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ClinicalTrials.gov ID

NCT02133170

Lead Sponsor

Instituto de Investigación Hospital Universitario La PazOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

140Estimated

Last Update Posted

May 7, 2014Estimated

Start Date

Sep 2014

Primary Completion Date

Jan 2016Estimated

Completion Date

Jun 2016Estimated

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

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.

• Bipolar
• Depressive Symptoms

• Mindfulness Based Cognitive Therapy (MBCT)
• Psychoeducation
• Standard treatment

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Instituto de Investigación Hospital Universitario La PazOTHER

Collaborators

Instituto de Salud Carlos IIIOTHER_GOV

consuelo.dios@salud.madrid.org