Depression Agency-Based Collaboration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01566318
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : December 13, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven M. Albert, University of Pittsburgh

March 27, 2012
March 29, 2012
December 13, 2016
March 2012
February 2016   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01566318 on Archive Site
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Depression Agency-Based Collaboration
Depression Agency-Based Collaborative (Depression ABC)
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Major Depression
  • Anxiety Disorder
Behavioral: Problem-Solving Therapy
6-8 sessions over 8 weeks, with booster
  • Experimental: Problem solving therapy (PST)
    6-8 sessions of PST, with booster, delivered over 8 weeks
    Intervention: Behavioral: Problem-Solving Therapy
  • No Intervention: Usual care
    Usual agency care, monitored for mental health services
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2016
February 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30MH090333 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Steven M. Albert, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Steven M Albert, PhD University of Pittsburgh
University of Pittsburgh
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP