- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07316335
The Effect of Cognitive Behavioral Model-Based Psychoeducation on Social Exclusion, Hopelessness, and Relapse Levels in Individuals Diagnosed With Substance Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- People experiencing acute exacerbations
- People who continue to use alcohol or substances
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
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.
|
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.
|
|
No Intervention: control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
16 weeks
|
|
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 |
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relapse Coping Skills Scale
Time Frame: 8 weeks
|
1. 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. |
8 weeks
|
|
Substance Use Coping Strategies Scale
Time Frame: 8 weeks
|
2. 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. |
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AİBU-HF-ŞL-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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