Randomized controlled trial of videoconference based cognitive behavial therapy for stressor-related disorders

JRCT ID: jRCT1032220619

Registered date:08/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: stressor-related disorders, stressor-related depression
• Date of first enrollment: 08/02/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Remote cognitive behavioral therapy using a video conferencing system will be conducted weekly 50-minute individual sessions for 6 consecutive weeks in addition to regular medical care.

Outcome(s)

• Primary Outcome: IES-R total score from session1 to session 6

Secondary Outcome

Change of score from session1 to session6 by patients
1) Strengths and Difficulties Questionnaire(SDQ)
2) Patient Health Questionnaire-9(PHQ-9)
3) Generalized Anxiety Disorder-7(GAD-7)
4) Euro QOL 5 Dimension (EQ-5D-5L)
5) Relationship Questionnaire(RQ)
6) Adverse Childhood Experiences(ACEs)
7) Brief Core Schema Scale
8) Beck Depression Inventory Second Edition(BDI)
9) Event-related Psychological Distress24

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria set to target
1) Have a diagnosis of stressor related disorders group(adjustment disorders, adjustment-like disorders, unspecified stressor-related disorder) or stressor related depressive disorders( major depressive disorder, persistent depressive disorder) with a current episode of distress or disability with emotional or behavioral symptoms within 3 months in response to a clearly identified stressor
3) Between 16 and 65 years old
4) Given written consent of their own free will (16 and 17 years old who have been fully informed of the study and who have given written consent of their own free will by themselves and their guardians)
5) Have a mental and physical condition that allows them to understand and sustainably practice cognitive behavioal therapy for at least 2 months
6) Have the ability and environment to use the Internet and computers to receive cognitive behavioal therapy using a videoconferencing system
7) To attend their physician, with or without medication, but no new medications or changes in medication are planned in the future

Exclude criteria

Those who meet any of the following conditions are not eligible.
1) Organic mental disorder, psychosis including schizophrenia, bipolar disorder, mental retardation, autism spectrum disorder, substance abuse/substance dependence disorder, and those at imminent risk of suicide
2) Post Traumatic Stress Disorder(PTSD), Acute Stress Disorder
3) Persons on trail (including those in mediation)
4) Have difficulty in contacting the researchers
5) Judged to be inappropriate for conducting this study safely by the researchers

Related Information

• Primary Sponsor: Shimizu Eiji
• Secondary Sponsor: Akutsu Misa,Ministry of Education, Culture, Sports, Science and Technology