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Adapting the "Do More, Feel Better" Intervention for Older People Living With HIV

28 oktober 2026 bijgewerkt door: Susan Graham, University of Washington

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

48

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Susan M Graham, MD MPH PhD
  • Telefoonnummer: 206-351-0414
  • E-mail: grahamsm@uw.edu

Studie Contact Back-up

  • Naam: Isabell Griffith Fillipo, BA
  • Telefoonnummer: 206-685-4585
  • E-mail: irgf@uw.edu

Studie Locaties

  • Verenigde Staten
    • Washington
      • Seattle, Washington, Verenigde Staten, 98195
        • University of Washington

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: Adapted "Do More, Feel Better" Intervention

Lay-delivered behavioral activation intervention, adapted based on interviews and theater testing with the target audience
Gedragsmatig: "Do More, Feel Better" for Older People with HIV

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Acceptability of Intervention Measure (AIM)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Session attendance
Tijdsspanne: week 9

Session attendance will be calculated as the proportion of intervention sessions attended out of nine possible sessions.
week 9
Exit interview
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hamilton Rating Scale for Depression (Ham-D)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Index of engagement in HIV care
Tijdsspanne: 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
HIV-1 RNA viral load
Tijdsspanne: 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
Date of last clinic visit
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, week 24

Provider-reported most recent CD4 count, obtained for participants who grant permission for release of this information.
Baseline, week 24

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Washington

Medewerkers

National Institute of Mental Health (NIMH)

Onderzoekers

  • Hoofdonderzoeker: Susan M Graham, MD MPH PhD, University of Washington

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

8 november 2027

Primaire voltooiing (Geschat)

26 juni 2028

Studie voltooiing (Geschat)

25 september 2028

Studieregistratiedata

Eerst ingediend

20 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 oktober 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

28 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R34MH143573 (Subsidie/contract van de Amerikaanse NIH)
  • 1R34MH143573-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

IDP will be shared with the NIMH Data Archive.

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

Deidentified data on arm, primary and secondary outcomes, and basic demographic characteristics will be available through the NIMH Data Archives.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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