The goal of the study is to explore the effects on quality of life of an experimental treatment module that attempts to change trauma related attributions and cognitions in patients with remaining PTSD symptoms.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Self-report questionnaires are used to measure quality of life (MANSA-12vn),
attribution style (experimental questionnaire), trauma related cognitions
(PTCI), and trauma related symptoms (PCL-5).
Secondary outcome
N.A.
Background summary
There is a fairly large group of patients who suffer from trauma related
symptoms, even after receiving trauma-focused treatment. An explanation for
this may be found in cognitive factors such as attribution style, the tendency
of humans to explain unusual, unwanted and unexpected events in terms of cause
and consequence, and posttrauma cognitions. Changing trauma related
attributions and cognitions seems to be important for decreasing trauma related
symptoms and improving quality of life. An intervention for patients who do not
benefit from evidence-based trauma treatment which can contribute to a
meaningful and qualitatively better existence is missing. The project team
wishes to fulfill this need by developing a treatment module. The effectivity
of this treatment module is investigated through this study.
Study objective
The goal of the study is to explore the effects on quality of life of an
experimental treatment module that attempts to change trauma related
attributions and cognitions in patients with remaining PTSD symptoms.
Study design
The study is a randomized controlled trial on the effect of an experimental
treatment module for patients with remaining trauma related symptoms. The study
is quantitative in nature.
Intervention
Based on available literature and multidisciplinary guidelines, an experimental
treatment module has been developed. A treatment protocol has been drafted
stating the content of all sessions. The treatment protocol will remain
unchanged from the start until the end of the study. The experimental treatment
module is focused on changing attribution style, using cognitive behavioral
therapy as a theoretical framework. The experimental treatment module is also
in line with the concept of 'positive health' and contains pragmatic social
interventions.
Study burden and risks
Participants participate in this study on a voluntary basis. Prior to
participatation, expectations are clarified. Specifically, participants are
informed that they will have to fill in some additional questionnaires besides
regular Routine Outcome Monitoring measures. The extra burden in time for these
questionnaires is 10 minutes per assessment. Participation in the experimental
treatment module requires physical presence of the participants and active
participation during the sessions and between the sessions. The total duration
in time is 17 hours over 24 weeks. The physical burden on participants is
minimal. As for the mental burden, the experimental treatment module requires
participants' attention, concentration and commitment. Besides filling in the
questionnaire and physical presence and participation during the treatment
sessions, there is no other burden. Risks for damage to health is deemed
minimal.
Bethaniestraat 10
's-Hertogenbosch 5211LJ
NL
Bethaniestraat 10
's-Hertogenbosch 5211LJ
NL
Listed location countries
Age
Inclusion criteria
- All participants are adult (18-63 years)
- All adutls are competent
- All participants have undergone trauma focused treatment
- Despite this treatment, participants continue to experience trauma related
symptoms (PCL score of 33 or more)
Exclusion criteria
- Participants who do not have trauma related symptoms
- Participants whose attitude towards the intervention is not in line with the
goal of the study (e.g. participant primarily expects symptom reduction instead
of improvement in quality of life)
- Participants who do not have sufficient mastery of the Dutch language
- Participants who show an acute high risk for suicide
- Participants who actively and excessively use substances
- Participants who show behavioral problems causing interpersonal conflicts
and/ or disturbing the group proces
- Participants who are suspected to or diagnosed with simulation (as
demonstrated by clinical asessment)
- Participants whose mental capacity is limited (as demonstrated by clinical
asessment)
- Participants whom have a psychological/psychotherapeutic treatment during the
experimental intervention
- Participants of which their medication is altered during the experimental
intervention
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81918.068.22 |