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

NCT ID: NCT03730805

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2019-01-31

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.

Conditions

Khat Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention + open mindset

ASSIST-linked Brief Intervention plus prior induction of deliberative mindset

Group Type: EXPERIMENTAL

ASSIST-linked Brief Intervention

Intervention Type: 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).

Induction of Deliberative Mindset

Intervention Type: 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.

Intervention + closed mindset

ASSIST-linked Brief Intervention plus prior induction of closed mindset

Group Type: EXPERIMENTAL

ASSIST-linked Brief Intervention

Intervention Type: 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).

Induction of Implemental Mindset

Intervention Type: 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.

Intervention alone

ASSIST-linked Brief Intervention without prior induction of any mindset

Group Type: EXPERIMENTAL

ASSIST-linked Brief Intervention

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

Induction of Deliberative Mindset

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Induction of Implemental Mindset

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Screening and Brief Intervention; Induction of Open Mindset; Induction of Closed Mindset

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jimma University

OTHER

Sponsor Role: collaborator

University of Konstanz

OTHER

Sponsor Role: lead

Responsible Party

Michael Odenwald

Managing Director, Outpatient Clinic for Psychotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Odenwald, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Konstanz

Locations

Jimma University

Jimma, , Ethiopia

Countries

Ethiopia

References

Gollwitzer, P., & Keller, L. (2016). Mindset Theory. In V. Zeigler-Hill & T. K. Shackleford (Eds.), Encyclopedia of Personality and Individual Differences. New York: Springer.

Reference Type: BACKGROUND

Corsi, P. M. (1972). Human memory and the medial temporal region of the brain. Dissertation Abstracts International, 34, 819B.

Reference Type: BACKGROUND

Harding TW, Climent CE, Diop M, Giel R, Ibrahim HH, Murthy RS, Suleiman MA, Wig NN. The WHO collaborative study on strategies for extending mental health care, II: The development of new research methods. Am J Psychiatry. 1983 Nov;140(11):1474-80. doi: 10.1176/ajp.140.11.1474.

Reference Type: BACKGROUND

PMID: 6624995 (View on PubMed)

Humeniuk R, Ali R, Babor T, Souza-Formigoni ML, de Lacerda RB, Ling W, McRee B, Newcombe D, Pal H, Poznyak V, Simon S, Vendetti J. A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries. Addiction. 2012 May;107(5):957-66. doi: 10.1111/j.1360-0443.2011.03740.x. Epub 2012 Feb 28.

Reference Type: BACKGROUND

PMID: 22126102 (View on PubMed)

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.

Reference Type: BACKGROUND

Miller, W. R., & Rollnick, S. (1991). Motivational interviewing : preparing people to change addictive behavior. New York: Guilford Press.

Reference Type: BACKGROUND

Widmann M, Warsame AH, Mikulica J, von Beust J, Isse MM, Ndetei D, al'Absi M, Odenwald MG. Khat Use, PTSD and Psychotic Symptoms among Somali Refugees in Nairobi - A Pilot Study. Front Public Health. 2014 Jun 30;2:71. doi: 10.3389/fpubh.2014.00071. eCollection 2014.

Reference Type: BACKGROUND

PMID: 25072043 (View on PubMed)

Sobell, L. C., & Sobell, M. B. (1995). Alcohol Timeline Followback Users's Manual. Toronto: Addiction Research Foundation.

Reference Type: BACKGROUND

Bien TH, Miller WR, Tonigan JS. Brief interventions for alcohol problems: a review. Addiction. 1993 Mar;88(3):315-35. doi: 10.1111/j.1360-0443.1993.tb00820.x.

Reference Type: BACKGROUND

PMID: 8461850 (View on PubMed)

Raven JC. Matrix Tests. Ment Health (Lond). 1940 Jan;1(1):10-18. No abstract available.

Reference Type: BACKGROUND

PMID: 28908970 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

KHAT ASSIST 2018

Identifier Type: -

Identifier Source: org_study_id