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

Study Overview
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Brief Summary
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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.

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

Conditions
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Khat Abuse

Intervention / Treatment
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* Behavioral: ASSIST-linked Brief Intervention
* Behavioral: Induction of Deliberative Mindset
* Behavioral: Induction of Implemental Mindset


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention + open mindset<br>ASSIST-linked Brief Intervention plus prior induction of deliberative mindset | Behavioral: ASSIST-linked Brief Intervention<br>* 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).<br>* Other names: Screening and Brief Intervention;Behavioral: Induction of Deliberative Mindset<br>* 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.<br>* Other names: Induction of Open Mindset;|
| Experimental: Intervention + closed mindset<br>ASSIST-linked Brief Intervention plus prior induction of closed mindset | Behavioral: ASSIST-linked Brief Intervention<br>* 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).<br>* Other names: Screening and Brief Intervention;Behavioral: Induction of Implemental Mindset<br>* 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.<br>* Other names: Induction of Closed Mindset;|
| Experimental: Intervention alone<br>ASSIST-linked Brief Intervention without prior induction of any mindset | Behavioral: ASSIST-linked Brief Intervention<br>* 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).<br>* Other names: Screening and Brief Intervention;|
| Experimental: Control + open mindset<br>In stead of intervention, a neuropsychological assessment (Raven's Standard Progressive Matrices; SPM; Raven, 1940) with prior induction of an open mindset is conduced. | Behavioral: Induction of Deliberative Mindset<br>* 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.<br>* Other names: Induction of Open Mindset;|
| Experimental: Control + closed mindset<br>In stead of intervention, a neuropsychological assessment (Raven's Standard Progressive Matrices; SPM; Raven, 1940) with prior induction of a closed mindset is conduced. | Behavioral: Induction of Implemental Mindset<br>* 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.<br>* Other names: Induction of Closed Mindset;|
| No Intervention: Control alone<br>In stead of intervention, a neuropsychological assessment (Raven's Standard Progressive Matrices; SPM; Raven, 1940) without prior induction of any mindset is conduced. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| khat use quantity (standard units) | 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. | 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)) | 
| days with khat use | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Problem solving | 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. | 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)) | 
| Working memory | The researchers use the Corsi Block Tapping Task (Corsi, 1972) to assess the visio-spacial working memory performance of the respondent. | 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)) | 
| Symptoms of depression and anxiety | 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. | 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)) | 
| Symptoms of khat-induced psychosis | 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). | 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)) | 
| Resistance during intervention session | Counsellors rate the participants degree of cooperativeness and resistance with the method developed by Haller et al. (2018). | Immediately after the intervention session (ASSIST-linked BI) or control session (SPM assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catha Edulis, Khat, Qat, Khat Use Disorder, Screening and Brief Intervention, ASSIST