Substance Use DisordersNCT05941195
Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation
A study testing Psychoeducation in people with Substance Use Disorders and Self Efficacy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders, Self Efficacy, Addiction
- What is being tested?
- Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University Faculy of Nursing, Division Mental HealthNursing
Aydin
About this study
Official title: Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation on Addiction Profile, Self-efficacy and Addiction Course in Substance Use Disorder Randomized Controlled Experimental Study
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.
Read the detailed description
It can be said that alcohol/substance nurses, by applying cognitive behavioral approach-based psychoeducation to patients with substance use disorders, can have a positive effect on reducing the severity of addiction, increasing their self-efficacy levels, and providing the care, education and counseling support that patients need.
The aim of this study is to examine the effects of cognitive behavioral approach-based psychoeducation applied to patients with substance use disorder on addiction profiles, self-efficacy levels and addiction courses.
- Conditions
- Substance Use Disorders, Self Efficacy, Addiction
- Being tested
- Psychoeducation
- Keywords
- Substance Use Disorder, Psychosocial Intervention, Self Efficacy, Psychiatric Nursing
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Psychoeducation |
| non-intervention control group | No intervention | Control group: The control group continued to receive the routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: 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 .
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: The last measurement was made at the 5th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Dec 2022
- Primary completion28 Feb 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following recruitment, person who the substance use disorder were divided into a study and a control group by randomization (1:1 randomization)
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihan Kocairi, Aydin Adnan Menderes University
- Investigators
- Fatma DEMİRKIRAN, Phd, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941195
- Sponsor's protocol ID
- Adnan MU
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Publications
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.
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.
PubMed 34392509Sherer 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation on Addiction Profile, Self-efficacy and Addiction Course in Substance Use Disorder Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT05941195
- Acronym / sponsor ID
- Adnan MU
- Conditions
- Substance Use Disorders, Self Efficacy, Addiction
- Keywords
- Substance Use Disorder, Psychosocial Intervention, Self Efficacy, Psychiatric Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It can be said that alcohol/substance nurses, by applying cognitive behavioral approach-based psychoeducation to patients with substance use disorders, can have a positive effect on reducing the severity of addiction, increasing their self-efficacy levels, and providing the care, education and counseling support that patients need.
The aim of this study is to examine the effects of cognitive behavioral approach-based psychoeducation applied to patients with substance use disorder on addiction profiles, self-efficacy levels and addiction courses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following recruitment, person who the substance use disorder were divided into a study and a control group by randomization (1:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| psychoeducation applied experimental group | Experimental | Other: PsychoeducationThe 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. |
| non-intervention control group | No intervention | –Control group: The control group continued to receive the routine care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationIn 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. | Other | psychoeducation applied experimental group |
Primary outcome
Addiction Profile Index (Bapi) Clinical Form
Time frame: The first measurement was made in the 1st week.
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 .
Addiction Profile Index (Bapi) Clinical Form
Time frame: The last measurement was made at the 5th week.
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.
Addiction Outcome Assessment Index (AOAI)
Time frame: The first measurement was made in the 1st week.
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 .
Addiction Outcome Assessment Index (AOAI)
Time frame: The last measurement was made at the 5th week.
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 .
Self-Efficacy Scale (SES)
Time frame: The first measurement was made in the 1st week.
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.
Self-Efficacy Scale (SES)
Time frame: The last measurement was made at the 5th week.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- BackgroundÖgel 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: PubMed 34392509Simsek 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.
- BackgroundSherer 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.
- BackgroundGözüm S, Aksayan S. Öz-etkililik-yeterlik ölçeği'nin türkçe formunun güvenilirlik ve geçerliliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi. 1999; 2(1): 21-34.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma DEMİRKIRAN, Phd principal investigator
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Substance Use Disorders and Self Efficacy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Addiction Profile Index (Bapi) Clinical Form (time frame: The first measurement was made in the 1st week.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941195, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.