Mapping And Preventing Relapse Risk in Polydrug Users

NCT ID: NCT07161986

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-24
• Study Completion Date: 2025-08-24

Brief Summary

This Interventional two-arm comparative study will evaluate whether a mindfulness-based strategy (MBS) improves outcomes for adults with substance use disorders (polydrug users) compared with treatment-as-usual (TAU). The primary question is whether MBS lowers cravings and reduces relapse risk relative to TAU; secondary aims include improvements in emotion regulation, coping, depressive/anxiety symptoms, mindfulness, and motivation to change. The design includes two arms (MBS vs TAU) with baseline and post-intervention assessments; adherence within the MBS arm will also be examined (e.g., high- vs low-adherence) to test whether greater adherence yields better primary and secondary outcomes than TAU. Primary outcomes are craving and relapse risk; secondary outcomes are emotion regulation, coping, depressive and anxiety symptoms, mindfulness, and motivation to change. Hypotheses predict that MBS will reduce cravings and depressive/anxiety symptoms and improve mindfulness and emotion regulation as compared to TAU; that psychological network structure will differ by relapse-risk level and by adherence subgroup; and that motivation to change will mediate MBS effects.

Detailed Description

This prospective observational, two-arm comparative study is to evaluate whether a mindfulness-based strategy (MBS) improves clinical and psychosocial outcomes and reduces relapse risk among adults with substance use disorders (polydrug users). The main question is whether long-term participation in MBS lowers cravings and reduces relapse risk compared with treatment-as-usual (TAU). The design includes two arms-an MBS arm (participants receiving the mindfulness-based strategy as part of care) and a TAU arm (participants receiving treatment as usual)-with adherence to MBS also analyzed (e.g., high- vs low-adherence subgroups). Participants will be adults with SUDs/polydrug use; the target sample size is 130 Participants with MBS (n=60) and TAU (n=70). Baseline and post-intervention assessments were conducted, using measures culturally adapted to Urdu. The objectives are to test whether MBS reduces substance cravings and relapse risk relative to TAU; assess improvements in emotion regulation, coping, mindfulness, depression, anxiety, and motivation to change; examine how adherence to MBS relates to outcomes; and use network analysis to characterize connections among psychological variables and compare structures by relapse risk, adherence level. The hypotheses are: H1 (Primary/Secondary): MBS will reduce cravings and Relapse Risk (primary) and depressive/anxiety symptoms, improve mindfulness, motivation to Change and emotion regulation (secondary). H2 (Primary/Secondary): Higher MBS adherence will yield better primary (Reduce craving, relapse risk) and secondary outcomes than TAU. H3: Network density/connectivity among psychological variables will differ by relapse-risk level within MBS. H4: Post-test network structures will differ between high- vs low-adherence MBS participants. H5: The Study 2 network will show weaker links between relapse factors and symptoms than Study 1, reflecting MBS impact. H6: MBS will improve coping skills, emotion regulation, and mindfulness. H7: Motivation to change will mediate the relationship between MBS participation and outcomes. Primary outcomes are craving and relapse risk (Relapse Risk Scale; subscales: compulsivity to use, abstinence-violation effect, anxiety problems, low self-efficacy). Secondary outcomes include emotion regulation (CERQ: self-blame, acceptance, rumination, positive refocusing, planning, positive reappraisal, putting into perspective, catastrophizing, other-blame), mindfulness (MAAS; note that higher scores indicate lower mindfulness ), depression, anxiety, and stress (DASS-21), coping (Brief COPE Urdu: emotion-focused, avoidance-focused, problem-focused), and motivation to change (RCQ: precontemplation, contemplation, action). Analytically, group comparisons will contrast MBS versus TAU on primary and secondary outcomes with stratification by MBS adherence; network analysis will compare network density and structure across relapse-risk strata, adherence subgroups, and between Study 2 and Study 1; and mediation models will test whether motivation to change mediates MBS effects on outcomes.

Conditions

Drug Addiction; Polysubstance Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mindfullness Based Intervention

Mindfullness based intervention arm is taking intervention which is based on Mindfullness based sobriety manaual for Relpase prevention and craving as primary outcome

Group Type: ACTIVE_COMPARATOR

Mindfullness based Sobriety (MBS)

Intervention Type: BEHAVIORAL

MBS is combination of Mindfullness , Relapse prevention, motivational interviewing , acceptance and commitment therapy. It helps in dealing underlying depression and anxiety issues among Polysubstance use. it Cover most of underlying problem faced by person with addiction.

Treatment As Usual

Treatment as usual group would take tradational treatment at rehablitataion center not particular intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfullness based Sobriety (MBS)

MBS is combination of Mindfullness , Relapse prevention, motivational interviewing , acceptance and commitment therapy. It helps in dealing underlying depression and anxiety issues among Polysubstance use. it Cover most of underlying problem faced by person with addiction.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Individuals resided in Drug rehabilitations center with polysubstance use diagnosed particularly with illicit drug use.
• Age would be from 18 to 85 years
• Must include Patients after detox and withdrawal symptoms.

Exclusion Criteria

• Individuals with any form of physical or intellectual disability will not be eligible to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Psychology, Chinese Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Yonghui Professor, Institute Of Psychology,Chinese Acedmy of Sciences

Role: STUDY_CHAIR

Institute Of Psychology,Chinese Acedmy of Sciences

Romana Younas PhD fellow, Mphil ClPsy

Role: PRINCIPAL_INVESTIGATOR

Institute of Psychology,Chinese Acedmy Of Sciences

Salman Shahzad Professor

Role: STUDY_DIRECTOR

Institute of Clinical Psychology,Universitry of Karachi,Pakistan

Locations

Save Life Foundation

Abbottābād, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

References

Priddy SE, Howard MO, Hanley AW, Riquino MR, Friberg-Felsted K, Garland EL. Mindfulness meditation in the treatment of substance use disorders and preventing future relapse: neurocognitive mechanisms and clinical implications. Subst Abuse Rehabil. 2018 Nov 16;9:103-114. doi: 10.2147/SAR.S145201. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30532612 (View on PubMed)

Other Identifiers

2021ZD0202104

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H24149

Identifier Type: -

Identifier Source: org_study_id