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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychopharmacological + MBCT | Active Comparator | psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT) |
|
| psychopharmacological + psychoeducation | Active Comparator | psychopharmacological treatment plus structured group psychoeducation; |
|
| Psychopharmacological treatment. | Other | Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Changes in scale score of Clinical Global Impression CGI-BP |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Changes in the Young Mania Rating Scale (YMRS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Consuelo De Dios Perrino, MD PhD | Contact | consuelo.dios@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Consuelo De Dios Perrino, MD PhD | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santiago Apostol | Vitoria-Gasteiz | Alava | 01004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38250270 | Derived | 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. | |
| 25124510 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| Psychoeducation | Behavioral | 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 | Behavioral | Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment. |
|
Changes in scale score of Clinical Global Impression CGI-BP from baseline (V0) to visit 1 |
| from baseline (V0) to week 8 (V1) |
| 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) |
| Cognitive changes | Changes at the end of the intervention will be assessed with the following measures:
| from baseline (V0) to week 8 (V1) |
| Functioning | Changes in total scale score of the Functioning Assessment Short Test (FAST) | from baseline (V0) to week 8 (V1) |
| 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) |
| 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) |
Changes in the Young Mania Rating Scale (YMRS) from baseline (V0 ) to week 24 (V2) |
| from baseline (V0 ) to week 24 (V2) |
| 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) |
| Cognitive changes | Cognitive changes: changes at the end of the intervention will be assessed with the following measures:
| from baseline (V0 ) to week 24 (V2) |
| Functioning: | Functioning: changes in total scale score of the Functioning Assessment Short Test (FAST) | from baseline (V0 ) to week 24 (V2) |
| 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) |
| 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) |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
|
| Derived |
| 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. |
| D001523 |
| Mental Disorders |
| D004191 |
| Behavioral Disciplines and Activities |