NCT05941195

Brief Summary

This study, which was planned to examine the effects of cognitive behavioral approach-based psychoeducation on addiction profiles, self-efficacy levels and addiction courses in patients with substance use disorders, was carried out as a randomized controlled experimental study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

June 2, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

Substance Use DisorderPsychosocial InterventionSelf EfficacyPsychiatric Nursing

Outcome Measures

Primary Outcomes (6)

  • Addiction Profile Index (Bapi) Clinical Form

    Addiction Profile Index Clinical Form was created by adding 21 questions to the Addiction Profile Index developed in 2012 to measure the severity of addiction. It consists of 58 questions in total and has 11 sub-dimensions. It evaluates different dimensions of addictions of alcohol and substance users. Two of the six domains of the scale measure mental state, while the others measure some personal characteristics related to addiction .

    The first measurement was made in the 1st week.

  • Addiction Profile Index (Bapi) Clinical Form

    Addiction Profile Index Clinical Form was created by adding 21 questions to the Addiction Profile Index developed in 2012 to measure the severity of addiction. It consists of 58 questions in total and has 11 sub-dimensions. It evaluates different dimensions of addictions of alcohol and substance users. Two of the six domains of the scale measure mental state, while the others measure some personal characteristics related to addiction.

    The last measurement was made at the 5th week.

  • Addiction Outcome Assessment Index (AOAI)

    The Addiction Outcome Index (BASI) was developed to measure the treatment course and recovery level of addiction in all areas and to be used in follow-up. The score that can be obtained from the scale is between 0-32. A decrease of 3.5 points from the total score of the scale in clinical follow-up indicates a reliable change .

    The first measurement was made in the 1st week.

  • Addiction Outcome Assessment Index (AOAI)

    The Addiction Outcome Index (BASI) was developed to measure the treatment course and recovery level of addiction in all areas and to be used in follow-up. The score that can be obtained from the scale is between 0-32. A decrease of 3.5 points from the total score of the scale in clinical follow-up indicates a reliable change .

    The last measurement was made at the 5th week.

  • Self-Efficacy Scale (SES)

    The scale was first developed in the English language in 1982. It was adapted into Turkish in 1999 and follows the course of self-efficacy expectations that need to be changed in individual therapy during the therapy process. The Self-Efficacy Scale consists of 23 items and 4 sub-factors. A minimum of 23 and a maximum of 115 points can be obtained from the scale. A high total score from the scale indicates that the individual's self-efficacy perception is at a good level.

    The first measurement was made in the 1st week.

  • Self-Efficacy Scale (SES)

    The scale was first developed in the English language in 1982 . It was adapted into Turkish in 1999 and follows the course of self-efficacy expectations that need to be changed in individual therapy during the therapy process. The Self-Efficacy Scale consists of 23 items and 4 sub-factors. A minimum of 23 and a maximum of 115 points can be obtained from the scale. A high total score from the scale indicates that the individual's self-efficacy perception is at a good level.

    The last measurement was made at the 5th week.

Study Arms (2)

psychoeducation applied experimental group

EXPERIMENTAL

The patients in the experimental group received a total of 5 weeks (9 sessions) of cognitive-behavioral-based psychoeducation, consisting of 45-60 minutes, 2 sessions per week and the first session preparation session. In the sessions, the topics determined by using learning activities such as lecture, discussion, summarization, role-play, question/answer and exercises were explained and discussed. At the end of each session, homework was given to facilitate the patient's cognitive and behavioral change between sessions.

Other: Psychoeducation

non-intervention control group

NO INTERVENTION

Control group: The control group continued to receive the routine care.

Interventions

In the cognitive behavioral approach based psychoeducation given to the experimental group patients; "Addiction and Its Effects", "Increasing and Maintaining Motivation", "The Cognitive Model and the Cognitive Model of Addiction", "Automatic Thoughts That Increase Impulse to Substance Use", "Dysfunctional Beliefs Regarding Substance Use", "High Risk Situations and Coping Skills", " The topics of "Prevention of Slippage and Recurrence" and "Problem Solving" are included.

psychoeducation applied experimental group

Eligibility Criteria

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

You may qualify if:

  • To be diagnosed with "Substance Use Disorder" according to The Diagnostic and Statistical Manual of Mental Disorders-V,
  • To be over 18 years old,
  • Volunteering to participate in the research.

You may not qualify if:

  • Other than Substance Use Disorder, chronic, requiring ongoing help and care the presence of a medical illness,
  • Being illiterate (the types of scales to be used must be self-report forms) because of).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University Faculy of Nursing, Division Mental HealthNursing

Aydin, Turkey (Türkiye)

Location

Related Publications (4)

  • Ögel K, Koç C, Başabak A, İşmen EM, Görücü S. Bağımlılık profil indeksi klinik formunun (BAPİ-K) geliştirilmesi: Geçerlik ve güvenilirlik Çalışması. Bağımlılık Dergisi.2015; 16(2), 57-69.

    BACKGROUND
  • Simsek M, Dinc M, Ogel K. The Validity aand Reliability of the Addiction Outcome Assessment Index (AOAI). Turk Psikiyatri Derg. 2021 Summer;32(2):129-136. doi: 10.5080/u23461. English, Turkish.

    PMID: 34392509BACKGROUND
  • Sherer M, Maddux JE, Mercandante B, Prentice-Dunn S, Jacobs B, Rogers R W. The self-efficacy scale: Construction and validation. Psychological reports.1982; 51(2), 663-671.

    BACKGROUND
  • Gözüm S, Aksayan S. Öz-etkililik-yeterlik ölçeği'nin türkçe formunun güvenilirlik ve geçerliliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi. 1999; 2(1): 21-34.

    BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Fatma DEMİRKIRAN, Phd

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Following recruitment, person who the substance use disorder were divided into a study and a control group by randomization (1:1 randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 2, 2023

First Posted

July 12, 2023

Study Start

December 1, 2022

Primary Completion

February 28, 2023

Study Completion

May 30, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Shared Documents
CSR
Time Frame
2 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations