Bipolar DisorderNCT06131866
Acceptance and Commitment Therapy Based Psychoeducation, Meaning of Life and Coping Skills in Bipolar Disorder
A study testing Psychoeducation based on Acceptance and Commitment Therapy in people with Bipolar Disorder and Coping Skills, run by Kubra TOHUMCU at 1 site in Turkey (Türkiye).
Trial summary
This research will be conducted to determine the effect of acceptance and commitment therapy-based psychoeducation on coping skills and finding meaning in life in patients with bipolar disorder. This research is planned as a randomised controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Coping Skills
- What is being tested?
- Psychoeducation based on Acceptance and Commitment Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 20 Mar 2024
- 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 receiving outpatient treatment with the diagnosis of Bipolar Disorder according to DSM-5
- Being in euthymic mood according to the doctor's control at the time of the interview
- Having no problem in understanding and speaking Turkish
- Being literate
- Being in the 18-65 age group
- Not having undergone such training for the last 1 year
Who cannot join
- Presence of serious sensory and cognitive disabilities that would prevent answering the questionnaire
- Refusal to participate in the study after being informed
- Having another psychiatric diagnosis in addition to the diagnosis of bipolar disorder
- Having an attack period during the education process
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Şahinbey, 27010
About this study
Official title: The Effect of Acceptance and Commitment Therapy Based Psychoeducation on Meaning and Purpose of Life and Coping Skills in Patients With Bipolar Disorder
This research will be conducted to determine the effect of acceptance and commitment therapy-based psychoeducation on coping skills and finding meaning in life in patients with bipolar disorder. This research is planned as a randomised controlled experimental study. The study will be conducted with euthymic stage patients diagnosed with bipolar disorder who applied to Adıyaman Besni State Hospital psychiatry outpatient clinic using randomisation method. According to the power analysis result, the study will be applied to a total of 40 individuals, 20 experimental and 20 control. "Individual Information Form" regarding socio-demographic characteristics, "Coping Attitudes Evaluation Scale COPE-R" and "Meaning and Purpose of Life Scale" will be used to collect the data. Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group. Pre-tests will be applied to the patients in the intervention and control groups just before the training, post-test will be applied to the intervention group immediately after the training sessions are completed, and follow-up test will be applied one month after the post-test, i.e. in the 12th week. After the pre-test was applied to the control group, the post-test will be applied in the 8th week and the follow-up test will be applied in the 12th week without any intervention. In the evaluation of the data; descriptive statistical methods (frequency, mean), t-test, one way Anova and correlation analyses will be used. Permission was obtained from the University Ethics Committee, the relevant institution and the individuals participating in the study.
Read the detailed description
Bipolar disorder negatively affects individuals' mental and physical health, interpersonal relationships, educational and occupational functions. Factors such as personality structure, coping with stress and social adaptation skills play an important role in the course of the disease as well as neurobiological factors. Bipolar disorder is a difficult condition for people to cope with due to its chronic nature and these individuals have problems in interpersonal relationships and coping with stress. Beyond what is perceived in relation to normal life, bipolar disorder causes individuals to experience large and complex extra dimensions in all aspects of their lives and to struggle for meaning in their lives. Three indicators of an individual's psychological well-being are the individual's goals in life, awareness of his/her existing potential and the quality of interpersonal relationships. In bipolar disorder, which also affects the psychological well-being of individuals, individuals often do not achieve complete remission despite pharmacotherapy. In addition to pharmacotherapy, various psychosocial interventions such as cognitive behavioural therapies and psychoeducation have been developed and applied to treat bipolar disorder. Acceptance and Commitment Therapy is one of the leading types of therapy methods called the third generation of cognitive behavioural therapies. Instead of teaching individuals to control their feelings, thoughts, sensations, memories and other subjective situations, acceptance and stability therapy teaches individuals to recognise and accept these experiences and, most importantly, to embrace their negative experiences. Acceptance and commitment therapy aims to change individuals' relationships with the emotions, thoughts, memories and physical sensations that they fear and avoid. It uses acceptance and awareness strategies to teach individuals to focus on the present moment and to reduce avoidance and cognitive attachment. Thus, individuals learn to clarify their goals and values and learn to adhere to behaviour change strategies. Acceptance and commitment therapy is one of the psychotherapies supported by the American Psychological Association for most psychiatric conditions, including psychosis. The transdiagnostic nature of acceptance and commitment therapy is compatible with mood disorders as well as psychotic symptoms. Acceptance and commitment therapy has been shown to be effective in many psychopathological conditions, including bipolar disorder. It is stated in the literature that an innovative group intervention combining acceptance and commitment therapy and psychoeducation approaches may be beneficial in individuals with bipolar disorder. Psychoeducational programmes are auxiliary interventions that complement pharmacological treatment in order to further reduce the burden of the disease and relapses in mental disorders. The effectiveness of psychoeducation in patients with bipolar disorder has been shown in many studies.
- Conditions
- Bipolar Disorder, Coping Skills
- Being tested
- Psychoeducation based on Acceptance and Commitment Therapy
- Keywords
- Bipolar Disorder, Copin Skills, Meaning and Purpose of Life, Acceptance and Commitment Therapy, Psychoeducation, Randomised Controlled Trial
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation based on Acceptance and Commitment TherapyOther
Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group.
| Study group | Role | What they receive |
|---|---|---|
| intervention group 1 in which psychoeducation based on acceptance and commitment therapy was applied | Experimental | After explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected. In the 12th week, follow-up test will be applied and evaluation will be made. Receives: Other: Psychoeducation based on Acceptance and Commitment Therapy |
| Control group 1 | No intervention | After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied. Then, the post-test will be applied 8 weeks later without any intervention. One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned. |
| Intervention group 2 in which psychoeducation based on acceptance and commitment therapy was applied | Experimental | After explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected. In the 12th week, follow-up test will be applied and evaluation will be made. Receives: Other: Psychoeducation based on Acceptance and Commitment Therapy |
| Control group 2 | No intervention | After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied. Then, the post-test will be applied 8 weeks later without any intervention. One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned. |
| Intervention group 3 in which psychoeducation based on acceptance and commitment therapy was applied | Experimental | After explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected. In the 12th week, follow-up test will be applied and evaluation will be made. Receives: Other: Psychoeducation based on Acceptance and Commitment Therapy |
| Control group 3 | No intervention | After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied. Then, the post-test will be applied 8 weeks later without any intervention. One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned. |
| Intervention group 4 in which psychoeducation based on acceptance and commitment therapy was applied | Experimental | After explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected. In the 12th week, follow-up test will be applied and evaluation will be made. Receives: Other: Psychoeducation based on Acceptance and Commitment Therapy |
| Control group 4 | No intervention | After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied. Then, the post-test will be applied 8 weeks later without any intervention. One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance and commitment therapy-based psychoeducation and the level of finding meaning in life in patients with bipolar disorder
The effect of acceptance and commitment therapy-based psychoeducation on individuals' levels of finding meaning in life in patients with bipolar disorder Personal Information Form and Meaning and Purpose of Life Scale pretests will be applied to the patients in the intervention group before the training. Afterwards, acceptance and stability-based psychoeducation consisting of 8 modules will be applied. Post-tests will be administered after the sessions and a follow-up test will be administered one month later (at the 12th week). Meaning and Purpose of Life Scale minimum score=17, maximum score=85. The high score obtained from the scale indicates that the level of meaning in the lives of individuals is high.
Measured: up to 12 weeks
Secondary outcomes (1)
Acceptance and commitment therapy-based psychoeducation and coping skills in patients with bipolar disorder
The effect of acceptance and commitment therapy-based psychoeducation on coping skills levels in patients with bipolar disorder Personal Information Form and Coping Attitudes Evaluation Scale COPE-R pretests will be applied to the patients in the intervention group before the training. Afterwards, acceptance and stability-based psychoeducation consisting of 8 modules will be applied. Post-tests will be administered after the sessions and a follow-up test will be administered one month later (at the 12th week). Coping Attitudes Rating Scale COPE-R minimum score=32, maximum score=128. The high score obtained from the scale indicates a high level of coping attitude.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start15 Sep 2022
- Primary completion25 Feb 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Randomised controlled trial consisting of a total of 8 groups, 4 experimental and 4 control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubra TOHUMCU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubra TOHUMCU, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131866
- Sponsor's protocol ID
- GAÜN KThmc
- Status last verified
- Mar 2024
- First submitted
- 3 Nov 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy Based Psychoeducation on Meaning and Purpose of Life and Coping Skills in Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06131866
- Acronym / sponsor ID
- GAÜN KThmc
- Conditions
- Bipolar Disorder, Coping Skills
- Keywords
- Bipolar Disorder, Copin Skills, Meaning and Purpose of Life, Acceptance and Commitment Therapy, Psychoeducation, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kubra TOHUMCUUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 14 Nov 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 research will be conducted to determine the effect of acceptance and commitment therapy-based psychoeducation on coping skills and finding meaning in life in patients with bipolar disorder. This research is planned as a randomised controlled experimental study. The study will be conducted with euthymic stage patients diagnosed with bipolar disorder who applied to Adıyaman Besni State Hospital psychiatry outpatient clinic using randomisation method. According to the power analysis result, the study will be applied to a total of 40 individuals, 20 experimental and 20 control. "Individual Information Form" regarding socio-demographic characteristics, "Coping Attitudes Evaluation Scale COPE-R" and "Meaning and Purpose of Life Scale" will be used to collect the data. Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group. Pre-tests will be applied to the patients in the intervention and control groups just before the training, post-test will be applied to the intervention group immediately after the training sessions are completed, and follow-up test will be applied one month after the post-test, i.e. in the 12th week. After the pre-test was applied to the control group, the post-test will be applied in the 8th week and the follow-up test will be applied in the 12th week without any intervention. In the evaluation of the data; descriptive statistical methods (frequency, mean), t-test, one way Anova and correlation analyses will be used. Permission was obtained from the University Ethics Committee, the relevant institution and the individuals participating in the study.
Detailed description
Bipolar disorder negatively affects individuals' mental and physical health, interpersonal relationships, educational and occupational functions. Factors such as personality structure, coping with stress and social adaptation skills play an important role in the course of the disease as well as neurobiological factors. Bipolar disorder is a difficult condition for people to cope with due to its chronic nature and these individuals have problems in interpersonal relationships and coping with stress. Beyond what is perceived in relation to normal life, bipolar disorder causes individuals to experience large and complex extra dimensions in all aspects of their lives and to struggle for meaning in their lives. Three indicators of an individual's psychological well-being are the individual's goals in life, awareness of his/her existing potential and the quality of interpersonal relationships. In bipolar disorder, which also affects the psychological well-being of individuals, individuals often do not achieve complete remission despite pharmacotherapy. In addition to pharmacotherapy, various psychosocial interventions such as cognitive behavioural therapies and psychoeducation have been developed and applied to treat bipolar disorder. Acceptance and Commitment Therapy is one of the leading types of therapy methods called the third generation of cognitive behavioural therapies. Instead of teaching individuals to control their feelings, thoughts, sensations, memories and other subjective situations, acceptance and stability therapy teaches individuals to recognise and accept these experiences and, most importantly, to embrace their negative experiences. Acceptance and commitment therapy aims to change individuals' relationships with the emotions, thoughts, memories and physical sensations that they fear and avoid. It uses acceptance and awareness strategies to teach individuals to focus on the present moment and to reduce avoidance and cognitive attachment. Thus, individuals learn to clarify their goals and values and learn to adhere to behaviour change strategies. Acceptance and commitment therapy is one of the psychotherapies supported by the American Psychological Association for most psychiatric conditions, including psychosis. The transdiagnostic nature of acceptance and commitment therapy is compatible with mood disorders as well as psychotic symptoms. Acceptance and commitment therapy has been shown to be effective in many psychopathological conditions, including bipolar disorder. It is stated in the literature that an innovative group intervention combining acceptance and commitment therapy and psychoeducation approaches may be beneficial in individuals with bipolar disorder. Psychoeducational programmes are auxiliary interventions that complement pharmacological treatment in order to further reduce the burden of the disease and relapses in mental disorders. The effectiveness of psychoeducation in patients with bipolar disorder has been shown in many studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- Randomised controlled trial consisting of a total of 8 groups, 4 experimental and 4 control
| Arm | Type | Receives |
|---|---|---|
| intervention group 1 in which psychoeducation based on acceptance and commitment therapy was applied | Experimental | Other: Psychoeducation based on Acceptance and Commitment TherapyAfter explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected. In the 12th week, follow-up test will be applied and evaluation will be made. |
| Control group 1 | No intervention | –After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied. Then, the post-test will be applied 8 weeks later without any intervention. One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned. |
| Intervention group 2 in which psychoeducation based on acceptance and commitment therapy was applied | Experimental | Other: Psychoeducation based on Acceptance and Commitment TherapyAfter explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected. In the 12th week, follow-up test will be applied and evaluation will be made. |
| Control group 2 | No intervention | –After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied. Then, the post-test will be applied 8 weeks later without any intervention. One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned. |
| Intervention group 3 in which psychoeducation based on acceptance and commitment therapy was applied | Experimental | Other: Psychoeducation based on Acceptance and Commitment TherapyAfter explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected. In the 12th week, follow-up test will be applied and evaluation will be made. |
| Control group 3 | No intervention | –After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied. Then, the post-test will be applied 8 weeks later without any intervention. One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned. |
| Intervention group 4 in which psychoeducation based on acceptance and commitment therapy was applied | Experimental | Other: Psychoeducation based on Acceptance and Commitment TherapyAfter explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected. In the 12th week, follow-up test will be applied and evaluation will be made. |
| Control group 4 | No intervention | –After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied. Then, the post-test will be applied 8 weeks later without any intervention. One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be receiving outpatient treatment with the diagnosis of Bipolar Disorder according to DSM-5
- Being in euthymic mood according to the doctor's control at the time of the interview
- Having no problem in understanding and speaking Turkish
- Being literate
- Being in the 18-65 age group
Key exclusion criteria (4 listed)
- Presence of serious sensory and cognitive disabilities that would prevent answering the questionnaire
- Refusal to participate in the study after being informed
- Having another psychiatric diagnosis in addition to the diagnosis of bipolar disorder
- Having an attack period during the education process
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 |
|---|---|---|
| Psychoeducation based on Acceptance and Commitment TherapyAcceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group. | Other | Intervention group 2 in which psychoeducation based on acceptance and commitment therapy was applied, Intervention group 3 in which psychoeducation based on acceptance and commitment therapy was applied, Intervention group 4 in which psychoeducation based on acceptance and commitment therapy was applied, intervention group 1 in which psychoeducation based on acceptance and commitment therapy was applied |
Primary outcome
Acceptance and commitment therapy-based psychoeducation and the level of finding meaning in life in patients with bipolar disorder
Time frame: up to 12 weeks
The effect of acceptance and commitment therapy-based psychoeducation on individuals' levels of finding meaning in life in patients with bipolar disorder Personal Information Form and Meaning and Purpose of Life Scale pretests will be applied to the patients in the intervention group before the training. Afterwards, acceptance and stability-based psychoeducation consisting of 8 modules will be applied. Post-tests will be administered after the sessions and a follow-up test will be administered one month later (at the 12th week). Meaning and Purpose of Life Scale minimum score=17, maximum score=85. The high score obtained from the scale indicates that the level of meaning in the lives of individuals is high.
1 secondary outcome
Acceptance and commitment therapy-based psychoeducation and coping skills in patients with bipolar disorder
Time frame: up to 12 weeks
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 22 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 based on Acceptance and Commitment Therapy in people with Bipolar Disorder and Coping Skills, run by Kubra TOHUMCU 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 6 inclusion and 4 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 22 Mar 2024. 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?
Acceptance and commitment therapy-based psychoeducation and the level of finding meaning in life in patients with bipolar disorder (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2024.