Case Series for Traumatized Refugees With Khat Dependence

Posttraumatic Stress Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259530
• Other study ID #: 01DG13020_a
• Status: Completed
• Phase: N/A
• First received: September 30, 2014
• Last updated: May 10, 2017
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Severe Psychotic Disorder Suicidality Mental Disability

Related Conditions & MeSH terms

• Disease
• Khat Use Disorder
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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

Locations

Country	Name	City	State
Kenya	Africa Mental Health Foundation	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	Africa Mental Health Foundation

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posttraumatic Stress Diagnostic Scale (PDS)	Pre-post change of self-reported PTSD-symptom severity	3 months
Primary	Time-Line Follow Back(TLFB)	Pre-post change of self-reported days with khat use	3 months
Secondary	Hopkins Symptom Checklist (HSCL)	Pre-post change of self-reported depressive symptoms	3 months