Clinical Trial: A Qualitative Investigation of Intervention Experiences and a Preliminary Evaluation of the Efficacy of Acceptance and Commitment Therapy for Insomnia (ACT-I) and Cognitive Behavioral Therapy for Insomnia (CBT-I) in University Students with Insomnia Symptoms: A Pilot Study Using a Crossover Single-Case Design (Japan)

Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063457) titled 'A Study of Experiences and Effects of Two Psychological Intervention Programs for University Students with Insomnia Symptoms' on Nov. 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Tokyo Kasei University

Condition: Condition - Insomnia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to investigate the characteristics of participants' experiences with Acceptance and Commitment Therapy for Insomnia (ACT-I) and Cognitive Behavioral Therapy for Insomnia (CBT-I) in university students with insomnia symptoms. ACT-I and CBT-I will be delivered using a crossover design, and data obtained from semi-structured interviews with participants who have experienced both interventions will be qualitatively analyzed. Particular attention will be paid to ease of engaging in the interventions, ease of continuing the intervention components, satisfaction with and perceived fit of the interventions, perceived changes in sleep and daily life through the interventions, and differences in experiences related to the order of the interventions. As a secondary objective, insomnia severity, subjective happiness, and psychological flexibility regarding sleep problems will be repeatedly assessed using sleep diaries and questionnaires, and changes in these outcomes associated with each intervention will be examined over time to preliminarily evaluate the efficacy of both interventions. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Following a two-week baseline period, Acceptance and Commitment Therapy for Insomnia (ACT-I) will be delivered once weekly for three weeks, for a total of three sessions. A semi-structured interview will be conducted one week after completion of ACT-I, followed by an additional one-week follow-up period. Cognitive Behavioral Therapy for Insomnia (CBT-I) will then be delivered once weekly for three weeks, for a total of three sessions. A semi-structured interview will be conducted one week after completion of CBT-I, followed by an additional one-week follow-up period. Regarding the content of each intervention, ACT-I will include values clarification, committed action, acceptance, cognitive defusion, and mindfulness. CBT-I will include sleep hygiene education, sleep restriction, stimulus control, and cognitive restructuring. Interventions/Control_2 - Following a two-week baseline period, CBT-I will be delivered once weekly for three weeks, for a total of three sessions. A semi-structured interview will be conducted one week after completion of CBT-I, followed by an additional one-week follow-up period. ACT-I will then be delivered once weekly for three weeks, for a total of three sessions. A semi-structured interview will be conducted one week after completion of ACT-I, followed by an additional one-week follow-up period. Regarding the content of each intervention, ACT-I will include values clarification, committed action, acceptance, cognitive defusion, and mindfulness. CBT-I will include sleep hygiene education, sleep restriction, stimulus control, and cognitive restructuring.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. University students enrolled at Tokyo Kasei University. 2. Aged 18 years or older. 3. A total score of 10 or higher on the Insomnia Severity Index (ISI). Key exclusion criteria - 1. Individuals currently receiving medical treatment for a chronic physical illness, psychiatric disorder, or sleep disorder. 2. Individuals suspected of having a sleep disorder other than insomnia disorder, such as obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder, or a circadian rhythm sleep-wake disorder. Target Size - 6

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 07 Day Date of IRB - 2026 Year 09 Month 17 Day Anticipated trial start date - 2026 Year 11 Month 02 Day Last follow-up date - 2027 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072370

Disclaimer: Curated by HT Syndication.