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

October 28, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Susan M Graham, MD MPH PhD
  • Phone Number: 206-351-0414
  • Email: grahamsm@uw.edu

Study Contact Backup

  • Name: Isabell Griffith Fillipo, BA
  • Phone Number: 206-685-4585
  • Email: irgf@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No 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.
Experimental: Adapted "Do More, Feel Better" Intervention

Lay-delivered behavioral activation intervention, adapted based on interviews and theater testing with the target audience
Behavioral: "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention Measure (AIM)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: week 9

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression (Ham-D)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, week 24

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 8, 2027

Primary Completion (Estimated)

June 26, 2028

Study Completion (Estimated)

September 25, 2028

Study Registration Dates

First Submitted

October 20, 2026

First Submitted That Met QC Criteria

October 28, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

October 28, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH143573 (U.S. NIH Grant/Contract)
  • 1R34MH143573-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IDP will be shared with the NIMH Data Archive.

IPD Sharing Time Frame

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 Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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