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

Primary Purpose

Bipolar, Depressive Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy (MBCT)
Psychoeducation
Standard treatment
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar focused on measuring BIPOLAR DISORDER, DEPRESSIVE SYMPTOMS, MINDFULNESS, PSYCHOEDUCATION, BIPOLAR PATIENTS WITH DEPRESSIVE SYMPTOMS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Santiago Apostol
  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Psychopharmacological + MBCT

psychopharmacological + psychoeducation

Psychopharmacological treatment.

Arm Description

psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT)

psychopharmacological treatment plus structured group psychoeducation;

Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.

Outcomes

Primary Outcome Measures

Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)
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

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

Full Information

First Posted
April 30, 2014
Last Updated
May 6, 2014
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT02133170
Brief Title
"Mindfulness vs Psychoeducation in Bipolar Disorder"
Acronym
BI-MIND
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar, Depressive Symptoms
Keywords
BIPOLAR DISORDER, DEPRESSIVE SYMPTOMS, MINDFULNESS, PSYCHOEDUCATION, BIPOLAR PATIENTS WITH DEPRESSIVE SYMPTOMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychopharmacological + MBCT
Arm Type
Active Comparator
Arm Description
psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT)
Arm Title
psychopharmacological + psychoeducation
Arm Type
Active Comparator
Arm Description
psychopharmacological treatment plus structured group psychoeducation;
Arm Title
Psychopharmacological treatment.
Arm Type
Other
Arm Description
Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy (MBCT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard treatment
Intervention Description
Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.
Primary Outcome Measure Information:
Title
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)
Description
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.
Time Frame
from baseline (V0) to week 8 (V1)
Secondary Outcome Measure Information:
Title
Changes in the global score of Young Mania Rating Scale (YMRS)
Description
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)
Time Frame
from baseline (V0) to week 8 (V1)
Title
Changes in scale score of Clinical Global Impression CGI-BP
Description
Changes in scale score of Clinical Global Impression CGI-BP from baseline (V0) to visit 1
Time Frame
from baseline (V0) to week 8 (V1)
Title
Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A
Description
Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A from baseline (V0) to visit 1
Time Frame
from baseline (V0) to week 8 (V1)
Title
Cognitive changes
Description
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
Time Frame
from baseline (V0) to week 8 (V1)
Title
Functioning
Description
Changes in total scale score of the Functioning Assessment Short Test (FAST)
Time Frame
from baseline (V0) to week 8 (V1)
Title
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):
Description
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1
Time Frame
from baseline (V0) to week 8 (V1)
Title
Recurrence
Description
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.
Time Frame
from baseline (V0) to week 8 (V1)
Other Pre-specified Outcome Measures:
Title
changes in the overall score of the Hamilton Depression Rating Scale (HDRS )
Description
Changes in the overall score of the Hamilton Depression Rating Scale (HDRS ) from baseline (V0 ) to week 24 (V2)
Time Frame
from baseline (V0 ) to week 24 (V2)
Title
Changes in the Young Mania Rating Scale (YMRS)
Description
Changes in the Young Mania Rating Scale (YMRS) from baseline (V0 ) to week 24 (V2)
Time Frame
from baseline (V0 ) to week 24 (V2)
Title
Changes in the overall score of the Hamilton anxiety Scale HAM- A
Description
changes in the overall score of the Hamilton anxiety Scale HAM- A from baseline (V0 ) to week 24 (V2)
Time Frame
from baseline (V0 ) to week 24 (V2)
Title
Cognitive changes
Description
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
Time Frame
from baseline (V0 ) to week 24 (V2)
Title
Functioning:
Description
Functioning: changes in total scale score of the Functioning Assessment Short Test (FAST)
Time Frame
from baseline (V0 ) to week 24 (V2)
Title
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF)
Description
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 2
Time Frame
from baseline (V0 ) to week 24 (V2)
Title
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):
Description
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1 (end of intervention).
Time Frame
from baseline (V0) to week 8 (V1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Consuelo De Dios Perrino, MD PhD
Email
consuelo.dios@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Consuelo De Dios Perrino, MD PhD
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Santiago Apostol
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarita Sanz Herrero, MD
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Consuelo De Dios Perrino
Email
consuelo.dios@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Consuelo De Dios Perrino, MD PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25124510
Citation
Lahera G, Bayon C, Fe Bravo-Ortiz M, Rodriguez-Vega B, Barbeito S, Saenz M, Avedillo C, Villanueva R, Ugarte A, Gonzalez-Pinto A, de Dios C. Mindfulness-based cognitive therapy versus psychoeducational intervention in bipolar outpatients with sub-threshold depressive symptoms: a randomized controlled trial. BMC Psychiatry. 2014 Aug 15;14:215. doi: 10.1186/s12888-014-0215-x.
Results Reference
derived
Links:
URL
http://idipaz.es
Description
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