臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 13, 2021
Last modified on	Oct. 20, 2021
Trial ID	jRCT1030210374

Scientific Title	Feasibility of cognitive processing therapy for posttraumatic stress disorder co-occurring with alcohol use disorder.
Public Title	Feasibility of cognitive processing therapy for PTSD patients with drinking problems.

Contact for Scientific Queries	Name	Ito Masaya
	Affiliation	National Center of Neurology and Psychiatry
	Address	4-1-1 Ogawa-Higashi, Kodaira,Tokyo
	Telephone	+81-42-341-2711
	E-mail	masayait@ncnp.go.jp
Contact for Public Queries	Name	Takagishi Yuriko
	Affiliation	Surugadai University
	Address	698 Azu,Hanno,Saitama
	Telephone	+81-42-972-1111
	E-mail	takagishi.yuriko@surugadai.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 13, 2021
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) DSM-5 diagnosis of Posttraumatic Stress Disorder assessed by CAPS-5 2) Alcohol use disorder at baseline assessed by M.I.N.I.7.0.0 3) Ages 20 years or older, and 70 years or younger at baseline 4) Subjects who give full consent in the participation of the study
	Exclusion Criteria	1) No current manic episode or current psychotic disorders at baseline assessed by M.I.N.I.7.0.0 2) No serious suicidal ideation at baseline assessed by M.I.N.I.7.0.0 3) No severe or unstable physical disorders or major cognitive deficits at baseline 4) No alcohol withdrawal symptoms (such as hallucinations, convulsions, and tremors) that require any urgent treatments 5) Not in need of inpatient care 6) No structured psychotherapy at baseline 7) Other relevant reason decided by the investigators
	Age Minimum	20age old over
	Age Maximum	70age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Posttraumatic Stress Disorder, Alcohol use disorder
Intervention(s)		Cognitive processing therapy is a psychotherapy for PTSD (Resick et al., 2014). Twelve to sixteen weekly sessions (50 minutes for each) will be conducted during the intervention period of 16 weeks.
Health Condition(s) Keyword		Posttraumatic Stress Disorder, Alcohol use disorder
Intervention(s) Keyword		cognitive processing therapy
Health Condition(s) Code		D013313, D000437
Intervention(s) Code		D015928
Primary Outcome(s)		Efficacy: Posttraumatic stress symptoms assessed by PTSD Check List for DSM 5 (PCL-5) at 17 week
Secondary Outcome(s)		Efficacy: 1) Degree of problem drinking (Alcohol Use Disorders Identification Test Consumption; AUDIT-C) 2) Craving for drinkingl (VAS) 3) Severity of subjective depressive Symptoms (Patient Health Questionnaire 9; PHQ -9) 4) Suicidal ideation (Suicidal Ideation Attributes Scale; SIDAS) Feasibility: 1) Severe adverse events

Primary Sponsor	National Center of Neurology and Psychiatry

Source of Monetary Support	Japan Society for the Promotion of Science (JSPS)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics committee, National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Telephone	+81-42-341-2711
E-Mail	rinri-jimu@ncnp.go.jp
Approval Status	Approval
Date of approval	Aug. 06, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 20, 2021	(this page)	Changes
1	Oct. 13, 2021	Detail

List of change history