"Mindfulness vs Psychoeducation in Bipolar Disorder"

Not Applicable

• Conditions: Bipolar; Depressive Symptoms
• Interventions: Behavioral: Mindfulness Based Cognitive Therapy (MBCT); Behavioral: Psychoeducation; Behavioral: Standard treatment

• Registration Number: NCT02133170
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric care with standard pharmacologic treatment.

Detailed Description

This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric care with standard pharmacologic treatment. After written informed consent is signed, patients meeting the inclusion criteria are randomized (2:2:1 ratio) through a Random Allocation Software. All three groups are assessed at baseline (t0), immediately after completing the program (t1; 8 weeks) and at follow-up six months after randomization. The assessments include the following variables: depression, anxiety, general and social cognition, global functioning, BDNF, and other clinical variables. The evaluator who collected the biomarkers and the clinical and psychometric data will be blind to treatment. The interrater variability between all researchers will be checked.

Study Timeline

• Study First Submitted: 2014-04-30
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-06
• Last Update Submitted: 2014-05-06
• Study First Posted: 2014-05-07
• Last Update Posted: 2014-05-07
• Study Start: 2014-09
• Primary Completion: 2016-01
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Age: 18-60 years
• BD type I or II, in clinical remission of acute mood episode at least in the three months prior to study
• Having presented an acute affective episode in the past 3 years
• Having presented at least two depressive episodes throughout his life.
• Monotherapy or combination with a mood stabilizer (lithium, valproate, carbamazepine or lamotrigine) at optimal doses (ie, in serum levels within the therapeutic range: 0.6-1.2 mEq / L for lithium, 50-100 ug / ml for valproate, and 5-12 mcg / mL for carbamazepine), or quetiapine monotherapy or in combination with the aforementioned stabilizers, or any oral atypical antipsychotic in combination with an antidepressant
• Hamilton Depression Rating Scale [HDRS]-17 score ≥ 8 and ≤ 19 and Young Mania Rating Scale [YMRS] score <8
• Being able to understand and comply with the requirements of the trial
• Written consent to participate in the study.

Exclusion Criteria

• Any acute mood episode in the 12 weeks before the start of the trial.
• Any current DSM -5 diagnosis different from bipolar disorder (including substance or alcohol use disorder at the time of study entry, except if it is under complete remission. Not applicable to nicotine or caffeine)
• Risk of suicide or self/hetero aggressiveness
• Pregnancy
• Severe and unstable medical pathology.
• Patients who are currently receiving structured psychotherapy or structured group psychoeducation about bipolar disorder, or who have received structured psychoeducation in the past 5 years
• Patients who are treated with a different mood stabilizer to lithium , valproate , carbamazepine , lamotrigine, a classic antipsychotic or antidepressant monotherapy at the time of the randomization
• Treatment with a depot antipsychotic
• Participation in another clinical trial within 4 weeks prior to randomization
• Mental Retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychopharmacological + MBCT	Mindfulness Based Cognitive Therapy (MBCT)	psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT)
psychopharmacological + psychoeducation	Psychoeducation	psychopharmacological treatment plus structured group psychoeducation;
Psychopharmacological treatment.	Standard treatment	Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.

Primary Outcome Measures

Name	Time	Method
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)	from baseline (V0) to week 8 (V1)	Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS), from baseline (V0) to week 8 (v1) for each of the treatment groups.

Secondary Outcome Measures

Name	Time	Method
Changes in scale score of Clinical Global Impression CGI-BP	from baseline (V0) to week 8 (V1)	Changes in scale score of Clinical Global Impression CGI-BP from baseline (V0) to visit 1
Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A	from baseline (V0) to week 8 (V1)	Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A from baseline (V0) to visit 1
Cognitive changes	from baseline (V0) to week 8 (V1)	Changes at the end of the intervention will be assessed with the following measures: * sustained and selective attention; * working memory and executive functions; * perception of the attitude of mindfulness ( FFMQ ) in patients in the experimental group; * scales of social cognition
Functioning	from baseline (V0) to week 8 (V1)	Changes in total scale score of the Functioning Assessment Short Test (FAST)
Changes in the global score of Young Mania Rating Scale (YMRS)	from baseline (V0) to week 8 (V1)	Changes in the global score of Young Mania Rating Scale (YMRS) from baseline (V0) to visit 1 (at the end of surgery 8 weeks (v1)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):	from baseline (V0) to week 8 (V1)	Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1
Recurrence	from baseline (V0) to week 8 (V1)	Recurrence, defined as the emergence of a new acute episode whether depressive, mixed, hypo or manic at any time throughout the study, according to DSM-5 clinical criteria or when the score on the HDRS scale is ≥ 20 ( depressive episode ) or the Young scale ( YMRS ≥ 8) (hypo/manic episode), or a change drug or hospitalization is needed.

Trial Locations

Locations (2)

Hospital Santiago Apostol; 🇪🇸 Vitoria, Alava, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain