Cognitive Behavioral Therapy for Insomnia with RTMS

NCT ID: NCT04258618

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-04
• Study Completion Date: 2021-01-31

Brief 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. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS

Group Type: ACTIVE_COMPARATOR

CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS

Intervention Type: BEHAVIORAL

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.

rTMS (repetitive Transcranial Magnetic Stimulation)

Subjects will be getting Transcranial Magnetic Stimulation as part of their standard of care.

Group Type: OTHER

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

Interventions

CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS

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.

Intervention Type: BEHAVIORAL

Repetitive Transcranial Magnetic Stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drug Abuse Research Training Program

UNKNOWN

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Norred, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34563744 (View on PubMed)

Other Identifiers

00089725

Identifier Type: -

Identifier Source: org_study_id