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Substance Use DisordersNCT07174960

Life-Skills Training Program: Its Effect on Self-efficacy Among Patients With Substance Use Disorders

A study testing Life-Skills Training Program in people with Substance Use Disorders, run by Ain Shams University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years, men only
Conditions the study is for
Substance Use Disorders
What is being tested?
Life-Skills Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesEgypt
Study dates
1 Feb 2024to 25 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • male patients with substance use disorders
  • aged 20 to 50 years
  • who had experienced at least one relapse episode.
  • All participants had completed a minimum of three weeks in detoxification and were actively involved in a structured rehabilitation program at the time of the study

Who cannot join

  • Patients with chronic physical illnesses (e.g., diabetes, hypertension, or viral hepatitis)
  • comorbid psychiatric disorders (e.g., schizophrenia, bipolar disorder, or depression) were excluded

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • El Abbasia Mental Health Hospital

    Cairo, El Abbasia, 11511

  • faculty of Nursing Ain Shams University

    Cairo, El Abbasia, 11511

Other trials in Egypt

About this study

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

Read the 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

Being tested
Life-Skills Training Program
Keywords
Life-Skills, Substance use disorders, self-efficacy, relapse, Addiction
Medical subject headings
Substance-Related Disorders, Recurrence, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Life-Skills Training ProgramBehavioural

    This study aims to assess the impact of a life-skills training program on self-efficacy in patients with substance use disorders. The program is designed to prevent relapse by equipping individuals with crucial skills for managing triggers and challenges. It focuses on developing constructive coping strategies, effective stress and craving management techniques, social competencies like assertiveness, and emotional regulation abilities including anger control. By enhancing these domains, the intervention seeks to strengthen patients' confidence in their capacity to resist substance use and make adaptive decisions, thereby reducing relapse risk.

Study groups in NCT07174960
Study groupRoleWhat they receive
Quasi-experimental one group Pre-post testOtherA 16-session program to boost self-efficacy \& prevent relapse in SUD patients. It combines theoretical knowledge (5 sessions) with practical skills training (10 sessions) across cognitive skills, communication, and emotional skills. Uses interactive methods like role-play \& discussion to teach vital life skills for recovery.
Receives: Behavioral: Life-Skills Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interview Questionnaire

    Patients' characteristics. such as age, marital status (Single, Married, Divorced,\& Widowed), Education levels (Read/ write, Primary, Secondary, and University or more) residence (Urban \&Rural), Monthly income ( Enough, Fairly enough, \& Not enough), Occupation (Don't work, Handicraft's work, and Administrative job) Number of Family members ( =2, =3, and ≥ 4)

    Measured: The assessment period for each participant was 10 weeks from the start of their participation in the study.

Secondary outcomes (1)
  1. Clinical Data (Addiction History)

    Covered detailed information regarding the substance use history, including the types of substances used, duration of use (Less than 1 year, 1 -<5 years, 5 -<10 years, ≥ 10 years), route of administration (oral, inhalation, smoking, smell, and injection, history of previous treatment attempts (yse, no, number of times) types of treatment admissions (voluntary, \& involuntary) and presence of substance cravings and numbers.

    Measured: The assessment period for each participant was 10 weeks from the start of their participation in the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start1 Feb 2024
  3. Primary completion30 Apr 2024
  4. Study completion25 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
life-skills training program
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174960
Sponsor's protocol ID
NUR1. 25.01.527
Status last verified
Jan 2026
First submitted
21 Aug 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol, Informed Consent Form (ICF), all IPD that underlie results in a publication

Publications

  • Moshki M, Hassanzade T, Taymoori P. Effect of Life Skills Training on Drug Abuse Preventive Behaviors among University Students. Int J Prev Med. 2014 May;5(5):577-83.

    PubMed 24932389
  • Ebrahem SM, Badawy SA, Hassan RA, Radwan HA, Shokr EA, Hussein AA. Effect of Telehealth Nursing Intervention on Psychological Status and Coping Strategies Among Parents During COVID-19 Pandemic. Holist Nurs Pract. 2023 Jan-Feb 01;37(1):34-44. doi: 10.1097/HNP.0000000000000561.

    PubMed 36378090
  • Abdelmouttelb AA, Elewa SMM, Abdelsalhen FA, Ibrahim FM. Life-skills training program: its effect on self-efficacy among patients with substance use disorders. BMC Psychol. 2026 Jan 21;14(1):119. doi: 10.1186/s40359-025-03907-2.

    PubMed 41566382

Questions about this trial

What is this clinical trial studying?

A study testing Life-Skills Training Program in people with Substance Use Disorders, run by Ain Shams University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interview Questionnaire (time frame: The assessment period for each participant was 10 weeks from the start of their participation in the study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07174960, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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Clinical Trial NCT07174960 | AzTrials