Back to resultsInvestigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation
Primary Purpose
Substance Use Disorders, Self Efficacy, Addiction
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for Substance Use Disorders focused on measuring Substance Use Disorder, Psychosocial Intervention, Self Efficacy, Psychiatric Nursing
Eligibility Criteria
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).
Sites / Locations
- Aydın Adnan Menderes University Faculy of Nursing, Division Mental HealthNursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
psychoeducation applied experimental group
non-intervention control group
Arm Description
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.
Control group: The control group continued to receive the routine care.
Outcomes
Primary Outcome Measures
Addiction Profile Index (Bapi) Clinical Form
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 .
Addiction Profile Index (Bapi) Clinical Form
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.
Addiction Outcome Assessment Index (AOAI)
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 .
Addiction Outcome Assessment Index (AOAI)
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 .
Self-Efficacy Scale (SES)
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.
Self-Efficacy Scale (SES)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05941195
First Posted
June 2, 2023
Last Updated
July 3, 2023
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT05941195
Brief Title
Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study, which was planned to examine the effects of cognitive behavioral approach-based psychoeducation on addiction profiles, self-efficacy levels and addiction courses in patients with substance use disorders, was carried out as a randomized controlled experimental study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Self Efficacy, Addiction
Keywords
Substance Use Disorder, Psychosocial Intervention, Self Efficacy, Psychiatric Nursing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Following recruitment, person who the substance use disorder were divided into a study and a control group by randomization (1:1 randomization)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
psychoeducation applied experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
non-intervention control group
Arm Type
No Intervention
Arm Description
Control group: The control group continued to receive the routine care.
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Addiction Profile Index (Bapi) Clinical Form
Description
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 .
Time Frame
The first measurement was made in the 1st week.
Title
Addiction Profile Index (Bapi) Clinical Form
Description
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.
Time Frame
The last measurement was made at the 5th week.
Title
Addiction Outcome Assessment Index (AOAI)
Description
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 .
Time Frame
The first measurement was made in the 1st week.
Title
Addiction Outcome Assessment Index (AOAI)
Description
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 .
Time Frame
The last measurement was made at the 5th week.
Title
Self-Efficacy Scale (SES)
Description
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.
Time Frame
The first measurement was made in the 1st week.
Title
Self-Efficacy Scale (SES)
Description
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.
Time Frame
The last measurement was made at the 5th week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma DEMİRKIRAN, Phd
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aydın Adnan Menderes University Faculy of Nursing, Division Mental HealthNursing
City
Aydın
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
IPD Sharing Time Frame
2 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
34392509
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
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Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation
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