Clinical trial NCT01566318: Depression Agency-Based Collaboration
Official title: Depression Agency-Based Collaborative (Depression ABC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Anxiety Disorder
Keywords: Depression
Anxiety
Geriatric mental health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-03-29
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Major depressive disorder
timeFrame: 12 months
measure: Generalized anxiety disorder
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven M Albert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.