Cognitive Behavioral Therapy for Insomnia With rTMS

• ClinicalTrials.gov Identifier: NCT04258618
• Recruitment Status: Recruiting
• First Posted: February 6, 2020
• Last Update Posted: August 6, 2020
• Sponsor: Medical University of South Carolina
• Collaborator: Drug Abuse Research Training Program
• Information provided by (Responsible Party): Michael Norred, Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression; Insomnia	Behavioral: CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS; Device: Repetitive Transcranial Magnetic Stimulation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CBT-I Targeting Co-morbid Insomnia in Patients Receiving rTMS for Treatment-Resistant Major Depressive Disorder
• Actual Study Start Date: August 4, 2020
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS	Behavioral: 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.
rTMS (repetitive Transcranial Magnetic Stimulation); Subjects will be getting Transcranial Magnetic Stimulation as part of their standard of care.	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.

Secondary Outcome Measures :

1. Change in Epworth Sleepiness Scale [ Time Frame: 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.
2. Change in Insomnia Severity Index Scale [ Time Frame: 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).
3. Change in Patient Health Questionnaire - 9 [ Time Frame: 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.
4. Change in Pittsburgh Sleep Quality Index [ Time Frame: 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.
5. Change in Hamilton Rating Scale for Depression 17 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: Morgan Dancy; 843-876-5141

Locations

United States, South Carolina

Medical University of South; Recruiting

Charleston, South Carolina, United States, 29425

Contact: Michael Norred, MD

Sponsors and Collaborators

Medical University of South Carolina

Drug Abuse Research Training Program

Investigators

• Principal Investigator: Michael Norred, MD; Medical University of South Carolina

More Information

• Responsible Party: Michael Norred, Principal Investigator; Resident physician in Internal Medicine and Psychiatry, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT04258618
• Other Study ID Numbers: 00089725
• First Posted: February 6, 2020
• Last Update Posted: August 6, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders