Substance Use Disorder (SUD)NCT04885569
Culturally Adapted Motivational Interviewing With CBT and Mindfulness Based Relapse Prevention for Substance Use Disorder in Pakistan (CAMIAB)
A study testing Motivational interviewing with CBT (MICBT), Mindfulness based Relapse Prevention (MBRP) and CAMIAB in people with Substance Use Disorder (SUD), run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Motivational interviewing with CBT (MICBT), Mindfulness based Relapse Prevention (MBRP) and CAMIAB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Have undergone through the process of detoxification before study intervention
Who cannot join
- Any evidence of organic brain disease, clinically significant cooccurring medical illness or mental illness to the extent that can impede their ability to provide informed consent or engagement in the intervention.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Recovery Oasis
Lahore
Junaid Ahmad
About this study
Official title: Feasibility Study of Culturally Adapted Cognitive Behavioral Therapy Based Integrated Motivational Interviewing and Mindfulness Intervention for Substance Use Disorder in Pakistan (CAMIAB)
The study has both quantitative and qualitative components. The aim of study is to:
- 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
- Test the feasibility and acceptability of the integrated intervention called CAMIAB ('CAMIAB' means success in Urdu) in a randomized control trial (RCT).
Read the detailed description
This study aims to culturally adapt the existing Motivational Interviewing with CBT (MICBT) and integrate this with Mindfulness-Based Relapse Prevention (MBRP) intervention for people with SUD and to test the feasibility, and acceptability of the intervention in a randomized control trial (RCT). First phase will be cultural adaptation of intervention through focus groups and individual interviews with key stakeholders . Phase two will be to test integrated MICBT and MBRP on a small group of participants N=12.
Third phase will be a feasibility factorial randomized control trial with 260 participants with SUD (n=65). Participants will be recruited from primary care hospitals and drug rehabilitation centers in Karachi, Lahore, Rawalpindi, Hyderabad, and Peshawar Pakistan. Intervention will take place weekly over a period of 12 weeks. The intervention will consist of individual as well as group sessions. Assessments will be completed at baseline, after completion of intervention (12th week) and 24th week post randomization. All assessments will be administered by masked research assistants (RAs), not involved in delivering intervention sessions. The therapists delivering the intervention will be trained and will be provided ongoing supervisions by a senior therapist.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- Motivational interviewing with CBT (MICBT), Mindfulness based Relapse Prevention (MBRP), CAMIAB
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing with CBT (MICBT)Behavioural
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)Behavioural
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.
CAMIABBehavioural
This will be integrated CBT based motivational interviewing plus mindfulness based relapse prevention intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing with CBT (MICBT) | Experimental | Participants in this arm will receive a total of 12 weekly sessions of CBT based Motivational Interviewing over a period of 12 weeks. Receives: Behavioral: Motivational interviewing with CBT (MICBT) |
| Mindfulness based Relapse Prevention Group (MBRP) | Experimental | Participants in this arm will receive a total of 12 weekly sessions of mindfulness intervention over a period of 12 weeks. Receives: Behavioral: Mindfulness based Relapse Prevention (MBRP) |
| Integrated MICBT and MBRP Group (CAMIAB) | Experimental | This will be integrated MICBT plus MBRP intervention. Participants will receive a total of 12 weekly sessions of this integrated CAMIAB intervention. Receives: Behavioral: CAMIAB |
| Treatment as usual (TAU) | No intervention | This will be routine care psychological treatment that they will be receiving. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: From baseline to 3rd month (at the end of intervention)
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.
Measured: From baseline to 3rd month (at the end of intervention)
Secondary outcomes (4)
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.
Measured: Change in problem scores from Baseline to 3rd Month and 6th month
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.
Measured: Change in scores from baseline to 3rd Month and 6th month
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".
Measured: Change in scores from baseline to 3rd Month and 6th month
Client service receipt inventory
CSRI will be used to estimate the health and social services received.
Measured: Changes from baseline to 3rd Month and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Dec 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Bashir Chaudhry, Prof., Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885569
- Sponsor's protocol ID
- PILL-CAMIAB-001
- Status last verified
- Sep 2024
- First submitted
- 25 Apr 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asif M, Khoso AB, Husain MA, Shahzad S, Van Hout MC, Rafiq NU, Lane S, Chaudhry IB, Husain N. Culturally adapted motivational interviewing with cognitive behavior therapy and mindfulness-based relapse prevention for substance use disorder in Pakistan (CAMAIB): protocol for a feasibility factorial randomised controlled trial. Pilot Feasibility Stud. 2023 Apr 24;9(1):67. doi: 10.1186/s40814-023-01296-0.
PubMed 37095571
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Culturally Adapted Cognitive Behavioral Therapy Based Integrated Motivational Interviewing and Mindfulness Intervention for Substance Use Disorder in Pakistan (CAMIAB)
- ClinicalTrials.gov ID
- NCT04885569
- Acronym / sponsor ID
- PILL-CAMIAB-001
- Conditions
- Substance Use Disorder (SUD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has both quantitative and qualitative components. The aim of study is to:
- 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
- Test the feasibility and acceptability of the integrated intervention called CAMIAB ('CAMIAB' means success in Urdu) in a randomized control trial (RCT).
Detailed description
This study aims to culturally adapt the existing Motivational Interviewing with CBT (MICBT) and integrate this with Mindfulness-Based Relapse Prevention (MBRP) intervention for people with SUD and to test the feasibility, and acceptability of the intervention in a randomized control trial (RCT). First phase will be cultural adaptation of intervention through focus groups and individual interviews with key stakeholders . Phase two will be to test integrated MICBT and MBRP on a small group of participants N=12.
Third phase will be a feasibility factorial randomized control trial with 260 participants with SUD (n=65). Participants will be recruited from primary care hospitals and drug rehabilitation centers in Karachi, Lahore, Rawalpindi, Hyderabad, and Peshawar Pakistan. Intervention will take place weekly over a period of 12 weeks. The intervention will consist of individual as well as group sessions. Assessments will be completed at baseline, after completion of intervention (12th week) and 24th week post randomization. All assessments will be administered by masked research assistants (RAs), not involved in delivering intervention sessions. The therapists delivering the intervention will be trained and will be provided ongoing supervisions by a senior therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing with CBT (MICBT) | Experimental | Behavioral: Motivational interviewing with CBT (MICBT)Participants in this arm will receive a total of 12 weekly sessions of CBT based Motivational Interviewing over a period of 12 weeks. |
| Mindfulness based Relapse Prevention Group (MBRP) | Experimental | Behavioral: Mindfulness based Relapse Prevention (MBRP)Participants in this arm will receive a total of 12 weekly sessions of mindfulness intervention over a period of 12 weeks. |
| Integrated MICBT and MBRP Group (CAMIAB) | Experimental | Behavioral: CAMIABThis will be integrated MICBT plus MBRP intervention. Participants will receive a total of 12 weekly sessions of this integrated CAMIAB intervention. |
| Treatment as usual (TAU) | No intervention | –This will be routine care psychological treatment that they will be receiving. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Have undergone through the process of detoxification before study intervention
Key exclusion criteria (1 listed)
- Any evidence of organic brain disease, clinically significant cooccurring medical illness or mental illness to the extent that can impede their ability to provide informed consent or engagement in the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing with CBT (MICBT)The culturally adapted MICBT will include approaches of motivational interviewing and offer ways of managing difficulties from a cognitive behavioural formulation. | Behavioural | Motivational Interviewing with CBT (MICBT) |
| Mindfulness based Relapse Prevention (MBRP)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. | Behavioural | Mindfulness based Relapse Prevention Group (MBRP) |
| CAMIABThis will be integrated CBT based motivational interviewing plus mindfulness based relapse prevention intervention group. | Behavioural | Integrated MICBT and MBRP Group (CAMIAB) |
Primary outcome
Feasibility measures
Time frame: From baseline to 3rd month (at the end of intervention)
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%.
Acceptability measure
Time frame: From baseline to 3rd month (at the end of intervention)
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.
4 secondary outcomes
The Maudsley Addiction Profile
Time frame: Change in problem scores from Baseline to 3rd Month and 6th month
The Short Warwick-Edinburgh Mental Well-being Scale
Time frame: Change in scores from baseline to 3rd Month and 6th month
EuroQol-5
Time frame: Change in scores from baseline to 3rd Month and 6th month
Client service receipt inventory
Time frame: Changes from baseline to 3rd Month and 6th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 37095571Asif M, Khoso AB, Husain MA, Shahzad S, Van Hout MC, Rafiq NU, Lane S, Chaudhry IB, Husain N. Culturally adapted motivational interviewing with cognitive behavior therapy and mindfulness-based relapse prevention for substance use disorder in Pakistan (CAMAIB): protocol for a feasibility factorial randomised controlled trial. Pilot Feasibility Stud. 2023 Apr 24;9(1):67. doi: 10.1186/s40814-023-01296-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Bashir Chaudhry, Prof. principal investigator
Pakistan Institute of Living and Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing with CBT (MICBT), Mindfulness based Relapse Prevention (MBRP) and CAMIAB in people with Substance Use Disorder (SUD), run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Bashir Chaudhry, Prof. (02135871845, imran.chaudhry@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measures (time frame: From baseline to 3rd month (at the end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.