Substance use disorders (SUD) are defined as problematic patterns of consumption of psychoactive substances associated with clinical impairment, relapse over time and accompanied with tremendous burden for society and the affected individuals [1]. Opioids are class of drugs that include the illicit drug heroin as well as the prescription pain relievers oxycodone, hydrocodone, codeine, morphine, fentanyl and others [2].

In Egypt, a series of epidemiological studies on psychoactive drug use were conducted. Those concerned with secondary school students revealed 5.05% for the use of cannabis and 0.84% for the use of opium [3]. National survey for the psychiatric and SUD made in Egypt 2023 conducted by ministry of health revealed that SUD was 5.4% and from those with SUDs, opiated was 39.5% [4]. People recovering from drug abuse face work-related challenges.

There are a variety of effective psychological and behavioral therapies for managing SUDs such as cognitive-behavioral therapy (CBT), motivational enhancement therapy, and 12-step facilitation therapy [5]. Interventions such as MI and CBT that focus on motivation, problem solving, communication, mental health (i.e., anger, depression) and substances may be particularly useful for incarcerated youth [6]. This is because these youth may have significant mental health and substance issues but lack motivation and skills as problem-solving and communication to address them.

Mindfulness has been described as, “the awareness that emerges through paying attention, on purpose, in the present moment, and nonjudgmentally to the unfolding of experience” [7].

Mindfulness-based cognitive therapy (MBCT), focus on addressing these challenges by modifying thought and behavior patterns, effectively preventing relapses. Considering the importance of psychological and coping strategies in addiction treatment, this study evaluated the effectiveness of CBT and MBCT in reducing opioid relapses and improving the quality of life (QOL) for individuals with opioid dependence. To avoid suffering, an individual either clings to positive states (e.g., craving) or avoids negative states [7]. QoL is a key but underused treatment outcome in SUD care [8].

The aim of this work was to develop a structured, integrated rehabilitation program specifically designed for relapse prevention among patients diagnosed with opioid use disorder (OUD), evaluate the efficacy of this integrated intervention in reducing relapse rates, assess its impact on patients’ QOL and identify significant clinical, psychological, and sociodemographic predictors of relapse within this population, in participants attending the Psychiatry and Neurology Center, Tanta University.

Quasi-experimental study design was carried out to evaluate the efficacy of an integrated rehabilitation program for relapse prevention among individuals with OUD on 100 male patients with OUD as per diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) criteria, aged from 18 to 45 years old. The study was done after approval from the Ethical Committee Tanta University Hospitals, Tanta, Egypt (approval code:36264MD66/4/23). An informed written consent was obtained from the patient or relatives of the patients.

Those who were unable to comply with the study protocol (e.g., due to time constraints or intellectual disability), serious or unstable medical conditions within the past six months (e.g., infective endocarditis, human immunodeficiency virus (HIV), hepatitis B or C), significant cognitive impairment, comorbid severe psychiatric disorders (e.g., active psychosis, panic disorder, current manic episode) were excluded from the study.

The validated Arabic version of the WHOQOL-BREF [10] was used to assess QoL across four domains: physical health, psychological health, social relationships, and environment.

Internal consistency of the scale was verified in a pilot sample of 30 patients, yielding a Cronbach’s alpha of 0.781. QoL was assessed at baseline, 3 months and reassessed after six months.

A comprehensive rehabilitation program was developed for individuals with SUDs, particularly opioid dependence, followed a systematic, evidence-based methodology. The program integrates six core therapeutic components: Motivational Therapy, CBT-based relapse prevention, family psychoeducation, peer support groups, twelve-step facilitation therapy, and mindfulness-based relapse prevention. The overarching goal was to create an intervention that is clinically effective, culturally appropriate, and practically feasible for the target population. The methodology comprised three interrelated phases: a systematic review of existing rehabilitation programs, a targeted literature review to substantiate the selected therapeutic components, and expert consultation to refine the structure, content, and delivery of the program.

A targeted literature review was conducted using peer-reviewed journals, clinical practice guidelines, and meta-analyses published over the past two decades. Search terms included “motivational therapy,” “CBT relapse prevention,” “family psychoeducation,” “peer support groups,” “twelve-step facilitation,” and “mindfulness-based relapse prevention,” in conjunction with “substance use disorder” and “opioid dependence.” Priority was given to randomized controlled trials (RCTs), meta-analyses, and longitudinal studies.

The review confirmed the individual efficacy of each therapeutic modality, thereby supporting their integration into a comprehensive rehabilitation framework. Motivational interviewing (MI) was found to significantly enhance treatment engagement and strengthen commitment to recovery goals [11]. CBT demonstrated efficacy in reducing relapse risk by promoting cognitive restructuring and the development of adaptive coping [12]. Family Psychoeducation contributed to improved recovery outcomes through increased family involvement and education about the nature and impact of addiction [13] .Peer support groups fostered greater social connectedness and accountability, offering participants a sense of belonging and mutual encouragement [14].Twelve-step facilitation therapy was shown to increase long-term adherence to abstinence-oriented recovery models by promoting spiritual engagement and peer-based support (Project MATCH, 1997). Finally, Mindfulness-Based Relapse Prevention was associated with improved emotional regulation and reductions in craving, helping individuals respond to triggers with greater self-awareness and composure [15].Collectively, these findings provide a robust empirical foundation for the integration of these modalities into a multi-disciplinary intervention targeting the motivational, cognitive, behavioral, social, and emotional dimensions of recovery.

In the third phase, five psychiatrists with specialized expertise in addiction treatment were engaged to evaluate and refine the program. These experts were selected based on their clinical experience (minimum of ten years), academic qualifications, and contributions to addiction research. They reviewed a comprehensive draft of the program, including session outlines, objectives, content, and homework assignments. Evaluations were conducted using structured questionnaires (5-point Likert scales) and semi-structured interviews, focusing on therapeutic coherence, content relevance, implementation feasibility, and cultural adaptability.

The experts assessed the program’s clarity, feasibility, cultural relevance, and therapeutic coherence. They praised the integration of multiple evidence-based modalities, structured homework assignments, and the emphasis on family involvement. Key recommendations included refining session objectives, incorporating facilitator training in mindfulness practices, adapting scheduling for greater accessibility, and increasing cultural tailoring for Arabic-speaking participants. A consensus meeting facilitated the resolution of discrepancies and guided the final revisions, which included clearer session goals, a facilitator training module, culturally relevant examples, and flexible delivery formats.

The socio-demographic analysis showed no significant differences between the active treatment and control groups (P > 0.05). The route of drug administration was similar in both groups (P = 0.65). Sniffing (35.5%) was the most common method, followed by injection (around 33%), multiple routes (15.6%), and oral use (13-15.6%). The active treatment group significantly showed reduced relapse rates compared to controls at both three months (P = 0.001) and six months (P = 0.001). Table 1

Data was presented as mean ± SD. *: Statistically significant at P ≤ 0.05. OUD: Opioid Use Disorder. _X2: for chi-square test. t: independent sample Student’s t test.

#: Relapse confirmed by positive urine test

Craving was significantly lower in the active treatment group (40%) vs. control (88.9%, P = 0.001). No group differences were found in prior detox attempts, duration of use, or heroin dose. Table 2

Data are presented as mean ± SD or frequency (%). *: Statistically significant at P ≤ 0. 05.. _X2: for chi-square test.

Baseline ASI scores were similar, the active treatment group showed significant improvements across all domains in six months. Table 3

Data are presented as mean ± SD.*: Statistically significant at P ≤ 0.05). ASI: Addiction Severity Index. Paired sample Student’s t- test

Active treatment and control groups showed non statistically significant differences in baseline QOL scores across all domains (P > 0.05). The active treatment group showed a significant and progressive improvement in all QOL domains over six months (P = 0.001 from baseline to three months; P < 0.05 from three to six months). In contrast, the control group showed no significant QOL changes during the same period. Among relapse cases, QOL improvements were limited, with only environmental quality reaching significance. Conversely, participants who maintained abstinence demonstrated significant improvements across all QOL domains throughout the study (P < 0.05). Table 4

†: Statistically significant at P ≤ 0.05 between Active treatment versus Control group at 3 months

#: Statistically significant at P ≤ 0.05 between Active treatment versus Control group at 6 months

¥: Statistically significant at P ≤ 0.05 between Relapse versus Abstinence cases at 3 months

^π: : Statistically significant at P ≤ 0.05 between Relapse versus Abstinence cases at 6 months

Survival analysis showed that active treatment significantly reduced relapse risk (HR = 0.65, P = 0.001). Unemployment (HR = 4.98, P = 0.003), illiteracy (HR = 3.43, P = 0.03), and being single (HR = 16.24, P = 0.003) were strong predictors of relapse. Divorced individuals also had elevated risk (HR = 3.43, P = 0.027). Other factors, including age, general employment, and ASI domains, were not significant, highlighting the stronger impact of social over clinical factors on relapse. Table 5

OUD: Opioid Use Disorder, HR: Hazard ratio, Cl: Confidence Interval, ASI: Addiction Severity Index, B: The regression coefficients predict the hazard for relapse. A positive coefficient indicates a positive relationship between the covariate and the hazard for the relapse (higher values on the covariates are associated with less survival time). A negative coefficient indicates a negative relationship between the covariate and the hazard for the terminal event. Higher values on the covariate are associated with longer survival time. Hazard ratio less than 1 are associated with negative regression slopes, whereas values greater than 1 are associated with positive slopes. A hazard ratio of 1 indicates there no change in the hazard per unit change on the covariate.

The present study investigated the impact of a structured relapse prevention program for individuals with opioid use disorder (OUD), comparing outcomes between an active treatment group and a control group across multiple domains including relapse rates, craving intensity, addiction severity, quality of life (QOL), and relapse predictors.

In this study, relapse rates in the active treatment group were 33.3% in three months and 44.4% in six months, significantly lower than the control group’s rates of 67.6% and 77.8%, respectively (P = 0.001). These findings underscore the short-term efficacy of the intervention in delaying relapse. These results were consistent with studies incorporating opioid agonist therapy (OAT). For example, Pashaei et al. [16] reported that patients receiving CBT with methadone had a relapse rate of 36.4%, compared to 63.6% for those receiving methadone alone. However, Goweid et al. [17] reported higher relapse rates in a study conducted at Alexandria University using CBT alone (54.3% at three months and 77.1% at six months), suggesting that the addition of mindfulness and MI in the current study may have contributed to the improved outcomes.

Importantly, craving was significantly reduced among participants receiving active treatment (60%) compared with controls (88.9%). Conversely, a non-significant association was identified between previous psychiatric history and relapse in the active treatment group, aligning with findings by Clark et al [18]., though contrasting with Harsh et al. [19], who observed a significant relationship in a larger cohort. These inconsistencies may stem from methodological variations, including sample size and follow-up duration.

Regarding ASI, the present study demonstrated significant post-intervention decreases in ASI scores across all six domains medical, legal, occupational, substance use, social, and psychiatric in participants who received the active treatment. In particular, the decline in substance-use severity (mean from 7.58 to 2.50) and psychiatric symptoms (from 3.78 to 1.30) aligned with research highlighting the value of comprehensive interventions that target both the physiological and psychosocial dimensions of OUD [20]. Similar reductions in ASI scores have been documented in interventions incorporating mindfulness and cognitive-behavioral components in studies by Moore et al. [21]; Rice et al. [22]; Bolivar et al. [23].

These findings were further supported by recent work by McClain et al. [24], who documented comparable improvements in multiple ASI domains among OUD patients receiving mindfulness-based sessions.

In this study an addiction management program at Tanta Neuropsychiatry and Neurosurgery Center, established comparable baseline characteristics between the active treatment and control groups was crucial for attributing any observed differences to the intervention. Indeed, pre-intervention. QOL measures did not differ significantly between the two groups (all P > 0.05), which aligned with research Ismail et al. [25] indicating that individuals entering opioid treatment programs often share similar psychosocial vulnerabilities.

After six months, the active treatment group showed significant improvements in every QOL domain: Physical Health scores rose from 44.55 (± 13.98) to 70.40 (± 11.75), Psychological Health from 46.42 (± 15.35) to 71.09 (± 11.98), and both social interaction and environmental quality followed a similarly robust upward trend (P = 0.001 for all).

These findings confirm the initial hypothesis and corroborate findings by Vederhus et al. [26], and Manning et al. [27], who similarly reported substantial QOL improvements among individuals achieving abstinence. Conversely, the Control Group displayed non-significant changes in QOL (all P > 0.05), consistent with earlier work underscoring the limitations of minimal or standard treatment approaches by Kelly et al. [28].

The survival analysis conducted to examine the factors associated with relapses to OUD over a six-month follow-up period revealed several significant social determinants that influenced outcomes. Among the most notable findings was the significant protective effect of being in the treatment group, which yielded a hazard ratio (HR) of 0.65 P = 0.001). This result was consistent with multiple recent studies, such as Komasi et al. [29] which demonstrated that structured treatment interventions including counseling and medication-assisted therapy (MAT) significantly reduce the likelihood of relapses among individuals with OUD. Similarly, a quasi- experimental study by Zullig et al. [30] concluded that individuals receiving long-term treatment support had greater retention and lower rates of recurrence. These findings reinforce the central role of structured interventions in mitigating relapse risk and support the ongoing expansion of access to such programs, especially in vulnerable populations.

Another important finding from the analysis was the impact of unemployment on relapse risk. Individuals who were unemployed showed a markedly higher risk of relapse (HR = 4.98, P = 0.003). This result aligned with economic and social theories of addiction, which propose that a lack of structured daily activities, income insecurity, and psychological distress contribute to relapse vulnerability. A study by Nolte-Troha et al. [31] observed that unemployed patients were nearly five times more likely to relapse within 12 months of completing a treatment program. These findings emphasized the importance of integrating vocational training and job placement services into addiction recovery frameworks.

Educational status also emerged as a significant factor as being illiterate was associated with a greater risk of relapses (HR = 3.434, P = 0.03). For instance, Nguyen et al. [32] found that individuals with secondary or higher education had significantly lower relapse rates due to better understanding of treatment protocols and healthier coping strategies. Addressing educational gaps through health education and supportive learning initiatives may be an effective adjunct to relapse prevention strategies.

Marital status was another critical predictor in the model as unmarried participants exhibited the highest relapse risk (HR = 3.43, P = 0.027). These findings were consistent with the literature indicating that social isolation and lack of familial support were key triggers. In comparison, married individuals, though not significant in this analysis, often benefit from emotional stability and social reinforcement. A recent cross-sectional study by Brousseau et al. [33] suggested that married individuals had better treatment retention and reduced recurrence due to family accountability and spousal support. These results underscored the role of social relationships and the need for interventions that foster community and family engagement.

Notably, clinical and psychosocial measures such as the ASI subscales including psychological, medical, drug, employment, family, and legal, did not reach statistical significance in this study. While these domains were often considered integral to comprehensive addiction assessments, their non-significance may reflect overlapping variance with stronger social predictors or the relatively short duration of follow-up. Other studies, such as that by Mar Gica et al. [34] showed these variables to be more predictive over longer follow-up periods or in larger, more diverse cohorts. It was possible that their effects mediated through more direct social determinants such as unemployment and marital disruption.

Future programs should integrate vocational assistance, health education, and family engagement to enhance recovery outcomes. Moreover, long-term follow-up and larger sample size were recommended to further delineate the complex interplay between psychosocial and clinical factors in sustaining recovery.

Limitations of the study included the non-randomized study design which would come second in terms of evidence following the more powerful randomized controlled study design.

Conducting this study in absence of OAT, no similar studies using psychotherapy interventions as single therapeutic modality against OUD were found that represents a challenge for us to compare our results with the results of similar studies. Efficacy of relapse prevention model was only assessed over short duration after psychotherapy intervention (at end of psychotherapy program) while further follow up assessments must be considered over long durations to be able to assess its accurate efficacy

The study revealed that an integrated rehabilitation program was significantly effective in reducing relapse rates and improving the QoL of individuals with OUD. A significantly lower rate of recovery in both three months and six months indicated the effectiveness of the rehabilitation program in maintaining abstinence over time. A marked reduction in the ASI

Through multiple domains after six months, the positive impact of comprehensive treatment on addiction severity and the overall well-being of patients. There were substantial improvements in all aspects of QoL (physical health, psychological health, social interaction, and environmental quality), demonstrating the holistic benefits of the rehabilitation program.

The study indicated that the positive outcomes of the active treatment group were sustained over the six-month period, suggesting that integrated rehabilitation programs had a lasting impact on recovery from OUD.