Nurse's RoleNCT04152525
The Effect of Awareness-Based Education Given to Individuals With Substance Use Disorder on Self-Efficacy Perception
A study testing Psychoeducation in people with Nurse's Role and Self Efficacy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse's Role, Self Efficacy, Substance Use Disorders
- What is being tested?
- Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 7 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be able to communicate,
- 18 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-Based Education Given to Individuals With Substance-Use Disorder According to SelfEfficacy Theory on Self-Efficacy Perception
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).
Read the detailed description
Substance use disorders are among the most important problems of our time. It has become a public health problem which is very common in developed and developing countries and affects the individual and the family as well as the society. Treatment of this problem, which leads to important disorders in many parts of individuals' lives, is quite difficult. Primary treatment is carried out by pharmacological methods. In cases where pharmacological methods are not sufficient, treatment is supported with psycho-social methods.
The aim is to identify the effect of mindfulness-based education, which is in accordance with self-efficacy theory, given to individuals who have substance abuse disorders.
The research was planned as a test model with pretest-posttest control groups. Individuals who have been diagnosed with substance abuse in the substance abuse clinic of Turgut Özal Medical Center, and at the Substance Abuse Treatment and Education Centre of Gaziantep 25 Aralık State Hospital formed the core of this study. The research was conducted between January 2018-May 2019. 112 patients, 56 in the treatment and 56 in the control group, participated in the study. Scientific research started after ethical approval. Mindfulness therapy was applied to experimental group patients. For the data collection, the Socio-Demographic Characteristics Questionnaire and Self-Efficacy scale were used. Kolmogorov-smirnov distribution test was used for normal distribution and Cronbach's alpha was used for internal consistency. Percentage, mean and standard deviation in evaluation of patients' demographic data, chi-square test in parametric cases in comparison of control variables of experimental and control groups, Fisher's exact test in non-parametric cases, t-test in dependent groups in comparison of mean scores of experimental and control groups, score in test and control groups in itself. t test was used in independent groups.
- Conditions
- Nurse's Role, Self Efficacy, Substance Use Disorders
- Being tested
- Psychoeducation
- Keywords
- Mindfulness, Theory
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Psychoeducation |
| control group | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: first day of study
Secondary outcomes (2)
self-efficacy score posttest for experimental group
Self-efficacy level increased in 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.
Measured: 2 month later
self-efficacy score posttest for control group
Self-efficacy level did not change in 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.
Measured: 2 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Jan 2018
- Primary completion10 Dec 2018
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- 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
- Single Blinded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNA BAYIR, 1, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152525
- Sponsor's protocol ID
- KaratayUB
- Status last verified
- Nov 2019
- First submitted
- 30 Sep 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32907766
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Education Given to Individuals With Substance-Use Disorder According to SelfEfficacy Theory on Self-Efficacy Perception
- ClinicalTrials.gov ID
- NCT04152525
- Acronym / sponsor ID
- KaratayUB
- Conditions
- Nurse's Role, Self Efficacy, Substance Use Disorders
- Keywords
- Mindfulness, Theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 5 Nov 2019 (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 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).
Detailed description
Substance use disorders are among the most important problems of our time. It has become a public health problem which is very common in developed and developing countries and affects the individual and the family as well as the society. Treatment of this problem, which leads to important disorders in many parts of individuals' lives, is quite difficult. Primary treatment is carried out by pharmacological methods. In cases where pharmacological methods are not sufficient, treatment is supported with psycho-social methods.
The aim is to identify the effect of mindfulness-based education, which is in accordance with self-efficacy theory, given to individuals who have substance abuse disorders.
The research was planned as a test model with pretest-posttest control groups. Individuals who have been diagnosed with substance abuse in the substance abuse clinic of Turgut Özal Medical Center, and at the Substance Abuse Treatment and Education Centre of Gaziantep 25 Aralık State Hospital formed the core of this study. The research was conducted between January 2018-May 2019. 112 patients, 56 in the treatment and 56 in the control group, participated in the study. Scientific research started after ethical approval. Mindfulness therapy was applied to experimental group patients. For the data collection, the Socio-Demographic Characteristics Questionnaire and Self-Efficacy scale were used. Kolmogorov-smirnov distribution test was used for normal distribution and Cronbach's alpha was used for internal consistency. Percentage, mean and standard deviation in evaluation of patients' demographic data, chi-square test in parametric cases in comparison of control variables of experimental and control groups, Fisher's exact test in non-parametric cases, t-test in dependent groups in comparison of mean scores of experimental and control groups, score in test and control groups in itself. t test was used in independent groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Blinded
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: PsychoeducationThe 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. |
| control group | No intervention | –Routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be able to communicate,
- 18 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,
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| PsychoeducationThe 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 | experimental group |
Primary outcome
self-efficacy score pretest for experimental group
Time frame: first day of study
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.
self-efficacy score pretest for control group
Time frame: first day of study
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.
2 secondary outcomes
self-efficacy score posttest for experimental group
Time frame: 2 month later
self-efficacy score posttest for control group
Time frame: 2 month later
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 5 Nov 2019.
- Derived from this study: PubMed 32907766Bayir 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.
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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.
BERNA BAYIR, 1 principal investigator
KTO Karatay 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 Nurse's Role and Self Efficacy, run by KTO Karatay 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 4 inclusion and 6 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 5 Nov 2019. 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?
self-efficacy score pretest for experimental group (time frame: first day of study). The study lists 2 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 NCT04152525, which also lists 1 linked publication.
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 5 Nov 2019.