NCT07316335

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

February 25, 2025

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

February 25, 2025

Last Update Submit

January 2, 2026

Conditions

Keywords

Psychoeducation based on cognitive behavioral modelsubstance use disorderhopesocial exclusion

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    16 weeks

Secondary Outcomes (2)

  • Relapse Coping Skills Scale

    8 weeks

  • Substance Use Coping Strategies Scale

    8 weeks

Study Arms (2)

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.

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.

Interventions

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.

experimental group

Eligibility Criteria

Age18 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • People experiencing acute exacerbations
  • People who continue to use alcohol or substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related DisordersSocial Isolation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist nurse

Study Record Dates

First Submitted

February 25, 2025

First Posted

January 5, 2026

Study Start

January 30, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 5, 2026

Record last verified: 2025-12