Case Series for Traumatized Refugees With Khat Dependence

May 10, 2017 updated by: Michael Odenwald, University of Konstanz

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Africa Mental Health Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

PTSD (DSM-IV) Khat Dependence (DSM-IV)

Exclusion Criteria:

Severe Psychotic Disorder Suicidality Mental Disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated Psychotherapeutic Intervention
Integrated treatment of khat use disorder and PTSD
Behavioral: Integrated Psychotherapeutic Intervention
Evidence-based standard tools for the treatment of PTSD and comorbid khat dependence: Community Reinforcement Approach, Relapse Prevention, Narrative Exposure Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic Stress Diagnostic Scale (PDS)
Time Frame: 3 months
Pre-post change of self-reported PTSD-symptom severity
3 months
Time-Line Follow Back(TLFB)
Time Frame: 3 months
Pre-post change of self-reported days with khat use
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopkins Symptom Checklist (HSCL)
Time Frame: 3 months
Pre-post change of self-reported depressive symptoms
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Konstanz

Collaborators

Africa Mental Health Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

October 5, 2014

First Posted (Estimate)

October 8, 2014

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01DG13020_a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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