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

NCT04335279 | Completed Results

• 1 other identifier: 2021-2286
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Scleroderma; Systemic Sclerosis; COVID-19; E-health; Anxiety; Mental health; Trial; Coronavirus; RCT

Outcome Measures

Primary Outcomes (1)

• Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0

  The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Raw scores are converted into T scores standardised in the US adult general population (mean=50, standard deviation=10). Higher scores represent more anxiety.

  4-weeks post-randomization

Secondary Outcomes (7)

• Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0

  10-weeks post-randomization

• Depression Symptoms: Patient Health Questionnaire (PHQ-8)

  4-weeks post-randomization, 10-weeks post-randomization

• Loneliness: University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6)

  4-weeks post-randomization, 10-weeks post-randomization

• Boredom: Multidimensional State Boredom Scale (MSBS-8)

  4-weeks post-randomization, 10-weeks post-randomization

• Physical Activity: International Physical Activity Questionnaire - Modified for the Elderly (IPAQ-E)

  4-weeks post-randomization, 10-weeks post-randomization

Study Arms (2)

SPIN-CHAT: Videoconference Intervention

EXPERIMENTAL

Participants in the SPIN-CHAT videoconference intervention group will receive a brief group videoconference intervention aimed at the management of worry and anxiety 3 times per week for 4 weeks during the COVID-19 crisis. Each group will include 8 participants and sessions will be approximately 60- to 90-minutes each. Each intervention group will be moderated by a member of the research team or by leaders who have been trained in our SPIN support group leader training program.

Other: SPIN-CHAT Program

Wait-list Control

NO INTERVENTION

Participants in the wait-list control group will not receive the training program and will have no access to the resources indicated above for the duration of the trial. Wait-list controls will be given access to the program post-trial.

Interventions

SPIN-CHAT Program OTHER

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.

SPIN-CHAT: Videoconference Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Classified as having SSc by a physician
• PROMIS Anxiety 4a v1.0 T-score greater than or equal to 55
• Have regular, reliable internet access
• Be fluent in English or French

You may not qualify if:

• Receiving counseling or therapy currently
• Having a positive test for the COVID-19 virus

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (2)

• Wurz A, Duchek D, Ellis K, Bansal M, Carrier ME, Tao L, Dyas L, Kwakkenbos L, Levis B, El-Baalbaki G, Rice DB, Wu Y, Henry RS, Bustamante L, Harb S, Hebblethwaite S, Patten SB, Bartlett SJ, Varga J, Mouthon L, Markham S, Thombs BD, Culos-Reed SN; SPIN-CHAT Patient Advisory Team; Program Facilitators; Scleroderma Patient-centered Intervention Network Investigators. A qualitative interview study exploring the psychological health impacts of the SPIN-CHAT program among people with systemic sclerosis at the onset of COVID-19: perceptions of trial participants and research team members. Disabil Rehabil. 2024 Feb;46(3):533-545. doi: 10.1080/09638288.2023.2169775. Epub 2023 Jan 28.

  PMID: 36708187 DERIVED

• Thombs BD, Kwakkenbos L, Levis B, Bourgeault A, Henry RS, Levis AW, Harb S, Tao L, Carrier ME, Bustamante L, Duchek D, Dyas L, El-Baalbaki G, Ellis K, Rice DB, Wurz A, Nordlund J, Gagarine M, Turner KA, Ostbo N, Culos-Reed N, Hebblethwaite S, Patten S, Bartlett SJ, Varga J, Mouthon L, Markham S, Martin MS, Benedetti A; SPIN-CHAT Patient Advisory Team and Program Facilitators; Scleroderma Patient-centered Intervention Network Investigators. Effects of a multi-faceted education and support programme on anxiety symptoms among people with systemic sclerosis and anxiety during COVID-19 (SPIN-CHAT): a two-arm parallel, partially nested, randomised, controlled trial. Lancet Rheumatol. 2021 Jun;3(6):e427-e437. doi: 10.1016/S2665-9913(21)00060-6. Epub 2021 Apr 16.

  PMID: 33899008 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic; COVID-19; Anxiety Disorders; Psychological Well-Being; Coronavirus Infections

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Personal Satisfaction; Behavior

Results Point of Contact

• Title: Dr. Brett Thombs
• Organization: Lady Davis Institute

brett.thombs@mcgill.ca

514-340-8222

Study Officials

• Brett D Thombs, PhD

  Lady Davis Institute, Sir Mortimer B. Davis Jewish General Hospital, McGill University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator, Lady Davis Institute for Medical Research, Sir Mortimer B. Davis Jewish General Hospital; Professor, Faculty of Medicine, McGill University

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: April 9, 2020
• Primary Completion: June 3, 2020
• Study Completion: July 24, 2020
• Last Updated: February 1, 2023
• Results First Posted: February 1, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after the collection of the primary outcome
• Access Criteria: Approval of proposed purpose for data access

Locations

CA (1)