Depression Agency-Based Collaboration

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01566318
First received: March 27, 2012
Last updated: March 28, 2012
Last verified: March 2012
  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 Phase
Major Depression
Anxiety Disorder
Behavioral: Problem-Solving Therapy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Major depressive disorder [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient Health Questionnaire score > 9 with confirming diagnostic interview

  • Generalized anxiety disorder [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis


Estimated Enrollment: 130
Study Start Date: March 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566318

Contacts
Contact: Steven A Albert, PhD 412-383-8693 smalbert@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Steven M Albert, PhD    412-383-8693    smalbert@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Steven M Albert, PhD University of Pittsburgh
  More Information

Publications:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01566318     History of Changes
Other Study ID Numbers: P30MH090333-PRC1
Study First Received: March 27, 2012
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Depression
Anxiety
Geriatric mental health

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

ClinicalTrials.gov processed this record on July 24, 2014