Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder (A2BipoLife)

University Hospital Tuebingen

Status: Completed

Conditions: Bipolar Disorder

Treatments: Behavioral: SEKT - Cognitive-Behavioral-Emotional; Behavioral: FEST - Clinical Supportive Educational

Study type: Interventional

Funder types: Other

Identifiers

NCT02506322

01EE1404C

Details and patient eligibility

About

This efficacy study compares an adjuvant specific psychotherapy and an active control intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain remission. Patients should be in their early (18-30 yr.) phase of illness without having suffered of to many affective episodes (below 6), already. In addition, psychological, social, and neurobiological mediators and moderators well be identified.

Full description

There is still a lack of controlled outcome and follow-up studies about the role of adjuvant psychotherapy in Bipolar Disorder. By treating older subjects having suffered of multiple affective episodes, the potential benefit of psychotherapy to prevent relapse and help to adjust to this chronic illness might be underestimated. In addition, the investigators have no knowledge of mechanism (mediators) of positive changes by successful psychotherapy and of subjects with good outcome of adjuvant psychotherapy (moderators, indicators, predictors). Possible mediators and moderators can be sociodemographic, psychological (cognitive, interactional), and/or biological (neuronal, genetic). The planned study will address all three areas of questions. In a multi-center study, 300 younger subjects suffering of a Bipolar Disorder will be included and provide with one of two treatments in addition to stable medication. Moderators and mediators are selected on promising preliminary results and based on a psycho-biological understanding of Bipolar Disorder.

Enrollment: 318 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bipolar I and Bipolar II Disorder,
• 18 to 55 years of age,
• giving informed consent to assessment, treatment, and randomization,
• currently remitted (for at least 4 weeks) and taking medication,
• less than 6 previous affective episodes

Exclusion criteria

• currently symptomatic (depressed, manic, hypomanic),
• suicidal,
• not taking medication,
• schizo-affective, schizophrenic, borderline personality disorder,
• not giving or withdrawing consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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318 participants in 2 patient groups

SEKT Cognitive-Behavioral-Emotional

Experimental group

Description:

Specific psychotherapy (SEKT - 4 modules) for typical problems of Bipolar patients to maintain remission and to prevent relapse. Including classical elements of self observation, psychoeducation, cognitive and behavioral interventions, social rhythm but also emotion regulation and meta-cognitive techniques. Delivered in a group setting in 4 one day treatment workshops, each one month apart. Homework assignment and electronical monitoring during time between sessions.

Treatment:

Behavioral: SEKT - Cognitive-Behavioral-Emotional

FEST Clinical Supportive Educational

Active Comparator group

Description:

This supportive, active control psychotherapy (FEST) is using general principals and non-specific interventions such as positive attitude, optimism, support, empathy, focus on emotion, self-help, strengthening and eliciting own resources, time and room for discussion of personal experiences. Psychoeducation about illness and drug treatment (mood stabilizer) to facilitate compliance.

Treatment:

Behavioral: FEST - Clinical Supportive Educational