Depression Agency-Based Collaboration

Not Applicable

Completed

• Conditions: Major Depression; Anxiety Disorder
• Interventions: Behavioral: Problem-Solving Therapy

• Registration Number: NCT01566318
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-29
• Primary Completion: 2016-02
• Study Completion: 2016-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-11
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Problem solving therapy (PST)	Problem-Solving Therapy	6-8 sessions of PST, with booster, delivered over 8 weeks

Primary Outcome Measures

Name	Time	Method
Major depressive disorder	12 months	Patient Health Questionnaire score \> 9 with confirming diagnostic interview
Generalized anxiety disorder	12 months	Generalized anxiety disorder score \>=10, and meets criteria for SCID or PRIME-MD diagnosis

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States