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

28 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Susan M Graham, MD MPH PhD
  • Numero di telefono: 206-351-0414
  • Email: grahamsm@uw.edu

Backup dei contatti dello studio

  • Nome: Isabell Griffith Fillipo, BA
  • Numero di telefono: 206-685-4585
  • Email: irgf@uw.edu

Luoghi di studio

    • Washington
      • Seattle, Washington, Stati Uniti, 98195
        • University of Washington

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.

Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability of Intervention Measure (AIM)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: week 9

Session attendance will be calculated as the proportion of intervention sessions attended out of nine possible sessions.

week 9
Exit interview
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hamilton Rating Scale for Depression (Ham-D)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, week 24

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

Baseline, week 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

8 novembre 2027

Completamento primario (Stimato)

26 giugno 2028

Completamento dello studio (Stimato)

25 settembre 2028

Date di iscrizione allo studio

Primo inviato

20 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • R34MH143573 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 1R34MH143573-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

IDP will be shared with the NIMH Data Archive.

Periodo di condivisione 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.

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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