Insomnia ChronicNCT04719143
Effects of Insomnia Treatment on Metabolism in Patients With Depression
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Insomnia Chronic and Insomnia, run by University of Pennsylvania at 1 site in United States.
Trial summary
This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Insomnia Chronic, Insomnia, Insomnia, Primary
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 20 Dec 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Insomnia Severity Index > 14
- Meet diagnostic criteria for Insomnia
- Meet diagnostic criteria for Major Depressive Disorder
- Either currently taking an SSRI/SNRI or no antidepressant
Who cannot join
- BMI > 30
- Those with unstable medical conditions defined by change in diagnosis or medication in past 2 months
- Those with clinically significant comorbid psychiatric conditions (e.g., Bipolar disorder)
- Those with known untreated sleep apnea or other clinically significant sleep disorder other than insomnia
- Those currently taking medications that affect sleep or metabolism (e.g., stimulants, thyroid meds)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.
- Conditions
- Insomnia Chronic, Insomnia, Insomnia, Primary, Depression, Depressive Symptoms
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Keywords
- Metabolism, Metabolomics
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
Subjects receive 6-8 CBT-I sessions in an individual format.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic Assays
Blood samples will be collected at enrollment . We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control.
Measured: Baseline (week 0)
Metabolomic Assays
Blood samples will be collected 2 weeks following the completion of CBT-I to examine metabolic markers of response to CBT-I. We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control.
Measured: 2 weeks post-treatment (week 10 on average)
Insomnia Severity Index
A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.
Measured: Baseline (week 0)
Insomnia Severity Index
A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.
Measured: 2 weeks post-treatment (week 10 on average)
Insomnia Severity Index
A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.
Measured: 3 months post-treatment (week 20 on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start20 Dec 2018
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719143
- Sponsor's protocol ID
- 831841
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insomnia Treatment on Metabolism in Patients With Depression
- ClinicalTrials.gov ID
- NCT04719143
- Acronym / sponsor ID
- 831841
- Conditions
- Insomnia Chronic, Insomnia, Insomnia, Primary, Depression, Depressive Symptoms
- Keywords
- Metabolism, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 22 Jan 2021 (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 project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Insomnia Severity Index > 14
- Meet diagnostic criteria for Insomnia
- Meet diagnostic criteria for Major Depressive Disorder
- Either currently taking an SSRI/SNRI or no antidepressant
Key exclusion criteria (5 listed)
- BMI > 30
- Those with unstable medical conditions defined by change in diagnosis or medication in past 2 months
- Those with clinically significant comorbid psychiatric conditions (e.g., Bipolar disorder)
- Those with known untreated sleep apnea or other clinically significant sleep disorder other than insomnia
- Those currently taking medications that affect sleep or metabolism (e.g., stimulants, thyroid meds)
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 |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I)Subjects receive 6-8 CBT-I sessions in an individual format. | Behavioural | CBT-I |
Primary outcome
Metabolomic Assays
Time frame: Baseline (week 0)
Blood samples will be collected at enrollment . We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control.
Metabolomic Assays
Time frame: 2 weeks post-treatment (week 10 on average)
Blood samples will be collected 2 weeks following the completion of CBT-I to examine metabolic markers of response to CBT-I. We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control.
Insomnia Severity Index
Time frame: Baseline (week 0)
A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.
Insomnia Severity Index
Time frame: 2 weeks post-treatment (week 10 on average)
A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.
Insomnia Severity Index
Time frame: 3 months post-treatment (week 20 on average)
A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Insomnia Chronic and Insomnia, run by University of Pennsylvania at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jan 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic Assays (time frame: Baseline (week 0)). The study lists 5 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 17 Jan 2023.