Chronic InsomniaNCT06969053
Effect of MIT for CI With Anxiety
A study testing Mindfulness Intervention Therapy plus Sleep Hygiene Education and Sleep Hygiene Education in people with Chronic Insomnia and Anxiety Disorders, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Chronic Insomnia, Anxiety Disorders
- What is being tested?
- Mindfulness Intervention Therapy plus Sleep Hygiene Education and Sleep Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with Insomnia Disorder according to DSM-5 criteria.
- Pittsburgh Sleep Quality Index (PSQI) total score > 5.
- Age 8 years or older.
- Educational level of at least junior high school.
- Voluntarily agree to participate and provide written informed consent.
- Presence of anxiety symptoms, defined as Hamilton Anxiety Rating Scale (HAMA) score ≥ 14.
Who cannot join
- Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.
- Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.
- Pregnant or breastfeeding women.
- Currently undergoing any psychological therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Hongxing Wang, MD & PhD, +86 13911127385, wanghongxing@xwh.ccmu.edu.cn
About this study
Official title: Evaluation of Mindfulness Intervention Therapy in Treating Chronic Insomnia (CI) With Comorbid Anxiety
This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms.
- Conditions
- Chronic Insomnia, Anxiety Disorders
- Being tested
- Mindfulness Intervention Therapy plus Sleep Hygiene Education, Sleep Hygiene Education
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Intervention Therapy plus Sleep Hygiene EducationBehavioural
Participants will receive a 6-week program combining Mindfulness Intervention Therapy (MIT) and Sleep Hygiene Education (SHE). MIT includes body scan, mindful breathing, breathing space exercises, mindful walking, sitting meditation, loving-kindness meditation, and development of a personalized mindfulness practice plan. Sessions are conducted daily for 50 minutes. SHE provides structured guidance on optimizing sleep schedules, bedroom environment, and reducing stimulants such as caffeine and alcohol.
Sleep Hygiene EducationBehavioural
Participants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| MIT + SHE | Experimental | Not described Receives: Behavioral: Mindfulness Intervention Therapy plus Sleep Hygiene Education |
| SHE only | Active comparator | Not described Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
Measured: Baseline, 6 weeks
Secondary outcomes (11)
The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The DBAS assessing sleep related cognitions in 16 items rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive dysfunctional beliefs.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.
The SF-36 quantifying the quality of life in relation to health status consists of 36-items with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The total score ranges from 0-100 (the worst possible to the most possible).
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The PHQ-4 comprises a 2-item depression scale and a 2-item anxiety scale. Each instrument can reach values from 0-6. Higher Scores are indicating higher distress.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The BDI assessing the existence and severity of symptoms of depression consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe depressive symptoms.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The BAI assessing the existence and severity of symptoms of anxiety consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe anxiety.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The PHQ-15 measuring somatic distress consists of 15 items, and the total score ranges from 0 to 30 with higher scores indicating more severe somatic distress.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The PDQ-D-5 assessing perceived cognitive deficits from the patient's perspective consists of 5 items, and the total score ranges from 0 to 20 with higher scores indicating greater perceived deficit.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
The LES assessing the perceived stress and number of stressful life events experienced consists of 48 items which are classified into three dimensions: family life events (28 items), work and study events (13 items), and social events (7 items) with higher scores in LES perceived greater stressfulness.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Nov 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969053
- Sponsor's protocol ID
- CI+CA-MIT
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
PubMed 20350028
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mindfulness Intervention Therapy in Treating Chronic Insomnia (CI) With Comorbid Anxiety
- ClinicalTrials.gov ID
- NCT06969053
- Acronym / sponsor ID
- CI+CA-MIT
- Conditions
- Chronic Insomnia, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIT + SHE | Experimental | Behavioral: Mindfulness Intervention Therapy plus Sleep Hygiene Education |
| SHE only | Active comparator | Behavioral: Sleep Hygiene Education |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Insomnia Disorder according to DSM-5 criteria.
- Pittsburgh Sleep Quality Index (PSQI) total score > 5.
- Age 8 years or older.
- Educational level of at least junior high school.
- Voluntarily agree to participate and provide written informed consent.
Key exclusion criteria (4 listed)
- Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.
- Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.
- Pregnant or breastfeeding women.
- Currently undergoing any psychological therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Intervention Therapy plus Sleep Hygiene EducationParticipants will receive a 6-week program combining Mindfulness Intervention Therapy (MIT) and Sleep Hygiene Education (SHE). MIT includes body scan, mindful breathing, breathing space exercises, mindful walking, sitting meditation, loving-kindness meditation, and development of a personalized mindfulness practice plan. Sessions are conducted daily for 50 minutes. SHE provides structured guidance on optimizing sleep schedules, bedroom environment, and reducing stimulants such as caffeine and alcohol. | Behavioural | MIT + SHE |
| Sleep Hygiene EducationParticipants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality. | Behavioural | SHE only |
Primary outcome
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
Time frame: Baseline, 6 weeks
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
11 secondary outcomes
The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Results publication: PubMed 20350028Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention Therapy plus Sleep Hygiene Education and Sleep Hygiene Education in people with Chronic Insomnia and Anxiety Disorders, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxing Wang, MD & PhD (+86 13911127385, wanghongxing@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks (time frame: Baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06969053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.