NCT02472483

Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Centre Hospitalier St Anne · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a large sample of refractory bipolar I patients on mood stabilizers.

Detailed description

In recent years, various controlled studies showed that psychoeducational interventions have been effective in decreasing relapse and improving outcomes for bipolar disorders. However, samples were often small, compromising statistical power, and with a large variety of patients. The investigators therefore tested if a CBT group psychoeducation program + MBCT decreased relapses and improved outcomes in a large sample of refractory bipolar I patients on mood stabilizers. Patients were tested at recruitment, at 6-month follow-up CBT and at 2-month follow-up MBCT using clinical interviews and self-report questionnaires. The primary outcome measure of efficacy was relapse during the follow-up requiring either hospitalization, modification of treatment or HDRS ≥ 16 or MRS ≥ 6. The secondary outcome measure was symptomatic and functional improvement.

Conditions

• Bipolar Disorder
• Anxious Disorder
• Alcohol Dependence

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive and Behavior Therapy (CBT)	20-weeks CBT
BEHAVIORAL	Mindfulness Based Cognitive Therapy (MBCT)	8-weeks MBCT

Timeline

• Start date: 2012-09-13
• Primary completion: 2019-09-13
• Completion: 2019-09-13
• First posted: 2015-06-16
• Last updated: 2019-11-01

Locations

1 site across 1 country: France