NCT06497868

Brief 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. 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 1, 2024

Last Update Submit

July 9, 2024

Conditions

Keywords

Bipolar DisorderSelf-compassioncognitive-behavioral therapyAnxiety DisordersDepressive DisorderEmotional regulationMental Imagery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Psychiatrie - CHU de Strasbourg - France

Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Bipolar DisorderAnxiety DisordersDepressive DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 12, 2024

Study Start

June 20, 2024

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations