NCT01508377

Brief Summary

For several years now, a very successful treatment of posttraumatic stress disorders has been offered in the Netherlands and in Germany. The contact between clients and therapists takes place exclusively via Internet. The therapists follow a scientifically tested treatment protocol, that defines fixed treatment elements that are adapted to the specific situation of the client. The participants can write at home, in their familiar environment which makes it easier to work on trauma related issues with their therapist. In the last years the treatment was offered in Arabic as well indicating to be an effective treatment for Posttraumatic Stress Disorder (PTSD) in Arabic-speaking countries. The treatment lasts five weeks. During that time-frame, participants write several texts. The participants decide when they want to write. Each time after having received two texts, the therapists provide feedback and further instructions. The therapists are all trained psychologists, who have received additional training in the interpretation of texts and for the application of the treatment protocol. The investigators hypothesize that both interventions will significantly improve clinical symptoms of PTSD. Furthermore, the investigators expect improvements in secondary outcomes such as anxiety, depression and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

4 years

First QC Date

December 22, 2011

Last Update Submit

January 30, 2016

Conditions

Keywords

posttraumatic stress disorderinternet-based psychotherapycognitive restructuringexposure

Outcome Measures

Primary Outcomes (1)

  • Change in posttraumatic stress

    Change in Posttraumatic Stress Diagnostic Scale from baseline to post-treatment and 3-months-follow-up

    baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

Secondary Outcomes (3)

  • Change in anxiety

    baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

  • Change in depression

    baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

  • Change in quality of life

    baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

Study Arms (2)

Treatment of PTSD with cognitive restructuring

EXPERIMENTAL

In this arm the PTSD treatment can be divided into three phases. First phase: self-confrontation (4 essays) Second phase: cognitive restructuring (4 essays) Third phase: parting (2 essays)

Behavioral: Exposure for PTSD with cognitive restructuring

Treatment of PTSD without cognitive restructuring

EXPERIMENTAL

In this arm the PTSD treatment can be divided into only two phases. Compared to the other arm the phase dealing with cognitive restructuring is excluded. First phase: self-confrontation (4 essays) Second phase: parting (2 essays)

Behavioral: Exposure for PTSD without cognitive restructuring

Interventions

The treatment lasts five weeks. During that time-frame, participants write ten texts for 45 minutes, twice a week. Each time after having received two texts, the therapists provide feedback and further instructions, which are based upon the manual (Lange et al., 2003) The long version of the PTSD treatment (including cognitive restructuring) can be divided into three phases. First phase - self-confrontation (4 essays) At the beginning the participants receive psychoeducation about the mechanisms of exposure before writing four essays about their emotionally most painful memories. Second phase - cognitive restructuring (4 essays) Again the participants write four texts, however, this time they go beyond mere descriptions and use their experiences to write a supportive letter to an imaginary friend who had been through the same experience. Third phase - parting (2 essays) In the third phase, two texts are written in the form of a letter to document the past in a worthy document.

Treatment of PTSD with cognitive restructuring

The treatment lasts five weeks. During that time-frame, participants write ten texts for approximately 45 minutes, twice a week. Each time after having received two texts, the therapists provide feedback and further instructions, which are based upon the manual (Lange et al., 2003). The short version of the PTSD treatment can be divided into only two phases. Compared to the long version the phase dealing with cognitive restructuring is excluded. First phase - self-confrontation (4 essays) At the beginning the participants receive psychoeducation about the mechanisms of exposure before writing four essays about their emotionally most painful memories. Third phase - parting (2 essays) In the third phase, two texts are written in the form of a letter to document the past in a worthy document.

Treatment of PTSD without cognitive restructuring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • traumatic experience
  • must suffer from posttraumatic stress
  • must be fluent in written Arabic
  • must have access to the Internet during the treatment

You may not qualify if:

  • suicidal intentions
  • substance abuse
  • psychotic experience
  • dissociation
  • currently receiving psychotherapy elsewhere
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment Center for Torture Victims Berlin/Freie Universität Berlin

Berlin, 10559, Germany

Location

Related Publications (1)

  • Bottche M, Wagner B, Vohringer M, Heinrich M, Stein J, Selmo P, Stammel N, Knaevelsrud C. Is only one cognitive technique also effective? Results from a randomized controlled trial of two different versions of an internet-based cognitive behavioural intervention for post-traumatic stress disorder in Arabic-speaking countries. Eur J Psychotraumatol. 2021 Jul 15;12(1):1943870. doi: 10.1080/20008198.2021.1943870. eCollection 2021.

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Christine Knaevelsrud, PhD

    Freie Universität Berlin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 22, 2011

First Posted

January 12, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 2, 2016

Record last verified: 2016-01

Locations