UMIN-CTR Clinical Trial

Public title

The effectiveness of adapting the goal attainment approach using Goal Attainment Scale (GAS) for the treatment of burning mouth syndrome

Acronym

Adapting GAS for BMS

Scientific Title

Adapting Goal Attainment Scaling (GAS) for the treatment of burning mouth syndrome: A real-world clinical prospective cohort study protocol

Scientific Title:Acronym

Adapting GAS for BMS: A prospective cohort study

Region

Japan

Condition

Burning mouth syndrome

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to assess the usefulness of adapting GAS for the treatment of BMS.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The assessment of goal attainment scores by using GAS and the calculation of GAS T-scores will be performed at 4, 8, 12, 24 weeks after the initiation of BMS treatment.

Key secondary outcomes

The effectiveness of adapting GAS will be analyzed by comparing analysis of GAS T-scores with the results of other questionnaires and assessment tools for treatment efficacy taken at 4, 8, 12, 24 weeks after the initiation of BMS treatment.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who are diagnosed with BMS, who undergo psychopharmacotherapy at our department and who can make goals using GAS.

Key exclusion criteria

The patients who are under 20-year-old and who have been already prescribed antipsychotics or antidepressant from other medical facilities.

Target sample size

150

Name of lead principal investigator

1st name	Akira
Middle name
Last name	Toyofuku

Organization

Tokyo Medical and Dental University

Division name

Department of Psychosomatic Dentistry

Zip code

113-8549

Address

1-5-45 Yushima Bunkyo-ku, Tokyo

TEL

0358035898

Email

toyoompm@tmd.ac.jp

Name of contact person

1st name	Akira
Middle name
Last name	Toyofuku

Organization

Tokyo Medical and Dental University

Division name

Department of Psychosomatic Dentistry

Zip code

113-8549

Address

1-5-45 Yushima Bunkyo-ku, Tokyo

TEL

0358035898

Homepage URL

Email

toyoompm@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Ethical Committee of Tokyo Medical and Dental University Dental Hospital

Address

1-5-45 Yushima Bunkyo-ku, Tokyo

Tel

03-5803-5405

Email

d-hyoka.adm@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2024

Year

01

Month

19

Day

Date of IRB

Anticipated trial start date

2024

Year

04

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(1) Phase 1: Pilot study
The availability of GAS for BMS, including the possibility and time to take making reliable goals in clinical situation, will be examined involving 30 patients with BMS.
(2) Phase 2: Clinical study
In phase 2, 120 BMS outpatients will be involved. All patients will set at least two clinical goals at the initiation of psychopharmacotherapy and will be assess their attainments in 5 grades (+2 to -2) followed by calculation of T-scores with the importance and the achievement number at 4, 8, 12, 24 weeks after initiation of psychopharmacotherapy for BMS. Pain qualities and severities (Short-form McGill's Pain Scale: SF-MPQ), Oral Dysesthesia Rating Scale: Oral DRS), depression (Zung's self-rating Depressive Scale), and pain catastrophizing (Pain Catastrophizing Scale: PCS) are also assessed at the initiation and 4, 8, 12, 24 weeks after the initiation of psychopharmacotherapy for BMS. In the follow-up duration, the clinical improvement is assessed with previous tools (Clinical global improvement, patients' global improvement impression of change scale), and usefulness and satisfaction of GAS are assessed in 7 grades by both patients and practitioners.
The usefulness of adapting GAS for the treatment of BMS will be discussed, following analysis of relations described below:
1. The relation between GAS, demographic data, SF-MPQ, Oral DRS, SDS, and PCS.
2. The relation between GAS and CGI, PGIC.
3. The relation between GAS T-score and satisfaction.

Registered date

2024

Year

01

Month

19

Day

Last modified on

2024

Year

01

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060936