NCT02133170

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

April 30, 2014

Last Update Submit

May 6, 2014

Conditions

BipolarDepressive Symptoms

Keywords

BIPOLAR DISORDERDEPRESSIVE SYMPTOMSMINDFULNESSPSYCHOEDUCATIONBIPOLAR PATIENTS WITH DEPRESSIVE SYMPTOMS

Outcome Measures

Primary Outcomes (1)

  • 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.

    from baseline (V0) to week 8 (V1)

Secondary Outcomes (7)

  • Changes in the global score of Young Mania Rating Scale (YMRS)

    from baseline (V0) to week 8 (V1)

  • Changes in scale score of Clinical Global Impression CGI-BP

    from baseline (V0) to week 8 (V1)

  • Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A

    from baseline (V0) to week 8 (V1)

  • Cognitive changes

    from baseline (V0) to week 8 (V1)

  • Functioning

    from baseline (V0) to week 8 (V1)

  • +2 more secondary outcomes

Other Outcomes (7)

  • changes in the overall score of the Hamilton Depression Rating Scale (HDRS )

    from baseline (V0 ) to week 24 (V2)

  • Changes in the Young Mania Rating Scale (YMRS)

    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 more other outcomes

Study Arms (3)

Psychopharmacological + MBCT

ACTIVE COMPARATOR

psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT)

Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

psychopharmacological + psychoeducation

ACTIVE COMPARATOR

psychopharmacological treatment plus structured group psychoeducation;

Behavioral: Psychoeducation

Psychopharmacological treatment.

OTHER

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

Behavioral: Standard treatment

Interventions

Mindfulness Based Cognitive Therapy (MBCT)BEHAVIORAL

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.

Psychopharmacological + MBCT
PsychoeducationBEHAVIORAL

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 + psychoeducation
Standard treatmentBEHAVIORAL

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

Psychopharmacological treatment.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Santiago Apostol

Vitoria-Gasteiz, Alava, 01004, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (2)

  • Carracedo-Sanchidrian D, de Dios-Perrino C, Bayon-Perez C, Rodriguez-Vega B, Bravo-Ortiz MF, Ortega MA, Gonzalez-Pinto AM, Lahera G. Effect of mindfulness-based cognitive therapy vs. psychoeducational intervention on plasma brain-derived neurotrophic factor and cognitive function in bipolar patients: a randomized controlled trial. Front Psychiatry. 2024 Jan 5;14:1279342. doi: 10.3389/fpsyt.2023.1279342. eCollection 2023.

    PMID: 38250270DERIVED

  • 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.

    PMID: 25124510DERIVED

Related Links

MeSH Terms

Conditions

DepressionBipolar Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Consuelo De Dios Perrino, MD PhD

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Consuelo De Dios Perrino, MD PhD

CONTACT

consuelo.dios@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 7, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

ES(2)