NCT02253589

Brief Summary

Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to a one-session brief intervention or waiting list. Reductions in khat use will be measured from pre- to post-assessment which will be one month apart. After one month, the waiting list will receive the same intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year 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

2 months

First QC Date

September 24, 2014

Last Update Submit

May 10, 2017

Conditions

Khat Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Time-Line-Follow-Back: Self-reported days with khat use and amount of khat use

    Participants report in a calender for each day of the past month whether they used khat and how much of it.

    one month

Secondary Outcomes (1)

  • Time-Line-Follow-Back: other substance use

    One month

Study Arms (2)

Waiting list

NO INTERVENTION

Participants will assessment only during study, same intervention after posttest

Intervention

EXPERIMENTAL

Participants assigned to this arm will receive the modified ASSIST-linked Brief Intervention

Behavioral: modified ASSIST-linked Brief Intervention

Interventions

modified ASSIST-linked Brief InterventionBEHAVIORAL

Trained counsellors support participant's motivation to reduce or stop khat use in a 20 minute counselling session.

Also known as: Motivational Interviewing
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals

You may not qualify if:

  • Severe psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tawakal Clinic

Nairobi, Kenya

Location

Related Publications (1)

  • Widmann M, Apondi B, Musau A, Warsame AH, Isse M, Mutiso V, Veltrup C, Schalinski I, Ndetei D, Odenwald M. Reducing Khat use among Somalis living in Kenya: a controlled pilot study on the modified ASSIST-linked brief intervention delivered in the community. BMC Public Health. 2022 Dec 5;22(1):2271. doi: 10.1186/s12889-022-14681-w.

    PMID: 36471268DERIVED

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

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

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 1, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

KE(1)