Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program

Summary

Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks.

Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (\> 40% have interstitial lung disease) and common use of immunosuppressant drugs.

The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support.

Conditions

• Scleroderma
• Scleroderma, Systemic
• Systemic Sclerosis

Interventions

OTHER

SPIN-CHAT Program

Each session will include 3 segments: (1) engagement via therapeutic recreation activities (20-30 minutes); (2) education on information management and anxiety management through psychological and other strategies (20-30 minutes); and (3) open discussion and social support (20-30 minutes). Educational segment topics will include (1) healthy information management and social connection (session 1); (2) managing worry (sessions 2, 6, 10); (3) relaxation strategies (sessions 3; 7, 11); (4) adapted home exercise (sessions 4, 8, 12); and (5) activity engagement at home (sessions 5 and 9). All educational segments will be supported by resource materials available to participants via an online SPIN-CHAT resource link. Supervision and support of group moderators will be provided by a trained social worker. Educational segments in each session will be delivered by a research team member with experience and training related to the topic.

Sponsors & Collaborators

• Lady Davis Institute

  lead OTHER

Principal Investigators

• Brett D Thombs, PhD · Lady Davis Institute, Sir Mortimer B. Davis Jewish General Hospital, McGill University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-09

Primary Completion

2020-06-03

Completion

2020-07-24

Countries

• Canada

Study Locations