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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

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.

Condition or disease Intervention/treatment Phase
Major Depression Anxiety Disorder Behavioral: Problem-Solving Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Depression Agency-Based Collaborative (Depression ABC)
Study Start Date : March 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Major depressive disorder [ Time Frame: 12 months ]
    Patient Health Questionnaire score > 9 with confirming diagnostic interview

  2. Generalized anxiety disorder [ Time Frame: 12 months ]
    Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566318

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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
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Principal Investigator: Steven M Albert, PhD University of Pittsburgh

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Responsible Party: Steven M. Albert, Professor, University of Pittsburgh Identifier: NCT01566318     History of Changes
Other Study ID Numbers: P30MH090333-PRC1
P30MH090333 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Steven M. Albert, University of Pittsburgh:
Geriatric mental health

Additional relevant MeSH terms:
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Depressive Disorder
Anxiety Disorders
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders