Depression Agency-Based Collaboration
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression Anxiety Disorder |
Behavioral: Problem-Solving Therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Depression Agency-Based Collaborative (Depression ABC) |
- Major depressive disorder [ Time Frame: 12 months ] [ Designated as safety issue: No ]Patient Health Questionnaire score > 9 with confirming diagnostic interview
- Generalized anxiety disorder [ Time Frame: 12 months ] [ Designated as safety issue: No ]Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis
| Estimated Enrollment: | 130 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Problem solving therapy (PST)
6-8 sessions of PST, with booster, delivered over 8 weeks
|
Behavioral: Problem-Solving Therapy
6-8 sessions over 8 weeks, with booster
|
|
No Intervention: Usual care
Usual agency care, monitored for mental health 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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Steven A Albert, PhD | 412-383-8693 | smalbert@pitt.edu |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Contact: Steven M Albert, PhD 412-383-8693 smalbert@pitt.edu | |
| Principal Investigator: | Steven M Albert, PhD | University of Pittsburgh |
More Information
Publications:
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01566318 History of Changes |
| Other Study ID Numbers: | P30MH090333-PRC1 |
| Study First Received: | March 27, 2012 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Depression Anxiety Geriatric mental health |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Depressive Disorder, Major |
Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 16, 2013