Cognitive Behavioral Therapy for Insomnia with RTMS

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Insomnia; Depression

Treatments: Device: Repetitive Transcranial Magnetic Stimulation; Behavioral: CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04258618

00089725

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

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

Active Comparator group

Treatment:

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

rTMS (repetitive Transcranial Magnetic Stimulation)

Other group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation