Clinical trial NCT04258618: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Insomnia
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Drug Abuse Research Training Program
First posted: 2020-02-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Number of Reported Unanticipated Adverse Events
timeFrame: Baseline through post intervention (6 weeks)
measure: Percentage of patients completing CBT-I program
timeFrame: Determined post intervention (6 weeks)
Secondary outcomes:
measure: Change in Epworth Sleepiness Scale
timeFrame: Baseline and post intervention (6 weeks)
measure: Change in Insomnia Severity Index Scale
timeFrame: Baseline through post intervention (6 weeks)
measure: Change in Patient Health Questionnaire - 9
timeFrame: Baseline through post intervention (6 weeks)
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: Baseline and post intervention (6 weeks)
measure: Change in Hamilton Rating Scale for Depression 17
timeFrame: Baseline and post intervention (6 weeks)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael Norred, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.