DepressionNCT04258618
Cognitive Behavioral Therapy for Insomnia with RTMS
A study testing CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS and Repetitive Transcranial Magnetic Stimulation in people with Depression and Insomnia, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Depression and insomnia occur together in a substantial number of patients. Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depression, Insomnia
- What is being tested?
- CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS and Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2020to 31 Jan 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-85 years old
- Patients starting rTMS treatment for MDD
- Co-morbid insomnia as determined by meeting the following criteria: (a) Requiring more than 30 minutes to fall asleep at the beginning of the night or more than 30 minutes of time awake after initially falling asleep for at least 3 nights per week for at least 3 months - - An insomnia severity index score of 15 or more
- Manifested sleep disturbances or associated daytime symptoms causing significant distress or impairment in social, occupational or other areas of functioning
- Reliable access to a computer with internet access.
Who cannot join
- Obligation to an irregular sleep schedule that prevents the adoption of intervention strategies such as shift workers
- Participants who have received or are receiving CBT-I targeting insomnia in the past, or those who have initiated a new sedative medication, or sedating antidepressant within 2-weeks preceding enrollment
- Comorbid psychiatric disorders, including bipolar disorder, psychotic disorders or depression with psychotic features
- Presence of another untreated sleep disorder such as obstructive sleep apne
- Pregnancy
- Active substance use disorder within the past 3 months
- Use of medications that reduce the seizure threshold including Buproprion, stimulants or augmenting thyroid medications (for those without history of hypothyroid)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South
Charleston, South Carolina, 29425
About this study
Official title: CBT-I Targeting Co-morbid Insomnia in Patients Receiving RTMS for Treatment-Resistant Major Depressive Disorder
Depression and insomnia occur together in a substantial number of patients. Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. A form of cognitive behavioral therapy (CBT) has been developed that specifically helps with insomnia (CBT-I). The study team will give CBT-I to patients who are being treated with TMS for depression, who also have insomnia, to determine if it helps insomnia symptoms.
- Conditions
- Depression, Insomnia
- Being tested
- CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS, Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMSBehavioural
Cognitive Behavioral Therapy for insomnia (CBT-I) with rTMS (repetitive Transcranial Magnetic Stimulation) will be performed as part of this study by the PI. This includes weekly, one hour sessions addressing sleep for 6 weeks.
Repetitive Transcranial Magnetic StimulationDevice
Participants in this study will be undergoing repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder as part of their clinical treatment. This involves magnetic stimulation with specific settings to a specific region of the brain to help treat depression. Treatment time ranges, but is around 30 minutes per session and occurs 5 days a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS | Active comparator | Not described Receives: Behavioral: CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS |
| rTMS (repetitive Transcranial Magnetic Stimulation) | Other | Subjects will be getting Transcranial Magnetic Stimulation as part of their standard of care. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Reported Unanticipated Adverse Events
Tolerability of CBT-I with TMS determined by patient reported adverse event as assessed by red cap form
Measured: Baseline through post intervention (6 weeks)
Percentage of patients completing CBT-I program
Feasibility of implementation of CBT-I as assessed by completion percentage of patients enrolled.
Measured: Determined post intervention (6 weeks)
Secondary outcomes (5)
Change in Epworth Sleepiness Scale
Assessing pre and post TMS treatment changes of ESS in TMS + CBT-I group vs no CBT-I group. The scale is scored 0-24 assessing degree of sleepiness. Cutoff scores are as follows: 0-7:It is unlikely that you are abnormally sleepy. 8-9:You have an average amount of daytime sleepiness; 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention;16-24:You are excessively sleepy and should consider seeking medical attention. This scale is often used clinically for obstructive sleep apnea, but can be useful to assess daytime impact of insomnia.
Measured: Baseline and post intervention (6 weeks)
Change in Insomnia Severity Index Scale
Assessing pre and post TMS treatment changes of ISI in TMS + CBT-I group vs no CBT-I group. This scale is scored 0-28 and is used to assess severity of insomnia with cutoff scores as follows: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia;15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe).
Measured: Baseline through post intervention (6 weeks)
Change in Patient Health Questionnaire - 9
Assessing pre and post TMS treatment changes of PHQ-9 in TMS + CBT-I group vs no CBT-I group. This scale is used to assess depression severity. Cutoff scores are as follows: 0-4: Minimal or none; 5-9: Mild; 10-14: Moderate; 15-19: Moderately severe; 20-27: Severe.
Measured: Baseline through post intervention (6 weeks)
Change in Pittsburgh Sleep Quality Index
Assessing pre and post TMS treatment changes of PSQI in TMS + CBT-I group vs no CBT-I group. This scale is a 9-item questionnaire assessing sleep quality. The score is determined by adding up 7 components, with a score of 5 or greater being considered poor sleep.
Measured: Baseline and post intervention (6 weeks)
Change in Hamilton Rating Scale for Depression 17
Assessing pre and post TMS treatment changes of HRSD 17 in TMS + CBT-I group vs no CBT-I group. This is a 17- item scale assessing severity of depression symptoms and is scored out of 58 (8 questions scored out of 5 and 9 questions scored out of 2), with 0-7 considered normal and > 20 considered at least moderate severity.
Measured: Baseline and post intervention (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start4 Aug 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
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 DepressionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Abuse Research Training Program
- Responsible party
- Sponsor
- Investigators
- Michael Norred, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258618
- Sponsor's protocol ID
- 00089725
- Status last verified
- Oct 2024
- First submitted
- 4 Feb 2020
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norred MA, Haselden LC, Sahlem GL, Wilkerson AK, Short EB, McTeague LM, George MS. TMS and CBT-I for comorbid depression and insomnia. Exploring feasibility and tolerability of transcranial magnetic stimulation (TMS) and cognitive behavioral therapy for insomnia (CBT-I) for comorbid major depressive disorder and insomnia during the COVID-19 pandemic. Brain Stimul. 2021 Nov-Dec;14(6):1508-1510. doi: 10.1016/j.brs.2021.09.007. Epub 2021 Sep 23. No abstract available.
PubMed 34563744
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT-I Targeting Co-morbid Insomnia in Patients Receiving RTMS for Treatment-Resistant Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04258618
- Acronym / sponsor ID
- 00089725
- Conditions
- Depression, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Drug Abuse Research Training Program
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 6 Feb 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.
Depression and insomnia occur together in a substantial number of patients. Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. A form of cognitive behavioral therapy (CBT) has been developed that specifically helps with insomnia (CBT-I). The study team will give CBT-I to patients who are being treated with TMS for depression, who also have insomnia, to determine if it helps insomnia symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS | Active comparator | Behavioral: CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS |
| rTMS (repetitive Transcranial Magnetic Stimulation) | Other | Device: Repetitive Transcranial Magnetic StimulationSubjects will be getting Transcranial Magnetic Stimulation as part of their standard of care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-85 years old
- Patients starting rTMS treatment for MDD
- Co-morbid insomnia as determined by meeting the following criteria: (a) Requiring more than 30 minutes to fall asleep at the beginning of the night or more than 30 minutes of time awake after initially falling asleep for at least 3 nights per week for at least 3 months - - An insomnia severity index score of 15 or more
- Manifested sleep disturbances or associated daytime symptoms causing significant distress or impairment in social, occupational or other areas of functioning
- Reliable access to a computer with internet access.
Key exclusion criteria (7 listed)
- Obligation to an irregular sleep schedule that prevents the adoption of intervention strategies such as shift workers
- Participants who have received or are receiving CBT-I targeting insomnia in the past, or those who have initiated a new sedative medication, or sedating antidepressant within 2-weeks preceding enrollment
- Comorbid psychiatric disorders, including bipolar disorder, psychotic disorders or depression with psychotic features
- Presence of another untreated sleep disorder such as obstructive sleep apne
- Pregnancy
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 |
|---|---|---|
| CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMSCognitive Behavioral Therapy for insomnia (CBT-I) with rTMS (repetitive Transcranial Magnetic Stimulation) will be performed as part of this study by the PI. This includes weekly, one hour sessions addressing sleep for 6 weeks. | Behavioural | CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS |
| Repetitive Transcranial Magnetic StimulationParticipants in this study will be undergoing repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder as part of their clinical treatment. This involves magnetic stimulation with specific settings to a specific region of the brain to help treat depression. Treatment time ranges, but is around 30 minutes per session and occurs 5 days a week for 6 weeks. | Device | rTMS (repetitive Transcranial Magnetic Stimulation) |
Primary outcome
Number of Reported Unanticipated Adverse Events
Time frame: Baseline through post intervention (6 weeks)
Tolerability of CBT-I with TMS determined by patient reported adverse event as assessed by red cap form
Percentage of patients completing CBT-I program
Time frame: Determined post intervention (6 weeks)
Feasibility of implementation of CBT-I as assessed by completion percentage of patients enrolled.
5 secondary outcomes
Change in Epworth Sleepiness Scale
Time frame: Baseline and post intervention (6 weeks)
Change in Insomnia Severity Index Scale
Time frame: Baseline through post intervention (6 weeks)
Change in Patient Health Questionnaire - 9
Time frame: Baseline through post intervention (6 weeks)
Change in Pittsburgh Sleep Quality Index
Time frame: Baseline and post intervention (6 weeks)
Change in Hamilton Rating Scale for Depression 17
Time frame: Baseline and post intervention (6 weeks)
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 24 Oct 2024.
- Derived from this study: PubMed 34563744Norred MA, Haselden LC, Sahlem GL, Wilkerson AK, Short EB, McTeague LM, George MS. TMS and CBT-I for comorbid depression and insomnia. Exploring feasibility and tolerability of transcranial magnetic stimulation (TMS) and cognitive behavioral therapy for insomnia (CBT-I) for comorbid major depressive disorder and insomnia during the COVID-19 pandemic. Brain Stimul. 2021 Nov-Dec;14(6):1508-1510. doi: 10.1016/j.brs.2021.09.007. Epub 2021 Sep 23. No abstract available.
- 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.
Michael Norred, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS and Repetitive Transcranial Magnetic Stimulation in people with Depression and Insomnia, run by Medical University of South Carolina 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 5 inclusion and 7 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 24 Oct 2024. 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?
Number of Reported Unanticipated Adverse Events (time frame: Baseline through post intervention (6 weeks)). The study lists 2 primary outcomes in all. 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 NCT04258618, 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 24 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.