Depressive Symptoms Clinical Trial
— BI-MINDOfficial 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
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Santiago Apostol | Vitoria | Alava |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Hospital Universitario La Paz | Instituto de Salud Carlos III |
Spain,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
Completed |
NCT05702086 -
Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Recruiting |
NCT06100146 -
Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls
|
N/A | |
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Completed |
NCT05376397 -
Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
|
N/A | |
Terminated |
NCT04367636 -
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19
|
N/A | |
Completed |
NCT04403126 -
To Increase Psychological Well-being by the Implementation of Forgiveness Education
|
N/A | |
Recruiting |
NCT05078424 -
Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
|
N/A | |
Recruiting |
NCT06053775 -
Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Recruiting |
NCT04082052 -
Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
|
N/A | |
Completed |
NCT04011540 -
Digital Data in Mental Health Therapy
|
N/A | |
Not yet recruiting |
NCT06413849 -
Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers
|
N/A | |
Not yet recruiting |
NCT03659591 -
Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost
|
N/A | |
Completed |
NCT02314390 -
Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial
|
N/A | |
Completed |
NCT01628016 -
The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms
|
N/A | |
Completed |
NCT01786083 -
Caring for Family Caregivers:a Research-action Study
|
N/A |