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Effects of an Internet-based Intervention for Posttraumatic Stress Disorder

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exposure for PTSD with cognitive restructuring
Exposure for PTSD without cognitive restructuring
Sponsored by
Berlin Center for the Treatment of Torture Victims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring posttraumatic stress disorder, internet-based psychotherapy, cognitive restructuring, exposure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Treatment Center for Torture Victims Berlin/Freie Universität Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment of PTSD with cognitive restructuring

Treatment of PTSD without cognitive restructuring

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in anxiety
Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up
Change in depression
Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up
Change in quality of life
Change in EUROHIS-QOL from baseline to post-treatment and from post-treatment to 3-months-follow-up

Full Information

First Posted
December 22, 2011
Last Updated
January 30, 2016
Sponsor
Berlin Center for the Treatment of Torture Victims
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1. Study Identification

Unique Protocol Identification Number
NCT01508377
Brief Title
Effects of an Internet-based Intervention for Posttraumatic Stress Disorder
Official Title
Additive Effect of Cognitive Restructuring in a Web-based Treatment for Traumatized Arab People
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Berlin Center for the Treatment of Torture Victims

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: 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 PTSD in Arabic-speaking countries. Method: Traumatized Arabic-speaking participants are allocated at random to a long version (10 sessions) of a manualized writing approach over 6 weeks or to a short version, where the part concerning the cognitive restructuring is excluded. The investigators expect the treatment to be useful for traumatized clients, especially for those who have no access to psychological help otherwise and they 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. Additionally the investigators are interested, if the short form where the cognitive part is excluded and the focus will be more on confrontation is effective similarly. Conclusion: If the interventions prove to be an effective treatment for PTSD in Arabic-speaking countries, the results will lend to support to the establishment of internet-based approaches, especially in countries, where face-to-face therapy cannot be provided. Furthermore a shorter treatment could improve the compliance of the participants, particularly in post-conflict regions where people cannot attend long therapeutic interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
posttraumatic stress disorder, internet-based psychotherapy, cognitive restructuring, exposure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment of PTSD with cognitive restructuring
Arm Type
Experimental
Arm Description
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)
Arm Title
Treatment of PTSD without cognitive restructuring
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Exposure for PTSD with cognitive restructuring
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure for PTSD without cognitive restructuring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in posttraumatic stress
Description
Change in Posttraumatic Stress Diagnostic Scale from baseline to post-treatment and 3-months-follow-up
Time Frame
baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Secondary Outcome Measure Information:
Title
Change in anxiety
Description
Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up
Time Frame
baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Title
Change in depression
Description
Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up
Time Frame
baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Title
Change in quality of life
Description
Change in EUROHIS-QOL from baseline to post-treatment and from post-treatment to 3-months-follow-up
Time Frame
baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: traumatic experience must suffer from posttraumatic stress must be fluent in written Arabic must have access to the Internet during the treatment Exclusion Criteria: suicidal intentions substance abuse psychotic experience dissociation currently receiving psychotherapy elsewhere pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Knaevelsrud, PhD
Organizational Affiliation
Freie Universität Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
Treatment Center for Torture Victims Berlin/Freie Universität Berlin
City
Berlin
ZIP/Postal Code
10559
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34345377
Citation
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.
Results Reference
derived
Links:
URL
http://ilajnafsy.bzfo.de
Description
Treatment web-page

Learn more about this trial

Effects of an Internet-based Intervention for Posttraumatic Stress Disorder

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