- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04152525
The Effect of Awareness-Based Education Given to Individuals With Substance Use Disorder on Self-Efficacy Perception
The Effect of Mindfulness-Based Education Given to Individuals With Substance-Use Disorder According to SelfEfficacy Theory on Self-Efficacy Perception
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Substance use disorders are among the most important problems of our time. It has become a public health problem which is very common in developed and developing countries and affects the individual and the family as well as the society. Treatment of this problem, which leads to important disorders in many parts of individuals' lives, is quite difficult. Primary treatment is carried out by pharmacological methods. In cases where pharmacological methods are not sufficient, treatment is supported with psycho-social methods.
The aim is to identify the effect of mindfulness-based education, which is in accordance with self-efficacy theory, given to individuals who have substance abuse disorders.
The research was planned as a test model with pretest-posttest control groups. Individuals who have been diagnosed with substance abuse in the substance abuse clinic of Turgut Özal Medical Center, and at the Substance Abuse Treatment and Education Centre of Gaziantep 25 Aralık State Hospital formed the core of this study. The research was conducted between January 2018-May 2019. 112 patients, 56 in the treatment and 56 in the control group, participated in the study. Scientific research started after ethical approval. Mindfulness therapy was applied to experimental group patients. For the data collection, the Socio-Demographic Characteristics Questionnaire and Self-Efficacy scale were used. Kolmogorov-smirnov distribution test was used for normal distribution and Cronbach's alpha was used for internal consistency. Percentage, mean and standard deviation in evaluation of patients' demographic data, chi-square test in parametric cases in comparison of control variables of experimental and control groups, Fisher's exact test in non-parametric cases, t-test in dependent groups in comparison of mean scores of experimental and control groups, score in test and control groups in itself. t test was used in independent groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karatay
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Konya, Karatay, Turkey, 42020
- KTO Karatay University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- To be able to communicate,
- 18 years and older,
- Diagnosis of substance use disorder according to the diagnostic criteria in DSM-V,
- No prior training in awareness therapy or self-efficacy theory,
Exclusion Criteria:
- Patients who actively use alcohol or psychoactive substances,
- Those who show withdrawal symptoms due to substance use disorder,
- Psychotic patients due to substance use
- Want to leave the work
- who cannot continue psychoeducation regularly
- low mental capacity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
The mindfulness-based education programme that was conducted by the researcher and aimed at increasing self-efficacy in substance addicts was conducted within eight sessions, 2 days a week for 4 weeks.
|
The mindfulness-based education programme that was conducted by the researcher and aimed at increasing self-efficacy in substance addicts was conducted within eight sessions, 2 days a week for 4 weeks.
|
|
No Intervention: control group
Routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-efficacy score pretest for experimental group
Time Frame: first day of study
|
self-efficacy level determined by pretest for the experimental group.The lowest score that can be obtained from the scale was evaluated as 23 and the highest as 115.The higher the score, the higher the level of self-efficacy.
|
first day of study
|
|
self-efficacy score pretest for control group
Time Frame: first day of study
|
self-efficacy level determined by pretest for the control group.The lowest score that can be obtained from the scale was evaluated as 23 and the highest as 115.
The higher the score, the higher the level of self-efficacy.
|
first day of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-efficacy score posttest for experimental group
Time Frame: 2 month later
|
Self-efficacy level increased in experimental group.
The lowest score that can be obtained from the scale was evaluated as 23 and the highest as 115.
The higher the score, the higher the level of self-efficacy.
|
2 month later
|
|
self-efficacy score posttest for control group
Time Frame: 2 month later
|
Self-efficacy level did not change in the control group.
The lowest score that can be obtained from the scale was evaluated as 23 and the highest as 115.
The higher the score, the higher the level of self-efficacy.
|
2 month later
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: BERNA BAYIR, 1, KTO Karatay University
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaratayUB
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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