Clinical trial NCT03730805: The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students
Official title: The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Khat Abuse
Keywords: Catha Edulis
Khat
Qat
Khat Use Disorder
Screening and Brief Intervention
ASSIST
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Jimma University
First posted: 2018-11-05
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* second year student or higher year student at Jimma University
* khat use in the month prior to baseline
* participant's wish to reduce or stop khat use

Exclusion Criteria:

* severe substance use, except khat
* inability to read and write Amharic or Oromo languages
* ongoing acute episode of severe mental disorder
* current suicidal ideation

Primary outcomes:
measure: khat use quantity (standard units)
timeFrame: Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group))
measure: days with khat use
timeFrame: Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group))
Secondary outcomes:
measure: Problem solving
timeFrame: Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group))
measure: Working memory
timeFrame: Change from T1 (Baseline at study entry) to T2 (Two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group))
measure: Symptoms of depression and anxiety
timeFrame: Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group))
measure: Symptoms of khat-induced psychosis
timeFrame: Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group))
measure: Resistance during intervention session
timeFrame: Immediately after the intervention session (ASSIST-linked BI) or control session (SPM assessment)
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University
Study officials:
affiliation: University of Konstanz
name: Michael Odenwald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gollwitzer, P., & Keller, L. (2016). Mindset Theory. In V. Zeigler-Hill & T. K. Shackleford (Eds.), Encyclopedia of Personality and Individual Differences. New York: Springer.
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citation: Humeniuk R, Ali R, Babor T, Souza-Formigoni ML, de Lacerda RB, Ling W, McRee B, Newcombe D, Pal H, Poznyak V, Simon S, Vendetti J. A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries. Addiction. 2012 May;107(5):957-66. doi: 10.1111/j.1360-0443.2011.03740.x. Epub 2012 Feb 28.
citation: Humeniuk, R., Henry-Edwards, S., Ali, R., Poznyak, V., Monteiro, M., & World Health Organization. (2010). The ASSIST-linked Brief Intervention for Hazardous and Harmful Substance Use: Manual for Use in Primary Care. Geneva: World Health Organization.
citation: Miller, W. R., & Rollnick, S. (1991). Motivational interviewing : preparing people to change addictive behavior. New York: Guilford Press.
citation: Widmann M, Warsame AH, Mikulica J, von Beust J, Isse MM, Ndetei D, al'Absi M, Odenwald MG. Khat Use, PTSD and Psychotic Symptoms among Somali Refugees in Nairobi - A Pilot Study. Front Public Health. 2014 Jun 30;2:71. doi: 10.3389/fpubh.2014.00071. eCollection 2014.
citation: Sobell, L. C., & Sobell, M. B. (1995). Alcohol Timeline Followback Users's Manual. Toronto: Addiction Research Foundation.
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citation: Raven JC. Matrix Tests. Ment Health (Lond). 1940 Jan;1(1):10-18. No abstract available.
citation: Haller, N., Keller, L., Treiber, J., Schrietter, F., & Odenwald, M. (2018). The effect of mindset inductions on motivational interventions to reduce alcohol use: a pilot studies among university students. Poster presentation at the German Addiction Conference, September 17 - 20, 2018, Hamburg, Germany.