Evaluación de una intervención adaptativa de salud móvil con apoyo entre pares para veteranos de atención primaria con malestar psicológico (Peer mHealth)
Evaluación de una Intervención Adaptativa de Salud Móvil con Apoyo de Pares para Veteranos de Atención Primaria con Angustia Psicológica
Many Veterans experience psychological distress including depression, post-traumatic stress disorder (PTSD), anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Background: Psychological distress in Veterans Affairs (VA) primary care patients is common and often not adequately treated. The VA has a suite of evidence-informed mobile health applications (mHealth apps) for psychological distress that are frequently downloaded, but most Veterans do not use them enough to experience health benefits. Support from helping professionals, such as peer specialists, can increase app use and health benefits. The study team found that peer-supported mHealth is feasible to deliver in VA primary care, increases app engagement and is associated with high satisfaction and improved Veteran health. However, not all individuals need the same amount of support when using mHealth. This study will test an adaptive intervention using a SMART design to match patient need with specific doses of peer support for mHealth.
Significance: The long-term goal is to improve the health of Veterans with psychological distress by developing a brief and efficient stepped-care intervention that can be feasibly implemented in VA primary care settings. This proposal is highly aligned with the priorities of the operational partners in the Offices of Mental Health and Patient Centered Care & Cultural Transformation and VA BBMH. The findings will support the VA-wide expansion of the Peers in PACT program, per recent STRONG Act legislation.
Innovation & Impact: Key innovations include the use of a SMART design to develop an adaptive intervention for a high-priority patient population and the novel application of the Supportive Accountability model in which human support is critical to enhancing adherence to mHealth interventions. The proposal will also provide much needed data on the effectiveness of peers to deliver brief, structured interventions.
Specific Aims: 1) Test the effectiveness of a) stage 1 (Peer mHealth vs. Self-Managed mHealth), b) stage 2 interventions (4 sessions of Peer mHealth vs. Peer Whole Health) among slow responders and c) the embedded stepped-care treatment sequences on psychological distress and secondary outcomes (e.g., app use, cost, mental health service use, symptoms, functioning) at 12 weeks. 2) Examine candidate tailoring variables as predictors of outcomes in a) stage 1 (i.e., motivation, coping self-efficacy) and b) stage 2 (i.e., app use and unmet social needs). Race/ethnicity and sex/gender will also be explored as moderators. 3) Assess barriers and facilitators to implementing adaptive interventions for peer mHealth in PACT by interviewing key VHA leadership, staff and Veteran stakeholders.
Methodology: Participants (N=384) with significant psychological distress who are not engaged in specialty mental health care will be randomized at Stage 1 to receive either Self-Managed mHealth or one peer phone call to support mHealth. Participant response, defined as a reliable decrease in psychological distress (5-point decrease in any DASS-21 subscale) will be measured after 4 weeks. Stage 2 randomization will assign slow responders to step-up to additional mHealth peer phone calls or an alternative peer support model (peer-delivered Whole Health). Stage 1 early responders will continue/ step-down to Self-Managed mHealth. All participants will be reassessed at 12, 16 and 24 weeks post-enrollment. Psychological distress is the primary outcome. Secondary outcomes include app use, mental health service use, cost, psychological symptoms (e.g., depression, anxiety, stress, PTSD, anger, sleep), and functioning (e.g., social functioning).
Next Steps/ Implementation: Should these results support the effectiveness of the adaptive intervention, the investigators will disseminate peer training through the Peers in PACT and Tech into Care VA networks. The investigators will also prepare a new ORD application to systemically investigate how the adaptive intervention can be implemented in VA.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Kyle Possemato, PhD
- Número de teléfono: 53551 (315) 425-4400
- Correo electrónico: kyle.possemato@va.gov
Ubicaciones de estudio
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California
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Palo Alto, California, Estados Unidos, 94304-1207
- Aún no reclutando
- VA Palo Alto Health Care System, Palo Alto, CA
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Contacto:
- Jennifer Smith
- Correo electrónico: Jennifer.Smith@va.gov
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Massachusetts
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Bedford, Massachusetts, Estados Unidos, 01730-1114
- Aún no reclutando
- VA Bedford HealthCare System, Bedford, MA
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Contacto:
- Andrew Peckham
- Correo electrónico: Andrew.Peckham@va.gov
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48105-2303
- Aún no reclutando
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Contacto:
- Rebecca Sripada
- Correo electrónico: Rebecca.Sripada@va.gov
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New York
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Syracuse, New York, Estados Unidos, 13210-2716
- Reclutamiento
- Syracuse VA Medical Center, Syracuse, NY
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Contacto:
- Kyle Possemato, PhD
- Número de teléfono: 53551 (315) 425-4400
- Correo electrónico: kyle.possemato@va.gov
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Investigador principal:
- Kyle Possemato, PhD
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4551
- Aún no reclutando
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Contacto:
- Travis Cos
- Correo electrónico: travis.cos@va.gov
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Veteran enrolled in primary care at one of 3 VA facilities (Philadelphia, PA; Ann Arbor, MI; and Bedford, MA)
- clinically significant psychological distress on at least one DASS-21 subscale (Depression => 10, Anxiety => 8, Stress => 13)
Exclusion Criteria:
- symptoms that may preclude active engagement in the intervention such as gross cognitive impairment or current symptoms of mania or psychosis
- suicide risk as measured by the P4 Suicide Assessment
- plan to engage in psychotherapy during the intervention period
- started or changed the dose of a psychotropic medication in the last two months
- voice a preference to be directly referred to mental health specialty care
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Stage 1
Stage 1 randomization |
Patients use mHealth apps to manage psychological distress Patients receive one session with a peer while using mHealth apps to manage psychological distress |
|
Experimental: Stage 2
Stage 2 randomization |
Patients use mHealth apps to manage psychological distress Patients receive 4 sessions with a peer while using mHealth apps to manage psychological distress Patients receive 4 session with a peer focused on Whole Health |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depression Anxiety and Stress Scale
Periodo de tiempo: baseline to 24 weeks
|
Depression Anxiety and Stress Scale is a widely used measure of psychological distress consisting of 21 items measured on a 4-point scale. The total score ranges from 0-63. Higher scores indicate greater severity. |
baseline to 24 weeks
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Post Traumatic Stess Checklist-5
Periodo de tiempo: baseline to 24 weeks
|
Self report measure assessing the 21 symptoms of post-traumatic stress disorder (PTSD) on a 5 point scale. Total score ranges from 0-105. Higher scores indicate greater severity. |
baseline to 24 weeks
|
|
Insomnia Severity Index
Periodo de tiempo: baseline to 25 weeks
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Self report measure assessing insomnia with 7 questions on a 5 point scale. Total score range from 0-28. Higher scores indicate greater severity. |
baseline to 25 weeks
|
|
Dimensions of Anger Reactions
Periodo de tiempo: baseline to 24 weeks
|
Self report measure assessing anger with 5 items on a 5 point scale. Total score ranges from 5-25. Higher scores indicate greater severity. |
baseline to 24 weeks
|
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Brief Inventory of Psychosocial Functioning
Periodo de tiempo: baseline to 24 weeks
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Self report measure of psychosocial functioning measured with 7 items on 7 point scale. Total ranges from 0-42. Higher scores indicate more dysfunction. |
baseline to 24 weeks
|
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Satisfaction with Life Questionnaire
Periodo de tiempo: baseline to 24 weeks
|
Self report measure assessing life satisfaction with 5 items on an eight point scale. Total score ranges from 5-35. High scores indicate greater satisfaction. |
baseline to 24 weeks
|
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Client Satisfaction Questionnaire
Periodo de tiempo: baseline to 24 weeks
|
Self report measure assessing participant satisfaction with study interventions with 8 items measures on a 4 point scale. Total score ranges from 0-24. Higher scores indicate greater satisfaction. |
baseline to 24 weeks
|
Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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University of Rhode Island Change Assessment
Periodo de tiempo: baseline to 24 weeks
|
Self report measure assessing patient motivation to address psychological distress with 12 items on a 5 point scale. Total score ranges from 12 to 60. Higher scores indicate more motivation. |
baseline to 24 weeks
|
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Coping Self Efficacy Scale
Periodo de tiempo: baseline to 24 weeks
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Self report measure to assess patient self efficacy to address psychological distress with 26 items on a 11 point scale. Total score ranges from 0-260 with higher scores indicating greater self-efficacy. |
baseline to 24 weeks
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Assessing Circumstances and Offering Resources for Needs
Periodo de tiempo: baseline to 24 weeks
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Measure of unmet social needs that include 11 questions. The total score ranges from 0-48 with higher scores indicating more unmet needs. |
baseline to 24 weeks
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Kyle Possemato, PhD, Syracuse VA Medical Center, Syracuse, NY
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- HSR4-014-24W
- 1I01RD000522-01A2 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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producto fabricado y exportado desde los EE. UU.
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