Clinical trial NCT02133170: "Mindfulness vs Psychoeducation in Bipolar Disorder"
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
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar
Depressive Symptoms
Keywords: BIPOLAR DISORDER
DEPRESSIVE SYMPTOMS
MINDFULNESS
PSYCHOEDUCATION
BIPOLAR PATIENTS WITH DEPRESSIVE SYMPTOMS
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2014-05-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)
timeFrame: from baseline (V0) to week 8 (V1)
Secondary outcomes:
measure: Changes in the global score of Young Mania Rating Scale (YMRS)
timeFrame: from baseline (V0) to week 8 (V1)
measure: Changes in scale score of Clinical Global Impression CGI-BP
timeFrame: from baseline (V0) to week 8 (V1)
measure: Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A
timeFrame: from baseline (V0) to week 8 (V1)
measure: Cognitive changes
timeFrame: from baseline (V0) to week 8 (V1)
measure: Functioning
timeFrame: from baseline (V0) to week 8 (V1)
measure: Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):
timeFrame: from baseline (V0) to week 8 (V1)
measure: Recurrence
timeFrame: from baseline (V0) to week 8 (V1)
Other outcomes:
measure: changes in the overall score of the Hamilton Depression Rating Scale (HDRS )
timeFrame: from baseline (V0 ) to week 24 (V2)
measure: Changes in the Young Mania Rating Scale (YMRS)
timeFrame: from baseline (V0 ) to week 24 (V2)
measure: Changes in the overall score of the Hamilton anxiety Scale HAM- A
timeFrame: from baseline (V0 ) to week 24 (V2)
measure: Cognitive changes
timeFrame: from baseline (V0 ) to week 24 (V2)
measure: Functioning:
timeFrame: from baseline (V0 ) to week 24 (V2)
measure: Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: from baseline (V0 ) to week 24 (V2)
measure: Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):
timeFrame: from baseline (V0) to week 8 (V1)
Locations:
city: Vitoria
country: Spain
facility: Hospital Santiago Apostol
state: Alava
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Consuelo De Dios Perrino, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.