- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05941195
Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation
Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation on Addiction Profile, Self-efficacy and Addiction Course in Substance Use Disorder Randomized Controlled Experimental Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It can be said that alcohol/substance nurses, by applying cognitive behavioral approach-based psychoeducation to patients with substance use disorders, can have a positive effect on reducing the severity of addiction, increasing their self-efficacy levels, and providing the care, education and counseling support that patients need.
The aim of this study is to examine the effects of cognitive behavioral approach-based psychoeducation applied to patients with substance use disorder on addiction profiles, self-efficacy levels and addiction courses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aydın, Turkey
- Aydın Adnan Menderes University Faculy of Nursing, Division Mental HealthNursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To be diagnosed with "Substance Use Disorder" according to The Diagnostic and Statistical Manual of Mental Disorders-V,
- To be over 18 years old,
- Volunteering to participate in the research.
Exclusion Criteria:
- Other than Substance Use Disorder, chronic, requiring ongoing help and care the presence of a medical illness,
- Being illiterate (the types of scales to be used must be self-report forms) because of).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: psychoeducation applied experimental group
The patients in the experimental group received a total of 5 weeks (9 sessions) of cognitive-behavioral-based psychoeducation, consisting of 45-60 minutes, 2 sessions per week and the first session preparation session.
In the sessions, the topics determined by using learning activities such as lecture, discussion, summarization, role-play, question/answer and exercises were explained and discussed.
At the end of each session, homework was given to facilitate the patient's cognitive and behavioral change between sessions.
|
In the cognitive behavioral approach based psychoeducation given to the experimental group patients; "Addiction and Its Effects", "Increasing and Maintaining Motivation", "The Cognitive Model and the Cognitive Model of Addiction", "Automatic Thoughts That Increase Impulse to Substance Use", "Dysfunctional Beliefs Regarding Substance Use", "High Risk Situations and Coping Skills", " The topics of "Prevention of Slippage and Recurrence" and "Problem Solving" are included.
|
|
No Intervention: non-intervention control group
Control group: The control group continued to receive the routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Addiction Profile Index (Bapi) Clinical Form
Time Frame: The first measurement was made in the 1st week.
|
Addiction Profile Index Clinical Form was created by adding 21 questions to the Addiction Profile Index developed in 2012 to measure the severity of addiction.
It consists of 58 questions in total and has 11 sub-dimensions.
It evaluates different dimensions of addictions of alcohol and substance users.
Two of the six domains of the scale measure mental state, while the others measure some personal characteristics related to addiction .
|
The first measurement was made in the 1st week.
|
|
Addiction Profile Index (Bapi) Clinical Form
Time Frame: The last measurement was made at the 5th week.
|
Addiction Profile Index Clinical Form was created by adding 21 questions to the Addiction Profile Index developed in 2012 to measure the severity of addiction.
It consists of 58 questions in total and has 11 sub-dimensions.
It evaluates different dimensions of addictions of alcohol and substance users.
Two of the six domains of the scale measure mental state, while the others measure some personal characteristics related to addiction.
|
The last measurement was made at the 5th week.
|
|
Addiction Outcome Assessment Index (AOAI)
Time Frame: The first measurement was made in the 1st week.
|
The Addiction Outcome Index (BASI) was developed to measure the treatment course and recovery level of addiction in all areas and to be used in follow-up.
The score that can be obtained from the scale is between 0-32.
A decrease of 3.5 points from the total score of the scale in clinical follow-up indicates a reliable change .
|
The first measurement was made in the 1st week.
|
|
Addiction Outcome Assessment Index (AOAI)
Time Frame: The last measurement was made at the 5th week.
|
The Addiction Outcome Index (BASI) was developed to measure the treatment course and recovery level of addiction in all areas and to be used in follow-up.
The score that can be obtained from the scale is between 0-32.
A decrease of 3.5 points from the total score of the scale in clinical follow-up indicates a reliable change .
|
The last measurement was made at the 5th week.
|
|
Self-Efficacy Scale (SES)
Time Frame: The first measurement was made in the 1st week.
|
The scale was first developed in the English language in 1982.
It was adapted into Turkish in 1999 and follows the course of self-efficacy expectations that need to be changed in individual therapy during the therapy process.
The Self-Efficacy Scale consists of 23 items and 4 sub-factors.
A minimum of 23 and a maximum of 115 points can be obtained from the scale.
A high total score from the scale indicates that the individual's self-efficacy perception is at a good level.
|
The first measurement was made in the 1st week.
|
|
Self-Efficacy Scale (SES)
Time Frame: The last measurement was made at the 5th week.
|
The scale was first developed in the English language in 1982 .
It was adapted into Turkish in 1999 and follows the course of self-efficacy expectations that need to be changed in individual therapy during the therapy process.
The Self-Efficacy Scale consists of 23 items and 4 sub-factors.
A minimum of 23 and a maximum of 115 points can be obtained from the scale.
A high total score from the scale indicates that the individual's self-efficacy perception is at a good level.
|
The last measurement was made at the 5th week.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma DEMİRKIRAN, Phd, Aydin Adnan Menderes University
Publications and helpful links
General Publications
- Ögel K, Koç C, Başabak A, İşmen EM, Görücü S. Bağımlılık profil indeksi klinik formunun (BAPİ-K) geliştirilmesi: Geçerlik ve güvenilirlik Çalışması. Bağımlılık Dergisi.2015; 16(2), 57-69.
- Simsek M, Dinc M, Ogel K. The Validity aand Reliability of the Addiction Outcome Assessment Index (AOAI). Turk Psikiyatri Derg. 2021 Summer;32(2):129-136. doi: 10.5080/u23461. English, Turkish.
- Sherer M, Maddux JE, Mercandante B, Prentice-Dunn S, Jacobs B, Rogers R W. The self-efficacy scale: Construction and validation. Psychological reports.1982; 51(2), 663-671.
- Gözüm S, Aksayan S. Öz-etkililik-yeterlik ölçeği'nin türkçe formunun güvenilirlik ve geçerliliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi. 1999; 2(1): 21-34.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adnan MU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
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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