Health TrialsbyHealthPanel

Culturally Adapted Motivational Interviewing With CBT and Mindfulness Based Relapse Prevention for Substance Use Disorder in Pakistan (CAMIAB)

ConditionSubstance Use Disorder (SUD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPakistan Institute of Living and Learning

About this trial

The study has both quantitative and qualitative components. The aim of study is to:

1. Culturally adapt and integrate the existing Motivational Interviewing with Cognitive Behavioral Therapy(MICBT) and Mindfulness based Relapse Prevention (MBRP) for people with Substance Use Disorder (SUD) in Pakistan 2. Test the feasibility and acceptability of the integrated intervention called CAMIAB ('CAMIAB' means success in Urdu) in a randomized control trial (RCT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with substance use disorder

Meeting DSM-V criteria for substance use disorder

Age 18 years and above

Being able to understand spoken or written Urdu

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Motivational interviewing with CBT (MICBT)

    Behavioral

    The culturally adapted MICBT will include approaches of motivational interviewing and offer ways of managing difficulties from a cognitive behavioural formulation.

  • Mindfulness based Relapse Prevention (MBRP)

    Behavioral

    MBRP will incorporate cognitive-behavioural skills (i.e., effective coping skills, self-efficacy, and recognizing common antecedents of relapse) with mindfulness-based practices to decrease the probability of relapse by increasing awareness and flexible responding in the presence of substance use triggers.

  • CAMIAB

    Behavioral

    This will be integrated CBT based motivational interviewing plus mindfulness based relapse prevention intervention group.

Treatment groups

260 Participants
are divided into 4 treatment groups
Group A: Motivational Interviewing with CBT (MICBT)Experimental treatment 1 intervention
Group B: Mindfulness based Relapse Prevention Group (MBRP)Experimental treatment 1 intervention
Group C: Integrated MICBT and MBRP Group (CAMIAB)Experimental treatment 1 intervention
Group D: Treatment as usual (TAU)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility measures

Feasibility will be determined by recruitment rates, adherence rate and retention rates. The criterion for success of feasibility is to recruit \>50% of eligible participants, adherence rate (number of home assignments completed; \> 50%) and retention rate of 70%.

Time frame
From baseline to 3rd month (at the end of intervention)
2

Acceptability measure

Acceptability will be determined based on the number of sessions attended by participants and success criterion for intervention acceptability is mean attendance rate of at least 8 sessions.

Time frame
From baseline to 3rd month (at the end of intervention)

Secondary outcomes

1

The Maudsley Addiction Profile

The Maudsley Addiction Profile is a brief, questionnaire that measures problems in four domains: substance use, health risk behaviour, physical and psychological health, and personal/social functions.

Time frame
Change in problem scores from Baseline to 3rd Month and 6th month
2

The Short Warwick-Edinburgh Mental Well-being Scale

The Short Warwick-Edinburgh Mental Well-being Scale is a 7 items measure that will be used to measure mental wellbeing. It consists of 7 statements on a 5 point Likert scale. The minimum scale score is 7 and the maximum is 35. The high score indicates high mental wellbeing.

Time frame
Change in scores from baseline to 3rd Month and 6th month
3

EuroQol-5

Quality of life will be measured using EuroQoL (EQ-5D) scale. This is a standardized instrument to measure health status and associated population utility weights. It measures five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression) at different levels that include "no problems, slight problems, moderate problems, severe problems, and unable to do/extreme".

Time frame
Change in scores from baseline to 3rd Month and 6th month
4

Client service receipt inventory

CSRI will be used to estimate the health and social services received.

Time frame
Changes from baseline to 3rd Month and 6th month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pakistan Institute of Living and Learning

Lead sponsor

Source ClinicalTrials.gov
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