Protocol for a partially nested randomised controlled trial 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

Objective: Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences o...

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Veröffentlicht in:	Journal of Psychosomatic Research 2020-08, Vol.135
Hauptverfasser:	Thombs, B.D., Kwakkenbos, L., Bourgeault, A., Harb, S., Gagarine, M., Rice, D., Bustamante, L., Ellis, K., Wu, Y., Neupane, D., Carboni-Jimenez, A., Henry, R.S., Krishnan, A., Sun, Y., Levis, B., He, C., Turner, K.A., Benedetti, A., Culos-Reed, N., El-Baalbaki, G., Hebblethwaite, S., Patten, S., Varga, J., Gietzen, A., Guillot, G., Nielsen, K., Richard, M., Sauve, M., Welling, J., Baron, M., Furst, D.E., Malcarne, V., Mouthon, L., Nielson, W.R., Riggs, R., Wigley, F., Boutron, I., Ells, C., Fligelstone, K., Frech, T., Godard, D., Harel, D., Hinchcliff, M., Johnson, S.R., Larche, M., Leite, C., Pope, J., Portales, A., Rannou, F., Reyna, T.S.R., Schouffoer, A.A., Suarez-Almazor, M.E., Agard, C., Andre, M., Arsenault, G., Benzidia, I., Berthier, S., Bruns, A., Carreira, P., Casadevall, M., Chaigne, B., Chung, L., Cohen, P., Correia, C., Dagenais, P., Denton, C., Dubois, S., Dunogue, B., Fare, R., Fortin, P.R., Gordon, J., Gyger, G., Hachulla, E., Hoa, S., Jones, N., Fernandes, A.J.D., Kafaja, S., Lambert, M., Launay, D., Liang, P., Maillard, H., Marie, I., Martin, T., Mekinian, A., Melchor, S., Nikpour, M., Olagne, L., Proudman, S., Regent, A., Riviere, S., Rodriguez, E., Roux, S., Smith, D., Spiera, R., Steen, V., Sutton, E., Terrier, B., Thorne, C., Wilcox, P., Ayala, M.C.
Format:	Artikel
Sprache:	eng
Schlagworte:	Anxiety Coronavirus COVID-19 Mental health RCT Scleroderma Systemic sclerosis Trial
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Zusammenfassung:	Objective: Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.Methods: The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score >= 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT 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. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via video-conference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention.Ethics and dissemination: The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.
DOI:	10.1016/j.jpsychores.2020.110132