Substance Use Disorder (SUD)NCT07316335
The Effect of Cognitive Behavioral Model-Based Psychoeducation on Social Exclusion, Hopelessness, and Relapse Levels in Individuals Diagnosed With Substance Use Disorder
A study testing Cognitive Behavioral Therapy (CBT) Theoretical Basic Training Group in people with Substance Use Disorder (SUD), run by Ataturk University.
Trial summary
This research was planned to measure the effect of cognitive behavioral model-based psychoeducation on the level of social exclusion and hope in individuals diagnosed with substance use disorder, as well as teaching them to cope with the relapses they struggle with. Read more about this study
- Who is it for?
- Ages 18 weeks and older
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Cognitive Behavioral Therapy (CBT) Theoretical Basic Training Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being between the ages of 18 and 65,
- Being diagnosed with substance use disorder according to DSM-V,
- Absence of comorbid diagnosis (bipolar disorder, anorexia/bulimia nervosa, psychotic symptoms)
Who cannot join
- People experiencing acute exacerbations
- People who continue to use alcohol or substances
About this study
This research was planned to measure the effect of cognitive behavioral model-based psychoeducation on the level of social exclusion and hope in individuals diagnosed with substance use disorder, as well as teaching them to cope with the relapses they struggle with.
Read the detailed description
Substance addiction is a problem that all societies in the world are exposed to and is increasing in society.It is a serious public health problem. Substance use disorder affects individuals despite the negative consequences in bio-psycho-social areas, people continue to use psychoactive substances.a brain that continues with cravings, cravings for substance use, remissions, and relapses is the disease. There are many problems that continue with relapses and vary depending on the individual's addiction process. In the treatment of problematic substance use disorders, in addition to pharmacological treatment, psychotherapy and psychosocial approaches in which the person can actively participate Adding it to the treatment increases the success rate of the treatment. Psychosocial in substance addiction cognitive behavioral model-based approach, one of the intervention programs, It appears as one of the preferred intervention programs for addicts. Relapse prevention based on cognitive behavioral foundations developed by Marlatt and Gordon relapse prevention program helps reduce the risk of relapse in conditions such as substance use disorders focuses. This program includes various cognitive-behavioral skills that can be effective at different stages of the process. includes approaches. These approaches aim to increase individuals' hopes and improve their social skills.
It aims to develop and strengthen skills in coping with high-risk situationsProgram, It includes strategies that will help individuals regain their self-confidence. This, to ensure that individuals do not despair during the recovery process and that their motivation remains high.
supports their retention. Individuals are healthier and more effective in social interactions and relationships.
aims to communicate. Developing social skills as well as strengthening support systems It also focuses on supporting positive social interactions. The program allows individuals to It offers strategies to help students cope with high-risk situations associated with their use. This skills to cope with situations, the risk of falling behind when faced with risky situations, can reduce it. This relapse prevention program enables individuals to achieve sustainable improvement throughout the treatment process. While helping them achieve their goals, it also aims to minimize the risk of falling behind.
Integration of cognitive behavioral approaches, individuals' healthy lifestyle choices It supports them to become aware of and strengthen these choicesIn this way, they are more likely to learn to cope with and sustain chronic conditions such as substance use disorders.
becomes.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- Cognitive Behavioral Therapy (CBT) Theoretical Basic Training Group
- Keywords
- Psychoeducation based on cognitive behavioral model, substance use disorder, hope, social exclusion
- Medical subject headings
- Substance-Related Disorders, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT) Theoretical Basic Training GroupBehavioural
It was planned to measure the effect of cognitive behavioral model-based psychoeducation on the level of social exclusion and hope in individuals diagnosed with substance use disorder, as well as teaching them to cope with the relapses they struggle with.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Before starting the program, the researcher received a Cognitive Behavioral Therapy (CBT) Theoretical Basic Training certificate. During the preparation of the Cognitive Behavioral Model-Based Psychoeducation Program, first of all, studies in the literature and books on the subject were examined, using both domestic and international sources. While creating training topics, the Cognitive Behavioral Model, which includes various cognitive and behavioral approaches designed to achieve the goal at each stage of the relapse process, was used. Each psychoeducation session will focus on planned topics such as informing patients about substance addiction, teaching them how to cope with high-risk situations, providing skills that can prevent relapses, providing impulse management, teaching stress coping skills, and increasing hope. Before starting the application, expert opinions will be presented and arrangements will be made in line with the suggestions. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) Theoretical Basic Training Group |
| control group | No intervention | The control group will not be given any training or information during this period. They will continue their normal routines and treatments in daily life. After the training process ends, a post-test will be applied to the control group. After the study is completed, psychoeducation will be given to the control group if they request. |
What is being measured
The primary outcome is the main question the study is designed to answer.
implementation of psychoeducation based on the cognitive behavioral model - Social Exclusion Level
Outcome Measure: Social Exclusion Scale
Description:
The Social Exclusion Scale will be used to assess participants' levels of exclusion from social relationships and withdrawal from social participation. Total scale scores will be used for quantitative analysis. The minimum and maximum possible scores and the interpretation of higher scores (indicating greater or lower levels of social exclusion) will be specified in the data analysis plan.
Measured: 16 weeks
implementation of psychoeducation based on the cognitive behavioral model - Hopelessness Level
Outcome Measure: Beck Hopelessness Scale (BHS)
Description:
The Beck Hopelessness Scale will be used to measure participants' levels of hopelessness. Total scores obtained from the scale will reflect the severity of hopelessness. The minimum and maximum possible scores and the interpretation that higher scores indicate higher levels of hopelessness
Measured: 16 weeks
Secondary outcomes (2)
Relapse Coping Skills Scale
- Relapse Coping Level
Outcome Measure: Relapse Coping Skills Scale
Description:
Participants' levels of coping with relapse will be assessed using a structured scale or subscale designed to evaluate relapse coping skills. Total scores obtained from the scale will be used to reflect participants' levels of relapse coping. The score range and interpretation of higher scores will be specified in the data analysis plan.
Measured: 8 weeks
Substance Use Coping Strategies Scale
- Substance Use Coping Strategies
Outcome Measure: Substance Use Coping Strategies Scale
Description:
Coping strategies related to substance use will be assessed using a psychometric scale measuring cognitive and behavioral coping skills. Outcomes will be analyzed based on total scale scores, reflecting participants' use of adaptive coping strategies.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research was planned as a randomized controlled experimental type study.44 people planned to be included in the research sample will be selected by simple random method. Then, it was planned to include 22 patients in the experimental group and 22 patients in the control group by randomization method. During this process, a list of 44 patients who voluntarily agreed to participate in the research will be created. In this list, patients will be numbered from 1 to 44. Then, with the software at http://www.randomizer.org, 22 out of 44 numbers will be randomly assigned to the experimental group and 22 to the control group. After the assignment, patients corresponding to the numbers in the experimental group will be included in the experimental group and patients corresponding to the numbers in the control group will be included in the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Laloglu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316335
- Sponsor's protocol ID
- AİBU-HF-ŞL-01
- Status last verified
- Dec 2025
- First submitted
- 25 Feb 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Behavioral Model-Based Psychoeducation on Social Exclusion, Hopelessness, and Relapse Levels in Individuals Diagnosed With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT07316335
- Acronym / sponsor ID
- AİBU-HF-ŞL-01
- Conditions
- Substance Use Disorder (SUD)
- Keywords
- Psychoeducation based on cognitive behavioral model, substance use disorder, hope, social exclusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Jan 2026 (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.
This research was planned to measure the effect of cognitive behavioral model-based psychoeducation on the level of social exclusion and hope in individuals diagnosed with substance use disorder, as well as teaching them to cope with the relapses they struggle with.
Detailed description
Substance addiction is a problem that all societies in the world are exposed to and is increasing in society.It is a serious public health problem. Substance use disorder affects individuals despite the negative consequences in bio-psycho-social areas, people continue to use psychoactive substances.a brain that continues with cravings, cravings for substance use, remissions, and relapses is the disease. There are many problems that continue with relapses and vary depending on the individual's addiction process. In the treatment of problematic substance use disorders, in addition to pharmacological treatment, psychotherapy and psychosocial approaches in which the person can actively participate Adding it to the treatment increases the success rate of the treatment. Psychosocial in substance addiction cognitive behavioral model-based approach, one of the intervention programs, It appears as one of the preferred intervention programs for addicts. Relapse prevention based on cognitive behavioral foundations developed by Marlatt and Gordon relapse prevention program helps reduce the risk of relapse in conditions such as substance use disorders focuses. This program includes various cognitive-behavioral skills that can be effective at different stages of the process. includes approaches. These approaches aim to increase individuals' hopes and improve their social skills.
It aims to develop and strengthen skills in coping with high-risk situationsProgram, It includes strategies that will help individuals regain their self-confidence. This, to ensure that individuals do not despair during the recovery process and that their motivation remains high.
supports their retention. Individuals are healthier and more effective in social interactions and relationships.
aims to communicate. Developing social skills as well as strengthening support systems It also focuses on supporting positive social interactions. The program allows individuals to It offers strategies to help students cope with high-risk situations associated with their use. This skills to cope with situations, the risk of falling behind when faced with risky situations, can reduce it. This relapse prevention program enables individuals to achieve sustainable improvement throughout the treatment process. While helping them achieve their goals, it also aims to minimize the risk of falling behind.
Integration of cognitive behavioral approaches, individuals' healthy lifestyle choices It supports them to become aware of and strengthen these choicesIn this way, they are more likely to learn to cope with and sustain chronic conditions such as substance use disorders.
becomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research was planned as a randomized controlled experimental type study.44 people planned to be included in the research sample will be selected by simple random method. Then, it was planned to include 22 patients in the experimental group and 22 patients in the control group by randomization method. During this process, a list of 44 patients who voluntarily agreed to participate in the research will be created. In this list, patients will be numbered from 1 to 44. Then, with the software at http://www.randomizer.org, 22 out of 44 numbers will be randomly assigned to the experimental group and 22 to the control group. After the assignment, patients corresponding to the numbers in the experimental group will be included in the experimental group and patients corresponding to the numbers in the control group will be included in the control group.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT) Theoretical Basic Training GroupBefore starting the program, the researcher received a Cognitive Behavioral Therapy (CBT) Theoretical Basic Training certificate. During the preparation of the Cognitive Behavioral Model-Based Psychoeducation Program, first of all, studies in the literature and books on the subject were examined, using both domestic and international sources. While creating training topics, the Cognitive Behavioral Model, which includes various cognitive and behavioral approaches designed to achieve the goal at each stage of the relapse process, was used. Each psychoeducation session will focus on planned topics such as informing patients about substance addiction, teaching them how to cope with high-risk situations, providing skills that can prevent relapses, providing impulse management, teaching stress coping skills, and increasing hope. Before starting the application, expert opinions will be presented and arrangements will be made in line with the suggestions. |
| control group | No intervention | –The control group will not be given any training or information during this period. They will continue their normal routines and treatments in daily life. After the training process ends, a post-test will be applied to the control group. After the study is completed, psychoeducation will be given to the control group if they request. |
Who may qualify
- Ages
- 18 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18 and 65,
- Being diagnosed with substance use disorder according to DSM-V,
- Absence of comorbid diagnosis (bipolar disorder, anorexia/bulimia nervosa, psychotic symptoms)
Key exclusion criteria (2 listed)
- People experiencing acute exacerbations
- People who continue to use alcohol or substances
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 |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) Theoretical Basic Training GroupIt was planned to measure the effect of cognitive behavioral model-based psychoeducation on the level of social exclusion and hope in individuals diagnosed with substance use disorder, as well as teaching them to cope with the relapses they struggle with. | Behavioural | experimental group |
Primary outcome
implementation of psychoeducation based on the cognitive behavioral model - Social Exclusion Level
Time frame: 16 weeks
Outcome Measure: Social Exclusion Scale Description: The Social Exclusion Scale will be used to assess participants' levels of exclusion from social relationships and withdrawal from social participation. Total scale scores will be used for quantitative analysis. The minimum and maximum possible scores and the interpretation of higher scores (indicating greater or lower levels of social exclusion) will be specified in the data analysis plan.
implementation of psychoeducation based on the cognitive behavioral model - Hopelessness Level
Time frame: 16 weeks
Outcome Measure: Beck Hopelessness Scale (BHS) Description: The Beck Hopelessness Scale will be used to measure participants' levels of hopelessness. Total scores obtained from the scale will reflect the severity of hopelessness. The minimum and maximum possible scores and the interpretation that higher scores indicate higher levels of hopelessness
2 secondary outcomes
Relapse Coping Skills Scale
Time frame: 8 weeks
Substance Use Coping Strategies Scale
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) Theoretical Basic Training Group in people with Substance Use Disorder (SUD), run by Ataturk University.
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 3 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: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
implementation of psychoeducation based on the cognitive behavioral model - Social Exclusion Level (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.