Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT07174960
Brief Summary:
The goal of this clinical trial is to evaluate the effect of life-skills training program on self-efficacy among patients with substance in purposive sample male participants diagnosed with substance use disorders, aged from 20 :50 years old. Hypothesis Participants' Self-efficacy will be improved after implementation the life skills training program.
A quasi-experimental one-group pretest-post-test design was used
Detailed Description:
1. Introduction and Rationale Substance Use Disorders (SUDs) represent a significant global public health challenge, characterized by a chronic, relapsing-remitting cycle influenced by biological, behavioral, and environmental factors. In Egypt, the prevalence is estimated at 5.9%, with the highest exposure among youth (15-25 years) and the highest treatment demand in the 25-35 age group. Alarmingly, relapse rates post-treatment can reach 40-75% within weeks to months, underscoring the inadequacy of detoxification-focused models that neglect psychosocial rehabilitation.
A critical factor in sustaining recovery is self-efficacy (SE), particularly abstinence self-efficacy (ASE)-an individual's confidence in their ability to resist substance use in high-risk situations. Low SE is linked to poor motivation, increased withdrawal symptoms, and higher relapse susceptibility. Life skills, defined by the WHO as psychosocial competencies for adaptive and positive behavior, are foundational for managing triggers, stress, and social pressures. Training in these skills (e.g., problem-solving, communication, emotional regulation) is hypothesized to enhance SE, thereby reducing relapse risk. This study aimed to evaluate the effect of a structured life-skills training program on self-efficacy among patients with SUDs in a Cairo-based hospital.
2. Study Objectives and Hypothesis
Primary Aim: To evaluate the effect of a life-skills training program on self-efficacy among patients with SUDs.
Primary Hypothesis: Self-efficacy will significantly improve following the implementation of the life-skills training program.
3. Methods 3.1. Study Design: A quasi-experimental, one-group pre-test/post-test design was employed.
3.2. Setting: The study was conducted in the male addiction treatment and rehabilitation wards (detox and rehab) of the new building at El-Abbasia Mental Health Hospital in Cairo, Egypt.
3.3. Participants: A purposive sample of 45 male patients was recruited. Inclusion criteria were: age 20-50 years, a history of at least one relapse episode, being 3 weeks post-detoxification and engaged in rehabilitation, and being free from major comorbid physical (e.g., diabetes, hypertension) or psychiatric disorders. Sample size was determined via power analysis (α=0.05, β=0.15) based on a previous study.
3.4. Intervention (Life-Skills Training Program): The researcher-developed program, reviewed by supervisors and grounded in literature, comprised 15 core sessions (5 theoretical, 10 practical) plus orientation and closure sessions, delivered over 60 minutes each.
Theoretical Component (Sessions 1-5): Covered SUD concepts, substance classifications, risk factors, relapse triggers, recovery stages, craving management, and introductions to self-efficacy and life skills.
Practical Component (Sessions 6-15): Focused on applied skill-building across three domains:
Cognitive (Sessions 6-8): Problem-solving, decision-making, time management, and cognitive restructuring.
Communication (Sessions 9-12): Refusal, assertiveness, negotiation, and non-violent communication skills.
Emotional (Sessions 13-15): Anger management, meditation, relaxation techniques, and emotional regulation.
Pedagogy: Interactive methods were used, including open discussions, brainstorming, role-playing, demonstrations, videos, and handouts. Each session included homework review, feedback, objective setting, and a Q\&A period.
3.5. Data Collection Tools:
Tool I: Interview Questionnaire: Collected socio-demographic and clinical data (substance type, history, treatment trials).
Tool II: Alcohol Abstinence Self-Efficacy Scale (AASE): A validated 40-item scale measuring confidence to abstain across four domains: Negative Affect, Social/Positive Situations, Physical Concerns, and Craving/Urges. Rated on a 5-point Likert scale (1=No Confidence to 5=Excellent Confidence). Total scores range from 40-200. Demonstrated high reliability in this study (Cronbach's α = 0.968).
3.6. Data Collection Procedure: The 7-month study (Feb-Aug 2024) followed stages: ethical approvals, baseline (pre-test) data collection using Tools I and II, program implementation for two cohorts (n=25, n=20), and post-intervention (post-test) data collection in September 2024 using the AASE.
3.7. Statistical Analysis: Data were analyzed using SPSS v26. Descriptive statistics (frequencies, percentages, means, standard deviations) described the sample. A paired t-test was used to compare pre- and post-intervention self-efficacy scores, with a significance level of p \< 0.05.
Ethics: Approved by the Faculty of Nursing, Ain Shams University IRB (ID: NUR1.25.01.527). Informed consent was obtained from all participants
Study:
NCT07174960
Study Brief:
Protocol Section:
NCT07174960