Depression Agency-Based Collaboration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Depression Agency-Based Collaborative (Depression ABC)

Conditions
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Major Depression, Anxiety Disorder

Intervention / Treatment
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* Behavioral: Problem-Solving Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Problem solving therapy (PST)<br>6-8 sessions of PST, with booster, delivered over 8 weeks | Behavioral: Problem-Solving Therapy<br>* 6-8 sessions over 8 weeks, with booster<br>|
| No Intervention: Usual care<br>Usual agency care, monitored for mental health services | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major depressive disorder | Patient Health Questionnaire score > 9 with confirming diagnostic interview | 12 months | 
| Generalized anxiety disorder | Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Anxiety, Geriatric mental health