InsomniaNCT04585282
CBT for Insomnia With Anxiety and Depression
A study testing Plus Cognitive behavioral therapy of insomnia（CBT-I plus） and Cognitive behavioral therapy of insomnia（CBT-I） in people with Insomnia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Plus Cognitive behavioral therapy of insomnia（CBT-I plus） and Cognitive behavioral therapy of insomnia（CBT-I）
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, male and female
- Meet the diagnostic criteria of DSM-5 for insomnia, the Pittsburgh Sleep Quality Index (PSQI) scale total score ≥10
- May be accompanied by depression symptoms, but currently does not meet any depression disorders diagnostic criteria,14≤HAMD-17≤23
- May be accompanied by anxiety symptoms, but currently does not meet any anxiety disorders diagnostic criteria ,14≤HAMA≤29
- Have sufficient education and understanding to complete this study to be examined and evaluated
- Voluntary participation in this clinical trial and signature of informed consent.
Who cannot join
- DSM-5 other sleep problems, such as apnea syndrome, restless leg syndrome
- Women who are pregnant, nursing or planning to become pregnant during the study
- Insomnia caused by alcohol or substance abuse
- Severe cognitive problems
- Patients who were previously or currently diagnosed as bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stress related disorders, separation disorders, eating disorders
- Patients with history of epilepsy or other serious somatic diseases
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- Persons receiving MECT treatment for nearly one month
- Excluding those who have received systemic psychotherapy for more than 3 months in a row
- The researchers believe that it is not suitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Chengmei Yuan, 86-13818132592, yuanchengmei@yeah.net
About this study
Official title: A Randomized Controlled Study of Cognitive Behavioral Therapy for Insomnia With Anxiety and Depression
Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia.
Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
Read the detailed description
The purpose of this study was to explore the treatment of cognitive behavioral enhancement of insomnia (cbt-i plus), which was randomly divided into cbt-i plus intervention group (Study Group) and cbt-i intervention group (control group). The study group used the unified cognitive behavioral therapy manual for insomnia (cbt-i plus) for one-to-one individual treatment intervention, once a week, 45-50 minutes each time, a total of 8 times; the control group used the unified cognitive behavioral therapy manual for insomnia (cbt-i) for one-on-one treatment intervention, once a week, 45-50 minutes each time, a total of 8 times. The related indexes were evaluated at baseline, 2 weeks, 4 weeks and 8 weeks after enrollment, and were followed up at 12 weeks and 24 weeks after enrollment. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
- Conditions
- Insomnia
- Being tested
- Plus Cognitive behavioral therapy of insomnia（CBT-I plus）, Cognitive behavioral therapy of insomnia（CBT-I）
- 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.
Plus Cognitive behavioral therapy of insomnia（CBT-I plus）Behavioural
Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms.
Cognitive behavioral therapy of insomnia（CBT-I）Behavioural
Cognitive behavioral therapy of insomnia is mainly aimed at correcting the bad behaviors and beliefs among the maintenance factors of insomnia, which is considered as the first-line treatment program of insomnia disorder. Cognitive behavioral therapy of insomnia mainly includes five important components: sleep restriction, secondary control, cognitive therapy, relaxation therapy and sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The study group was treated with intensive cognitive behavioral therapy for insomnia. Receives: Behavioral: Plus Cognitive behavioral therapy of insomnia（CBT-I plus） |
| control group | Active comparator | The control group was treated with traditional cognitive behavioral therapy for insomnia. Receives: Behavioral: Cognitive behavioral therapy of insomnia（CBT-I） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of sleep efficiency
Sleep efficiency was measured by sleep diary
Sleep efficiency was measured by sleep diary
Measured: Change from Baseline Sleep efficiency at 8 weeks
Change of depressive symptoms
The measurement tool is Hamilton Depression Scale-17 items,the minimum score of the scale was 0 and the maximum score was 52. The higher the score was, the more serious the depression was.
Measured: Change from Baseline Sleep efficiency at 8 weeks
Change of anxiety symptoms
The measurement tool is Hamilton Anxiety Scale,
the minimum score of the scale was 0 and the maximum score was 56. The higher the score was, the more serious the anxiety was.
Measured: Change from Baseline Sleep efficiency at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Aug 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Model description
- In this study, patients were randomly assigned to study group and control group by random number table.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengmei Yuan, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585282
- Sponsor's protocol ID
- Chengmei Yuan
- Status last verified
- Jul 2020
- First submitted
- 9 Sep 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Cognitive Behavioral Therapy for Insomnia With Anxiety and Depression
- ClinicalTrials.gov ID
- NCT04585282
- Acronym / sponsor ID
- Chengmei Yuan
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 14 Oct 2020 (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.
Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia.
Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
Detailed description
The purpose of this study was to explore the treatment of cognitive behavioral enhancement of insomnia (cbt-i plus), which was randomly divided into cbt-i plus intervention group (Study Group) and cbt-i intervention group (control group). The study group used the unified cognitive behavioral therapy manual for insomnia (cbt-i plus) for one-to-one individual treatment intervention, once a week, 45-50 minutes each time, a total of 8 times; the control group used the unified cognitive behavioral therapy manual for insomnia (cbt-i) for one-on-one treatment intervention, once a week, 45-50 minutes each time, a total of 8 times. The related indexes were evaluated at baseline, 2 weeks, 4 weeks and 8 weeks after enrollment, and were followed up at 12 weeks and 24 weeks after enrollment. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- In this study, patients were randomly assigned to study group and control group by random number table.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Plus Cognitive behavioral therapy of insomnia（CBT-I plus）The study group was treated with intensive cognitive behavioral therapy for insomnia. |
| control group | Active comparator | Behavioral: Cognitive behavioral therapy of insomnia（CBT-I）The control group was treated with traditional cognitive behavioral therapy for insomnia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years, male and female
- Meet the diagnostic criteria of DSM-5 for insomnia, the Pittsburgh Sleep Quality Index (PSQI) scale total score ≥10
- May be accompanied by depression symptoms, but currently does not meet any depression disorders diagnostic criteria,14≤HAMD-17≤23
- May be accompanied by anxiety symptoms, but currently does not meet any anxiety disorders diagnostic criteria ,14≤HAMA≤29
- Have sufficient education and understanding to complete this study to be examined and evaluated
Key exclusion criteria (9 listed)
- DSM-5 other sleep problems, such as apnea syndrome, restless leg syndrome
- Women who are pregnant, nursing or planning to become pregnant during the study
- Insomnia caused by alcohol or substance abuse
- Severe cognitive problems
- Patients who were previously or currently diagnosed as bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stress related disorders, separation disorders, eating disorders
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 |
|---|---|---|
| Plus Cognitive behavioral therapy of insomnia（CBT-I plus）Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms. | Behavioural | intervention group |
| Cognitive behavioral therapy of insomnia（CBT-I）Cognitive behavioral therapy of insomnia is mainly aimed at correcting the bad behaviors and beliefs among the maintenance factors of insomnia, which is considered as the first-line treatment program of insomnia disorder. Cognitive behavioral therapy of insomnia mainly includes five important components: sleep restriction, secondary control, cognitive therapy, relaxation therapy and sleep hygiene. | Behavioural | control group |
Primary outcome
Change of sleep efficiency
Time frame: Change from Baseline Sleep efficiency at 8 weeks
Sleep efficiency was measured by sleep diary Sleep efficiency was measured by sleep diary
Change of depressive symptoms
Time frame: Change from Baseline Sleep efficiency at 8 weeks
The measurement tool is Hamilton Depression Scale-17 items,the minimum score of the scale was 0 and the maximum score was 52. The higher the score was, the more serious the depression was.
Change of anxiety symptoms
Time frame: Change from Baseline Sleep efficiency at 8 weeks
The measurement tool is Hamilton Anxiety Scale, the minimum score of the scale was 0 and the maximum score was 56. The higher the score was, the more serious the anxiety was.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- 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. This study is not recruiting at the moment.
Chengmei Yuan study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plus Cognitive behavioral therapy of insomnia（CBT-I plus） and Cognitive behavioral therapy of insomnia（CBT-I） in people with Insomnia, run by Shanghai Mental Health Center 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 9 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengmei Yuan (86-13818132592, yuanchengmei@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of sleep efficiency (time frame: Change from Baseline Sleep efficiency at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2020.