search
Back to results

The Effect of Awareness-Based Education Given to Individuals With Substance Use Disorder on Self-Efficacy Perception

Primary Purpose

Nurse's Role, Self Efficacy, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nurse's Role focused on measuring Mindfulness, Theory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

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.

Routine care

Outcomes

Primary Outcome Measures

self-efficacy score pretest for experimental group
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.
self-efficacy score pretest for control group
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.

Secondary Outcome Measures

self-efficacy score posttest for experimental group
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.
self-efficacy score posttest for control group
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.

Full Information

First Posted
September 30, 2019
Last Updated
November 1, 2019
Sponsor
KTO Karatay University
search

1. Study Identification

Unique Protocol Identification Number
NCT04152525
Brief Title
The Effect of Awareness-Based Education Given to Individuals With Substance Use Disorder on Self-Efficacy Perception
Official Title
The Effect of Mindfulness-Based Education Given to Individuals With Substance-Use Disorder According to SelfEfficacy Theory on Self-Efficacy Perception
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay 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 was conducted to determine the effect of mindfulness-based education given to individuals with substance-use disorder according to Self-Efficacy Theory on self-efficacy perception. Sample was 112 (ewperimental group: 56; control group: 56) alpha=0,05 and power=0,80 et the and of study. The experimental group recevied, prepared in accordance with mindfulness, self-efficacy theory psychoeducation program, the control group received routine care. Data were collected 2 times: pretest, 2 month after intervention (for experimental group) and 2 month after pretest (for control group).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nurse's Role, Self Efficacy, Substance Use Disorders
Keywords
Mindfulness, Theory

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single Blinded
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
self-efficacy score pretest for experimental group
Description
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.
Time Frame
first day of study
Title
self-efficacy score pretest for control group
Description
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.
Time Frame
first day of study
Secondary Outcome Measure Information:
Title
self-efficacy score posttest for experimental group
Description
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.
Time Frame
2 month later
Title
self-efficacy score posttest for control group
Description
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.
Time Frame
2 month later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNA BAYIR, 1
Organizational Affiliation
KTO Karatay University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KTO Karatay University
City
Konya
State/Province
Karatay
ZIP/Postal Code
42020
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
32907766
Citation
Bayir B, Aylaz R. The effect of mindfulness-based education given to individuals with substance-use disorder according to self-efficacy theory on self-efficacy perception. Appl Nurs Res. 2021 Feb;57:151354. doi: 10.1016/j.apnr.2020.151354. Epub 2020 Aug 27.
Results Reference
derived

Learn more about this trial

The Effect of Awareness-Based Education Given to Individuals With Substance Use Disorder on Self-Efficacy Perception

We'll reach out to this number within 24 hrs