We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001019998
Ethics application status
Approved
Date submitted
20/09/2011
Date registered
22/09/2011
Date last updated
2/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an Internet-based treatment of posttraumatic stress disorders (PTSD) and depression in Arabic-speaking countries: A randomized control trial
Scientific title
Internet-based writing therapy to reduce posttraumatic stress and depression symptoms in Arabic-speaking clients
Secondary ID [1] 263072 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder (PTSD) 270809 0
Depression 270810 0
Condition category
Condition code
Mental Health 271000 271000 0 0
Anxiety
Mental Health 271001 271001 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
According to their symptoms, the participants will be assigned to the treatment of posttraumatic stress or depression after the screening.

Treatment of Posttraumatic stress disorders:
The treatment lasts five weeks. During that time-frame, participants write ten texts for approximately 45 minutes, twice a week (10 essays in total), whereas the participants decide when they want to write. Each time after having received two texts, the therapists provide feedback and further instructions, which are based upon the manual (compare to "Interapy" developed by Lange et al., 2003) and consider the patient´s specific needs. It is important to mention that all communication during the treatment occurs exclusively via E-mails. Before and after treatment (as well as 3 and 12 months later) the participants are asked to complete any questionnaires to gather information about health-related issues and individual well-being.

The treatment of posttraumatic sress disorder 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. In the meantime they receive feedback and support by their individual therapists.

Second phase – cognitive restructuring (4 essays)
First of all there is again psychoeducation about the principles of cognitive restructuring. Again the particpants 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. Thus, the victim turns into an adviser.

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. Psychoeducation about the positive effects of social sharing is provided as well.

Treatment of Depression:
The treatment lasts six weeks and can be compared to the PTSD-Treatment concerning the basic conditions. The participants write as well texts for approximately 45 minutes, twice a week (11 essays in total), whereas the participants decide when they want to write. Each time after having received two texts, the therapists provide feedback and further instructions, which are based upon the manual (compare to "Interapy" developed by Lange et al., 2003) and consider the patient´s specific needs. It is important to mention that all communication during the treatment occurs exclusively via E-mails. Before and after treatment (as well as 3 and 12 months later) the participants are asked to complete any questionnaires to gather information about health-related issues and individual well-being.

The treatment of depression can be divided into five steps:

First of all the participants are asked whether there are special situations that cause depressive symptoms in particular and if there are any factors promoting them (step 1: behavior analysis; 3 essays). Afterwards there should be established a new daily structure, especially by planning positive activities (step 2: building up positive activities; 2 essays including homework).
Furthermore depressive clients frequently suffering from negative thoughts and in the next step they are asked to evaluate things in a different way (step 3: cognitive restructuring; 3 essays). In addition to that the treatment focusses on social interaction (step 4; 2 essays including homework and exercises). Because depressive clients have difficulty establishing new contacts, setting limits or saying "no", the participants are asked to do any homework and practice these things. At the end the focus will be on the main results of the treatment, what the clients have learned and how to use this to prevent depression prospectively (step 5: relapse prevention; 1 essay). Psychoeducation is also provided during the whole treatment.
Intervention code [1] 269423 0
Treatment: Other
Comparator / control treatment
Individuals assigned to the waiting list receive the same treatment after being reassessed after a period of six weeks.
Control group
Active

Outcomes
Primary outcome [1] 279664 0
Posttraumatic stress scale (PDS)
Timepoint [1] 279664 0
At pre-treatment, post-treatment, 3-months-follow-up, 12-months-follow-up
Primary outcome [2] 279665 0
Beck Depression Inventory (BDI)
Timepoint [2] 279665 0
At pre-treatment, post-treatment, 3-months-follow-up, 12-months-follow-up
Secondary outcome [1] 294153 0
Anxiety and Depression - Hopkins Symptom Checkliste-25 (HSCL-25)
Timepoint [1] 294153 0
At pre-treatment, post-treatment, 3-months-follow-up, 12-months-follow-up
Secondary outcome [2] 294154 0
Somatisation - Self Report Symptom Inventory (SCL-90-R)
Timepoint [2] 294154 0
At pre-treatment, post-treatment, 3-months-follow-up, 12-months-follow-up
Secondary outcome [3] 294155 0
Quality of Life - EUROHIS Quality of Life
Timepoint [3] 294155 0
At pre-treatment, post-treatment, 3-months-follow-up, 12-months-follow-up

Eligibility
Key inclusion criteria
PTSD-Treatment: traumatic experience, speaking Arabic, access to the Internet during the treatment

Depression-Treatment: suffering from depression, speaking Arabic, access to the Internet during the treatment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal intentions, substance abuse, psychotic experiences, dissociation, currently receiving psychotherapy elsewhere, serious depression with BDI Score > 29 (only for the PTSD treatment)

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 controlled trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Applicants included in the study will be randomized by a true random-number service (http://www.random.org), with participants being randomly allocated to the online group and to waiting list group. The randomization will be performed by the study coordinator and is not stratified by any participant characteristics.
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3852 0
Iraq
State/province [1] 3852 0

Funding & Sponsors
Funding source category [1] 269897 0
Charities/Societies/Foundations
Name [1] 269897 0
Misereor
Address [1] 269897 0
Bischoefliches Hilfswerk MISEREOR e.V
Mozartstrasse 9
52064 Aachen
Country [1] 269897 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] 268909 0
Individual
Name [1] 268909 0
Birgit Wagner
Address [1] 268909 0
MSB Medical School Berlin
Calandrellistrasse 1-9
12247 Berlin
Country [1] 268909 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271869 0
University of Leipzig
Ethics committee address [1] 271869 0
Ethic committee of the University of Leipzig
Institute of clinical pharmacology
Haertelstrasse 16
04107 Leipzig
Ethics committee country [1] 271869 0
Germany
Date submitted for ethics approval [1] 271869 0
Approval date [1] 271869 0
29/08/2011
Ethics approval number [1] 271869 0
263-11-22082011

Summary
Brief summary
Background:
For several years now, a very successful treatment of posttraumatic stress disorders as well as for depression 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. For the first time that treatment will be offered in Arabic.

Method:
Traumatised or depressed Arabic-speaking participants are allocated at random to 10 writing sessions of a manualized writing approach over 6 weeks or a waiting list control group. We expect the treatment to be useful for traumatised or depressed clients, especially for those who have no access to psychological help otherwise. We hypothesize that the intervention will significantly improve clinical symptoms of PTSD and depression. Furthermore, we expect improvements in secondary outcomes such as anxiety, somatisation and quality of life.

Conclusion:
If the intervention proves to be an effective treatment for PTSD and depression in Arabic-speaking countries, our results will lend to support to the establishment of internet-based approaches, especiallay in countries, where face-to-face therapy cannot be provided.

Additional information:
The ethics approval date occurs after the actual date of first participant enrolment. But no institutional review boards were in place in post-war Iraq; however the present research was conducted in accordance with the Helsinki Declaration as revised in 1989 (see also pilot-study, Wagner, Schulz, & Knaevelsrud, 2011). For the new treatment and funding phase the study was approved by the institutional review board at the University of Leipzig in Germany.
Trial website
http://www.ilajnafsy.org
Trial related presentations / publications
Public notes
The ethics approval date occurs after the actual date of first participant enrolment. But no institutional review boards were in place in post-war Iraq; however the present research was conducted in accordance with the Helsinki Declaration as revised in 1989 (see also pilot-study, Wagner, Schulz, & Knaevelsrud, 2011). For the new treatment and funding phase the study was approved by the institutional review board at the University of Leipzig in Germany.

Contacts
Principal investigator
Name 33183 0
Prof Christine Knaevelsrud
Address 33183 0
Treatment Center for Torture Victims GSZ Moabit Turmstrasse 21 10559 Berlin
Country 33183 0
Germany
Phone 33183 0
+49 (0)30 303 906 23
Fax 33183 0
+49 (0)30 303 906 71
Email 33183 0
c.knaevelsrud@bzfo.de
Contact person for public queries
Name 16430 0
Prof Christine Knaevelsrud
Address 16430 0
Treatment Center for Torture Victims
GSZ Moabit
Turmstrasse 21
10559 Berlin
Country 16430 0
Germany
Phone 16430 0
+49 (0)30 303 906 23
Fax 16430 0
+49 (0)30 303 906 71
Email 16430 0
c.knaevelsrud@bzfo.de
Contact person for scientific queries
Name 7358 0
Prof Christine Knaevelsrud
Address 7358 0
Treatment Center for Torture Victims
GSZ Moabit
Turmstrasse 21
10559 Berlin
Country 7358 0
Germany
Phone 7358 0
+49 (0)30 303 906 23
Fax 7358 0
+49 (0)30 303 906 71
Email 7358 0
c.knaevelsrud@bzfo.de

No information has been provided regarding IPD availability
Summary results
No Results