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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- 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.
- 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.
- 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
- Conditions
- Substance Use Disorders
- 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 group | Role | What they receive |
|---|---|---|
| Quasi-experimental one group Pre-post test | Other | A 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.
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)
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.
- First posted16 Sep 2025
- Study start1 Feb 2024
- Primary completion30 Apr 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelmouttelb Abdelkawy, Ain Shams University
- Investigators
- Abdelmouttelb Ab Abdelkawy, Ass/Lecturer, Principal investigator, Psychiatric/Mental Health Nursing Faculty of Nursing Ain Shams University-Cairo-Egypt.Fatma Mo Ibrahim, Assist/Prof, Study director, Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.Fatma At Abdelsalhen, Assist/Prof, Study director, Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.Sahar Ma Elewa, Professor, Study chair, Psychiatric/Mental Health Nursing Faculty of Nursing Ain Shams University-Cairo-Egypt.
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 24932389Ebrahem 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 36378090Abdelmouttelb 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life-Skills Training Program: Its Effect on Self-efficacy Among Patients With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07174960
- Acronym / sponsor ID
- NUR1. 25.01.527
- Conditions
- Substance Use Disorders
- Keywords
- Life-Skills, Substance use disorders, self-efficacy, relapse, Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- life-skills training program
| Arm | Type | Receives |
|---|---|---|
| Quasi-experimental one group Pre-post test | Other | Behavioral: Life-Skills Training ProgramA 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with chronic physical illnesses (e.g., diabetes, hypertension, or viral hepatitis)
- comorbid psychiatric disorders (e.g., schizophrenia, bipolar disorder, or depression) were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life-Skills Training ProgramThis 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. | Behavioural | Quasi-experimental one group Pre-post test |
Primary outcome
Interview Questionnaire
Time frame: The assessment period for each participant was 10 weeks from the start of their participation in the study.
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)
1 secondary outcome
Clinical Data (Addiction History)
Time frame: The assessment period for each participant was 10 weeks from the start of their participation in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 24932389Moshki 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.
- Background: PubMed 36378090Ebrahem 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.
- Results publication: PubMed 41566382Abdelmouttelb 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.
- Individual participant dataSharing planned: Yes. Study Protocol, Informed Consent Form (ICF), all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelmouttelb Ab Abdelkawy, Ass/Lecturer principal investigator
Psychiatric/Mental Health Nursing Faculty of Nursing Ain Shams University-Cairo-Egypt.
Fatma Mo Ibrahim, Assist/Prof study director
Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.
Fatma At Abdelsalhen, Assist/Prof study director
Psychiatric/Mental Health Nursing , Faculty of Nursing Ain Shams University-Cairo-Egypt.
2 sites in 1 country: see every site and its status.
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.