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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05812469
Other study ID # BA-project
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date March 1, 2023

Study information

Verified date April 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date March 1, 2023
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Being between the ages of 18-65 and able to read and write 2. Inpatient treatment with alcohol or substance abuse problem 3. To not have a psychiatric (severe depression, bipolar disorder or psychosis) or mental illness that would prevent participation in the study Exclusion Criteria: 1. Failure to participate in more than one session despite agreeing to participate in the research 2. Taking the decision to terminate treatment or early discharge by violating treatment rules during the treatment process 3. Not participating in post-discharge follow-up or post-test application

Study Design


Intervention

Behavioral:
Brain Awareness Intervention
effect of brain awareness intervention on metacognition, self-efficacy and treatment motivation in patients with alcohol and substance use disorders
Being Healthy Education
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.

Locations

Country Name City State
Turkey Halil Ibrahim Olcum Çorum

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
72 Hours
Primary 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.
72 Hours
Primary 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. 72 Hours
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