Depression Agency-Based Collaborative (Depression ABC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Major depressive disorder
Study Overview
Brief Summary
Seniors who receive supportive services face a variety of psychosocial vulnerabilities that put them at risk for depression. One group with very high risk is older adults receiving aging services through Medicaid waiver programs. This 3-year research uses a randomized controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem solving therapy [PST] and Brief Behavioral Therapy for Insomnia [BBTI]) to prevent depression in seniors receiving aging services.
Detailed Description
The research will determine (i) if a course of problem solving therapy (PST) and Brief Behavioral Therapy for Insomnia (BBTI), with boosters, reduces incidence of major depressive episodes over 12 months relative to usual care, and (ii) the extent to which behavioral therapies achieve these effects through enhancement of protective factors, such as greater self-efficacy, better targeting of services to address needs, and greater control over home environments.
Periodic blood draws will be used to assess biosignatures of depression. Guiding our investigations of pharmacogenetics, inflammation, and proteomics are synergistic interactions among the serotonergic system, the HPA axis, systemic inflammation, growth factors such as brain derived neuro-trophic factor (BDNF), psychosocial stressors, and vascular co-morbidity. Genetic variation in vasopressin receptors, potentially involved in both cardiovascular risk and social attachment, is also associated with recurrence of depression. Similarly, genetic variation in inflammation may influence antidepressant response and medical co-morbidity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age => 60 years
- •Modified Mini Mental State (3MS) Examination =>80
- •Receiving aging services or difficulty with 1+ ADL/IADL
- •PHQ-9 score > 0 and <= 9 (and question 1 or 2 is >0)
Exclusion Criteria
- •Major depressive episode or anxiety disorder within 12 mo
- •Ever diagnosed with bipolar disorder or schizophrenia
- •Drug or alcohol use disorder within the past 12 months
- •Currently taking antidepressants
- •Currently taking antianxiety med >4x/week for past 4 weeks
Arms & Interventions
Problem solving therapy (PST)
6-8 sessions of PST, with booster, delivered over 8 weeks
Intervention: Problem-Solving Therapy (Behavioral)
Usual care
Usual agency care, monitored for mental health services
Outcomes
Primary Outcomes
Major depressive disorder
Time Frame: 12 months
Patient Health Questionnaire score \> 9 with confirming diagnostic interview
Generalized anxiety disorder
Time Frame: 12 months
Generalized anxiety disorder score \>=10, and meets criteria for SCID or PRIME-MD diagnosis
Secondary Outcomes
No secondary outcomes reported
Investigators
Steven M. Albert
Professor
University of Pittsburgh