NCT05812469

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

March 1, 2023

Last Update Submit

April 2, 2023

Conditions

Keywords

Brain AwarenessPsychoeducationMetacognitionSelf-efficacyTreatment Motivation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

experimental group

EXPERIMENTAL

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

Behavioral: Brain Awareness Intervention

control group

ACTIVE COMPARATOR

38 patients will receive education about Being Healthy

Behavioral: Being Healthy Education

Interventions

effect of brain awareness intervention on metacognition, self-efficacy and treatment motivation in patients with alcohol and substance use disorders

experimental group

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.

control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halil Ibrahim Olcum

Çorum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Substance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is an experimentally designed study with a randomized control group and repeated measurements (pre-test, mid-test, post-test).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2023

First Posted

April 13, 2023

Study Start

April 1, 2021

Primary Completion

October 1, 2021

Study Completion

March 1, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations