- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07915934
Adapting the "Do More, Feel Better" Intervention for Older People Living With HIV
More than half of people living with HIV (PWH) in the United States are 50 years of age or older. Older PWH have a 2.3-fold increased risk of depression compared to their peers without HIV. The investigator team has developed a streamlined lay-delivered behavioral activation intervention called "Do More, Feel Better" that has been shown to decrease depressive symptoms among older adults obtaining services in community senior centers. The investigators propose to (1) identify barriers and facilitators to improving mental health among older PWH by using this intervention in the context of Ryan White case management services, (2) adapt and enhance the intervention to meet the needs of older PWH, and (3) conduct a pilot randomized controlled trial to determine the acceptability, feasibility, and appropriateness of the adapted DMFB intervention.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
More than half of people living with HIV (PWH) in the United States (US) are 50 years of age or older. Compared with those without HIV, older PWH have 2.3-fold increased risk of depression. The impact of unmitigated mental health symptoms and related conditions among this growing population is significant and includes social isolation, loss of independence, and poor engagement with healthcare, undermining progress towards ending the HIV epidemic. Due to a shortage behavioral health providers, there is growing interest in innovative interventions using community-based, peer-led approaches to improve access to effective mental health services. Behavioral activation is an evidence-based intervention that has shown promise for reducing depressive symptoms among older adults. The investigator team has developed a streamlined lay-delivered behavioral activation intervention called "Do More, Feel Better" (DMFB) that has been shown to decrease depressive symptoms among depressed (PHQ-9 ≥10) older adults obtaining services in community senior centers. Delivery of an adapted version of the DMFB intervention for older PWH with poor access to professional counseling could be relatively straightforward within the existing Ryan White HIV/AIDS program, supported by organizations that provide essential services such as non-medical case management to low-income PWH. Because the intervention is tailored to individual preferences and needs, it promises to be acceptable, especially after careful adaptation using input from community members and stakeholders. This study's aims are therefore: (1) to understand the impact of mental health issues on HIV care, functioning, and quality of life and identify multi-level barriers and facilitators that could influence participation in and delivery of an adapted DMFB intervention; (2) to adapt and enhance the DMFB intervention for delivery by case management program staff or volunteers to older PWH, following the ADAPT-ITT model in collaboration with community partners; and (3) to determine the acceptability, feasibility, and appropriateness of the adapted DMFB intervention compared to clinician-delivered Behavioral Activation therapy over 3 months in a pilot randomized controlled trial. Results of this research will have high impact by adapting an effective lay-delivered behavioral activation intervention for older PWH that is low-cost, scalable, and easily tailored to individual preferences and needs. Ongoing work on the DMFB intervention indicates that this lay-delivered intervention has great potential to produce concrete improvements in mental health and quality of life. The study's multidisciplinary team has a strong record of research on HIV care, geriatric mental health, HIV and aging, behavioral health and implementation science, and the experience with mixed methods approaches, intervention adaptation, and clinical trials necessary to successfully carry out this work. Adaptation of the DMFB intervention has the potential to be acceptable, feasible, effective and scalable when delivered within case management organizations, improving the lives and HIV outcomes of older PWH.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Susan M Graham, MD MPH PhD
- Número de teléfono: 206-351-0414
- Correo electrónico: grahamsm@uw.edu
Copia de seguridad de contactos de estudio
- Nombre: Isabell Griffith Fillipo, BA
- Número de teléfono: 206-685-4585
- Correo electrónico: irgf@uw.edu
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington
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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:
- ≥50 years of age
- living with HIV
- English-speaking
- elevated depressive symptoms (PHQ-9 ≥10)
- resident in Washington for ≥1 year
- assigned to a Ryan White case manager
- willing to undergo all study procedures
Exclusion Criteria: Participants in the Aim 1 and 2 work (interviews and theater testing) and those who serve as certification participants (for interventionist training) will be excluded from the trial. Other exclusion criteria include:
- active suicidal ideation
- a diagnosis of bipolar disorder, schizophrenia or psychosis
- dementia or Telephone Interview for Cognitive Status-modified (TICS-M) scores <21
- current regular psychotherapy
- antidepressant use, unless at stable doses for 12 weeks
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Usual care
The control condition will be usual care, which will likely involve some period waiting for an intake followed by supportive counseling sessions for treating depressive symptoms. Receipt of counseling and other supportive services during the trial for both the intervention and usual care groups will be closely tracked. |
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Experimental: Adapted "Do More, Feel Better" Intervention
Lay-delivered behavioral activation intervention, adapted based on interviews and theater testing with the target audience |
The adapted behavioral activation intervention will be delivered by trained lay interventionists and provided over 9 weekly sessions lasting 45-60 minutes in person, by telephone, or by Zoom. This intervention currently consists of an initial meeting for psychoeducation and compilation of a tailored list of enjoyable and rewarding activities the client will draw from and schedule, followed by 8 weekly sessions to monitor symptoms, review homework, and continue daily activity scheduling. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
Periodo de tiempo: week 3 and 9
|
4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater acceptability of the intervention. |
week 3 and 9
|
|
Intervention Appropriateness Measure (IAM)
Periodo de tiempo: week 3 and 9
|
4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater perceived appropriateness of the intervention. |
week 3 and 9
|
|
Feasibility of Intervention Measure (FIM)
Periodo de tiempo: week 3 and 9
|
4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater perceived feasibility of the intervention. |
week 3 and 9
|
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Session attendance
Periodo de tiempo: week 9
|
Session attendance will be calculated as the proportion of intervention sessions attended out of nine possible sessions. |
week 9
|
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Exit interview
Periodo de tiempo: week 9
|
Qualitative feedback on the adapted DMFB intervention and clinician-delivered BA therapy will be collected in exit interviews with a sample of participants from each arm |
week 9
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hamilton Rating Scale for Depression (Ham-D)
Periodo de tiempo: Baseline, week 3, week 6, week 9, week 12
|
The Ham-D 24-item scale is a semi-structured clinical interview that assesses depression severity. Scores range from 0 to 76, with higher scores indicating greater depressive-symptom severity. Scores 0-7 represent transient to no depressive symptoms; 8-13 mild depression; 14-18 moderate depression; 19-22 severe depression and above 22 very severe depression. |
Baseline, week 3, week 6, week 9, week 12
|
|
Behavioral activation for depression scale (BADS)
Periodo de tiempo: Baseline, week 3, week 6, week 9, week 12
|
The BADS is a 25-item scale assessing overall activity level based on four factors: activation, avoidance/rumination, work/school impairment and social impairment. Each item ranges from 0 ('not at all') to 6 ('completely'); total scores range from 0 to 150. Higher total scores indicate better behavioral activation and fewer depressive-avoidance behaviors. |
Baseline, week 3, week 6, week 9, week 12
|
|
Three-item self-report measure for medication adherence
Periodo de tiempo: Baseline, week 9, week 12
|
Wilson's three-item self-report measure for medication adherence assesses missed days during the past 30 days, frequency of taking medication as prescribed, and the person's rating of how well they took it. Scores range from 0-100 for the raw summary score, calculated as the mean of the three item scores. Higher scores indicate better medication adherence. |
Baseline, week 9, week 12
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|
Index of engagement in HIV care
Periodo de tiempo: Baseline, week 9, week 12
|
The CFAR Network of Integrated Clinical Systems 10-item index of engagement in HIV care includes 10 items rated on a 5-point Likert scale. The range of summed scores is from 10-50 and mean scores range from 1-5. Higher scores indicate better HIV care engagement. |
Baseline, week 9, week 12
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|
HIV-1 RNA viral load
Periodo de tiempo: Baseline, week 12
|
Dried blood spots will be collected for viral load testing through the University of Washington Department of Laboratory Medicine. Any viral load <200 copies/mL will be considered suppressed. |
Baseline, week 12
|
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Date of last clinic visit
Periodo de tiempo: Baseline, week 24
|
Provider-reported date of last clinic visit, obtained for participants who grant permission for release of this information. |
Baseline, week 24
|
|
Most recent viral load
Periodo de tiempo: Baseline, week 24
|
Provider-reported most recent viral load, obtained for participants who grant permission for release of this information. |
Baseline, week 24
|
|
Most recent CD4 count
Periodo de tiempo: Baseline, week 24
|
Provider-reported most recent CD4 count, obtained for participants who grant permission for release of this information. |
Baseline, week 24
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan M Graham, MD MPH PhD, University of Washington
Publicaciones y enlaces útiles
Publicaciones Generales
- Raue PJ, Hawrilenko M, Corey M, Lin J, Chen S, Mosser BA. "Do More, Feel Better": Pilot RCT of Lay-Delivered Behavioral Activation for Depressed Senior Center Clients. Behav Ther. 2022 May;53(3):458-468. doi: 10.1016/j.beth.2021.11.005. Epub 2021 Nov 26.
- Raue PJ, Dawson A, Hoeft T, Russo J, Ferguson D, Green L, Petersky C, Kaplan C. Acceptability of a lay-delivered intervention for depression in senior centers. Aging Ment Health. 2021 Mar;25(3):445-452. doi: 10.1080/13607863.2019.1698515. Epub 2019 Dec 4.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- R34MH143573 (Subvención/contrato del NIH de EE. UU.)
- 1R34MH143573-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
IDP will be shared with the NIMH Data Archive.
Marco de tiempo para compartir IPD
The protocol, statistical analysis plan, and ICF will be uploaded to ClinicalTrials.gov as soon as they are approved. The clinical study report and analytic code will be uploaded upon completion of the trial and its analysis.
Criterios de acceso compartido de IPD
Deidentified data on arm, primary and secondary outcomes, and basic demographic characteristics will be available through the NIMH Data Archives.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .