CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 307 enrolled
Drug / intervention
ASSIST-linked Brief Intervention +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03730805
NCT03730805N/ACompleted

The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students

University of Konstanz·interventional·Posted Nov 5, 2018·Updated Mar 24, 2020

In Brief

A clinical study evaluating ASSIST-linked Brief Intervention, Induction of Deliberative Mindset, and 1 other intervention for Khat Abuse. Completed, enrolled 307 participants across 1 site.

Detailed Summary

The leaves of the khat tree (catha edulis) are traditionally chewed in the countries around the Horn of Africa. They contain the amphetamine-like alkaloid cathinone and their use can produce a Substance Use Disorder. The researchers intent to validate an Amharic and an Oromo version of the WHO's ASSIST-linked Brief Intervention among khat-using Ethiopian university students. In an RCT, khat using students of Jimma University with initial motivation to stop or cut down khat use will be randomised to either an intervention or a control group. In the intervention group, the WHO's ASSIST-linked BI will be delivered in a single session by trained local counsellors. In the control group, participants will receive a neuropsychological assessment (Raven's Standard Progressive Matrices, SPM; Raven, 1972). Khat use, the neuropsychological variables and psychiatric symptoms will be assessed before the intervention and two weeks after it. Additionally, the researchers will measure the participants resistance during the session. The control group will receive the intervention after the post test. In order to study state variables that influence brief intervention effectivity, e.g. by increasing or reducing resistance, the researchers randomise subjects in each study arm to several short pre-interventions that are based on Gollwitzer's empirically well established Mindset Theory of Action Phases (for summary: Gollwitzer \& Keller, 2016). This means, before delivering the ASSIST-linked BI (intervention group) or before the SPM assessment (controlgroup) a specific psychological state will be induced by a brief writing task that theoretically should affect the openness to the intervention: (1) implemental mindset, (2) deliberative mindset, (3) no mindset induction. The researchers expect that khat use will be reduced more in the intervention condition compared to the control condition and that induced states influence the effectiveness of the intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKhat Abuse
CountriesEthiopia
CollaboratorsJimma University

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 5, 2018
Enrollment StartNov 15, 2018
Primary CompletionJan 15, 2019
Study CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.7 years ago

Interventions

ASSIST-linked Brief Interventionbehavioral

The intervention follows the WHO's ASSIST-linked Brief Intervention (Humenik et al., 2012; Humeniuk et al., 2010), a manualized one-session intervention that can be categorised as belonging to the Screening and Brief Intervention approach. It follows the FRAMES model (Bien et al., 1993) and contains techniques from Motivational Interviewing (Miller \& Rollnick, 1991).

Induction of Deliberative Mindsetbehavioral

Based on the Mindset Theory of Action Phases (Gollwitzer \& Keller, 2016), a brief writing task (writing down pros and cons for an unresolved personal problem of the participant's own choice) is used to induce a specific psychological state in which the individual is cognitively open to process new information.

Induction of Implemental Mindsetbehavioral

Based on the Mindset Theory of Action Phases (Gollwitzer \& Keller, 2016), a brief writing task (writing down steps necessary to implement a personal decision of the participant's choice that has not yet been put into practice) is used to induce a specific psychological state in which the individual is cognitively not open to process new information.