Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT02463266

Conditions

Depression

Anxiety

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

SUSTAIN Monitoring and Care Management

Study Details

Brief summary:

The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program is a telephone-based clinical service designed to help identify and manage behavioral health issues among PACE/PACENET enrollees. The purpose of the current project is to a) explore moderators of treatment response among beneficiaries in the SUSTAIN Clinical Program and b) to evaluate the sustained clinical effects of the program.

Conditions

Depression

Anxiety

Pain, Chronic

Study ID

NCT02463266

Start date

Mar, 2014

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 65 and older, males and females.
2. Participating in the SUSTAIN Clinical Program
3. For the 6 Month Outcome Research Evaluation, in addition to meeting criteria 1 and 2, willing to provide verbal informed consent to participate in the 6 Month Outcome Research Evaluation at the end of the acute phase of clinical care, usually at three months.

Exclusion Criteria:

  • Not meeting the inclusion criteria listed above.

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

SUSTAIN Monitoring and Care Management

SUSTAIN program participants who complete an initial clinical assessment and, if indicated, agree to follow-up services including Monitoring and/or Care Management.

Interventions

SUSTAIN Monitoring and Care Management

Program participants are offered clinical services based on symptom severity and clinical need. Follow-up Monitoring consists of up to 4 brief, structured assessments following the baseline clinical assessment. These follow-up contacts are conducted over the telephone by the HT/BHP and take place during the initial 12 weeks of pharmaceutical treatment. These brief interviews monitor symptoms, adherence, side effects, and response to treatment. Care Management incorporates the use of a BHP who has expertise in mental health assessment and is well versed in the delivery of algorithm-based management strategies. The BHP monitors and encourages patient acceptance and adherence to treatment recommendations through support, education, and motivational engagement.

Primary outcome measure

  • Veterans Rand - 12 Item Health Survey (VR-12) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Mary Beth Gibbons, PhD

(215)662-3488gibbonsm@pennmedicine.upenn.edu

Elizabeth Grecco, MSS, LCSW

(215) 746-2980egrecco@pennmedicine.upenn.edu

Locations

Department of Psychiatry (Center for Psychotherapy Research), University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mary Beth Gibbons, PhD

(215)662-3488gibbonsm@pennmedicine.upenn.edu

Principal Investigator:

Mary Beth Gibbons, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • Primary Care
  • Elderly
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-09-22.