NCT02259530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

September 30, 2014

Last Update Submit

May 10, 2017

Conditions

Posttraumatic Stress DisorderKhat Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Posttraumatic Stress Diagnostic Scale (PDS)

    Pre-post change of self-reported PTSD-symptom severity

    3 months

  • Time-Line Follow Back(TLFB)

    Pre-post change of self-reported days with khat use

    3 months

Secondary Outcomes (1)

  • Hopkins Symptom Checklist (HSCL)

    3 months

Study Arms (1)

Integrated Psychotherapeutic Intervention

EXPERIMENTAL

Integrated treatment of khat use disorder and PTSD

Behavioral: Integrated Psychotherapeutic Intervention

Interventions

Integrated Psychotherapeutic InterventionBEHAVIORAL

Evidence-based standard tools for the treatment of PTSD and comorbid khat dependence: Community Reinforcement Approach, Relapse Prevention, Narrative Exposure Therapy

Integrated Psychotherapeutic Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe Psychotic Disorder Suicidality Mental Disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Africa Mental Health Foundation

Nairobi, Kenya

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 8, 2014

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

KE(1)