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Cognitive Behavioral Therapy for Insomnia With rTMS

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ClinicalTrials.gov Identifier: NCT04258618
Recruitment Status : Completed
First Posted : February 6, 2020
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
Drug Abuse Research Training Program
Information provided by (Responsible Party):
Michael Norred, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 4, 2020
First Posted Date  ICMJE February 6, 2020
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE August 4, 2020
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy for Insomnia With rTMS
Official Title  ICMJE CBT-I Targeting Co-morbid Insomnia in Patients Receiving rTMS for Treatment-Resistant Major Depressive Disorder
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Insomnia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS
    Intervention: Behavioral: CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS
  • rTMS (repetitive Transcranial Magnetic Stimulation)
    Subjects will be getting Transcranial Magnetic Stimulation as part of their standard of care.
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2021)
2
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2020)
30
Actual Study Completion Date  ICMJE January 31, 2021
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04258618
Other Study ID Numbers  ICMJE 00089725
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Norred, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Drug Abuse Research Training Program
Investigators  ICMJE
Principal Investigator: Michael Norred, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP