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Completed

NCT Number: NCT03730805

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

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.

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Key information

Conditions

Khat Abuse Behavior Helping Behavior Social Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jimma University

Jimma, Ethiopia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASSIST-linked Brief Intervention

Behavioral

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).

Other names: Screening and Brief Intervention

Induction of Deliberative Mindset

Behavioral

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.

Other names: Induction of Open Mindset

Induction of Implemental Mindset

Behavioral

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.

Other names: Induction of Closed Mindset

Primary outcomes

  1. khat use quantity (standard units)

    Time frame: 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))

    The researchers assess the khat units consumed in the two weeks prior to the assessment with Sobell & Sobell's (1995) calender-based method, Timeline Follow Back.

  2. days with khat use

    Time frame: 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))

    The researchers assess the days with khat use in the two weeks prior to the assessment with Sobell & Sobell's (1995) calender-based method, Timeline Follow Back.

Secondary outcomes

  1. Problem solving

    Time frame: 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))

    The researchers use the Tower of Hanoi to assess the ability of the individual to solve a problem. Time to solve the problem in seconds sis recorded.

  2. Working memory

    Time frame: 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))

    The researchers use the Corsi Block Tapping Task (Corsi, 1972) to assess the visio-spacial working memory performance of the respondent.

  3. Symptoms of depression and anxiety

    Time frame: 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))

    The researchers use the sum scale of the Self-Report Questionnaire 20 (SRQ-20; Harding et al., 1983) to measure symptoms of depression and anxiety.

  4. Symptoms of khat-induced psychosis

    Time frame: 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))

    The researchers use four items from the WHO's Composite International Clinical Interview (CIDI) to assess khat-induced psychotic symptoms according to the procedure published by Widmann et al. (2014).

  5. Resistance during intervention session

    Time frame: Immediately after the intervention session (ASSIST-linked BI) or control session (SPM assessment)

    Counsellors rate the participants degree of cooperativeness and resistance with the method developed by Haller et al. (2018).

Sponsors and collaborators

Lead sponsor

University of Konstanz

Other

Collaborators

  • Jimma University

Registry information

Acronym: KhatAssist

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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