Trial Review

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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] 290337 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 3153 0
Depression 3158 0
Quality of life 3159 0
Post Traumatic Stress Disorder (PTSD) 3164 0
posttraumatic growth 300608 0
self-efficacy 300609 0
Condition category
Condition code
Mental Health 3319 3319 0 0
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] 2893 0
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] 4208 0
Posttraumatic stress scale (PDS)
Timepoint [1] 4208 0
At pre-treatment, post-treatment, 3-months-follow-up, 6 months-follow-up, 12 months-follow-up
Secondary outcome [1] 7101 0
Depression - Brief Symptom Inventory (BSI)
Timepoint [1] 7101 0
At pre-treatment, post-treatment, 3-months-follow-up, 6 months-follow-up, 12 months-follow-up
Secondary outcome [2] 7120 0
Quality of Life - EUROHIS-Quality of Life 8-item index (EUROHIS-QOL)
Timepoint [2] 7120 0
At pre-treatment, post-treatment, 3-months-follow-up, 6 months-follow-up, 12 months-follow-up
Secondary outcome [3] 7122 0
Anxiety - Brief Symptom Inventory (BSI)
Timepoint [3] 7122 0
At pre-treatment, post-treatment, 3-months-follow-up, 6 months-follow-up, 12 months-follow-up
Secondary outcome [4] 328412 0
Post traumatic growth Inventory(PTGI)
Timepoint [4] 328412 0
pre, post, 3,6, 12-month follow up
Secondary outcome [5] 328413 0
self-efficacy
Timepoint [5] 328413 0
pre, post, 3,6, 12 month follow up
Secondary outcome [6] 328414 0
Locus of control
Timepoint [6] 328414 0
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?
No
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
97
Recruitment outside Australia
Country [1] 967 0
Germany
State/province [1] 967 0

Funding & Sponsors
Funding source category [1] 3391 0
Charities/Societies/Foundations
Name [1] 3391 0
catania gGmbH
Country [1] 3391 0
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] 3036 0
Individual
Name [1] 3036 0
Philipp Kuwert
Address [1] 3036 0
Clinic for Psychiatry and Psychotherapy University of Greifswald
Rostocker Chaussee 70
18437 Stralsund
Country [1] 3036 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5423 0
Ernst-Moritz-Arndt-University Greifswald
Ethics committee address [1] 5423 0
Ethics committee country [1] 5423 0
Germany
Date submitted for ethics approval [1] 5423 0
Approval date [1] 5423 0
25/03/2008
Ethics approval number [1] 5423 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28590 0
Prof Christine Knaevelsrud
Address 28590 0
Habelschwerdter Allee 45
14195 Berlin
Country 28590 0
Germany
Phone 28590 0
0049 (0)30 838 55736
Fax 28590 0
Email 28590 0
[email protected]
Contact person for public queries
Name 11747 0
Maria Böttche
Address 11747 0
Treatment Center for Torture Victims
GSZ Moabit
Turmstrasse 21
10559 Berlin
Country 11747 0
Germany
Phone 11747 0
+49 (0)30 303 906 23
Fax 11747 0
+49 (0)30 303 906 71
Email 11747 0
[email protected]
Contact person for scientific queries
Name 2675 0
Dr. Christine Knaevelsrud
Address 2675 0
Freie Universität Berlin,
Habelschwerdter Allee, 45
14195 Berlin
Country 2675 0
Germany
Phone 2675 0
0049 (0)30 838 55736
Fax 2675 0
+49 (030) 838-458472
Email 2675 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEfficacy and Feasibility of a Therapist-Guided Internet-Based Intervention for Older Persons with Childhood Traumatization: A Randomized Controlled Trial.2017https://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.