search
Back to results

Cognitive Behavioral Therapy for Insomnia With rTMS

Primary Purpose

Depression, Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS
Repetitive Transcranial Magnetic Stimulation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medical University of South

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

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

rTMS (repetitive Transcranial Magnetic Stimulation)

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Reported Unanticipated Adverse Events
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
Feasibility of implementation of CBT-I as assessed by completion percentage of patients enrolled.

Secondary Outcome Measures

Change in Epworth Sleepiness Scale
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
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
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
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
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.

Full Information

First Posted
February 4, 2020
Last Updated
March 3, 2021
Sponsor
Medical University of South Carolina
Collaborators
Drug Abuse Research Training Program
search

1. Study Identification

Unique Protocol Identification Number
NCT04258618
Brief Title
Cognitive Behavioral Therapy for Insomnia With rTMS
Official Title
CBT-I Targeting Co-morbid Insomnia in Patients Receiving rTMS for Treatment-Resistant Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Drug Abuse Research Training Program

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS
Arm Type
Active Comparator
Arm Title
rTMS (repetitive Transcranial Magnetic Stimulation)
Arm Type
Other
Arm Description
Subjects will be getting Transcranial Magnetic Stimulation as part of their standard of care.
Intervention Type
Behavioral
Intervention Name(s)
CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
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 Measure Information:
Title
Number of Reported Unanticipated Adverse Events
Description
Tolerability of CBT-I with TMS determined by patient reported adverse event as assessed by red cap form
Time Frame
Baseline through post intervention (6 weeks)
Title
Percentage of patients completing CBT-I program
Description
Feasibility of implementation of CBT-I as assessed by completion percentage of patients enrolled.
Time Frame
Determined post intervention (6 weeks)
Secondary Outcome Measure Information:
Title
Change in Epworth Sleepiness Scale
Description
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.
Time Frame
Baseline and post intervention (6 weeks)
Title
Change in Insomnia Severity Index Scale
Description
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).
Time Frame
Baseline through post intervention (6 weeks)
Title
Change in Patient Health Questionnaire - 9
Description
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.
Time Frame
Baseline through post intervention (6 weeks)
Title
Change in Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Baseline and post intervention (6 weeks)
Title
Change in Hamilton Rating Scale for Depression 17
Description
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.
Time Frame
Baseline and post intervention (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Norred, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34563744
Citation
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.
Results Reference
derived

Learn more about this trial

Cognitive Behavioral Therapy for Insomnia With rTMS

We'll reach out to this number within 24 hrs