Improving Mood in Veterans in Primary Care
RCT of Behavioral Activation for Depression and Suicidality in Primary Care
The purpose of the Improving Mood in Veterans in Primary Care (IIR 14-047) is to evaluate a brief educational individual workshop that is meant to help Veterans better understand feelings of sadness and ways to improve their mood. This study is intended to evaluate and establish the workshop's effectiveness for use with Veterans in primary care settings.
The study involves up to 6 in-person meetings and 6 telephone interviews across a 6-month period of time. Approximately 144 Veterans will participate in the study. Using a procedure like the flip of a coin, the participants will have a one in two chance of receiving the brief educational workshop or treatment as usual condition.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
Depressive symptoms are the most common referral problem to integrated mental health providers within Veteran primary care clinics. Although there exist several empirically-based brief psychotherapies for depression in primary care, the most significant barrier to providing those psychotherapies is treatment duration (e.g., the treatments range from 6-8 sessions of 30-50 minutes) as it does not match typical treatment formats delivered by mental health providers working in primary care (i.e., 1-4 15-30 minute sessions). Therefore, this HSR&D study titled, RCT of Behavioral Activation for Depression and Suicidality in Primary Care, will examine the effectiveness of a brief version of an existing efficacious longer treatment for depression, called behavioral activation.
Objectives:
The overarching objectives of this study are to: 1) examine whether a 4-session manualized behavioral activation intervention (BA-PC) compared to Treatment as Usual (TAU) is effective in reducing self-reported depressive symptoms and subjective secondary outcomes such as sleep impairment and quality of life; 2) examine patient satisfaction, engagement, and receptivity to a 4-session BA-PC; and 3) explore the impact of BA-PC on suicidal ideation.
Methods:
The study will achieve these objectives using a randomized, controlled trial study design that has two conditions (4-session BA-PC and Treatment as Usual). Veterans will be recruited from three VA primary care settings in the Western portion of VISN 2 (Syracuse, Rochester, and Buffalo). The primary inclusion criteria for the study will be a report of depressive symptoms by primary care patients, who are not currently engaged in psychological treatment for depression. A total of 136 Veterans will be targeted for randomization. All Veterans will be assessed every 2 weeks for changes in mood and more comprehensive assessments will be completed at 6, 12, and 24 weeks.
Status:
Recruitment has ended as of 2/26/18 with 140 participants being randomized. Follow-up will continue for another 24 weeks. We are preparing the data for analysis.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Buffalo, New York, Estados Unidos, 14215
- VA Western New York Healthcare System, Buffalo, NY
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Canandaigua, New York, Estados Unidos, 14424
- Canandaigua VA Medical Center, Canandaigua, NY
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Syracuse, New York, Estados Unidos, 13210
- Syracuse VA Medical Center, Syracuse, NY
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Veterans:
- aged 18 years
- seeking or receiving primary care services at the Syracuse, Canandaigua, or Buffalo VA Medical Centers
- reporting at least moderate depressive symptoms
- stable course of antidepression medications
- stable course of outpatient treatment for anxiety or substance use disorders
Exclusion Criteria:
Veterans who are:
- unable to demonstrate an understanding of the informed consent
- non-English speaking
- reporting imminent risk of suicide
- have an unstable psychiatric condition
- currently involved in treatment for depression
- recently started antidepression medication or outpatient treatment for anxiety or substance use disorder
- currently involved or completed inpatient or intensive outpatient treatment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Brief Behavioral Activation
This is a 4-session individual workshop using behavioral activation techniques.
Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values.
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This is a 4-session individual workshop using behavioral activation techniques.
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Comparador activo: Usual Care
This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms.
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Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Depressive Symptoms at 12 Weeks
Periodo de tiempo: Baseline and 12 weeks
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The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms at baseline and 12 weeks.
The minimum value is 0 and the maximum value is 27.
Higher scores mean a worse outcome.
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Baseline and 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Quality of Life at 12 Weeks
Periodo de tiempo: Baseline and 12 weeks
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The investigators will use the Short Form-12 (SF-12) mental health domain to assess quality of life at baseline and 12 weeks.
The minimum score is 0 and maximum score is 100.
Higher scores mean better quality of life within mental health domain.
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Baseline and 12 weeks
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Change From Baseline in Sleep Disturbances at 12 Weeks
Periodo de tiempo: Baseline and 12 weeks
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The investigators will use the Insomnia Severity Index (ISI) to assess sleep disturbances at baseline and 12 weeks.
The minimum score is 0 and the maximum score is 28.
Higher scores on ISI mean worse sleep.
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Baseline and 12 weeks
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Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks
Periodo de tiempo: Baseline and 12 weeks
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The investigators will use the Environmental Observational Reward (EROS) scale to assess level of reward/positive mood at baseline and 12 weeks.
The minimum score is 10 and the maximum score is 40.
Higher scores mean increased level of positive mood obtained from environment.
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Baseline and 12 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks
Periodo de tiempo: Baseline and 12 weeks
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The investigators will use the Beck Scale for Suicidal Ideation to assess intensity of suicidal ideation within the past week at baseline and 12 weeks.
The minimum score is 0 and the maximum score is 38.
Higher scores mean worse suicidal ideation.
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Baseline and 12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jennifer Schum Funderburk, PhD, Syracuse VA Medical Center, Syracuse, NY
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIR 14-047
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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