Depression Agency-Based Collaboration

This study is currently recruiting participants.
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

March 27, 2012
March 28, 2012
March 2012
February 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01566318 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
February 2016
February 2015   (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
Both
60 Years and older
No
Contact: Steven A Albert, PhD 412-383-8693 smalbert@pitt.edu
United States
 
NCT01566318
P30MH090333-PRC1
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Steven M Albert, PhD University of Pittsburgh
University of Pittsburgh
March 2012

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