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A Psychoeducational Intervention for Brain Awareness, Metacognition, Self-efficacy and Treatment Motivation

Primary Purpose

Substance Use Disorders, Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Brain Awareness Intervention
Being Healthy Education
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Brain Awareness, Psychoeducation, Metacognition, Self-efficacy, Treatment Motivation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being between the ages of 18-65 and able to read and write Inpatient treatment with alcohol or substance abuse problem To not have a psychiatric (severe depression, bipolar disorder or psychosis) or mental illness that would prevent participation in the study Exclusion Criteria: Failure to participate in more than one session despite agreeing to participate in the research Taking the decision to terminate treatment or early discharge by violating treatment rules during the treatment process Not participating in post-discharge follow-up or post-test application

Sites / Locations

  • Halil Ibrahim Olcum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

psychoeducation and counseling provided as part of the Brain Awareness Intervention for the experimental group of 39 patients

38 patients will receive education about Being Healthy

Outcomes

Primary Outcome Measures

Metacognition Scale-30
There are five sub-factors of the PPI-30 scale: Positive beliefs (items 1,7,10,20,23 and 28), Uncontrollability and danger (items 2,3,4,9,11,16 and 22), Cognitive confidence (items 8,14,18,24,26 and 29), Need to control thoughts (items 6,13,15,21,25 and 27) and Cognitive awareness (items 5,12,17,19 and 30). The PPI-30 is a four-point Likert-type scale ranging from "1 - Strongly disagree" to "4 - Strongly agree". Scores between 30 and 120 can be obtained from the scale, there is no reverse-scored item, and a higher score indicates an increase in pathological metacognitive activity. It is reported that the Cronbach Alpha reliability value of the Turkish version of the scale is 0.86 and the Cronbach Alpha value of the sub-dimensions is between 0.72 and 0.93.
Self-Efficacy-Efficacy Scale
The 23-question form of the scale has four subscales: initiating the behavior, maintaining the behavior, completing the behavior and struggling with obstacles. The SCBS is a five-point Likert-type scale ranging from "1 - does not describe me at all" to "5 - describes me very well". Scores between 23 and 115 can be obtained from the scale. Items 2,4,5,6,7,10,11,12,12,14,16,17,18,20 and 22 in the scale are reverse-scored and an increase in the total score means that the individual's self-efficacy perception is at a good level. The Cronbach Alpha reliability value of the Turkish version of the scale is 0.81.
Treatment Motivation Questionnaire
The Treatment Motivation Questionnaire is a five-point Likert-type questionnaire ranging from "1 - Strongly disagree" to "5 - Strongly agree". A score between 26-130 can be obtained from the questionnaire. Items 13, 16, 21 and 24 in the questionnaire are reverse-scored in the opposite direction and an increase in the total score obtained from the questionnaire means that the individual's treatment motivation is high. The Cronbach Alpha reliability value of the Turkish version of the questionnaire is 0.84.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2023
Last Updated
April 2, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05812469
Brief Title
A Psychoeducational Intervention for Brain Awareness, Metacognition, Self-efficacy and Treatment Motivation
Official Title
The Effect of a Psychoeducational Intervention for Brain Awareness Applied on Patients With Alcohol and Substance Use Disorders on Metacognition, Self-efficacy and Treatment Motivation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

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
The aim of this study is to examine the effect of brain awareness intervention on metacognition, self-efficacy and treatment motivation in patients with alcohol and substance use disorders. It is an experimentally designed study with a randomized control group and repeated measurements (pre-test, mid-test, post-test).
Detailed Description
The aim of this study is to examine the effect of brain awareness intervention on metacognition, self-efficacy and treatment motivation in patients with alcohol and substance use disorders. It is an experimentally designed study with a randomized control group and repeated measurements (pre-test, mid-test, post-test). 77 inpatients at the Alcohol and Drug Addiction Treatment and Research Center included between April and October 2021. In addition to standard treatment, psychoeducation and counseling provided as part of the Brain Awareness Intervention for the experimental group of 39 patients. The control group of 38 patients will receive education about Being Healthy in addition to standard treatment and standard follow-up. Patients' pathological metacognitive activities, self-efficacy perceptions and treatment motivation will assessed with the Metacognition Scale-30, Self-Efficacy Scale and Treatment Motivation Questionnaire using one-way and two-way repeated measures analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Alcohol Use Disorder
Keywords
Brain Awareness, Psychoeducation, Metacognition, Self-efficacy, Treatment Motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is an experimentally designed study with a randomized control group and repeated measurements (pre-test, mid-test, post-test).
Masking
Participant
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
psychoeducation and counseling provided as part of the Brain Awareness Intervention for the experimental group of 39 patients
Arm Title
control group
Arm Type
Active Comparator
Arm Description
38 patients will receive education about Being Healthy
Intervention Type
Behavioral
Intervention Name(s)
Brain Awareness Intervention
Intervention Description
effect of brain awareness intervention on metacognition, self-efficacy and treatment motivation in patients with alcohol and substance use disorders
Intervention Type
Behavioral
Intervention Name(s)
Being Healthy Education
Intervention Description
This training included trainings on Healthy Nutrition, Sexually Transmitted Diseases, Importance of Physical Activity and Personal Hygiene prepared by the researcher in the form of presentations for the patients in the control group.
Primary Outcome Measure Information:
Title
Metacognition Scale-30
Description
There are five sub-factors of the PPI-30 scale: Positive beliefs (items 1,7,10,20,23 and 28), Uncontrollability and danger (items 2,3,4,9,11,16 and 22), Cognitive confidence (items 8,14,18,24,26 and 29), Need to control thoughts (items 6,13,15,21,25 and 27) and Cognitive awareness (items 5,12,17,19 and 30). The PPI-30 is a four-point Likert-type scale ranging from "1 - Strongly disagree" to "4 - Strongly agree". Scores between 30 and 120 can be obtained from the scale, there is no reverse-scored item, and a higher score indicates an increase in pathological metacognitive activity. It is reported that the Cronbach Alpha reliability value of the Turkish version of the scale is 0.86 and the Cronbach Alpha value of the sub-dimensions is between 0.72 and 0.93.
Time Frame
72 Hours
Title
Self-Efficacy-Efficacy Scale
Description
The 23-question form of the scale has four subscales: initiating the behavior, maintaining the behavior, completing the behavior and struggling with obstacles. The SCBS is a five-point Likert-type scale ranging from "1 - does not describe me at all" to "5 - describes me very well". Scores between 23 and 115 can be obtained from the scale. Items 2,4,5,6,7,10,11,12,12,14,16,17,18,20 and 22 in the scale are reverse-scored and an increase in the total score means that the individual's self-efficacy perception is at a good level. The Cronbach Alpha reliability value of the Turkish version of the scale is 0.81.
Time Frame
72 Hours
Title
Treatment Motivation Questionnaire
Description
The Treatment Motivation Questionnaire is a five-point Likert-type questionnaire ranging from "1 - Strongly disagree" to "5 - Strongly agree". A score between 26-130 can be obtained from the questionnaire. Items 13, 16, 21 and 24 in the questionnaire are reverse-scored in the opposite direction and an increase in the total score obtained from the questionnaire means that the individual's treatment motivation is high. The Cronbach Alpha reliability value of the Turkish version of the questionnaire is 0.84.
Time Frame
72 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being between the ages of 18-65 and able to read and write Inpatient treatment with alcohol or substance abuse problem To not have a psychiatric (severe depression, bipolar disorder or psychosis) or mental illness that would prevent participation in the study Exclusion Criteria: Failure to participate in more than one session despite agreeing to participate in the research Taking the decision to terminate treatment or early discharge by violating treatment rules during the treatment process Not participating in post-discharge follow-up or post-test application
Facility Information:
Facility Name
Halil Ibrahim Olcum
City
Çorum
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Psychoeducational Intervention for Brain Awareness, Metacognition, Self-efficacy and Treatment Motivation

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