Primary objectives: 1. To translate and adapt the iCBT program TELLUS for use in IFRC humanitarian aid workers2. To determine feasibility of TELLUS in terms of: completion rates and self-reported treatment credibility/ expectancySecondary objective:…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter will be the completion rate for the program and
self-reported treatment credibility/ expectancy.
Secondary outcome
Secondary outcomes measured at post-treatment will be symptoms of PTSD,
depression and anxiety, and functional disability.
Background summary
Humanitarian aid workers may often be exposed or witness complex emergencies.
Posttraumatic stress disorder (PTSD) is one of the most widespread and most
commonly studied mental health problems in such situations. However,
face-to-face treatment has limited utilization in the resource-constrained
settings, where humanitarian aid workers often operate. Therefore, the
utilization of remote care, such as internet-based services, has been
recommended. Internet-delivered cognitive behavioral therapy (iCBT) is a
treatment option with the potential to improve the access to evidence-based
care for humanitarian aid workers. Until now, only a few studies have evaluated
iCBT in the treatment of PTSD. However, no studies have yet explored the
feasibility of iCBT for humanitarian aid workers with PTSD.
Study objective
Primary objectives:
1. To translate and adapt the iCBT program TELLUS for use in IFRC humanitarian
aid workers
2. To determine feasibility of TELLUS in terms of: completion rates and
self-reported treatment credibility/ expectancy
Secondary objective:
3. To evaluate reductions in symptoms of PTSD, anxiety and depression and
functional disability to determine within Cohen*s d effect sizes to inform a
future RCT in IFRC humanitarian aid workers.
Study design
A pre-post pilot feasibility study will be carried out in 20 IFRC humanitarian
aid workers.
Intervention
TELLUS is a therapist-assisted internet-delivered treatment program based on
trauma-focused CBT components for individuals with PTSD. The treatment program
was developed by Prof. Dr. Gerhard Andersson (Linköping University, Sweden).
The TELLUS program contains eight text-based modules. Each module is presented
at the beginning of the week (Monday), and is expected to be completed by the
end of the same week (Sunday). The modules include psychoeducation, breathing
retraining, in-vivo exposure, exposure to memories, cognitive restructuring,
and relapse prevention. Each module has a homework assignment related to the
content of the module, which needs to be returned by email to the person
providing feedback by the end of the week (Saturday).
Study burden and risks
The burden of participation consists of completing one primary telephone
interview (duration: approximately 10 minutes), a secondary telephone interview
(duration: approximately 25 minutes) and five self-report questionnaires and
demographic questions (duration: approximately 27 minutes) at pre-treatment,
following the eight TELLUS modules for eight weeks (duration: approximately 180
minutes per week), completing two self-report questionnaires after the forth
module (duration: approximately 10 minutes), and completing one telephone
interview (duration: approximately 20 minutes) and four self-report
questionnaires (duration: approximately 20 minutes) at post-treatment. The
risks associated with participation are considered minimal, since the TELLUS
program has been shown to be an efficacious treatment option in a randomized
controlled trial. Participants may benefit from their participation, since
TELLUS has been shown to be helpful in reducing symptoms of posttraumatic
stress disorder. Nevertheless, it cannot be excluded that some participants may
become upset or experience distress during the interviews, self-report
assessments, and/or intervention. In case a participant fulfills exclusion
criteria, experiences strong emotional distress during the assessments or
intervention, does not respond to emails in time, or reports symptom increase,
the participant will be referred with his/her approval to the UNHCR Staff
Welfare Section for support.
Van den Boechorststraat 1
Amsterdam 1081BT
NL
Van den Boechorststraat 1
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are: 1) currently an international staff member or international volunteer at IFRC, 2) a full diagnosis of PTSD according to DSM-IV (APA, 1994), or subclinical PTSD with one intrusion, one avoidance, and one hyperarousal symptom according to DSM-IV (APA, 1994), as established with the Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998), 3) fluency in the English language, 4) access to internet and telephone/ Skype, 5) being on a current stable dose of medication or medication-free.
Exclusion criteria
Exclusion criteria are: 1) organic or psychotic disorders, substance dependence, or imminent suicide risk as established with the MINI, 2) presence of PTSD symptoms related to childhood trauma, 3) receiving psychological treatment at the time of inclusion, 4) experiencing on-going trauma or being under current threat.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL49966.029.14 |
OMON | NL-OMON20069 |