UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063457 |
|---|---|
| Receipt number | R000072370 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/29 12:50:17 |
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Basic information
Public title
A Study of Experiences and Effects of Two Psychological Intervention Programs for University Students with Insomnia Symptoms
Acronym
A Pilot Study of ACT-I and CBT-I for University Students with Insomnia
Scientific Title
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
Scientific Title:Acronym
A Pilot Study of ACT-I and CBT-I for University Students with Insomnia
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Qualitative investigation of intervention experiences (primary) and preliminary evaluation of efficacy (secondary)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is participants' experiences with ACT-I and CBT-I as assessed using verbatim transcripts of semi-structured interviews. Semi-structured interviews will be conducted twice, one week after completion of each intervention.
Key secondary outcomes
Secondary outcomes include insomnia severity, subjective happiness, psychological flexibility regarding sleep problems, and sleep parameters derived from sleep diaries. Insomnia severity will be assessed using the Insomnia Severity Index (ISI), subjective happiness using the Subjective Happiness Scale (SHS), and psychological flexibility regarding sleep problems using the Sleep Problem Acceptance Questionnaire (SPAQ). Sleep parameters, including sleep onset latency, wake after sleep onset, total sleep time, and sleep efficiency, will be assessed using sleep diaries.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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.
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
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 sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Isa |
| Middle name | |
| Last name | Okajima |
Organization
Tokyo Kasei University
Division name
Department of Psychological Counseling, Faculty of Humanities
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3961-5276
okajima-i@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Bando |
Organization
Graduate School of Tokyo Kasei University
Division name
Graduate School of Humanities and Life Sciences
Zip code
173-0003
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3961-5226
Homepage URL
424.bando@gmail.com
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Kasei University
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
Research Ethics Committee Graduate School of Human Life Science Tokyo Kasei University
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel
03-3961-5226
kenkyurinri-in@tokyo-kasei.ac.jp
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
| 2026 | Year | 11 | 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
| 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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072370
