NCT07161986

Mapping And Preventing Relapse Risk in Polydrug Users

Mapping Relapse Risk and Evaluating an Integrated Approach for Preventing Relapse in Polydrug Users: A Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Institute of Psychology, Chinese Academy of Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2025-06-24
• Primary completion: 2025-07-15
• Completion: 2025-08-24
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: Pakistan