Digital CBT for Insomnia and Depression

Summary

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.

Conditions

• Depression
• Insomnia

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Depression

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.

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

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.

BEHAVIORAL

Mood Monitoring

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• University of South Florida

  collaborator OTHER

• Harvard University

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• University of Rochester

  lead OTHER

Principal Investigators

• Wilfred Pigeon, PhD · University of Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-01

Primary Completion

2027-03-31

Completion

2027-09-18

Countries

• United States

Study Locations