Testing an Adaptive Intervention for Peer-Supported Mobile Health for Primary Care Veterans With Psychological Distress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self Managed mHealth, 1 session of peer mHealth, 4 sessions Peer mHealth, 4 sessions of Peer Whole Health.
- Who it may be relevant to
- Registry conditions: Psychological Distress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Many Veterans experience psychological distress including depression, PTSD, anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.
Detailed description
Background: Psychological distress in Veterans Affairs (VA) primary care patients is common and often not adequately treated. The VA has a suite of evidence-informed mobile health applications (mHealth apps) for psychological distress that are frequently downloaded, but most Veterans do not use them enough to experience health benefits. Support from helping professionals, such as peer specialists, can increase app use and health benefits. The study team found that peer-supported mHealth is feasible to deliver in VA primary care, increases app engagement and is associated with high satisfaction and improved Veteran health. However, not all individuals need the same amount of support when using mHealth. This study will test an adaptive intervention using a SMART design to match patient need with specific doses of peer support for mHealth.
Significance: The long-term goal is to improve the health of Veterans with psychological distress by developing a brief and efficient stepped-care intervention that can be feasibly implemented in VA primary care settings. This proposal is highly aligned with the priorities of the operational partners in the Offices of Mental Health and Patient Centered Care \& Cultural Transformation and VA BBMH. The findings will support the VA-wide expansion of the Peers in PACT program, per recent STRONG Act legislation.
Innovation \& Impact: Key innovations include the use of a SMART design to develop an adaptive intervention for a high-priority patient population and the novel application of the Supportive Accountability model in which human support is critical to enhancing adherence to mHealth interventions. The proposal will also provide much needed data on the effectiveness of peers to deliver brief, structured interventions.
Specific Aims: 1) Test the effectiveness of a) stage 1 (Peer mHealth vs. Self-Managed mHealth), b) stage 2 interventions (4 sessions of Peer mHealth vs. Peer Whole Health) among slow responders and c) the embedded stepped-care treatment sequences on psychological distress and secondary outcomes (e.g., app use, cost, mental health service use, symptoms, functioning) at 12 weeks. 2) Examine candidate tailoring variables as predictors of outcomes in a) stage 1 (i.e., motivation, coping self-efficacy) and b) stage 2 (i.e., app use and unmet social needs). Race/ethnicity and sex/gender will also be explored as moderators. 3) Assess barriers and facilitators to implementing adaptive interventions for peer mHealth in PACT by interviewing key VHA leadership, staff and Veteran stakeholders.
Methodology: Participants (N=384) with significant psychological distress who are not engaged in specialty mental health care will be randomized at Stage 1 to receive either Self-Managed mHealth or one peer phone call to support mHealth. Participant response, defined as a reliable decrease in psychological distress (5-point decrease in any DASS-21 subscale) will be measured after 4 weeks. Stage 2 randomization will assign slow responders to step-up to additional mHealth peer phone calls or an alternative peer support model (peer-delivered Whole Health). Stage 1 early responders will continue/ step-down to Self-Managed mHealth. All participants will be reassessed at 12, 16 and 24 weeks post-enrollment. Psychological distress is the primary outcome. Secondary outcomes include app use, mental health service use, cost, psychological symptoms (e.g., depression, anxiety, stress, PTSD, anger, sleep), and functioning (e.g., social functioning).
Next Steps/ Implementation: Should these results support the effectiveness of the adaptive intervention, the investigators will disseminate peer training through the Peers in PACT and Tech into Care VA networks. The investigators will also prepare a new ORD application to systemically investigate how the adaptive intervention can be implemented in VA.
Interventions
- Behavioral Self Managed mHealth
Patients use mHealth apps to manage psychological distress - Behavioral 1 session of peer mHealth
Patients receive one session with a peer while using mHealth apps to manage psychological distress - Behavioral 4 sessions Peer mHealth
Patients receive 4 sessions with a peer while using mHealth apps to manage psychological distress - Behavioral 4 sessions of Peer Whole Health
Patients receive 4 session with a peer focused on Whole Health
Primary outcome measures
- Depression Anxiety and Stress Scale [Time frame: baseline to 24 weeks]
Secondary outcome measures (6)
- Post Traumatic Stess Checklist-5 [Time frame: baseline to 24 weeks]
- Insomnia Severity Index [Time frame: baseline to 25 weeks]
- Dimensions of Anger Reactions [Time frame: baseline to 24 weeks]
- Brief Inventory of Psychosocial Functioning [Time frame: baseline to 24 weeks]
- Satisfaction with Life Questionnaire [Time frame: baseline to 24 weeks]
- Client Satisfaction Questionnaire [Time frame: baseline to 24 weeks]
Eligibility criteria
Inclusion criteria
- Veteran enrolled in primary care at one of 3 VA facilities (Philadelphia, PA; Ann Arbor, MI; and Bedford, MA)
- clinically significant psychological distress on at least one DASS-21 subscale (Depression => 10, Anxiety => 8, Stress => 13)
Exclusion criteria
- symptoms that may preclude active engagement in the intervention such as gross cognitive impairment or current symptoms of mania or psychosis
- suicide risk as measured by the P4 Suicide Assessment
- plan to engage in psychotherapy during the intervention period
- started or changed the dose of a psychotropic medication in the last two months
- voice a preference to be directly referred to mental health specialty care
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
- VA Bedford HealthCare System, Bedford, MA — Bedford
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor
- Syracuse VA Medical Center, Syracuse, NY — Syracuse
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia
Identifiers
NCT: NCT07507747 · HSR4-014-24W · 1I01RD000522-01A2