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Depression Agency-Based Collaboration

NCT ID: NCT01566318

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Major Depression Anxiety Disorder

Keywords

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Depression Anxiety Geriatric mental health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Problem solving therapy (PST)

6-8 sessions of PST, with booster, delivered over 8 weeks

Group Type EXPERIMENTAL

Problem-Solving Therapy

Intervention Type BEHAVIORAL

6-8 sessions over 8 weeks, with booster

Usual care

Usual agency care, monitored for mental health services

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Problem-Solving Therapy

6-8 sessions over 8 weeks, with booster

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Steven M. Albert

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven M Albert, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19255379 (View on PubMed)

Other Identifiers

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P30MH090333

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30MH090333-PRC1

Identifier Type: -

Identifier Source: org_study_id