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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04152525
Other study ID # KaratayUB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date May 7, 2019

Study information

Verified date November 2019
Source KTO Karatay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date May 7, 2019
Est. primary completion date December 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Psychoeducation
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.

Locations

Country Name City State
Turkey KTO Karatay University Konya Karatay

Sponsors (1)

Lead Sponsor Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. first day of study
Primary 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. first day of study
Secondary 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. 2 month later
Secondary 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. 2 month later
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