoint [3]

At pre-treatment, post-treatment, 3-months-follow-up, 6 months-follow-up, 12 months-follow-up

Secondary outcome [4]

Post traumatic growth Inventory(PTGI)

Timepoint [4]

pre, post, 3,6, 12-month follow up

Secondary outcome [5]

self-efficacy

Timepoint [5]

pre, post, 3,6, 12 month follow up

Secondary outcome [6]

Locus of control

Timepoint [6]

pre, post, 3,6, 12 months follow up

Eligibility

Key inclusion criteria

Traumatic experience during the II. WW, born during 1920 and 1946, civil victim of war, speaking German

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Significant cognitive impairement, suicidal intentions, substance abuse, physical disorders which complicate a participation, psychotic experiences, currently receiving psychotherapy elsewhere

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

central randomized by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

simple randomization by computer

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2008

Actual

7/05/2008

Date of last participant enrolment

Anticipated

Actual

4/03/2013

Date of last data collection

Anticipated

Actual

12/06/2014

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

Germany

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

catania gGmbH

Address [1]

Turmstrasse 21
10559 Berlin

Country [1]

Germany

Primary sponsor type

Individual

Name

Christine Knaevelsrud

Address

Treatment Center for Torture Victims
GSZ Moabit
Turmstraße 21
10559 Berlin

Country

Germany

Secondary sponsor category [1]

Individual

Name [1]

Philipp Kuwert

Address [1]

Clinic for Psychiatry and Psychotherapy University of Greifswald
Rostocker Chaussee 70
18437 Stralsund

Country [1]

Germany

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ernst-Moritz-Arndt-University Greifswald

Ethics committee address [1]

Ethics committee country [1]

Germany

Date submitted for ethics approval [1]

Approval date [1]

25/03/2008

Ethics approval number [1]

Summary

Brief summary

Background:
Recent studies of the consequences of former childhood war trauma in older adults reveal associations between trauma and posttraumatic symptoms (Posttraumatic stress disorder, PTSD) as well as physical health.
Only a few case studies have been reported on the efficacy of interventions adressing PTSD in older adults experiencing trauma in their childhood. The present study aims to examine the efficacy of a newly developed therapeutic cognitive-behavioral writing therapy (ITT) for traumatised war children of the II. WW.

Method: 
Traumatised former war children (65 years+) with (subtreshold) PTSD are allocated at random to 11 writing sessions of a manualized writing approach over 6 weeks or a waiting list control group. We expect ITT to be useful for childhood traumatised older adults with current PTSD symptoms. We hypothesize that the intervention will significantly improve clinical symptoms of PTSD. Furthermore, we expect improvements in secondary outcomes such as anxiety, depression and quality of life.

Conclusion:
If ITT proves to be an effective treatment for PTSD in former war children, our results will lend to support to the establishment of ITT in this group of patients. This study could make a contribution towards savings in health expenditure as it may provide the basis for a selective and directed use of psychotherapeutic interventions in a population that make enormous use of the health service.

Trial website

Trial related presentations / publications

Böttche, M., Pietrzak, R. H., Kuwert, P. & Knaevelsrud, C. (2015). Typologies of posttraumatic stress disorder in treatment-seeking older adults. International Psychogeriatrics.

Böttche, M., Kuwert, P., Pietrzak, R. H., & Knaevelsrud, C. (2015). Predictors of outcome of an Internet-based cognitive-behavioral therapy for posttraumatic stress disorder in older adults. Psychology and Psychtherapy: Theory, Research and Practice, DOI: 10.1111/papt.12069.

Knaevelsrud, C., Böttche, M., Pietrzak, R. H., Freyberger, H. J., Renneberg, B. & Kuwert, P. (2014) Integrative Testimonial Therapy (ITT) - a therapist-assisted internet-based writing therapy for traumatized child survivors of the 2nd World War with posttraumatic stress. Journal of Nervous and Mental Disease, 202(9), 651-658

Böttche, M., Berth, H., Knaevelsrud, C. & Kuwert, P. (2014). Affektverläufe in einer internetbasierten Schreibtherapie für ältere Kriegstraumatisierte. Zeitschrift für Gerontologie und Geriatrie, 47, 214-220.

Public notes

Contacts

Principal investigator

Name

Prof Christine Knaevelsrud

Address

Habelschwerdter Allee 45
14195 Berlin

Country

Germany

Phone

0049 (0)30 838 55736

Fax

Christine.knaevelsrud@fu-berlin.de

Contact person for public queries

Name

Maria Böttche

Address

Treatment Center for Torture Victims
GSZ Moabit
Turmstrasse 21
10559 Berlin

Country

Germany

Phone

+49 (0)30 303 906 23

Fax

+49 (0)30 303 906 71

m.boettche@bzfo.de

Contact person for scientific queries

Name

Dr. Christine Knaevelsrud

Address

Freie Universität Berlin,
Habelschwerdter Allee, 45
14195 Berlin

Country

Germany

Phone

0049 (0)30 838 55736

Fax

+49 (030) 838-458472

Christine.knaevelsrud@fu-berlin.de

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy and Feasibility of a Therapist-Guided Internet-Based Intervention for Older Persons with Childhood Traumatization: A Randomized Controlled Trial.	2017	https://dx.doi.org/10.1016/j.jagp.2017.02.024

N.B. These documents automatically identified may not have been verified by the study sponsor.

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