Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

28 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

48

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Susan M Graham, MD MPH PhD
  • Numéro de téléphone: 206-351-0414
  • E-mail: grahamsm@uw.edu

Sauvegarde des contacts de l'étude

  • Nom: Isabell Griffith Fillipo, BA
  • Numéro de téléphone: 206-685-4585
  • E-mail: irgf@uw.edu

Lieux d'étude

    • Washington
      • Seattle, Washington, États-Unis, 98195
        • University of Washington

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: 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.

Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Acceptability of Intervention Measure (AIM)
Délai: 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)
Délai: 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)
Délai: 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
Délai: week 9

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

week 9
Exit interview
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Hamilton Rating Scale for Depression (Ham-D)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, week 24

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

Baseline, week 24

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

8 novembre 2027

Achèvement primaire (Estimé)

26 juin 2028

Achèvement de l'étude (Estimé)

25 septembre 2028

Dates d'inscription aux études

Première soumission

20 octobre 2026

Première soumission répondant aux critères de contrôle qualité

28 octobre 2026

Première publication (Réel)

4 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • R34MH143573 (Subvention/contrat des NIH des États-Unis)
  • 1R34MH143573-01 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

IDP will be shared with the NIMH Data Archive.

Délai de partage 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.

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner