Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000401550
Ethics application status
Approved
Date submitted
7/09/2006
Date registered
13/09/2006
Date last updated
13/09/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of an Internet-based therapy (Interapy) for posttraumatic stress: a randomized controlled trial
Scientific title
The efficacy of an Internet-based therapy (Interapy) to improve psychopathological symptoms, in people who suffer from post-traumatic stress?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 1367 0
Condition category
Condition code
Mental Health 1460 1460 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10-sessionof 45 minutes (1 week assessment & 5 weeks treatment) cognitive-behavioral internet-based treatment for posttraumatic stress versus wait list control group.

The treatment consisted of three phases: 1) self-confrontation, 2) cognitive reconstruction, and 3) social sharing. In the first phase, patients focused on the most painful images and thoughts and described them in all emotional and sensory detail. The goal of the second phase was to form a new perspective on the traumatic event and to regain a sense of control by challenge dysfunctional automatic thinking and behavior patterns, and correct unrealistic assumptions. During the third phase, patients received psycho-education about the positive effects of social sharing. In a final letter, they then took symbolic leave of the traumatic event. At the beginning of each writing phase, patients proposed individual timetables as to when they planned to write. Halfway through and at the end of each treatment phase, patients received feedback and further writing instructions, which were based on the treatment manual but tailored to patients’ specific needs.
Intervention code [1] 1328 0
Treatment: Other
Comparator / control treatment
Individuals assigned to the waiting-list received the same treatment after being reassessed after a period of 5 weeks waiting.
Control group
Active

Outcomes
Primary outcome [1] 2013 0
Impact of Event Scale (revised) score (posttraumatic stress symptoms)
Timepoint [1] 2013 0
At pre-treatment, post-treatment, 3-month-follow-up and 18-month-follow-up
Secondary outcome [1] 3487 0
1.) Brief symptom inventory: depression
Timepoint [1] 3487 0
Pre-treatment; Post-treatment; 3-month-follow-up; 18-month-follow-up.
Secondary outcome [2] 3488 0
2.) Brief symptom inventory: anxiety
Timepoint [2] 3488 0
Pre-treatment; Post-treatment; 3-month-follow-up; 18-month-follow-up.

Eligibility
Key inclusion criteria
Traumatic event according to the DSM IV (Diagnostic & Statistical Manual of Mental Disorders. The Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association, is a handbook used frequently in diagnosing mental disorders.)- Posttraumatic stress symptoms- fluent in German.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pronounced dissociative tendenicies- risk of psychosis- severely depressed mood- suicidal intentions- substance abuse- currently receiving psychotherapeutic treatment 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 randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 390 0
Switzerland
State/province [1] 390 0

Funding & Sponsors
Funding source category [1] 1598 0
Charities/Societies/Foundations
Name [1] 1598 0
Weisser Ring (German Crime Victim Organization)
Country [1] 1598 0
Germany
Primary sponsor type
Individual
Name
Prof. Dr. Dr. Andreas Maercker, University of Zurich
Address
Country
Switzerland
Secondary sponsor category [1] 1403 0
Individual
Name [1] 1403 0
Dr. Christine Knaevelsrud, Treatment Center for Torture Victims, Berlin
Address [1] 1403 0
Country [1] 1403 0
Germany

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Background: The present study is designed to validate the efficacy of an Internet-based therapy (Interapy) for Posttraumatic Stress Disorder (PTSD) in a German speaking population. Also, the quality of the online therapeutic relationship, its development and its relevance as potential moderator of the treatment effects was investigated.
Method: Ninety-six patients with posttraumatic stress reactions were allocated at random to ten sessions of Internet-based cognitive behavioral therapy (CBT) conducted over a 5-week period or a wait list control group. Severity of PTSD was the primary outcome. Additional measures were depression, anxiety, dissociation and physical health. Follow-up assessments were conducted at the end of treatment and 3 month after treatment.
Results: From baseline to post-treatment assessment, PTSD severity and other psychopathological symptoms were significantly improved for the treatment group (intent-to-treat group x time interaction effect size d= 1.40). Additionally, patients of the treatment condition showed significantly greater reduction in co-morbid depression and anxiety as compared to the wait list condition. These effects were sustained during the 3-month follow-up period. High ratings of the therapeutic alliance and low drop-out rates indicated that a positive and stable therapeutic relationship could be established online. Significant improvement of the online working alliance in the course of treatment and a substantial association between the quality of the online relationship at the end of treatment and treatment outcome emerged.
Conclusion: Interapy proved to be a viable treatment alternative for PTSD with large effect sizes and time stable treatment effects. A stable and positive online therapeutic relationship can be established through the Internet which improved during the treatment process.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27935 0
Address 27935 0
Country 27935 0
Phone 27935 0
Fax 27935 0
Email 27935 0
Contact person for public queries
Name 10517 0
Christine Knaevelsrud
Address 10517 0
Treatment Center for Torture Victims
GSZ Moabit
Turmstr. 21
10559 Berlin
Country 10517 0
Germany
Phone 10517 0
++49 (0)30 - 303 906 23
Fax 10517 0
++49 (0)30 - 306 143 71
Email 10517 0
[email protected]
Contact person for scientific queries
Name 1445 0
Andreas Maercker
Address 1445 0
University of Zürich
Department Psychopathology
Scheuchzerstrasse 21
8006 Zürich
Country 1445 0
Switzerland
Phone 1445 0
++41 (0)44 634 52 20
Fax 1445 0
++41 (0)44 634 52 29
Email 1445 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
No additional documents have been identified.