Digital CBT for Insomnia and Depression

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT05456607
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy for Insomnia — BEHAVIORAL
    Cognitive Behavioral Therapy for Insomnia consists of the standard features of this well-established insomnia treatment that will be delivered in this study via a mobile optimized web app. Participants also have access to an intervention coach/guide as needed.
  • Cognitive Behavioral Therapy for Depression — BEHAVIORAL
    Cognitive Behavioral Therapy for Depression consists of the standard features of this well-established depression treatment that will be delivered in this study via a mobile optimized web app. Participants also have access to an intervention coach/guide as needed.
  • Mood Monitoring — BEHAVIORAL
    The mood monitoring intervention is based on mood tracking principles in broader mood management interventions, but without any psychoeducational content or cognitive-behavioral exercises. Instead, participants will get access to a mobile optimized web app that allows users to enter their mood, tag related events, and view trends over time to raise awareness of how activities influence certain mood states.

Study Details

This study has two primary objectives, each of which addresses critical clinical and research gaps for individuals who have co-occurring insomnia and depression. The first objective is to address whether sequential treatment of insomnia and depression is superior to a single treatment for either depression or for insomnia, and if so, which treatment sequence is optimal. The second objective is to determine if there are heterogeneity of treatment effects; that is, variation in which interventions are best for which individuals, and if so, to develop and individualized intervention rule to better match individuals with the treatment that is most likely to lead to the best outcomes. A large randomized trial will be conducted to meet these objectives.

Key Dates

Start date
May 1, 2023
Status verified
Jun 2025
Primary completion
Mar 31, 2027
Completion
Sep 18, 2027

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Online Mood Monitoring for 12 weeks
  • Experimental: Single Insomnia Treatment
    Cognitive-behavioral therapy for insomnia delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.
  • Experimental: Single Depression Treatment
    Cognitive-behavioral therapy for depression delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.
  • Experimental: Sequenced Depression and Insomnia Treatment
    Cognitive-behavioral therapy for depression followed by cognitive-behavioral therapy for insomnia each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the depression treatment only for 4 weeks after which the access to the insomnia treatment is also made available. Total duration of access for 12 weeks.
  • Experimental: Sequenced Insomnia and Depression Treatment
    Cognitive-behavioral therapy for insomnia followed by cognitive-behavioral therapy for depression each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the insomnia treatment only for 4 weeks after which the access to the depression treatment is also made available. Total duration of access for 12 weeks.

Primary Outcome Measure

Dual Remission of Depression and Insomnia [ Time Frame: 3 Months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Sleep Research LaboratoryRochesterNew York14642
Wilfred Pigeon, Ph.D.
[email protected]
585-275-2900

Find similar trials in Rochester, NY

By condition
DepressionInsomnia
By specialty
PsychiatryMental healthBehavioral healthSleep medicine
By research site
University of Rochester Sleep Research Laboratory· Rochester, NY

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