Clinical trial NCT04445805: Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
Official title: The INSPIRE Trial: Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Telemedecine
pregnancy
perinatal
Cognitive Arousal
depression
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these types of treatment will improve sleep and mood-related health risks in pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control.

Detailed description: The purpose of this randomized controlled trial is to determine the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control. The long-term goal is to maximize the effectiveness of insomnia treatment for perinatal women by adapting safe and efficacious treatments to meet the evolving needs of women through pregnancy and postpartum. Over half of pregnant women develop insomnia, which is associated with high rates of depression during pregnancy and postpartum. By successfully treating insomnia during pregnancy and improving cognitive-emotion regulation, mental health of pregnant and postpartum women may be substantially improved. In a prior clinical trial, Dr. Kalmbach (PI) showed that digital CBTI (i.e., fully automated online program) improved sleep during pregnancy, and offered some protection against sleep problems after childbirth. Women in this prior trial were highly satisfied with CBTI and the ability to participate in treatment remotely. However, the investigators identified important shortcomings of CBTI in this population. Namely, standard CBTI was ineffective at reducing cognitive arousal and depression. Preliminary data suggest that MBTI may effectively reduce cognitive arousal in insomnia patients, which has immense potential to enhance sleep and mental health outcomes in perinatal insomnia. Thus, the investigators will conduct a randomized controlled trial to determine the efficacy of MBTI and CBTI for perinatal insomnia relative to a minimal intervention control.

The current study is a 3-arm RCT comparing CBTI and MBTI to sleep education and hygiene minimal intervention control for the treatment of perinatal insomnia. 120 women with insomnia symptoms will be treated beginning in pregnancy and into early postpartum. CBTI and MBTI will address changes in sleep symptoms and challenges that emerge after childbirth. The investigators will collect outcome data on insomnia symptoms and related health outcomes (e.g., cognitive arousal, depression) after prenatal treatment and monthly across the first postpartum year. The investigators will determine the efficacy of the investigator's CBTI and MBTI protocols for perinatal insomnia relative to minimal intervention control. The investigators will then compare the effects of CBTI and MBTI on short- and long-term outcomes.

Eligibility criteria: Inclusion Criteria:

* (1) Gestational age at time of study enrollment must be less than or equal to 28 weeks
* (2) Insomnia Severity Index score \> 10
* (3) age 18 - 40 years
* (4) reliable and adequately fast internet connection at home, which is required to engage in telemedicine treatment (online video) and online study outcome assessments.

Exclusion Criteria:

* High risk pregnancy (e.g., pre-eclampsia, multiple pregnancy, age\>40)
* Bipolar disorder (contraindicated for CBTI)
* Seizures (contraindicated for CBTI)
* Active suicidal intent
* Shift work
* Patients who cannot reasonably engage in study activities including treatment or completing online surveys will be excluded regardless of reason. This may include inability to comprehend the English language, inability to hear therapist over video sessions, inability to understand and meaningfully answer study outcomes measures, or other barriers to participation.

Primary outcomes:
measure: Effectiveness of mindfulness based therapy for insomnia for changes in insomnia symptoms - Insomnia Severity Index (ISI)
timeFrame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Secondary outcomes:
measure: Effectiveness of mindfulness based therapy for insomnia for changes in depression symptoms- Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
measure: Effectiveness of mindfulness based therapy for insomnia for changes in cognitive arousal - Presleep Arousal Scale-Cognitive Factor
timeFrame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Medical Center
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: David Kalmbach, PhD
role: PRINCIPAL_INVESTIGATOR
References: