Digital CBT for Insomnia and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English-speaking
U.S. Military Veterans
endorse depression (Patient Health Questionnaire-depression score > 10)
endorse insomnia (Insomnia Severity Index score > 10).
Disqualifiers
pregnancy
history of bipolar disorder
history of psychosis
current use of anti-psychotic medications or mood stabilizers (e.g., lithium)
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Insomnia
BehavioralCognitive 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
BehavioralCognitive 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
BehavioralThe 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.
Treatment groups
1,200 Participants
are divided into 5 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: Single Insomnia TreatmentExperimental treatment 1 intervention
Group C: Single Depression TreatmentExperimental treatment 1 intervention
Group D: Sequenced Depression and Insomnia TreatmentExperimental treatment 2 interventions
Group E: Sequenced Insomnia and Depression TreatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dual Remission of Depression and Insomnia
The proportion of participants achieving dual remission in each study arm with Depression Remission defined as a total score of \< 5 on the Patient Health Questionnaire (PHQ-9) and Insomnia Remission defined as a total score of \< 8 on the Insomnia Severity Index (ISI).
Time frame
3 Months post-treatmentSecondary outcomes
1
Depression Response
The proportion of participants achieving a Depression treatment response defined as a ≥ 5 point reduction in the total PHQ-9 score
Time frame
3 Months post treatment2
Insomnia Response
The proportion of participants achieving an Insomnia treatment response defined as a ≥ 8 point reduction in the total ISI score
Time frame
3 Months post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
United States Department of Defense
Collaborator
University of South Florida
Collaborator
Harvard University
Collaborator
University of California, Irvine
Collaborator
Source ClinicalTrials.gov