臨床研究等提出・公開システム

Date of registration	June. 21, 2023
Last modified on	Mar. 29, 2024
Trial ID	jRCT1030230154

Scientific Title	A pilot study of the effect of the peer support group for people with Post-Acute Sequelae of COVID-19
Public Title	A pilot study of the peer support group for people with Post-Acute Sequelae of COVID-19

Contact for Scientific Queries	Name	Nishi Daisuke
	Affiliation	National Center of Neurology and Psychiatry
	Address	4-1-1, Ogawa-higashi-cho, Kodaira city, Tokyo
	Telephone	+81-42-341-2711
	E-mail	d-nishi@m.u-tokyo.ac.jp
Contact for Public Queries	Name	Hazumi Megumi
	Affiliation	National Center of Neurology and Psychiatry
	Address	4-1-1, Ogawa-higashi-cho, Kodaira city, Tokyo
	Telephone	+81-42-341-2711
	E-mail	mhazumi@ncnp.go.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		June. 21, 2023
Target sample size		172
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	supportive care
Key inclusion & exclusion criteria	Inclusion Criteria	1) Those who are18 years of age or older at the time of obtaining consent. 2) Those who reported to have symptoms after COVID-19 illness. 3) Those who eported PHQ-9 score of at least 5. 4) Those who have devices to participate in Zoom or online survey. 5) Those who have internet facilities. 6) Those who have an environment where online communications are available.
	Exclusion Criteria	1) Those who are unable to attend all of the sessions. 2) Those who selected 'more than half of the time' or 'almost every day' for the question about suicide intention in PHQ-9. 3) Those who were judged to be unsuitable for participating in the study by the researcher or their doctor.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		post-acute sequelae of COVID-19
Intervention(s)		online peer support sessions held one time per a week for one hour with online communication tools such as Zoom. Sessions will be conducted with three to six participants.
Health Condition(s) Keyword		COVID-19 Long-COVID Post-COVID post-acute sequelae of COVID-19
Intervention(s) Keyword		peer support, online, web-based
Primary Outcome(s)		Patient Health Questionnaire-9 (PHQ-9; Kronke et al, 2001; Muramatsu et al, 2007)
Secondary Outcome(s)		Generalized Health Disorder-7 (GAD-7; Spitzer et al, 2006; Muramatsu et al, 2009), UCLA three-item loneliness scale (Russell et al, 1966, Russell, 1978, Igarashi et al, 2019), Lubben Social Network Scale Short version (Lubben et al, 1988;Kurimoto et al, 2011, EuroQOL 5 Level (EQ-5D-5L;Herdman et al, 2011; Shiroiwa et al, 2016), Short From Health Survey 8 (SF-8; Fukuhara et al,2004,2021), Rothenberg self-esteem scale (Rosenberg,1965; Uchida et al,2010)

Primary Sponsor	Daisuke Nishi

Secondary Sponsor

Source of Monetary Support	The National Center of Neurology and Psychiatry
Secondary Sponsor	Not applicable

Name of Certified Review Board	The National Center of Neurology and Psychiatry Ethics Committee
Address	4-1-1, Ogawa-higashi cho, Kodaira city, Tokyo
Telephone	+81-42-341-2712-7828
E-Mail	crb-jimu@ncnp.go.jp
Approval Status	Approval
Date of approval	April. 07, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 29, 2024	(this page)	Changes
1	June. 21, 2023	Detail

List of change history