NCT04152525

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

September 30, 2019

Last Update Submit

November 1, 2019

Conditions

Keywords

MindfulnessTheory

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • self-efficacy score posttest for experimental group

    2 month later

  • self-efficacy score posttest for control group

    2 month later

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Other: Psychoeducation

control group

NO INTERVENTION

Routine care

Interventions

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.

experimental group

Eligibility Criteria

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

You may qualify if:

  • To be able to communicate,
  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, 42020, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • BERNA BAYIR, 1

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Single Blinded
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

November 5, 2019

Study Start

January 1, 2018

Primary Completion

December 10, 2018

Study Completion

May 7, 2019

Last Updated

November 5, 2019

Record last verified: 2019-11

Locations