Depression, Insomnia
Conditions
Brief summary
The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are: 1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression? 2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement? 3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity? Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.
Interventions
DEVICEDigital CBT-I
The digital CBT-I program is called Sleepio (Big Health, Ltd). Digital CBT-I will be delivered by an animated therapist in six weekly sessions that are approximately 10-20 minutes each. Sessions can be accessed via website or app at a time that is convenient for the participant. Session content is based on standard, in-person CBT-I protocols, and includes sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene education. The program is interactive, automated, and tailored to participant progress. Additionally, participants will receive supplemental CBT-I content tailored for prenatal and postpartum insomnia.
DEVICEDigital SHE
The digital SHE program was created by Big Health, Ltd and has a total of six sessions. The content for SHE includes education about sleep stages, sleep architecture, sleep cycles; education about importance of sleep for performance, mood, and health; recommendations for developing healthy sleep habits; recommendations for lifestyle factors that impact sleep; recommendations for creating a sleep-friendly bedroom.
Sponsors
University of California, San Francisco
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant 14-28 weeks gestation * 18 years or older * Daily access to a web-enabled computer, smart phone, or tablet * Current elevated insomnia symptom severity and insomnia disorder * English speaking
Exclusion criteria
* Current major depression * Taking or planning to take antidepressant medication (ADM) * Other diagnosed or suspected sleep disorder * Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest) * Night shift worker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID) | Baseline to 12 months postpartum | This is a binary outcome that measures whether a participant experienced a depressive episode at any point since randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Edinburgh Postnatal Depression Scale (EPDS) | Baseline to 12 months postpartum | The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity. |
| Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Patient Health Questionnaire-9 (PHQ-9) | Baseline to 12 months postpartum | The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity. |
| Change in suicidal ideation severity, as rated by the C-SSRS | Baseline to 12 months postpartum | The Columbia Suicide Severity Rating Scale suicidal ideation score ranges from 1-5, with greater scores indicating more severe ideation, based on the following categories: 1. \- Wish to be Dead 2. \- Non-specific Active Suicidal Thoughts 3. \- Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act 4. \- Active Suicidal Ideation with Some Intent to Act, without Specific Plan 5. \- Active Suicidal Ideation with Specific Plan and Intent |
| Change in anxiety symptom severity, as assessed by the GAD-7 | Baseline to 12 months postpartum | The Generalized Anxiety Disorder-7 score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity. |
| Change in prenatal insomnia symptom severity as a mediator of the effect of digital CBT-I on perinatal depression, as assessed by the ISI | Baseline to 10 weeks post-randomization (mediator) | The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity. |
| Baseline depressive symptom severity as a moderator, as assessed by the EPDS | Baseline | The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity. |
| Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9 | Baseline | The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer N Felder, PhD
University of California, San Francisco
Outcome results
None listed