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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335279
Recruitment Status : Active, not recruiting
First Posted : April 6, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Brett D Thombs, Sir Mortimer B. Davis - Jewish General Hospital

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.


Condition or disease Intervention/treatment Phase
Scleroderma Scleroderma, Systemic Systemic Sclerosis Other: SPIN-CHAT Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Partially Nested RCT to Evaluate the Effectiveness of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program to Reduce Anxiety Among At-Risk Scleroderma Patients
Actual Study Start Date : April 9, 2020
Actual Primary Completion Date : June 3, 2020
Estimated Study Completion Date : July 24, 2020


Arm Intervention/treatment
Experimental: SPIN-CHAT: Videoconference Intervention
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
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.

No Intervention: Wait-list Control
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.



Primary Outcome Measures :
  1. Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0 [ Time Frame: 4-weeks post-randomization ]
    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". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.


Secondary Outcome Measures :
  1. Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0 [ Time Frame: 10-weeks post-randomization ]
    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". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.

  2. Depression symptoms: Patient Health Questionnaire (PHQ-8) [ Time Frame: 4-weeks post-randomization, 10-weeks post-randomization ]
    PHQ-8 items measure depressive symptoms over the last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day) with higher scores (range 0 to 24) indicating more depressive symptoms. The PHQ-8 performs equivalently to the PHQ-9, which has been shown to be a valid measure of depressive symptoms in patients with scleroderma.

  3. Loneliness: University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6) [ Time Frame: 4-weeks post-randomization, 10-weeks post-randomization ]
    The 6-item ULS-6 is a short version of the 20-item ULS, which is designed to assess subjective feelings of loneliness and social isolation. Respondents indicate the degree to which feelings described in each item apply to them. Items are scored on a 4-point scale from 0 (never) to 3 (often); total scores range from 0 to 18.

  4. Boredom: Multidimensional State Boredom Scale (MSBS-8) [ Time Frame: 4-weeks post-randomization, 10-weeks post-randomization ]
    The full MSBS is a 29-item measure of state boredom with items on five factors that load onto a single higher-order factor. The 8-item MSBS is a short version with scores that correlate very closely to scores from the full MSBS (r = 0.96) Item responses are on a 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree) and assess the degree to which each item reflects the respondant's experience currently. Total scores range from 8 to 56 with higher scores reflecting greater boredom.

  5. Physical activity: International Physical Activity Questionnaire - modified for the elderly (IPAQ-E) [ Time Frame: 4-weeks post-randomization, 10-weeks post-randomization ]
    The 4-item IPAQ-E is a short-form version of the full IPAQ designed to assess physical activity over the last week, including time spent sitting, walking, and in moderate and vigorous physical activity. Compared to other short-form versions of the IPAQ, the IPAQ-E has examples of exercise specific to older adults.

  6. Adverse Effects [ Time Frame: 4-weeks post-randomization, 10-weeks post-randomization ]
    Adverse Effects will be assessed by ongoing monitoring during the trial and by asking participants post-intervention to describe any adverse experiences or outcomes that may have occurred.

  7. Fear: COVID-19 Fears Questionnaire for Chronic Medical Conditions [ Time Frame: 4-weeks post-randomization, 10-weeks post-randomization ]
    The COVID-19 Fears Questionnaire for Chronic Medical Conditions is a 10-item scale that ask participants to rate, on a typical day in the last week, how much they were afraid from "not at all" to "extremely" about aspects of COVID-19. Items are scored on a 5-point scale (range 1-5). Higher scores represent greater fear. The scale has been validated among people with scleroderma.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335279


Locations
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Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Lady Davis Institute
Investigators
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Principal Investigator: Brett D Thombs, PhD Lady Davis Institute, Sir Mortimer B. Davis Jewish General Hospital, McGill University
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Responsible Party: Brett D Thombs, Senior Investigator, Lady Davis Institute for Medical Research, Sir Mortimer B. Davis Jewish General Hospital; Professor, Faculty of Medicine, McGill University, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT04335279    
Other Study ID Numbers: SPIN-CHAT-001
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months after the collection of the primary outcome
Access Criteria: Approval of proposed purpose for data access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brett D Thombs, Sir Mortimer B. Davis - Jewish General Hospital:
Scleroderma
Systemic Sclerosis
COVID-19
E-health
Anxiety
Mental health
Trial
Coronavirus
RCT
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases