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Depression Agency-Based Collaboration

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ClinicalTrials.gov Identifier: NCT01566318
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven M. Albert, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE March 2012
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01566318 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Depression Agency-Based Collaboration
Official Title  ICMJE Depression Agency-Based Collaborative (Depression ABC)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Major Depression
  • Anxiety Disorder
Intervention  ICMJE Behavioral: Problem-Solving Therapy
6-8 sessions over 8 weeks, with booster
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2015)
104
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2012)
130
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01566318
Other Study ID Numbers  ICMJE P30MH090333-PRC1
P30MH090333 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven M. Albert, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Steven M Albert, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2016

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