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Depression Agency-Based Collaboration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566318
First Posted: March 29, 2012
Last Update Posted: December 13, 2016
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven M. Albert, University of Pittsburgh
  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
Major Depression Anxiety Disorder Behavioral: Problem-Solving Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Depression Agency-Based Collaborative (Depression ABC)

Resource links provided by NLM:


Further study details as provided by Steven M. Albert, University of Pittsburgh:

Primary Outcome 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


Enrollment: 104
Study Start Date: March 2012
Study Completion Date: June 2016
Primary Completion Date: February 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01566318


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

Publications:
Responsible Party: Steven M. Albert, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01566318     History of Changes
Other Study ID Numbers: P30MH090333-PRC1
P30MH090333 ( U.S. NIH Grant/Contract )
First Submitted: March 27, 2012
First Posted: March 29, 2012
Last Update Posted: December 13, 2016
Last Verified: December 2016

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

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