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Depression Agency-Based Collaboration

Primary Purpose

Major Depression, Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem-Solving Therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Major Depression focused on measuring Depression, Anxiety, Geriatric mental health

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Problem solving therapy (PST)

Usual care

Arm Description

6-8 sessions of PST, with booster, delivered over 8 weeks

Usual agency care, monitored for mental health services

Outcomes

Primary Outcome Measures

Major depressive disorder
Patient Health Questionnaire score > 9 with confirming diagnostic interview
Generalized anxiety disorder
Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis

Secondary Outcome Measures

Full Information

First Posted
March 27, 2012
Last Updated
December 11, 2016
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01566318
Brief Title
Depression Agency-Based Collaboration
Official Title
Depression Agency-Based Collaborative (Depression ABC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Anxiety Disorder
Keywords
Depression, Anxiety, Geriatric mental health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem solving therapy (PST)
Arm Type
Experimental
Arm Description
6-8 sessions of PST, with booster, delivered over 8 weeks
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual agency care, monitored for mental health services
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Therapy
Intervention Description
6-8 sessions over 8 weeks, with booster
Primary Outcome Measure Information:
Title
Major depressive disorder
Description
Patient Health Questionnaire score > 9 with confirming diagnostic interview
Time Frame
12 months
Title
Generalized anxiety disorder
Description
Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M Albert, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19255379
Citation
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.
Results Reference
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Depression Agency-Based Collaboration

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