"Mindfulness vs Psychoeducation in Bipolar Disorder"

Depressive Symptoms Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02133170
• Other study ID #: HULP: 4094
• Status: Not yet recruiting
• Phase: N/A
• First received: April 30, 2014
• Last updated: May 6, 2014
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2014
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Consuelo De Dios Perrino, MD PhD
• Email: consuelo.dios[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar
• Bipolar Disorder
• Depressive Symptoms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Santiago Apostol	Vitoria	Alava

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in the overall score of the Hamilton Depression Rating Scale (HDRS )	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)	No
Other	Changes in the Young Mania Rating Scale (YMRS)	Changes in the Young Mania Rating Scale (YMRS) from baseline (V0 ) to week 24 (V2)	from baseline (V0 ) to week 24 (V2)	No
Other	Changes in the overall score of the Hamilton anxiety Scale HAM- A	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)	No
Other	Cognitive changes	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)	No
Other	Functioning:	Functioning: changes in total scale score of the Functioning Assessment Short Test (FAST)	from baseline (V0 ) to week 24 (V2)	No
Other	Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF)	Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 2	from baseline (V0 ) to week 24 (V2)	No
Other	Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):	Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1 (end of intervention).	from baseline (V0) to week 8 (V1)	No
Primary	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)	No
Secondary	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)	from baseline (V0) to week 8 (V1)	No
Secondary	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	from baseline (V0) to week 8 (V1)	No
Secondary	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	from baseline (V0) to week 8 (V1)	No
Secondary	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 8 (V1)	No
Secondary	Functioning	Changes in total scale score of the Functioning Assessment Short Test (FAST)	from baseline (V0) to week 8 (V1)	No
Secondary	Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):	Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1	from baseline (V0) to week 8 (V1)	No
Secondary	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.	from baseline (V0) to week 8 (V1)	No

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