Motivational InterviewsNCT05428241
Motivational Interviewing in Patients With Bipolar Disorder
A study testing Assigned Interventions in people with Motivational Interviews and Bipolar Disorder, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: A poor therapeutic relationship, poor quality of life, impaired functioning, ineffective coping methods, and lack of motivation It is associated with poor adjustment (to symptoms, treatment, and environment) in patients with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Motivational Interviews, Bipolar Disorder
- What is being tested?
- Assigned Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 25 Dec 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 at least primary school graduate,
- Be willing to participate in research.
- Being between the ages of 18-65,
- Able to understand and speak Turkish,
- Patients who can understand scales and forms,
- Being registered in the euthymic period and Denizli Pamukkale University Health Research and Application Center Psychiatry Department Community Mental Health Center unit
- To have a diagnosis of bipolar disorder I-II for at least 1 year according to DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria.
Who cannot join
- Being under the age of 18 and over the age of 65,
- Being illiterate in Turkish,
- Having Mental Retardation,
- Being diagnosed with a mental illness other than bipolar disorder according to the DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria,
- Being in an manic or depressed attack period,
- Patients who have received or are continuing a similar education program.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University, Faculty of Health Science, Departmant of Psychiatric Nursing
Denizli, Denizli, Kınıklı Kampus, 20160
Halis Yılmaz, Msc, +90 553 048 99 58, halisyilmaz93@gmail.com
Gülay Yiğitoğlu, PhD, +90 258 6000 ext. 4339, gyigitoglu@pau.edu.tr
About this study
Official title: The Effect of Motivational Interviews on Coping, Functionality, Treatment Adherence and Quality of Life in Patients With Bipolar Disorder
Introduction: A poor therapeutic relationship, poor quality of life, impaired functioning, ineffective coping methods, and lack of motivation It is associated with poor adjustment (to symptoms, treatment, and environment) in patients with bipolar disorder. In order to achieve better compliance and results, the therapeutic relationship, coping skills, quality of life and functionality should be improved by increasing the motivation of individuals.
Purpose: This study was planned to examine the effects of motivational interviewing on coping, functioning, adherence to treatment and quality of life in patients with bipolar disorder.
Methods: In this single-blind, randomized controlled trial, simple randomization method and pretest-posttest control group design, experimental research design will be used. The work will take place at: Pamukkale University Health Research and Application Center, Psychiatric Hospital from July 2021 to February 2022 and including 48 individuals (24 in the experimental group and 24 in the control group). Working data it will be collected using personal information form, Morisky Medication Adherence Scale (MMAS), The World Health Organization Quality of Life Scale, the Short Form (WHOQOL-BREF), Assessment of Coping Attitudes Inventory (COPE), and Bipolar Disorder Functioning Questionnaire (BDFQ). The researchers will conduct a 6- session of motivational interviewing with the participants in the experimental group. No intervention will be made in the control group. Data will be analyzed on a pre-intervention, post-intervention and post-intervention 3 months (follow-up) basis.
Read the detailed description
Bipolar disorder is a serious mental disorder with depressive, manic or hypomanic episodes, which is completely normal or thought to be associated with minimal symptom levels, and is known to cause high mortality, morbidity, and loss of function in almost all areas. Gaining functionality in patients with bipolar disorder, improving their compliance with treatment and quality of life, and helping them to cope with stress are among the most important goals of treatment.
In individuals with bipolar disorder, stressful life events can lead to early onset of the disease, more frequent depression, psychotic symptoms, and problems such as anxiety. It is stated that patients with bipolar disorder have problems in interpersonal relationships and problems in coping with stress. When patients with a diagnosis of bipolar disorder in remission encounter a stressful life event, their functionality in the areas of work/school, family, and friends may be affected or even impaired.
Since bipolar disorder is a chronic disease, it is stated that it affects people's lives in terms of their functionality during remission periods as well as during attacks. Marriage-related problems, economic difficulties and substance use, together with the risk of suicide and irregular work history, can cause dysfunction in patients in wide psychosocial areas. It has been reported that the quality of life of patients whose functionality is impaired during the remission period also deteriorates.
Due to the early onset of bipolar disorder, the length of time until diagnosis, and inadequate treatment, it harms patients in terms of quality of life and expected psychosocial development. It is stated that depressive symptoms, being a woman, the length of time until the diagnosis, low socioeconomic and educational level are factors that increase the deterioration in the quality of life in rural areas in patients with bipolar disorder. In addition, the presence of another comorbidity accompanying bipolar disorder (anxiety, alcohol-substance addiction, etc.) also affects the quality of life. However, when the clinical studies on the disorder are examined, it is seen that the lack of compliance of the patients with the treatment causes the quality of life to deteriorate.
In bipolar disorder, low treatment compliance is caused by the patient's insufficient insight into the disease, reservations about the drug, negative clinical course of the disease, insufficient social and environmental support, economic difficulties, insufficient information about treatment, unfavorable conditions of the living environment or treatment center, the patient's and his/her environment's drug addiction. treatment and attitude towards bipolar disorder, prejudices caused by drug use in society, and cultural beliefs.
Poor therapeutic relationship, poor quality of life, impaired functioning, ineffective coping methods, and lack of motivation It is associated with poor adjustment (to symptoms, treatment, and environment) in patients with bipolar disorder. In order to achieve better compliance and results, the therapeutic relationship, coping skills, quality of life and functionality should be improved by increasing the motivation of individuals. Nurses need to establish a therapeutic relationship in order for the nursing care to produce effective results during the recovery process of these patients.
In this study, it is thought that Motivational Interviewing may be effective in increasing effective coping skills, functionality, adherence to treatment and quality of life in patients with bipolar disorder, and may shed light and guide psychiatric nursing interventions.
- Conditions
- Motivational Interviews, Bipolar Disorder
- Being tested
- Assigned Interventions
- Keywords
- Motivational Interviews, Bipolar Disorder, Coping, Functionality, Treatment Adherence, Quality of Life
- Medical subject headings
- Bipolar Disorder, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsBehavioural
Behavioral: 6 sessions of Motivational Interviewing and 3-month follow-up. 6 sessions of Motivational Interview will be applied to the working group. All sessions will be in the form of face-to-face meetings. Each interview will take an average of 45-60 minutes. With this intervention, it was aimed to increase the levels of coping with motivational interviewing, functionality, adherence to treatment and quality of life in bipolar disorder patients. Study data consists of personal information form, Morisky Treatment Adherence Scale (MMAS), World Health Organization Quality of Life Scale, Short Form (WHOQOL-BREF), Assessment of Coping Attitudes Inventory (COPE), Bipolar Disorder Functioning Questionnaire (BDFQ). Data will be analyzed pre-intervention, post-intervention and 3 months post-intervention. A drug and device will not be administered to participants.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Study group intervention consists 6-session Motivational Interviews and 3-month follow-up. Receives: Behavioral: Assigned Interventions |
| No Intervention | No intervention | Control group receives general care and the training booklet at the end of the study. Also includes 3-month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morisky Treatment Adherence Scale
The scale consists of four likert-type two-answer questions. The questions are in the form of closed-ended "yes and no". If all questions are answered "no", drug compliance is considered high, if "yes" is answered for one or two questions, drug compliance is considered medium, if yes to three or four questions, drug compliance is considered low. In the scale, 0-1 points indicate low, 2-3 points moderate, and 4 points high adherence to treatment.
Measured: Change from baseline Morisky Treatment Adherence Scale at 3 months
The World Health Organization Quality of Life Instrument, Short Form
It is a scale developed from the World Health Organization's WHOQOL-100 to assess quality of life. WHOQOL-BREF consists of 26 questions and four areas selected from WHOQOL-100. These 4 areas are physical, mental, social relations and environmental areas. The 3rd, 4th and 26th items of the scale are reverse scored. WHOQOL-BREF has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
Measured: Change from baseline The World Health Organization Quality of Life Instrument, Short Form at 3 months
Assessment of Coping Attitudes Inventory
There are 60 questions in total and 15 subscales, each consisting of four questions. Each subscale is answered over four options. These answers are: 1=I would never do anything like this; 2=I do very little like this; 3=I do this moderately; 4=I usually do it like this. Positive reinterpretation and growth, use of beneficial social support, active coping, religious coping, joking, holding back, use of emotional social support, acceptance, suppression of other occupations, and planning subscales represent adaptive coping methods, while mental distancing, problem-focused and problem-focused and expressing emotions, denial, behavioral distancing, and substance use subscales are considered as maladaptive coping methods. As a result, the high scores to be obtained from the subscales give the possibility to comment on which coping attitude is used more by the individual.
Measured: Change from baseline Assessment of Coping Attitudes Inventory at 3 months
Bipolar Disorder Functioning Questionnaire
The scale is in triple Likert type and the items are calculated by giving 1 point 'no or nothing', 2 points 'partly or sometimes', and 3 points 'yes or always'. The 1st and 3rd questions in the emotional functionality subscale, the 5th and 7th questions in the mental functionality subscale, the 8th, 10th and 11th questions in the sexual functionality subscale, and the 49th, 50th and 51st questions in the work subscale are reversed. is scored. The total score can range from 52 to 156. The scale does not have a cutoff score, and as the score increases, functionality also increases.
Measured: Change from baseline Assessment of Coping Attitudes Inventory at 3 months
Secondary outcomes (1)
Number of health care uses
According to the patient's declaration, number of hospitalizations.
Measured: Change in the number of initial health care use in the 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewsStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Randomized controlled pre-post test design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halis YILMAZ, Pamukkale University
- Investigators
- Gülay Yiğitoğlu, PhD, Study director, Pamukkale UniversityHalis Yılmaz, Msc, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428241
- Sponsor's protocol ID
- 60116787-020-155550
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be announced in a publication
Publications
Pakpour AH, Modabbernia A, Lin CY, Saffari M, Ahmadzad Asl M, Webb TL. Promoting medication adherence among patients with bipolar disorder: a multicenter randomized controlled trial of a multifaceted intervention. Psychol Med. 2017 Oct;47(14):2528-2539. doi: 10.1017/S003329171700109X. Epub 2017 Apr 27.
PubMed 28446253McKenzie K, Chang YP. The effect of nurse-led motivational interviewing on medication adherence in patients with bipolar disorder. Perspect Psychiatr Care. 2015 Jan;51(1):36-44. doi: 10.1111/ppc.12060. Epub 2014 Jan 17.
PubMed 24433493Laakso LJ. Motivational interviewing: addressing ambivalence to improve medication adherence in patients with bipolar disorder. Issues Ment Health Nurs. 2012 Jan;33(1):8-14. doi: 10.3109/01612840.2011.618238.
PubMed 22224961Ertem MY, Duman ZC. The effect of motivational interviews on treatment adherence and insight levels of patients with schizophrenia: A randomized controlled study. Perspect Psychiatr Care. 2019 Jan;55(1):75-86. doi: 10.1111/ppc.12301. Epub 2018 Jun 11.
PubMed 29888541Goldstein TR, Krantz ML, Fersch-Podrat RK, Hotkowski NJ, Merranko J, Sobel L, Axelson D, Birmaher B, Douaihy A. A brief motivational intervention for enhancing medication adherence for adolescents with bipolar disorder: A pilot randomized trial. J Affect Disord. 2020 Mar 15;265:1-9. doi: 10.1016/j.jad.2020.01.015. Epub 2020 Jan 7.
PubMed 31957686
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviews on Coping, Functionality, Treatment Adherence and Quality of Life in Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05428241
- Acronym / sponsor ID
- 60116787-020-155550
- Conditions
- Motivational Interviews, Bipolar Disorder
- Keywords
- Motivational Interviews, Bipolar Disorder, Coping, Functionality, Treatment Adherence, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 23 Jun 2022 (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.
Introduction: A poor therapeutic relationship, poor quality of life, impaired functioning, ineffective coping methods, and lack of motivation It is associated with poor adjustment (to symptoms, treatment, and environment) in patients with bipolar disorder. In order to achieve better compliance and results, the therapeutic relationship, coping skills, quality of life and functionality should be improved by increasing the motivation of individuals.
Purpose: This study was planned to examine the effects of motivational interviewing on coping, functioning, adherence to treatment and quality of life in patients with bipolar disorder.
Methods: In this single-blind, randomized controlled trial, simple randomization method and pretest-posttest control group design, experimental research design will be used. The work will take place at: Pamukkale University Health Research and Application Center, Psychiatric Hospital from July 2021 to February 2022 and including 48 individuals (24 in the experimental group and 24 in the control group). Working data it will be collected using personal information form, Morisky Medication Adherence Scale (MMAS), The World Health Organization Quality of Life Scale, the Short Form (WHOQOL-BREF), Assessment of Coping Attitudes Inventory (COPE), and Bipolar Disorder Functioning Questionnaire (BDFQ). The researchers will conduct a 6- session of motivational interviewing with the participants in the experimental group. No intervention will be made in the control group. Data will be analyzed on a pre-intervention, post-intervention and post-intervention 3 months (follow-up) basis.
Detailed description
Bipolar disorder is a serious mental disorder with depressive, manic or hypomanic episodes, which is completely normal or thought to be associated with minimal symptom levels, and is known to cause high mortality, morbidity, and loss of function in almost all areas. Gaining functionality in patients with bipolar disorder, improving their compliance with treatment and quality of life, and helping them to cope with stress are among the most important goals of treatment.
In individuals with bipolar disorder, stressful life events can lead to early onset of the disease, more frequent depression, psychotic symptoms, and problems such as anxiety. It is stated that patients with bipolar disorder have problems in interpersonal relationships and problems in coping with stress. When patients with a diagnosis of bipolar disorder in remission encounter a stressful life event, their functionality in the areas of work/school, family, and friends may be affected or even impaired.
Since bipolar disorder is a chronic disease, it is stated that it affects people's lives in terms of their functionality during remission periods as well as during attacks. Marriage-related problems, economic difficulties and substance use, together with the risk of suicide and irregular work history, can cause dysfunction in patients in wide psychosocial areas. It has been reported that the quality of life of patients whose functionality is impaired during the remission period also deteriorates.
Due to the early onset of bipolar disorder, the length of time until diagnosis, and inadequate treatment, it harms patients in terms of quality of life and expected psychosocial development. It is stated that depressive symptoms, being a woman, the length of time until the diagnosis, low socioeconomic and educational level are factors that increase the deterioration in the quality of life in rural areas in patients with bipolar disorder. In addition, the presence of another comorbidity accompanying bipolar disorder (anxiety, alcohol-substance addiction, etc.) also affects the quality of life. However, when the clinical studies on the disorder are examined, it is seen that the lack of compliance of the patients with the treatment causes the quality of life to deteriorate.
In bipolar disorder, low treatment compliance is caused by the patient's insufficient insight into the disease, reservations about the drug, negative clinical course of the disease, insufficient social and environmental support, economic difficulties, insufficient information about treatment, unfavorable conditions of the living environment or treatment center, the patient's and his/her environment's drug addiction. treatment and attitude towards bipolar disorder, prejudices caused by drug use in society, and cultural beliefs.
Poor therapeutic relationship, poor quality of life, impaired functioning, ineffective coping methods, and lack of motivation It is associated with poor adjustment (to symptoms, treatment, and environment) in patients with bipolar disorder. In order to achieve better compliance and results, the therapeutic relationship, coping skills, quality of life and functionality should be improved by increasing the motivation of individuals. Nurses need to establish a therapeutic relationship in order for the nursing care to produce effective results during the recovery process of these patients.
In this study, it is thought that Motivational Interviewing may be effective in increasing effective coping skills, functionality, adherence to treatment and quality of life in patients with bipolar disorder, and may shed light and guide psychiatric nursing interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized controlled pre-post test design
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Assigned InterventionsStudy group intervention consists 6-session Motivational Interviews and 3-month follow-up. |
| No Intervention | No intervention | –Control group receives general care and the training booklet at the end of the study. Also includes 3-month follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be at least primary school graduate,
- Be willing to participate in research.
- Being between the ages of 18-65,
- Able to understand and speak Turkish,
- Patients who can understand scales and forms,
Key exclusion criteria (6 listed)
- Being under the age of 18 and over the age of 65,
- Being illiterate in Turkish,
- Having Mental Retardation,
- Being diagnosed with a mental illness other than bipolar disorder according to the DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria,
- Being in an manic or depressed attack period,
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 |
|---|---|---|
| Assigned InterventionsBehavioral: 6 sessions of Motivational Interviewing and 3-month follow-up. 6 sessions of Motivational Interview will be applied to the working group. All sessions will be in the form of face-to-face meetings. Each interview will take an average of 45-60 minutes. With this intervention, it was aimed to increase the levels of coping with motivational interviewing, functionality, adherence to treatment and quality of life in bipolar disorder patients. Study data consists of personal information form, Morisky Treatment Adherence Scale (MMAS), World Health Organization Quality of Life Scale, Short Form (WHOQOL-BREF), Assessment of Coping Attitudes Inventory (COPE), Bipolar Disorder Functioning Questionnaire (BDFQ). Data will be analyzed pre-intervention, post-intervention and 3 months post-intervention. A drug and device will not be administered to participants. | Behavioural | Experimental |
Primary outcome
Morisky Treatment Adherence Scale
Time frame: Change from baseline Morisky Treatment Adherence Scale at 3 months
The scale consists of four likert-type two-answer questions. The questions are in the form of closed-ended "yes and no". If all questions are answered "no", drug compliance is considered high, if "yes" is answered for one or two questions, drug compliance is considered medium, if yes to three or four questions, drug compliance is considered low. In the scale, 0-1 points indicate low, 2-3 points moderate, and 4 points high adherence to treatment.
The World Health Organization Quality of Life Instrument, Short Form
Time frame: Change from baseline The World Health Organization Quality of Life Instrument, Short Form at 3 months
It is a scale developed from the World Health Organization's WHOQOL-100 to assess quality of life. WHOQOL-BREF consists of 26 questions and four areas selected from WHOQOL-100. These 4 areas are physical, mental, social relations and environmental areas. The 3rd, 4th and 26th items of the scale are reverse scored. WHOQOL-BREF has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
Assessment of Coping Attitudes Inventory
Time frame: Change from baseline Assessment of Coping Attitudes Inventory at 3 months
There are 60 questions in total and 15 subscales, each consisting of four questions. Each subscale is answered over four options. These answers are: 1=I would never do anything like this; 2=I do very little like this; 3=I do this moderately; 4=I usually do it like this. Positive reinterpretation and growth, use of beneficial social support, active coping, religious coping, joking, holding back, use of emotional social support, acceptance, suppression of other occupations, and planning subscales represent adaptive coping methods, while mental distancing, problem-focused and problem-focused and expressing emotions, denial, behavioral distancing, and substance use subscales are considered as maladaptive coping methods. As a result, the high scores to be obtained from the subscales give the possibility to comment on which coping attitude is used more by the individual.
Bipolar Disorder Functioning Questionnaire
Time frame: Change from baseline Assessment of Coping Attitudes Inventory at 3 months
The scale is in triple Likert type and the items are calculated by giving 1 point 'no or nothing', 2 points 'partly or sometimes', and 3 points 'yes or always'. The 1st and 3rd questions in the emotional functionality subscale, the 5th and 7th questions in the mental functionality subscale, the 8th, 10th and 11th questions in the sexual functionality subscale, and the 49th, 50th and 51st questions in the work subscale are reversed. is scored. The total score can range from 52 to 156. The scale does not have a cutoff score, and as the score increases, functionality also increases.
1 secondary outcome
Number of health care uses
Time frame: Change in the number of initial health care use in the 3rd month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Results publication: PubMed 28446253Pakpour AH, Modabbernia A, Lin CY, Saffari M, Ahmadzad Asl M, Webb TL. Promoting medication adherence among patients with bipolar disorder: a multicenter randomized controlled trial of a multifaceted intervention. Psychol Med. 2017 Oct;47(14):2528-2539. doi: 10.1017/S003329171700109X. Epub 2017 Apr 27.
- Results publication: PubMed 24433493McKenzie K, Chang YP. The effect of nurse-led motivational interviewing on medication adherence in patients with bipolar disorder. Perspect Psychiatr Care. 2015 Jan;51(1):36-44. doi: 10.1111/ppc.12060. Epub 2014 Jan 17.
- Results publication: PubMed 22224961Laakso LJ. Motivational interviewing: addressing ambivalence to improve medication adherence in patients with bipolar disorder. Issues Ment Health Nurs. 2012 Jan;33(1):8-14. doi: 10.3109/01612840.2011.618238.
- Results publication: PubMed 29888541Ertem MY, Duman ZC. The effect of motivational interviews on treatment adherence and insight levels of patients with schizophrenia: A randomized controlled study. Perspect Psychiatr Care. 2019 Jan;55(1):75-86. doi: 10.1111/ppc.12301. Epub 2018 Jun 11.
- Results publication: PubMed 31957686Goldstein TR, Krantz ML, Fersch-Podrat RK, Hotkowski NJ, Merranko J, Sobel L, Axelson D, Birmaher B, Douaihy A. A brief motivational intervention for enhancing medication adherence for adolescents with bipolar disorder: A pilot randomized trial. J Affect Disord. 2020 Mar 15;265:1-9. doi: 10.1016/j.jad.2020.01.015. Epub 2020 Jan 7.
- Individual participant dataSharing planned: Yes. Study results will be announced in a publication
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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.
Gülay Yiğitoğlu, PhD study director
Pamukkale University
Halis Yılmaz, Msc principal investigator
Pamukkale 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 Assigned Interventions in people with Motivational Interviews and Bipolar Disorder, run by Pamukkale 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 7 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: status not confirmed, as of the sponsor's last update on 23 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halis Yılmaz, Msc (+90 553 048 99 58, halisyilmaz93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morisky Treatment Adherence Scale (time frame: Change from baseline Morisky Treatment Adherence Scale at 3 months). The study lists 4 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 NCT05428241, which also lists 5 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 23 Jun 2022.