No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
1,200 (estimated)
Sponsor
University of Rochester · Other
Who this trial is looking for
This trial is looking for U.S. military veterans who experience both insomnia and depression. Participants will receive treatments to see if addressing both conditions together works better than treating them separately.
Are You a Good Fit for This Trial?
You may be able to join if
I speak English
I am a U.S. military veteran
I have been diagnosed with depression
I have been diagnosed with insomnia
You may not be able to join if
I am currently pregnant
I have a history of bipolar disorder
I have a history of psychosis
I am taking anti-psychotic medications or mood stabilizers
I have current suicidal thoughts with active intent
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* English-speaking
* U.S. Military Veterans
* endorse depression (Patient Health Questionnaire-depression score \> 10)
* endorse insomnia (Insomnia Severity Index score \> 10).
Exclusion Criteria are limited in accordance with real world effectiveness trials, but will include:
…
Inclusion Criteria:
* English-speaking
* U.S. Military Veterans
* endorse depression (Patient Health Questionnaire-depression score \> 10)
* endorse insomnia (Insomnia Severity Index score \> 10).
Exclusion Criteria are limited in accordance with real world effectiveness trials, but will include:
* pregnancy
* history of bipolar disorder
* history of psychosis
* current use of anti-psychotic medications or mood stabilizers (e.g., lithium)
* current suicidal ideation with active intent
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