Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Behavioral Therapy for Insomnia With rTMS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 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
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258618


Locations
Layout table for location information
United States, South Carolina
Medical University of South
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Drug Abuse Research Training Program
Investigators
Layout table for investigator information
Principal Investigator: Michael Norred, MD Medical University of South Carolina
Layout table for additonal 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    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders