Mapping And Preventing Relapse Risk in Polydrug Users
- Conditions
- Drug AddictionPolysubstance Addiction
- Registration Number
- NCT07161986
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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.
• Individuals with any form of physical or intellectual disability will not be eligible to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Craving From Enrollment to end of treatment at 6 weeks and then 2 week followup Craving Craving will be measured using a rating scale from 1 (minimum) to 10 (maximum), with higher scores indicating greater craving intensity.
Relpase Risk From Enrollment to end of treatment at 6 weeks and then 2 week followup Relapse Risk Relapse risk will be measured using the Relapse Risk Scale, consisting of four subscales: compulsivity to use, abstinence violation effect, anxiety problems, and low self-efficacy. Scores classify risk as: High (\>170), Moderate (98-170), or Low (\<98).
- Secondary Outcome Measures
Name Time Method mental Health Conditions From Enrollment to the end of treatment at 6 week and 2 week followup mental health condition such as Depression, Anxiety, and Stress will be measured using the DASS-21 (Aslam \& Kamal, 2017). Scores range: Depression (0-4), Anxiety (0-3), Stress (0-7). Higher scores reflect greater symptom severity
Emotional Regulation Skills From Enrollment to the end of treatment at 6 week and 2 week followup Measured using the Cognitive Emotion Regulation Questionnaire (Shahzad et al., 2022). Subscales include self-blame, acceptance, rumination, positive refocusing, planning, reappraisal, perspective, catastrophizing, and other-blame. Each subscale ranges from 4-20; total score ranges from 36-180. Higher scores indicate greater use of that strategy.
Mindfulness (MAAS) From Enrollment to the end of treatment at 6 week and 2 week followup Mindfulness Attention Awareness Scale (Bakhteyar et al., 2021). Higher scores (closer to 6) indicate higher levels of mindfulness.
Motivation to Change (RCQ) From Enrollment to the end of treatment at 6 week and 2 week followup Measured via Readiness to Change Questionnaire (Mubashir et al., 2025). Subscales: Precontemplation, Contemplation, Action. Subscale scores are calculated by summing the respective item scores and high scores indicate strong identification with that specific stage of change.
Trial Locations
- Locations (1)
Save Life Foundation
🇵🇰Abbottābād, Khyber Pakhtunkhwa, Pakistan
Save Life Foundation🇵🇰Abbottābād, Khyber Pakhtunkhwa, Pakistan