Testing the efficacy of cognitive-behavioral therapy for adjustment disorder

JRCT ID: jRCT1030240136

Registered date:03/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: adjustment disorder
• Date of first enrollment: 03/06/2024
• Target sample size: 68
• Study type: Interventional
• Intervention(s): The Group Rumination-Focused Cognitive Behavioral Therapy (G-RFCBT) program will be provided weekly for seven weeks in parallel with the usual outpatient psychiatric treatment. The G-RFCBT program consists of an initial session about the basics of cognitive-behavioral therapy and understanding rumination, followed by subsequent sessions on identifying and dealing with rumination, new alternatives to rumination, assertion skills, and a wrap-up session.

Outcome(s)

• Primary Outcome: Change in Patient Health Questionnaire-9 (PHQ-9) from pre- to post- assessment
• Secondary Outcome: Secondary outcomes will be changes in depressive symptoms (QIDS), anxiety symptoms (GAD-7), adjustment disorder symptoms (ADNM-20), depressive rumination (RSS-brooding/reflection), repetitive thoughts (Mini-CERTS), and health quality of life (EQ-5D-5L) at the pre-, post and follow-up assessments.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1. who meets the diagnostic criteria for ICD-11 adjustment disorder
2. who has been receiving outpatient care for adjustment disorder for at least three months
3. who meets Adjustment Disorder New Module-20 scale (ADNM-20) >=47.5, PHQ-9 >=10, and GAD-7 >=5 at the baseline evaluation
4. aged between 18 and 75 years old at the time of baseline evaluation

Exclude criteria

1. with DSM-5 autism spectrum disorder (severity level 1, 2, or 3)
2. patients who have imminent suicide ideation at the baseline evaluation
3. patients with severe organic brain lesions or cognitive dysfunction within the past year from the baseline evaluation
4. who have a serious or unstable physical condition at the baseline evaluation
5. patients who have serious personality disorder at the baseline evaluation

Related Information

• Primary Sponsor: Nakagawa Atsuo
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)