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

NCT03730805 | Completed

• 1 other identifier: KHAT ASSIST 2018
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 1

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

Keywords

Catha Edulis; Khat; Qat; Khat Use Disorder; Screening and Brief Intervention; ASSIST

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Problem solving

  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

  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

  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

  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

  Immediately after the intervention session (ASSIST-linked BI) or control session (SPM assessment)

Study Arms (6)

Intervention + open mindset

EXPERIMENTAL

ASSIST-linked Brief Intervention plus prior induction of deliberative mindset

Behavioral: ASSIST-linked Brief Intervention; Behavioral: Induction of Deliberative Mindset

Intervention + closed mindset

EXPERIMENTAL

ASSIST-linked Brief Intervention plus prior induction of closed mindset

Behavioral: ASSIST-linked Brief Intervention; Behavioral: Induction of Implemental Mindset

Intervention alone

EXPERIMENTAL

ASSIST-linked Brief Intervention without prior induction of any mindset

Behavioral: ASSIST-linked Brief Intervention

Control + open mindset

EXPERIMENTAL

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

Control + closed mindset

EXPERIMENTAL

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

Control alone

NO INTERVENTION

In stead of intervention, a neuropsychological assessment (Raven's Standard Progressive Matrices; SPM; Raven, 1940) without prior induction of any mindset is conduced.

Interventions

ASSIST-linked Brief Intervention 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).

Also known as: Screening and Brief Intervention

Intervention + closed mindset; Intervention + open mindset; Intervention alone

Induction of Deliberative Mindset 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.

Also known as: Induction of Open Mindset

Control + open mindset; Intervention + open mindset

Induction of Implemental Mindset 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.

Also known as: Induction of Closed Mindset

Control + closed mindset; Intervention + closed mindset

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• severe substance use, except khat
• inability to read and write Amharic or Oromo languages
• ongoing acute episode of severe mental disorder
• current suicidal ideation

Sponsors & Collaborators

• University of Konstanz: lead
• Jimma University: collaborator

Study Sites (1)

Jimma University

Jimma, Ethiopia

Location

Related Publications (11)

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

  BACKGROUND

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

  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.

  PMID: 6624995 BACKGROUND

• 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.

  PMID: 22126102 BACKGROUND

• 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.

  BACKGROUND

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

  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.

  PMID: 25072043 BACKGROUND

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

  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.

  PMID: 8461850 BACKGROUND

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

  PMID: 28908970 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Helping Behavior

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael Odenwald, PhD

  University of Konstanz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Director, Outpatient Clinic for Psychotherapy

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: November 15, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 31, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

ET (1)