NCT01566318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

3.9 years

First QC Date

March 27, 2012

Last Update Submit

December 11, 2016

Conditions

Keywords

DepressionAnxietyGeriatric mental health

Outcome Measures

Primary Outcomes (2)

  • Major depressive disorder

    Patient Health Questionnaire score \> 9 with confirming diagnostic interview

    12 months

  • Generalized anxiety disorder

    Generalized anxiety disorder score \>=10, and meets criteria for SCID or PRIME-MD diagnosis

    12 months

Study Arms (2)

Problem solving therapy (PST)

EXPERIMENTAL

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

Behavioral: Problem-Solving Therapy

Usual care

NO INTERVENTION

Usual agency care, monitored for mental health services

Interventions

6-8 sessions over 8 weeks, with booster

Problem solving therapy (PST)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related 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.

    PMID: 19255379BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Steven M Albert, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations