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Clinical Trials/NCT01566318
NCT01566318
Completed
Not Applicable

Depression Agency-Based Collaborative (Depression ABC)

University of Pittsburgh1 site in 1 country104 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depression
Sponsor
University of Pittsburgh
Enrollment
104
Locations
1
Primary Endpoint
Major depressive disorder
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven M. Albert

Professor

University of Pittsburgh

Eligibility Criteria

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

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

Study Sites (1)

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