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

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ClinicalTrials.gov Identifier: NCT03730805
Recruitment Status : Active, not recruiting
First Posted : November 5, 2018
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Jimma University
Information provided by (Responsible Party):
Michael Odenwald, University of Konstanz

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.

Condition or disease Intervention/treatment Phase
Khat Abuse Behavioral: ASSIST-linked Brief Intervention Behavioral: Induction of Deliberative Mindset Behavioral: Induction of Implemental Mindset Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : January 15, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: College Health

Arm Intervention/treatment
Experimental: Intervention + open mindset
ASSIST-linked Brief Intervention plus prior induction of deliberative mindset
Behavioral: ASSIST-linked Brief Intervention
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 Name: Screening and Brief Intervention

Behavioral: Induction of Deliberative Mindset
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 Name: Induction of Open Mindset

Experimental: Intervention + closed mindset
ASSIST-linked Brief Intervention plus prior induction of closed mindset
Behavioral: ASSIST-linked Brief Intervention
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 Name: Screening and Brief Intervention

Behavioral: Induction of Implemental 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.
Other Name: Induction of Closed Mindset

Experimental: Intervention alone
ASSIST-linked Brief Intervention without prior induction of any mindset
Behavioral: ASSIST-linked Brief Intervention
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 Name: Screening and Brief Intervention

Experimental: Control + open mindset
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
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 Name: Induction of Open Mindset

Experimental: Control + closed 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
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 Name: Induction of Closed Mindset

No Intervention: Control alone
In stead of intervention, a neuropsychological assessment (Raven's Standard Progressive Matrices; SPM; Raven, 1940) without prior induction of any mindset is conduced.



Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730805


Locations
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Ethiopia
Jimma University
Jimma, Ethiopia
Sponsors and Collaborators
University of Konstanz
Jimma University
Investigators
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Principal Investigator: Michael Odenwald, PhD University of Konstanz

Publications:
Gollwitzer, P., & Keller, L. (2016). Mindset Theory. In V. Zeigler-Hill & T. K. Shackleford (Eds.), Encyclopedia of Personality and Individual Differences. New York: Springer.
Corsi, P. M. (1972). Human memory and the medial temporal region of the brain. Dissertation Abstracts International, 34, 819B.
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.
Miller, W. R., & Rollnick, S. (1991). Motivational interviewing : preparing people to change addictive behavior. New York: Guilford Press.
Sobell, L. C., & Sobell, M. B. (1995). Alcohol Timeline Followback Users's Manual. Toronto: Addiction Research Foundation.
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.

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Responsible Party: Michael Odenwald, Managing Director, Outpatient Clinic for Psychotherapy, University of Konstanz
ClinicalTrials.gov Identifier: NCT03730805     History of Changes
Other Study ID Numbers: KHAT ASSIST 2018
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Odenwald, University of Konstanz:
Catha Edulis
Khat
Qat
Khat Use Disorder
Screening and Brief Intervention
ASSIST