Cognitive Behavioral Therapy for Insomnia with RTMS

NCT04258618 | Completed

• 1 other identifier: 00089725
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of Reported Unanticipated Adverse Events

  Tolerability of CBT-I with TMS determined by patient reported adverse event as assessed by red cap form

  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.

  Determined post intervention (6 weeks)

Secondary Outcomes (5)

• Change in Epworth Sleepiness Scale

  Baseline and post intervention (6 weeks)

• Change in Insomnia Severity Index Scale

  Baseline through post intervention (6 weeks)

• Change in Patient Health Questionnaire - 9

  Baseline through post intervention (6 weeks)

• Change in Pittsburgh Sleep Quality Index

  Baseline and post intervention (6 weeks)

• Change in Hamilton Rating Scale for Depression 17

  Baseline and post intervention (6 weeks)

Study Arms (2)

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

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

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

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

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

Repetitive Transcranial Magnetic Stimulation 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.

rTMS (repetitive Transcranial Magnetic Stimulation)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Drug Abuse Research Training Program: collaborator

Study Sites (1)

Medical University of South

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 34563744 DERIVED

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Magnetic Field Therapy; Therapeutics

Study Officials

• Michael Norred, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: August 4, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)