Integrative psychological program for bipolar disorder
Effects of an Integrative Program Combining Mindfulness-based Cognitive Therapy, Psychoeducation and Functional Remediation in Bipolar Disorder
NA · Consorcio Centro de Investigación Biomédica en Red (CIBER) · NCT04031560
This study is testing a new psychological program for people with bipolar disorder to see if it can improve their well-being better than just standard treatment alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Consorcio Centro de Investigación Biomédica en Red (CIBER) (other gov) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04031560 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of a brief integrative psychological program designed for patients with bipolar disorder, focusing on psychoeducation, mindfulness, and functional remediation. A total of 124 participants will be randomly assigned to either an experimental group receiving the integrative program or a control group receiving standard psychiatric treatment only. The program consists of 12 sessions, each lasting 90 minutes, and aims to enhance aspects of treatment that medication alone cannot address. Assessments will be conducted at baseline, after the intervention, and at a 12-month follow-up to evaluate the program's impact on patients' well-being.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with bipolar disorder type I or II who are currently euthymic or experiencing subthreshold symptoms.
Not a fit: Patients with significant physical or neurological illnesses, substance abuse issues, or those who have received psychosocial interventions in the past two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide patients with improved management of bipolar disorder symptoms and enhance their overall quality of life.
How similar studies have performed: Previous studies have shown promise in using integrative psychological approaches for bipolar disorder, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of BD type I or II according to DSM-5 criteria * euthymic or with subthreshold symptoms (HDRS \<14; YMRS \<8) * absence of an acute mood episode in the 3 months prior to the beginning of the intervention Exclusion Criteria: * estimated Intelligence Quotient (IQ) lower than 85, * significant physical or neurologic illness that can affect neuropsychological performance * DSM-5 criteria of substance abuse or dependence * inability to understand the purposes of the study * absence of psychosocial interventions in the past 2 years (psychoeducation group, functional remediation, mindfulness)
Where this trial is running
Barcelona
- Hospital Clinic of Barcelona — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Jose Sanchez-Moreno — Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study coordinator: Jose Sanchez-Moreno, PhD
- Email: jose.sanchez.moreno@cibersam.es
- Phone: +34932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Disorder, mindfulness, cognitive therapy, psychoeducation, functional remediation