Q3211488 (Q3211488): Difference between revisions
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(Created claim: summary (P836): The presence of subsyndromic symptoms (SS) in bipolar disorder (BD), especially of a depressive type, negatively influences the prognosis and progression of the disease: it increases the risk of affective relapses, worsens social, cognitive, and quality of life. Pharmacological treatment is essential, advising to complement it with psychosocial interventions. There is little data on how to treat depressive subsyndromic symptoms. Cognitive thera...) |
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The presence of subsyndromic symptoms (SS) in bipolar disorder (BD), especially of a depressive type, negatively influences the prognosis and progression of the disease: it increases the risk of affective relapses, worsens social, cognitive, and quality of life. Pharmacological treatment is essential, advising to complement it with psychosocial interventions. There is little data on how to treat depressive subsyndromic symptoms. Cognitive therapy based on mindfulness-Based Cognitive Therapy (MBCT) is a psychotherapeutic intervention that has proved effective in unipolar depression, and it is interesting to conduct studies of efficacy in bipolar disorder. Objective: Evaluate the efficacy of MBCT against short group structured psychoeducation in subdepressive symptomatology in patients with TB, and maintenance of response in the 6 months of post-intervention follow-up. Scenario: MBCT will be more effective in reducing subdepressive symptomatology and will improve cognitive functioning versus psychoeducational treatment. The hypothesis of an increase in BDNF levels is formulated after the intervention. Methodology: A randomised, multicenter, prospective versus active comparator clinical trial with blind evaluator. Patients will be assigned either to an experimental group (MBCT) added to their psychopharmacological treatment, or to a control group that will receive group structured psychoeducational treatment. A period of prior stabilisation of psychopharmacological treatment will be performed, evaluating lithium and valproate levels in the 6 weeks prior to randomisation. Screening, baseline, post-intervention evaluations will be carried out at 12 and 24 weeks post-intervention. (English) | |||||||||||||||
| Property / summary: The presence of subsyndromic symptoms (SS) in bipolar disorder (BD), especially of a depressive type, negatively influences the prognosis and progression of the disease: it increases the risk of affective relapses, worsens social, cognitive, and quality of life. Pharmacological treatment is essential, advising to complement it with psychosocial interventions. There is little data on how to treat depressive subsyndromic symptoms. Cognitive therapy based on mindfulness-Based Cognitive Therapy (MBCT) is a psychotherapeutic intervention that has proved effective in unipolar depression, and it is interesting to conduct studies of efficacy in bipolar disorder. Objective: Evaluate the efficacy of MBCT against short group structured psychoeducation in subdepressive symptomatology in patients with TB, and maintenance of response in the 6 months of post-intervention follow-up. Scenario: MBCT will be more effective in reducing subdepressive symptomatology and will improve cognitive functioning versus psychoeducational treatment. The hypothesis of an increase in BDNF levels is formulated after the intervention. Methodology: A randomised, multicenter, prospective versus active comparator clinical trial with blind evaluator. Patients will be assigned either to an experimental group (MBCT) added to their psychopharmacological treatment, or to a control group that will receive group structured psychoeducational treatment. A period of prior stabilisation of psychopharmacological treatment will be performed, evaluating lithium and valproate levels in the 6 weeks prior to randomisation. Screening, baseline, post-intervention evaluations will be carried out at 12 and 24 weeks post-intervention. (English) / rank | |||||||||||||||
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| Property / summary: The presence of subsyndromic symptoms (SS) in bipolar disorder (BD), especially of a depressive type, negatively influences the prognosis and progression of the disease: it increases the risk of affective relapses, worsens social, cognitive, and quality of life. Pharmacological treatment is essential, advising to complement it with psychosocial interventions. There is little data on how to treat depressive subsyndromic symptoms. Cognitive therapy based on mindfulness-Based Cognitive Therapy (MBCT) is a psychotherapeutic intervention that has proved effective in unipolar depression, and it is interesting to conduct studies of efficacy in bipolar disorder. Objective: Evaluate the efficacy of MBCT against short group structured psychoeducation in subdepressive symptomatology in patients with TB, and maintenance of response in the 6 months of post-intervention follow-up. Scenario: MBCT will be more effective in reducing subdepressive symptomatology and will improve cognitive functioning versus psychoeducational treatment. The hypothesis of an increase in BDNF levels is formulated after the intervention. Methodology: A randomised, multicenter, prospective versus active comparator clinical trial with blind evaluator. Patients will be assigned either to an experimental group (MBCT) added to their psychopharmacological treatment, or to a control group that will receive group structured psychoeducational treatment. A period of prior stabilisation of psychopharmacological treatment will be performed, evaluating lithium and valproate levels in the 6 weeks prior to randomisation. Screening, baseline, post-intervention evaluations will be carried out at 12 and 24 weeks post-intervention. (English) / qualifier | |||||||||||||||
point in time: 14 October 2021
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Revision as of 11:09, 14 October 2021
Project Q3211488 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3211488 in Spain |
Statements
20,000.0 Euro
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40,000.0 Euro
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50.0 percent
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1 January 2014
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30 September 2018
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FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS
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42°50'47.44"N, 2°40'20.64"W
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01059
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La presencia de síntomas subsindrómicos (SS) en el trastorno bipolar (TB), especialmente de tipo depresivo, influye negativamente en el pronóstico y la evolución de la enfermedad: aumenta el riesgo de recaídas afectivas, empeora el funcionamiento social, cognitivo, y la calidad de vida. El tratamiento farmacológico es esencial, aconsejándose complementarlo con intervenciones psicosociales. Hay escasos datos sobre cómo tratar los síntomas subsindrómicos depresivos. La terapia cognitiva basada en atención plena (Mindfulness-Based Cognitive Therapy, MBCT) es una intervención psicoterapéutica que se ha mostrado eficaz en la depresión unipolar, siendo interesante el realizar estudios de eficacia en el trastorno bipolar. Objetivo: Evaluar la eficacia de MBCT frente a psicoeducación estructurada grupal breve en la sintomatología subdepresiva en pacientes con TB, y el mantenimiento de la respuesta en los 6 meses de seguimiento postintervención. Hipótesis: MBCT será más eficaz en la reducción de la sintomatología subdepresiva y mejorará el funcionamiento cognitivo frente al tratamiento psicoeducativo. Se formula la hipótesis de un aumento de los niveles de BDNF tras la intervención. Metodología: Ensayo clínico aleatorizado, multicéntrico, prospectivo frente a comparador activo, con evaluador ciego. Los pacientes serán asignados bien a un grupo experimental (MBCT) añadido a su tratamiento psicofarmacológico, bien a un grupo control que recibirá tratamiento psicoeducativo estructurado grupal. Se realizará un período de estabilización previa del tratamiento psicofarmacológico, evaluando niveles de litio y de valproato, en las 6 semanas previas a la aleatorización. Se realizarán evaluaciones de screening, basal, post-intervención, a las 12 y a las 24 semanas post-intervención. (Spanish)
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The presence of subsyndromic symptoms (SS) in bipolar disorder (BD), especially of a depressive type, negatively influences the prognosis and progression of the disease: it increases the risk of affective relapses, worsens social, cognitive, and quality of life. Pharmacological treatment is essential, advising to complement it with psychosocial interventions. There is little data on how to treat depressive subsyndromic symptoms. Cognitive therapy based on mindfulness-Based Cognitive Therapy (MBCT) is a psychotherapeutic intervention that has proved effective in unipolar depression, and it is interesting to conduct studies of efficacy in bipolar disorder. Objective: Evaluate the efficacy of MBCT against short group structured psychoeducation in subdepressive symptomatology in patients with TB, and maintenance of response in the 6 months of post-intervention follow-up. Scenario: MBCT will be more effective in reducing subdepressive symptomatology and will improve cognitive functioning versus psychoeducational treatment. The hypothesis of an increase in BDNF levels is formulated after the intervention. Methodology: A randomised, multicenter, prospective versus active comparator clinical trial with blind evaluator. Patients will be assigned either to an experimental group (MBCT) added to their psychopharmacological treatment, or to a control group that will receive group structured psychoeducational treatment. A period of prior stabilisation of psychopharmacological treatment will be performed, evaluating lithium and valproate levels in the 6 weeks prior to randomisation. Screening, baseline, post-intervention evaluations will be carried out at 12 and 24 weeks post-intervention. (English)
14 October 2021
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Vitoria-Gasteiz
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Identifiers
PI13_00451
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