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

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ClinicalTrials.gov Identifier: NCT02133170
Recruitment Status : Unknown
Verified May 2014 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was:  Not yet recruiting
First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bipolar Depressive Symptoms Behavioral: Mindfulness Based Cognitive Therapy (MBCT) Behavioral: Psychoeducation Behavioral: Standard treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. Functioning [ Time Frame: from baseline (V0) to week 8 (V1) ]
    Changes in total scale score of the Functioning Assessment Short Test (FAST)

  6. 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

  7. 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.


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. Functioning: [ Time Frame: from baseline (V0 ) to week 24 (V2) ]
    Functioning: changes in total scale score of the Functioning Assessment Short Test (FAST)

  6. 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

  7. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133170


Contacts
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Contact: Consuelo De Dios Perrino, MD PhD consuelo.dios@salud.madrid.org

Locations
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Spain
Hospital Santiago Apostol Not yet recruiting
Vitoria, Alava, Spain, 01004
Principal Investigator: Margarita Sanz Herrero, MD         
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Contact: Consuelo De Dios Perrino       consuelo.dios@salud.madrid.org   
Principal Investigator: Consuelo De Dios Perrino, MD PhD         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Consuelo De Dios Perrino, MD PhD Hospital Universitario La Paz

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT02133170     History of Changes
Other Study ID Numbers: HULP: 4094
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
BIPOLAR DISORDER
DEPRESSIVE SYMPTOMS
MINDFULNESS
PSYCHOEDUCATION
BIPOLAR PATIENTS WITH DEPRESSIVE SYMPTOMS
Additional relevant MeSH terms:
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Bipolar Disorder
Depression
Bipolar and Related Disorders
Mental Disorders
Behavioral Symptoms