NCT06057961

Brief Summary

The goal of this clinical trial is to examine the effect of art therapy applied to individuals with substance use who are subject to probation on difficulty in emotion regulation, self-esteem and hopelessness. The main question\[s\] it aims to answer are: \[Is art therapy effective on the level of emotion regulation difficulties of individuals with substance use who are subject to probation?\] \[Is art therapy effective on the self-esteem level of individuals with substance use who are subject to probation?\]\[Is art therapy effective on the hopelessness level of individuals with substance use who are subject to probation?\] Data will be collected through scale forms and art therapy sessions. Within the scope of the pre-test application, data will be collected from all participants in the sample group using the "Personal Information Form", "Difficulties in Emotion Regulation Scale-Brief Form (DERS-16)", "Coopersmith Self-Esteem Scale", "Beck Hopelessness Scale". Art therapy will be applied face to face to the participants in the intervention group, in groups of 4-12 people, in the group guide room, on a common day and time determined by the group members and the researchers. Researchers will compare the experimental group and the control group to see whether art therapy applied to individuals with substance use who are subject to probation has an effect on emotion regulation difficulties, self-esteem and hopelessness.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 21, 2023

Last Update Submit

September 21, 2023

Conditions

Keywords

Substance UseProbationArt therapyPsychiatric Nursing

Outcome Measures

Primary Outcomes (3)

  • Difficulties in Emotion Regulation Scale-Brief Form (DERS-16)

    The Emotion Regulation Difficulty Scale-Short Form (DDGÖ-16), which is the short form of the Emotion Regulation Difficulty Scale developed by Gratz and Roemer (2004) to measure difficulties in regulating emotions, was developed by Bjureberg et al. (2016). The Turkish adaptation of DDGÖ-16 was made by Yiğit and Güzey Yiğit (2017). The Lilkert type scale consists of 16 items and is scored by grading the items between 1 (almost never) and 5 (almost always). There are no reverse coded items in the scale and there is no cut-off point. Scale, openness (1,2), goals (3,7,15), drive (4, 8,11), strategies (5, 6, 12, 14, 16), and nonacceptance (9, 10, 13). It consists of 5 sub-dimensions. High scores indicate greater difficulty in emotional regulation.

    Basseline and 8 weeks

  • Coopersmith Self-Esteem Scale

    The scale was prepared by Stanley Copersmith in 1986 and was developed to be applicable to various age groups, especially adults. The reliability and validity study in our country was conducted by Tufan and Turan and the test-retest reliability of the scale was found to be 0.65 and 0.76. The scale consists of 25 items and the items are marked as "like me" or "not like me". The items include statements about the individual's perspective on life, family relationships, social relationships and endurance. The scores obtained vary between 0 and 100, and evaluation is made according to whether self-esteem is lower or higher than average. A score below the average indicates low self-esteem, while a score above the average indicates high self-esteem

    Basseline and 8 weeks

  • Beck Hopelessness Scale

    Beck Hopelessness Scale, which measures the individual's negative expectations for the future, consists of a total of 20 items. The answer was "yes" to 11 of the items in the scale (Questions 2, 4, 7, 9, 11, 12, 14, 16, 17, 18, and 20), and to 9 items (Questions 1, 3, 5, 6, 8, (questions 10, 13, 15, and 19) are given one point each for a "no" answer. The lowest score to be obtained from the scale is 0 and the highest score is 20. High scores from the scale indicate that the individual's hopelessness is high.

    Basseline and 8 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

"Personal Information Form", "Difficulties in Emotion Regulation Scale-Brief Form (DERS-16)", "Coopersmith Self-Esteem Scale", "Beck Hopelessness Scale" will be applied to the intervention group as part of the pre-test application. In the research, art therapy will be applied face to face to the participants in the intervention group, in groups of 4-12 people, in the group guide room, on a common day and time determined by the group members and the researchers.The art therapy to be applied to the participants in the intervention group in the study consists of eight sessions.Each session is planned to last approximately 60-90 minutes.

Other: Art Therapy

Control

NO INTERVENTION

Individuals who meet the inclusion criteria and agree to participate in the research will be informed about the research and their verbal and written consent will be obtained. Interviews will be held to implement the pre-tests ("Personal Information Form", "Emotion Regulation Difficulties Scale-Short Form (DERS-16)", "Coopersmith Self-Esteem Scale", "Beck Hopelessness Scale"). A session will be held to implement the post-tests and to implement the "Awareness of Emotions" themed session with the intervention group to the control group.

Interventions

8 meetings in 1 year

Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are subject to probation within the scope of Article 191 of the Turkish Penal Code (purchasing, accepting or possessing drugs or stimulants for use, or using drugs or stimulants) between 2023-2024
  • Literate
  • Agreeing to participate in the research
  • Those aged 18 and over
  • Not under the influence of drugs
  • In accordance with the Probation Services Regulation , individuals who are deemed ready for group work as a result of individual interviews conducted by the probation specialist.
  • Individuals who do not have problems in terms of hearing, speaking and understanding that would prevent communication in the application to be performed.

You may not qualify if:

  • Illiterate
  • Under 18 years of age
  • Under the influence of drugs
  • In accordance with the Probation Services Regulation , individuals who are deemed not ready for group work as a result of individual interviews conducted by the probation specialist
  • Individuals with hearing, speaking and understanding problems that will prevent communication in the application to be performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin Probation Directorate

Mersin, Akdeniz, 33050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Seval Cüceler, PhD

    Toros University, Faculty of Health Sciences, Department of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seval Cüceler, MSc

CONTACT

Mualla YILMAZ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

October 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations