"Mindfulness vs Psychoeducation in Bipolar Disorder" (BI-MIND)

May 6, 2014 updated by: Instituto de Investigación Hospital Universitario La Paz

Comparative Efficacy of Two Adjunctive Psychosocial Interventions (Mindfulness or Psychoeducation) Versus Treatment as Usual in Bipolar Patients With Subsyndromal Deppresive Symptoms: A Pilot Randomized Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
    • Alava
      • Vitoria, Alava, Spain, 01004
        • Hospital Santiago Apostol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Psychopharmacological + MBCT
psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT)
Behavioral: Mindfulness Based Cognitive Therapy (MBCT)
The MBCT program is conducted in HULP (BRV and CBP), which also train therapists from Vitoria, in order to homogenize the intervention. Random sessions are video or audio recorded to be discussed and analyzed by the treatment team. The manualized MBCT therapy consists of 8 weekly sessions of 90 minutes and is applied in groups of approximately 10-15 patients. At least two programs in H. La Paz and two in the hospital de Santiago (Vitoria) will be provided.
Active Comparator: psychopharmacological + psychoeducation
psychopharmacological treatment plus structured group psychoeducation;
Behavioral: Psychoeducation
Psychoeducation program will be held in groups of 10 to 15 patients in 90-minute weekly sessions led by two therapists also outside the research team. The specific program of 8 sessions is focused addressing disease awareness, adherence to treatment and early detection of prodromal symptoms. Homework will also be included. The program is based on the Psychoeducation Manual for Bipolar Disorder . F.Colom , E.Vieta . Ars Medica, 2004. Attendance at least 80 % of the sessions of both interventions will be required to be considered complete.
Other: Psychopharmacological treatment.
Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.
Behavioral: Standard treatment
Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)
Time Frame: 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.
from baseline (V0) to week 8 (V1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the global score of Young Mania Rating Scale (YMRS)
Time Frame: 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)
from baseline (V0) to week 8 (V1)
Changes in scale score of Clinical Global Impression CGI-BP
Time Frame: from baseline (V0) to week 8 (V1)
Changes in scale score of Clinical Global Impression CGI-BP from baseline (V0) to visit 1
from baseline (V0) to week 8 (V1)
Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A
Time Frame: 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
from baseline (V0) to week 8 (V1)
Cognitive changes
Time Frame: 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
from baseline (V0) to week 8 (V1)
Functioning
Time Frame: from baseline (V0) to week 8 (V1)
Changes in total scale score of the Functioning Assessment Short Test (FAST)
from baseline (V0) to week 8 (V1)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):
Time Frame: from baseline (V0) to week 8 (V1)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1
from baseline (V0) to week 8 (V1)
Recurrence
Time Frame: 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.
from baseline (V0) to week 8 (V1)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in the overall score of the Hamilton Depression Rating Scale (HDRS )
Time Frame: from baseline (V0 ) to week 24 (V2)
Changes in the overall score of the Hamilton Depression Rating Scale (HDRS ) from baseline (V0 ) to week 24 (V2)
from baseline (V0 ) to week 24 (V2)
Changes in the Young Mania Rating Scale (YMRS)
Time Frame: from baseline (V0 ) to week 24 (V2)
Changes in the Young Mania Rating Scale (YMRS) from baseline (V0 ) to week 24 (V2)
from baseline (V0 ) to week 24 (V2)
Changes in the overall score of the Hamilton anxiety Scale HAM- A
Time Frame: from baseline (V0 ) to week 24 (V2)
changes in the overall score of the Hamilton anxiety Scale HAM- A from baseline (V0 ) to week 24 (V2)
from baseline (V0 ) to week 24 (V2)
Cognitive changes
Time Frame: from baseline (V0 ) to week 24 (V2)

Cognitive changes: 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
from baseline (V0 ) to week 24 (V2)
Functioning:
Time Frame: from baseline (V0 ) to week 24 (V2)
Functioning: changes in total scale score of the Functioning Assessment Short Test (FAST)
from baseline (V0 ) to week 24 (V2)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF)
Time Frame: from baseline (V0 ) to week 24 (V2)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 2
from baseline (V0 ) to week 24 (V2)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):
Time Frame: from baseline (V0) to week 8 (V1)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1 (end of intervention).
from baseline (V0) to week 8 (V1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Consuelo De Dios Perrino, MD PhD, Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP: 4094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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