Depression Agency-Based Collaboration

Overview

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.

Full Title of Study: “Depression Agency-Based Collaborative (Depression ABC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2016

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.

Interventions

  • Behavioral: Problem-Solving Therapy
    • 6-8 sessions over 8 weeks, with booster

Arms, Groups and Cohorts

  • Experimental: Problem solving therapy (PST)
    • 6-8 sessions of PST, with booster, delivered over 8 weeks
  • No Intervention: Usual care
    • Usual agency care, monitored for mental health services

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steven M. Albert, Professor – University of Pittsburgh
  • Overall Official(s)
    • Steven M Albert, PhD, Principal Investigator, University of Pittsburgh

References

van't Veer-Tazelaar PJ, van Marwijk HW, van Oppen P, van Hout HP, van der Horst HE, Cuijpers P, Smit F, Beekman AT. Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Arch Gen Psychiatry. 2009 Mar;66(3):297-304. doi: 10.1001/archgenpsychiatry.2008.555.

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