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Effect Of Art Therapy Applied to Individuals With Substance Use Subject to Supervised Release

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06057961
Recruitment Status : Not yet recruiting
First Posted : September 28, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Seval Cüceler, Mersin University

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.


Condition or disease Intervention/treatment Phase
Substance Use Other: Art Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Art Therapy Applied to Individuals With Substance Use Subject To Supervised Release on Emotion Regulation Difficulties, Self-Esteem and Hopeless
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
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
8 meetings in 1 year

No Intervention: Control
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.



Primary Outcome Measures :
  1. Difficulties in Emotion Regulation Scale-Brief Form (DERS-16) [ Time Frame: Basseline and 8 weeks ]
    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.

  2. Coopersmith Self-Esteem Scale [ Time Frame: Basseline and 8 weeks ]
    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

  3. Beck Hopelessness Scale [ Time Frame: Basseline and 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057961


Contacts
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Contact: Seval Cüceler, MSc +905541152873 seval.cuceler@gmail.com
Contact: Mualla YILMAZ, PhD +905359207263 mualley69@gmail.com

Locations
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Turkey
Mersin Probation Directorate
Mersin, Akdeniz, Turkey, 33050
Contact: Seval Cüceler, MSc    +905541152873    seval.cuceler@gmail.com   
Contact: Mualla YILMAZ, PhD    +905359207263    mualley69@gmail.com   
Sponsors and Collaborators
Mersin University
Investigators
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Principal Investigator: Seval Cüceler, PhD Toros University, Faculty of Health Sciences, Department of Nursing
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Responsible Party: Seval Cüceler, MSc, Mersin University
ClinicalTrials.gov Identifier: NCT06057961    
Other Study ID Numbers: MersinU-SC-01
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seval Cüceler, Mersin University:
Substance Use
Probation
Art therapy
Psychiatric Nursing
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders