Brett D Thombs1,2,3,4,5,6,7, Kylene Aguila8, Laura Dyas9, Marie-Eve Carrier8, Claire Fedoruk8, Linda Horwood8,10, Mara Cañedo-Ayala8, Maureen Sauvé11, Linda Kwakkenbos12, Vanessa L Malcarne13,14, Ghassan El-Baalbaki15, Sandra Peláez8,16, Kerri Connolly17, Marie Hudson8,18, Robert W Platt8,19. 1. Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada. brett.thombs@mcgill.ca. 2. Department of Psychiatry, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca. 3. Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca. 4. Department of Medicine, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca. 5. Department of Psychology, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca. 6. Department of Educational and Counselling Psychology, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca. 7. Biomedical Ethics Unit, McGill University, 4333 Cote Ste Catherine Road, Montreal, QC, H3T 1E4, Canada. brett.thombs@mcgill.ca. 8. Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada. 9. Scleroderma Foundation Michigan Chapter, Southfield, MI, USA. 10. Department of Psychiatry, McGill University, Montreal, QC, Canada. 11. Scleroderma Society of Ontario and Scleroderma Canada, Hamilton, ON, Canada. 12. Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands. 13. Department of Psychology, San Diego State University, California, USA. 14. San Diego Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California, California, USA. 15. Department of Psychology, Université du Québec à Montréal, Montreal, QC, Canada. 16. Department of Educational and Counselling Psychology, McGill University, Montreal, QC, Canada. 17. Scleroderma Foundation, Danvers, MA, USA. 18. Department of Medicine, McGill University, Montreal, QC, Canada. 19. Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada.
Abstract
BACKGROUND: Some people with rare diseases rely on peer-led support groups for disease-specific education and emotional and practical support. Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective tissue disease. Many people with SSc cannot access support groups, and, when support groups exist, they may not be sustained due to challenges that could be addressed via leader training. The Scleroderma Patient-centered Intervention Network (SPIN), along with SSc patient organization partners, developed a training program for SSc patient support group leaders, the Scleroderma Support group Leader EDucation (SPIN-SSLED) Program. We recently completed a feasibility trial in which we successfully delivered the program to two groups of support group leaders who reported a high level of satisfaction with the program and its delivery. The primary objective of the full-scale SPIN-SSLED trial is to evaluate the effect of the program on support group leaders' self-efficacy for carrying out their leadership role. Secondary objectives include evaluating effects on leader burnout, leader satisfaction (participation efficacy), and emotional distress. METHODS/ DESIGN: The SPIN-SSLED trial is a pragmatic randomized controlled trial (RCT) in which 180 support group leaders will be randomly allocated to training groups of 6 participants each or to a waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups, but not in the waitlist control. Participants allocated to the training program will receive the 13-module SPIN-SSLED Program, delivered via webinar over the course of 3 months in weekly 60-90-min sessions. The primary outcome is leader self-efficacy, measured by the Scleroderma Support Group Leader Self-efficacy Scale post-intervention. Secondary outcomes are leader self-efficacy at 3 months post-intervention, and leader burnout, volunteer job satisfaction (participation efficacy), and emotional distress post-intervention and at 3 months post-intervention. DISCUSSION: The SPIN-SSLED trial will test whether a training program for SSc patient support group leaders increases the self-efficacy of group leaders to carry out leadership tasks. The program has the potential to significantly improve the effectiveness and sustainability of existing SSc support groups, to increase the number of available support groups, and to be adapted for other chronic diseases. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03965780. Registered on 29 May 2019.
RCT Entities:
BACKGROUND: Some people with rare diseases rely on peer-led support groups for disease-specific education and emotional and practical support. Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective tissue disease. Many people with SSc cannot access support groups, and, when support groups exist, they may not be sustained due to challenges that could be addressed via leader training. The SclerodermaPatient-centered Intervention Network (SPIN), along with SScpatient organization partners, developed a training program for SScpatient support group leaders, the Scleroderma Support group Leader EDucation (SPIN-SSLED) Program. We recently completed a feasibility trial in which we successfully delivered the program to two groups of support group leaders who reported a high level of satisfaction with the program and its delivery. The primary objective of the full-scale SPIN-SSLED trial is to evaluate the effect of the program on support group leaders' self-efficacy for carrying out their leadership role. Secondary objectives include evaluating effects on leader burnout, leader satisfaction (participation efficacy), and emotional distress. METHODS/ DESIGN: The SPIN-SSLED trial is a pragmatic randomized controlled trial (RCT) in which 180 support group leaders will be randomly allocated to training groups of 6 participants each or to a waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups, but not in the waitlist control. Participants allocated to the training program will receive the 13-module SPIN-SSLED Program, delivered via webinar over the course of 3 months in weekly 60-90-min sessions. The primary outcome is leader self-efficacy, measured by the Scleroderma Support Group Leader Self-efficacy Scale post-intervention. Secondary outcomes are leader self-efficacy at 3 months post-intervention, and leader burnout, volunteer job satisfaction (participation efficacy), and emotional distress post-intervention and at 3 months post-intervention. DISCUSSION: The SPIN-SSLED trial will test whether a training program for SScpatient support group leaders increases the self-efficacy of group leaders to carry out leadership tasks. The program has the potential to significantly improve the effectiveness and sustainability of existing SSc support groups, to increase the number of available support groups, and to be adapted for other chronic diseases. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03965780. Registered on 29 May 2019.
Authors: Brett D Thombs; Linda Kwakkenbos; Marie-Eve Carrier; Angelica Bourgeault; Lydia Tao; Sami Harb; Maria Gagarine; Danielle Rice; Laura Bustamante; Kelsey Ellis; Delaney Duchek; Yin Wu; Parash Mani Bhandari; Dipika Neupane; Andrea Carboni-Jiménez; Richard S Henry; Ankur Krishnan; Ying Sun; Brooke Levis; Chen He; Kimberly A Turner; Andrea Benedetti; Nicole Culos-Reed; Ghassan El-Baalbaki; Shannon Hebblethwaite; Susan J Bartlett; Laura Dyas; Scott Patten; John Varga Journal: J Psychosom Res Date: 2020-05-14 Impact factor: 3.006
Authors: Brett D Thombs; Linda Kwakkenbos; Brooke Levis; Angelica Bourgeault; Richard S Henry; Alexander W Levis; Sami Harb; Lydia Tao; Marie-Eve Carrier; Laura Bustamante; Delaney Duchek; Laura Dyas; Ghassan El-Baalbaki; Kelsey Ellis; Danielle B Rice; Amanda Wurz; Julia Nordlund; Maria Gagarine; Kimberly A Turner; Nora Østbø; Nicole Culos-Reed; Shannon Hebblethwaite; Scott Patten; Susan J Bartlett; John Varga; Luc Mouthon; Sarah Markham; Michael S Martin; Andrea Benedetti Journal: Lancet Rheumatol Date: 2021-04-16
Authors: Marie-Nicole Discepola; Andrea Carboni-Jiménez; Linda Kwakkenbos; Richard S Henry; Jill Boruff; Ankur Krishnan; Carina Boström; S Nicole Culos-Reed; Marie Hudson; David M Leader; Malin Mattsson; Luc Mouthon; Robyn Wojeck; Elizabeth Yakes Jimenez; Maureen Sauve; Joep Welling; Geneviève Guillot; Andrea Benedetti; Brett D Thombs Journal: BMJ Open Date: 2021-05-04 Impact factor: 2.692
Authors: Linda Kwakkenbos; Nora Østbø; Marie-Eve Carrier; Warren R Nielson; Claire Fedoruk; Brooke Levis; Richard S Henry; Janet Pope; Tracy Frech; Shadi Gholizadeh; Sindhu R Johnson; Pamela Piotrowski; Lisa R Jewett; Jessica Gordon; Lorinda Chung; Dan Bilsker; Lydia Tao; Kimberly A Turner; Julie Cumin; Joep Welling; Catherine Fortuné; Catarina Leite; Karen Gottesman; Maureen Sauvé; Tatiana Sofia Rodriguez Reyna; Marie Hudson; Maggie Larche; Ward van Breda; Maria E Suarez-Almazor; Susan J Bartlett; Vanessa L Malcarne; Maureen D Mayes; Isabelle Boutron; Luc Mouthon; Andrea Benedetti; Brett D Thombs Journal: Pilot Feasibility Stud Date: 2022-02-26