Chronic InsomniaNCT06968013
Effect of WBT for CI With Depression
A study testing Well-Being Therapy and Sleep Hygiene Education in people with Chronic Insomnia and Depression Disorders, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Chronic Insomnia, Depression Disorders
- What is being tested?
- Well-Being Therapy 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
- 84 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, with a duration of at least 3 months.
- 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 depressive symptoms, defined as Hamilton Depression Scale (HAMD) score ≥ 16.
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: Investigating on the Efficacy of Well-Being Therapy (WBT) for Chronic Insomnia (CI) With Depressive Symptoms
This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.
Read the detailed description
According to DSM-IV criteria, approximately 6%-10% of the adult population in industrialized countries suffer from chronic insomnia (CI), characterized by difficulties in initiating or maintaining sleep accompanied by daytime symptoms persisting for at least four weeks. Chronic insomnia often leads to various psychiatric symptoms, with depressive symptoms being among the most common. For patients with CI and comorbid depressive symptoms, the most common treatment involves the use of antidepressant medications. However, while depressive symptoms may improve, insomnia symptoms often persist.
Among non-pharmacological interventions aimed at promoting psychological well-being, Well-Being Therapy (WBT) stands out as a brief and innovative psychotherapeutic approach. WBT is a structured, manualized, short-term therapy that incorporates self-monitoring of well-being episodes through the use of a diary, cognitive restructuring of interfering thoughts and behaviors, and homework assignments.
Previous research has demonstrated the effectiveness of WBT in alleviating stress in populations experiencing 'allostatic load.' This study seeks to evaluate the therapeutic effects of six WBT sessions on individuals with CI and comorbid depressive symptoms.
- Conditions
- Chronic Insomnia, Depression Disorders
- Being tested
- Well-Being Therapy, Sleep Hygiene Education
- Keywords
- Chronic Insomnia, Depression Disorders, Well-Being Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Being TherapyBehavioural
Participants will undergo Well-Being Therapy (WBT) sessions once daily for 50 minutes over a period of six weeks. The core elements of WBT include prompting participants to identify instances of well-being, contextualize these experiences using a structured diary, and recognize as well as restructure thoughts, beliefs, and behaviors that prematurely disrupt well-being. Additionally, the specific components of the six dimensions of the Psychological Well-Being (PWB) scale-autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance-are systematically integrated into different therapy sessions
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 |
|---|---|---|
| WBT-CI | Experimental | Not described Receives: Behavioral: Well-Being Therapy |
| SHE-CI | 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.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to evaluate sleep quality over a one-month period. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component is scored on a scale of 0 to 3, and the total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline and Week 6
Secondary outcomes (11)
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at 3, 6, and 12 Months
As mentioned in the previous text.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in Hamilton Depression Scale-17 (HAMD-17) Scores
The Hamilton Depression Scale-17 (HAMD-17) is a clinician-administered tool designed to assess the severity of depressive symptoms over the past week. It consists of 17 items that evaluate various aspects of depression, such as mood, guilt, insomnia, anxiety, and physical symptoms. Each item is scored on a scale, and the total score reflects the severity of depression.
The scoring criteria are as follows:
0-7: Normal (not depressed) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23 or above: Very severe depression.
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Baseline in Beck Depression Inventory-II (BDI-II) Scores
The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire designed to assess the severity of depressive symptoms. It consists of 21 items, each scored on a scale from 0 to 3, with a total score ranging from 0 to 63. The scoring interpretation is as follows:
0-13: Minimal depression 14-19: Mild depression 20-28: Moderate depression 29-63: Severe depression
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Baseline in Beck Anxiety Inventory (BAI) Scores
The scale contains 21 items and uses a 4-point scale method, with a total score of 15-25 as mild anxiety, 26-35 as moderate anxiety, and 36 or more as severe anxiety
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Baseline in Patient Health Questionnaire-4 (PHQ-4) Scores
The Patient Health Questionnaire-4 (PHQ-4) is a brief screening tool designed to assess symptoms of anxiety and depression. It consists of four items, with two questions focusing on anxiety and two on depression. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 12. The scoring interpretation is as follows:
0-2: None (minimal distress) 3-5: Mild distress 6-8: Moderate distress 9-12: Severe distress
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores
The 36-Item Short Form Health Survey (SF-36) is a widely used questionnaire designed to measure health-related quality of life. It evaluates eight domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health status.
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Snaith-Hamilton Pleasure Scale (SHAPS) Scores
The Snaith-Hamilton Pleasure Scale (SHAPS) is a self-report questionnaire designed to measure anhedonia, which is the reduced ability to experience pleasure. It consists of 14 items assessing various aspects of enjoyment in daily life, such as hobbies, social interactions, and sensory experiences. Each item is scored on a scale, and the total score ranges from 0 to 14, with higher scores indicating greater levels of anhedonia.
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) Scores
The Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) is a self-report questionnaire designed to assess maladaptive beliefs and attitudes related to sleep. It consists of items scored on a scale, typically using a visual analogue format or numerical ratings. The total score is calculated by averaging responses across all items, with higher scores indicating more dysfunctional beliefs about sleep.
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Insomnia Severity Index (ISI) Scores
The scale is divided into 7 sections with a total score of 0-28, with higher scores indicating more severe insomnia. The degree of insomnia is classified according to the scores: 0-7 indicates no insomnia, 8-14 is mild insomnia, 15-21 is moderate insomnia, and 22-28 is severe insomnia.
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Change in Self-rated Sleep Severity (0-10 Numeric Rating Scale)
The Self-rated Sleep Severity (0-10 Numeric Rating Scale) is a simple tool used to assess an individual's perception of their sleep quality or severity of sleep-related issues. Respondents rate their sleep on a scale from 0 to 10, where 0 represents no sleep problems and 10 indicates the most severe sleep difficulties.
Measured: Baseline, Week 6, 3 months, 6 months, and 12 months
Frequency and Severity of Adverse Events
Measured: Throughout study duration up to 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
- 84 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
- NCT06968013
- Sponsor's protocol ID
- WBT-CI-D-2025
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu X, Song P, Yin L, Wang K, Zhu B, Huang X, Niu Y, Leng H, Xue Q, Peng M, Min B, Shangguan F, Zhang P, Zhao W, Wang H, Lv J, Yang M, Wang P, Li D, Gao X, Feng K, Yun K, Cosci F, Wang H. The Role of Online Well-Being Therapy in Overcoming Allostatic Overload in Medical Workers: A Pilot Randomized Controlled Study. Psychother Psychosom. 2024;93(5):316-327. doi: 10.1159/000540924. Epub 2024 Sep 23.
PubMed 39312891
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating on the Efficacy of Well-Being Therapy (WBT) for Chronic Insomnia (CI) With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT06968013
- Acronym / sponsor ID
- WBT-CI-D-2025
- Conditions
- Chronic Insomnia, Depression Disorders
- Keywords
- Chronic Insomnia, Depression Disorders, Well-Being Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 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 explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.
Detailed description
According to DSM-IV criteria, approximately 6%-10% of the adult population in industrialized countries suffer from chronic insomnia (CI), characterized by difficulties in initiating or maintaining sleep accompanied by daytime symptoms persisting for at least four weeks. Chronic insomnia often leads to various psychiatric symptoms, with depressive symptoms being among the most common. For patients with CI and comorbid depressive symptoms, the most common treatment involves the use of antidepressant medications. However, while depressive symptoms may improve, insomnia symptoms often persist.
Among non-pharmacological interventions aimed at promoting psychological well-being, Well-Being Therapy (WBT) stands out as a brief and innovative psychotherapeutic approach. WBT is a structured, manualized, short-term therapy that incorporates self-monitoring of well-being episodes through the use of a diary, cognitive restructuring of interfering thoughts and behaviors, and homework assignments.
Previous research has demonstrated the effectiveness of WBT in alleviating stress in populations experiencing 'allostatic load.' This study seeks to evaluate the therapeutic effects of six WBT sessions on individuals with CI and comorbid depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WBT-CI | Experimental | Behavioral: Well-Being Therapy |
| SHE-CI | 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, with a duration of at least 3 months.
- 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 |
|---|---|---|
| Well-Being TherapyParticipants will undergo Well-Being Therapy (WBT) sessions once daily for 50 minutes over a period of six weeks. The core elements of WBT include prompting participants to identify instances of well-being, contextualize these experiences using a structured diary, and recognize as well as restructure thoughts, beliefs, and behaviors that prematurely disrupt well-being. Additionally, the specific components of the six dimensions of the Psychological Well-Being (PWB) scale-autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance-are systematically integrated into different therapy sessions | Behavioural | WBT-CI |
| 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-CI |
Primary outcome
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks
Time frame: Baseline and Week 6
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to evaluate sleep quality over a one-month period. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a scale of 0 to 3, and the total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
11 secondary outcomes
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at 3, 6, and 12 Months
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in Hamilton Depression Scale-17 (HAMD-17) Scores
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Baseline in Beck Depression Inventory-II (BDI-II) Scores
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Baseline in Beck Anxiety Inventory (BAI) Scores
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Baseline in Patient Health Questionnaire-4 (PHQ-4) Scores
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Snaith-Hamilton Pleasure Scale (SHAPS) Scores
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) Scores
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Change from Insomnia Severity Index (ISI) Scores
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Change in Self-rated Sleep Severity (0-10 Numeric Rating Scale)
Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months
Frequency and Severity of Adverse Events
Time frame: Throughout study duration up to 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 13 May 2025.
- Background: PubMed 39312891Liu X, Song P, Yin L, Wang K, Zhu B, Huang X, Niu Y, Leng H, Xue Q, Peng M, Min B, Shangguan F, Zhang P, Zhao W, Wang H, Lv J, Yang M, Wang P, Li D, Gao X, Feng K, Yun K, Cosci F, Wang H. The Role of Online Well-Being Therapy in Overcoming Allostatic Overload in Medical Workers: A Pilot Randomized Controlled Study. Psychother Psychosom. 2024;93(5):316-327. doi: 10.1159/000540924. Epub 2024 Sep 23.
- 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 Well-Being Therapy and Sleep Hygiene Education in people with Chronic Insomnia and Depression 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 13 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?
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks (time frame: Baseline and Week 6). 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 NCT06968013, 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 13 May 2025.