UMIN-CTR Clinical Trial

Basic information
Public title	Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes
Acronym	Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes
Scientific Title	Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes
Scientific Title:Acronym	Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of usefulness and safety of ACT for type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c change from baseline within 3 to 6 months and closest value after 3 months Self-care ability *Summary of Diabetes Self-Care Activities(SDSCA) All adverse events
Key secondary outcomes	Acceptance ability *Acceptance and Action Diabetes Question (AADQ)

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	type 2 diabetes
Key exclusion criteria	Patients with high blood sugar that could not be diagnosed by standard diagnostic system Gestational diabetes
Target sample size	0

Research contact person
Name of lead principal investigator	1st name Yoichi Middle name Last name Ohtake
Organization	Itami Seifu Hospital
Division name	Internal medecine
Zip code	664-0011
Address	5-79, Imoji, Itami Shi, Hyogo Ken
TEL	072-778-0500
Email	dmactsr@gmail.com

Public contact
Name of contact person	1st name Yoichi Middle name Last name Ohtake
Organization	Itami Seifu Hospital
Division name	Internal medecine
Zip code	664-0011
Address	5-79, Imoji, Itami Shi, Hyogo Ken
TEL	072-778-0500
Homepage URL
Email	dmactsr@gmail.com

Sponsor
Institute	Itami Seifu Hospital
Institute
Department

Funding Source
Organization	Japan Society of Psychosomatic Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Itami Seifu Hospital
Address	5-79, Imoji, Itami Shi, Hyogo Ken
Tel	072-778-0500
Email	dmactsr@gmail.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

<Search method> Electronic search 1. The Cochrane Central Register of Controlled Trials (CENTRAL); 2. MEDLINE via Ovid; Other resources 1. The World Health Organization International Clinical Trials Platform Search Portal (ICTRP) 2. Embase <Meta-analysis> Implemented using Review Manager software (RevMan 5.3). Use Random-effects model. <Subgroup analysis> Perform the following subgroup analysis to assess clinical research participant and intervention heterogeneity. 1. ACT session; less than 12 times, greater than or equal to 12 times 2. BMI; less than 30, greater than or equal to 30 <Sensitivity analysis> Perform the following sensitivity analysis on primary outcomes. 1. Exclusion of studies using imposed statistics. 2. Missing participants: Best-best scenario: all missing patients in the two groups remain unchanged Best-worst scenario: all missing patients in the intervention group remaining unchanged and all missing patients in the control group have outcomes Worst-best scenario: all missing patients in the intervention group have outcomes and all missing patients in the control group remain unchanged * primary analysis (worst-worst scenario: all missing patients in the two groups have outcomes)

Management information
Registered date	2019 Year 07 Month 01 Day
Last modified on	2019 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042173