Depression Agency-Based Collaboration

Major Depression Clinical Trial

Official title:

Depression Agency-Based Collaborative (Depression ABC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566318
• Other study ID #: P30MH090333-PRC1
• Secondary ID: P30MH090333
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: December 11, 2016
• Start date: March 2012
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Problem-Solving Therapy
6-8 sessions over 8 weeks, with booster

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major depressive disorder	Patient Health Questionnaire score > 9 with confirming diagnostic interview	12 months	No
Primary	Generalized anxiety disorder	Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis	12 months	No