Bipolar DisorderCOMPASS-TBNCT06497868
Self-compassion and Bipolar Disorder
An observational study of Bipolar Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Currently, pharmacotherapy is central in the management of bipolar disorder (BD), but does not guarantee satisfactory results for many patients. Existing psychotherapies, notably cognitive-behavioral therapy (CBT), show some effectiveness, but do not target the mechanisms that maintain the disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2024to 20 Jun 2025
- Phase
- Observational
- 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
Study population: Major subject (≥ 18 years old) with diagnosed bipolar disorder followed on an outpatient basis, in a day hospital or outside the hospital during the period from January 1, 2022 to February 29, 2024.
Who may be able to join
- Major subject (≥ 18 years old)
- Subject with diagnosed bipolar disorder followed on an outpatient basis, in a day hospital or outside the hospital during the period from January 1, 2022 to February 29, 2024.
- Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
- Judicial measures: care under constraint or patient deprived of liberty due to a legal measure
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Psychiatrie - CHU de Strasbourg - France
Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 67091
Luisa WEINER, Psychologist
Emilie CHARLES, Psychologist
About this study
Official title: Self-compassion and Bipolar Disorder: Evaluation of the Feasibility and Preliminary Effectiveness of Two Psychological Therapies Targeting Self-compassion
Currently, pharmacotherapy is central in the management of bipolar disorder (BD), but does not guarantee satisfactory results for many patients. Existing psychotherapies, notably cognitive-behavioral therapy (CBT), show some effectiveness, but do not target the mechanisms that maintain the disorder. Indeed, people with BD present a low level of self-compassion, suffer from comorbidities (e.g. anxiety, depression), and have a high level of emotional dysregulation, which can contribute to increasing the risk of relapse and mood instability.
In this context, it has been suggested that interventions targeting self-compassion could reduce BD psychopathology and strengthen emotional regulation skills.
Read more
Two psychological therapies targeting self-compassion could be promising in the treatment of BD: Compassion-Based Therapy (CBT) and Cognitive Therapy focused on Mental Imagery (mTCI). These approaches partly emphasize compassionate mental imagery to promote self-soothing and emotion management skills.
Studies on the feasibility and effectiveness of CBT and mTCI in the context of BD are few in number, and do not focus on their impact on emotional regulation abilities. Evaluating these therapies could lead to the development of more specific and effective interventions for people with TB.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Self-compassion, cognitive-behavioral therapy, Anxiety Disorders, Depressive Disorder, Emotional regulation, Mental Imagery
- Medical subject headings
- Bipolar Disorder, Anxiety Disorders, Depressive Disorder, Emotional Regulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effectiveness of the Compassion-Based Therapy (CBT) and the Cognitive Therapy focused on Mental Imagery (mTCI).
For the evaluation of these two psychological therapies targeting self-compassion, the Self Compassion Scale (SCS; Neff, 2003) will be used :
- The SCS is a 26-question self-assessment questionnaire with a response format of 5-point Likert type (from 1= almost never to 5= almost always).
- The score between :
- 1.0-2.49 is considered to be low,
- 2.5-3.5 is considered to be moderate,
- 3.51-5.0 is considered to be high.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start20 Jun 2024
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497868
- Sponsor's protocol ID
- 9243
- Acronym
- COMPASS-TB
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-compassion and Bipolar Disorder: Evaluation of the Feasibility and Preliminary Effectiveness of Two Psychological Therapies Targeting Self-compassion
- ClinicalTrials.gov ID
- NCT06497868
- Acronym / sponsor ID
- COMPASS-TB / 9243
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Self-compassion, cognitive-behavioral therapy, Anxiety Disorders, Depressive Disorder, Emotional regulation, Mental Imagery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 12 Jul 2024 (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.
Currently, pharmacotherapy is central in the management of bipolar disorder (BD), but does not guarantee satisfactory results for many patients. Existing psychotherapies, notably cognitive-behavioral therapy (CBT), show some effectiveness, but do not target the mechanisms that maintain the disorder. Indeed, people with BD present a low level of self-compassion, suffer from comorbidities (e.g. anxiety, depression), and have a high level of emotional dysregulation, which can contribute to increasing the risk of relapse and mood instability.
In this context, it has been suggested that interventions targeting self-compassion could reduce BD psychopathology and strengthen emotional regulation skills.
Two psychological therapies targeting self-compassion could be promising in the treatment of BD: Compassion-Based Therapy (CBT) and Cognitive Therapy focused on Mental Imagery (mTCI). These approaches partly emphasize compassionate mental imagery to promote self-soothing and emotion management skills.
Studies on the feasibility and effectiveness of CBT and mTCI in the context of BD are few in number, and do not focus on their impact on emotional regulation abilities. Evaluating these therapies could lead to the development of more specific and effective interventions for people with TB.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥ 18 years old) with diagnosed bipolar disorder followed on an outpatient basis, in a day hospital or outside the hospital during the period from January 1, 2022 to February 29, 2024.
Key inclusion criteria (3 listed)
- Major subject (≥ 18 years old)
- Subject with diagnosed bipolar disorder followed on an outpatient basis, in a day hospital or outside the hospital during the period from January 1, 2022 to February 29, 2024.
- Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.
Key exclusion criteria (2 listed)
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
- Judicial measures: care under constraint or patient deprived of liberty due to a legal measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the effectiveness of the Compassion-Based Therapy (CBT) and the Cognitive Therapy focused on Mental Imagery (mTCI).
Time frame: Up to 1 year
For the evaluation of these two psychological therapies targeting self-compassion, the Self Compassion Scale (SCS; Neff, 2003) will be used : * The SCS is a 26-question self-assessment questionnaire with a response format of 5-point Likert type (from 1= almost never to 5= almost always). * The score between : * 1.0-2.49 is considered to be low, * 2.5-3.5 is considered to be moderate, * 3.51-5.0 is considered to be high.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 12 Jul 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 France. 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 Luisa WEINER, PhD (33 3 88 11 65 11, luisa.weiner@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effectiveness of the Compassion-Based Therapy (CBT) and the Cognitive Therapy focused on Mental Imagery (mTCI). (time frame: Up to 1 year). 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 12 Jul 2024.