SSIPP vs. PST vs. WLC

NCT04887350 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-04-18

No results posted yet for this study

Summary

The COVID-19 pandemic and continued lockdown measures have led to social isolation that is likely disproportionately affecting community-dwelling seniors. This social isolation of seniors is expected to cause detrimental health effects especially in those who have an ongoing or new onset late life depressive episode. The COVID-19 pandemic has also made accessing formal psychotherapy services increasingly difficult due to an increased demand for these services and a limited number of trained professionals available to deliver these interventions. We plan to conduct an open label, pilot, randomized controlled trial (RCT), comparing a virtually delivered (telephone) student led mental health supportive initiative, Student Senior Isolation Prevention Partnership (SSIPP) (n=15) compared to a telephone delivered standard psychotherapy intervention, problem-solving therapy (PST) (n=15) versus a wait list control (n=15) in community-dwelling seniors suffering from late life depression. Participants in this study will be blinded to the hypothesis, while those performing data analysis will be blinded to treatment allocation. Both SSIPP and PST will be delivered via telephone as a weekly session for 12-weeks. Feasibility measures of recruitment, retention and costs will be collected as primary outcome measures. Self-rated measures of depression, anxiety, isolation and resilience will comprise secondary exploratory outcomes. We anticipate that it will be feasible to conduct an RCT of these telephone interventions, SSIPP and PST, in socially isolated community-dwelling seniors. Data from this study will be critical to plan a subsequent confirmatory large-scale RCT. It could be that telephone delivered medical student led supportive intervention, SSIPP and/or a telephone delivered psychotherapy initiative, PST, can be feasibly applied in the current pandemic to a high-risk population, isolated seniors suffering from depression.

Conditions

Interventions

BEHAVIORAL

Student-Senior Isolation Prevention Partnership (SSIPP)

The Student-Senior Isolation Prevention Partnership partners medical students with older adults in the community to provide social support and connection through regular phone calls. The goal of SSIPP is to reduce rates of anxiety, depression, and loneliness, while fostering resilience among seniors in our communities. This intervention will be delivered by phone to study participants once a week for a 30-60 minute session over a 12-week period.

BEHAVIORAL

Problem Solving Therapy (PST).

Problem Solving Therapy is a psychotherapeutic intervention that teaches community members to identify and clarify problems at hand, set clear, achievable goals, brain-storm solutions to the problem, select their preferred solution, implement this solution, and evaluate the outcomes. This intervention will be delivered by a trained healthcare professional by phone to study participants once a week for a 30-60 minute session over a 12-week period.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Akshya Vasudev, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2022-04-09
Completion
2022-04-09

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04887350 on ClinicalTrials.gov