An interventional study of ASSIST-linked Brief Intervention and Induction of Deliberative Mindset in Khat Abuse, sponsored by University of Konstanz. Completed at 1 site in Ethiopia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by University of Konstanz · Not applicable, Interventional, and Treatment
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.
University of Konstanz is the lead sponsor of 48 studies on the registry; none are open to participants now.
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Exclusion Criteria:
ASSIST-linked Brief Intervention plus prior induction of deliberative mindset
Behavioral: ASSIST-linked Brief Intervention · Behavioral: Induction of Deliberative Mindset
ASSIST-linked Brief Intervention plus prior induction of closed mindset
Behavioral: ASSIST-linked Brief Intervention · Behavioral: Induction of Implemental Mindset
ASSIST-linked Brief Intervention without prior induction of any mindset
Behavioral: ASSIST-linked Brief Intervention
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
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
In stead of intervention, a neuropsychological assessment (Raven's Standard Progressive Matrices; SPM; Raven, 1940) without prior induction of any mindset is conduced.
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).
Also known as: Screening and Brief Intervention
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.
Also known as: Induction of Open Mindset
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.
Also known as: Induction of Closed Mindset
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.
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))
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.
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))
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.
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))
Working memory
The researchers use the Corsi Block Tapping Task (Corsi, 1972) to assess the visio-spacial working memory performance of the respondent.
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))
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.
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))
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).
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))
Resistance during intervention session
Counsellors rate the participants degree of cooperativeness and resistance with the method developed by Haller et al. (2018).
Time frame: Immediately after the intervention session (ASSIST-linked BI) or control session (SPM assessment)
Plan to share: Undecided
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University of Konstanz