Cognitive Behavioral Therapy for Insomnia with RTMS

Not Applicable

Completed

• Conditions: Insomnia; Depression
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation; Behavioral: CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS

• Registration Number: NCT04258618
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2020-08-04
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS (repetitive Transcranial Magnetic Stimulation)	Repetitive Transcranial Magnetic Stimulation	Subjects will be getting Transcranial Magnetic Stimulation as part of their standard of care.
CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS	CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS	-

Primary Outcome Measures

Name	Time	Method
Number of Reported Unanticipated Adverse Events	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	Determined post intervention (6 weeks)	Feasibility of implementation of CBT-I as assessed by completion percentage of patients enrolled.

Secondary Outcome Measures

Name	Time	Method
Change in Epworth Sleepiness Scale	Baseline and post intervention (6 weeks)	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.
Change in Hamilton Rating Scale for Depression 17	Baseline and post intervention (6 weeks)	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.
Change in Insomnia Severity Index Scale	Baseline through post intervention (6 weeks)	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).
Change in Patient Health Questionnaire - 9	Baseline through post intervention (6 weeks)	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.
Change in Pittsburgh Sleep Quality Index	Baseline and post intervention (6 weeks)	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.

Trial Locations

Locations (1)

Medical University of South; 🇺🇸 Charleston, South Carolina, United States