Khat Abuse Clinical Trial
— KhatAssistOfficial title:
The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students
| Verified date | March 2020 |
| Source | University of Konstanz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 307 |
| Est. completion date | January 31, 2019 |
| Est. primary completion date | January 15, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Ethiopia | Jimma University | Jimma |
| Lead Sponsor | Collaborator |
|---|---|
| University of Konstanz | Jimma University |
Ethiopia,
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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)) | |
| Primary | 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 | 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)) | |
| Secondary | 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)) | |
| Secondary | 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)) | |
| Secondary | 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)) | |
| Secondary | 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) |