Research on Expecting Moms and Sleep Therapy

NCT02805998 | Completed Results

• 1 other identifier: 16-19537
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal is to utilize a randomized control design to examine efficacy of web-based cognitive behavior therapy (CBT-I) plus treatment as usual compared to treatment as usual alone for insomnia and depression outcomes among pregnant women with insomnia at high risk for depressive relapse/recurrence (n=208).

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index Scale Score

  Insomnia Severity Index (ISI). Scores on the ISI range from 0 to 28, with higher scores indicating more severe insomnia.

  Baseline to post-intervention (10 weeks post-randomization)

Secondary Outcomes (5)

• Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs

  Baseline to post-intervention, an average of 8 weeks

• Change in Sleep Duration, as Determined by Daily Sleep Logs

  Baseline to post-intervention, an average of 8 weeks

• Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score

  Baseline to post-intervention, an average of 8 weeks

• Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score

  Baseline to post-intervention, an average of 8 weeks

• Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator

  Baseline to post-intervention, an average of 8 weeks

Study Arms (2)

Web-based CBT-I

EXPERIMENTAL

Sleepio delivers CBT-I through 6 weekly web-sessions. Treatment content is based on CBT for insomnia manuals and includes a behavioral component (sleep restriction, stimulus control, and relaxation), a cognitive component (paradoxical intention, cognitive restructuring, mindfulness, positive imagery, putting the day to rest) and an educational component (psycho-education, sleep hygiene).

Behavioral: Web-based CBT-I; Other: Treatment as Usual

Treatment as Usual

OTHER

Our control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy. Use of non-study treatment will be tracked.

Other: Treatment as Usual

Interventions

Web-based CBT-I BEHAVIORAL

Web-based CBT-I

Treatment as Usual OTHER

Treatment as Usual; Web-based CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant up to 28 weeks gestation,
• years of age or older,
• Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia disorder as determined by the Sleep Condition Indicator (SCI) or Insomnia Severity Index (ISI) score ≥ 11
• regular access to a web-enabled computer, tablet, or smart phone.

You may not qualify if:

• Probable major depression (Edinburgh Postnatal Depression Scale (EPDS) score ≥ 15),
• self-reported bipolar disorder,
• self-reported history of psychosis,
• active suicidality defined as scoring \> 1 on EPDS item 10 or report of a specific suicide plan or recent attempt,
• shift work employee,

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94118, United States

Location

Related Publications (2)

• Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Randomized controlled trial of digital cognitive behavior therapy for prenatal insomnia symptoms: effects on postpartum insomnia and mental health. Sleep. 2022 Feb 14;45(2):zsab280. doi: 10.1093/sleep/zsab280.

  PMID: 34850238 DERIVED

• Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):484-492. doi: 10.1001/jamapsychiatry.2019.4491.

  PMID: 31968068 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Jennifer Felder
• Organization: UCSF

jennifer.felder@ucsf.edu

415-476-7014

Study Officials

• Jennifer N Felder, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 20, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-06

Locations

US (1)