Case Series for Traumatized Refugees With Khat Dependence
Primary Purpose
Posttraumatic Stress Disorder, Khat Use Disorder
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Integrated Psychotherapeutic Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
PTSD (DSM-IV) Khat Dependence (DSM-IV)
Exclusion Criteria:
Severe Psychotic Disorder Suicidality Mental Disability
Sites / Locations
- Africa Mental Health Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integrated Psychotherapeutic Intervention
Arm Description
Integrated treatment of khat use disorder and PTSD
Outcomes
Primary Outcome Measures
Posttraumatic Stress Diagnostic Scale (PDS)
Pre-post change of self-reported PTSD-symptom severity
Time-Line Follow Back(TLFB)
Pre-post change of self-reported days with khat use
Secondary Outcome Measures
Hopkins Symptom Checklist (HSCL)
Pre-post change of self-reported depressive symptoms
Full Information
NCT ID
NCT02259530
First Posted
September 30, 2014
Last Updated
May 10, 2017
Sponsor
University of Konstanz
Collaborators
Africa Mental Health Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02259530
Brief Title
Case Series for Traumatized Refugees With Khat Dependence
Official Title
Sustainable and Adapted Treatment Strategies to Restore Psychological Functioning and Mental Health Among Displaced Somalis: Preparation of a Multicenter Treatment Study (P114/02/2014): Pilot Study 3.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Africa Mental Health Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The research project will offer psychotherapeutic treatment to Somali refugees with PTSD and comorbid khat dependence. In this case series, evidence-based techniques will be applied and adapted to the cultural background of Somali refugees in Kenya.
Detailed Description
More than 500.000 Somali refugees live in Kenya. This group is especially burdened by high rates of exposure to traumatic events, high prevalence of PTSD and a high comorbidity with substance use disorders, mainly related to khat (catha edulis). There's a shortage of literature on psychotherapeutic methods that are applicable in this group. The aim of this case series is to develop modifications of standard therapeutic techniques to the Somali culture and to the needs of this group. Twenty successive cases will be recruited from a community clinic where refugees often seek for treatment because of psychiatric problems. Senior level psychotherapists will apply and adapt techniques and approaches like Community Reinforcement Approach (CRA), Relapse Prevention (RP), and Narrative Exposure Therapy (NET); all sessions will be video recorded. Regular supervision with external experts and group discussions will be held to evaluate and adapt the single procedures and techniques. The aim of this study is the development of a standardized approach that can be used in a Randomized Controlled Trial which will be conduced in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Khat Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrated Psychotherapeutic Intervention
Arm Type
Experimental
Arm Description
Integrated treatment of khat use disorder and PTSD
Intervention Type
Behavioral
Intervention Name(s)
Integrated Psychotherapeutic Intervention
Intervention Description
Evidence-based standard tools for the treatment of PTSD and comorbid khat dependence: Community Reinforcement Approach, Relapse Prevention, Narrative Exposure Therapy
Primary Outcome Measure Information:
Title
Posttraumatic Stress Diagnostic Scale (PDS)
Description
Pre-post change of self-reported PTSD-symptom severity
Time Frame
3 months
Title
Time-Line Follow Back(TLFB)
Description
Pre-post change of self-reported days with khat use
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hopkins Symptom Checklist (HSCL)
Description
Pre-post change of self-reported depressive symptoms
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PTSD (DSM-IV) Khat Dependence (DSM-IV)
Exclusion Criteria:
Severe Psychotic Disorder Suicidality Mental Disability
Facility Information:
Facility Name
Africa Mental Health Foundation
City
Nairobi
Country
Kenya
12. IPD Sharing Statement
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Case Series for Traumatized Refugees With Khat Dependence
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