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2/2-Sequenced Therapies for Comorbid and Primary Insomnias

Award Number: R01MH091053
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/07/2011
PERIOD OF PERFORMANCE END DATE: 02/28/2016

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2/2-Sequenced Therapies for Comorbid and Primary Insomnias - DESCRIPTION (provided by applicant): Chronic insomnia is a prevalent disorder associated with increased health care costs, impaired functioning, and an increased risk for developing serious psychiatric disorders. Cognitive Behavioral Therapy (CBT) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported approaches for insomnia management. Unfortunately, few studies have compared CBT and BzRA medications for insomnia treatment. Previous insomnia treatment studies also have been limited by small, highly screened study samples, fixed- dose and fixed-agent pharmacotherapy strategies that do not represent usual adjustable dosing practices, relatively short follow-up intervals, and reliance on self-reported or polysomnographically (PSG) assessed sleep parameters as outcomes, rather than on insomnia remission indicators that are more relevant to clinical practice. Finally, studies have yet to test the benefits of various treatment-sequencing strategies for those who do not respond to initial their insomnia therapies. This dual-site project will address these limitations. The two study sites will enroll a total of 320 participants who meet broad criteria for chronic insomnia disorder. Participants will be evaluated with clinical assessments and PSG, then randomly assigned to first-stage therapy with CBT or zolpidem (most widely-prescribed BzRA). Centrally trained therapists will administer CBT and zolpidem according to manualized, albeit flexible, treatment algorithms. Initial outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those who fail to achieve insomnia remission with first-line therapy will be encouraged to accept random assignment to a second, 6-week, medication (zolpidem or trazodone) or behavioral (standard or tailored CBT) treatment. All participants will be re-evaluated 12 weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing their final treatment. Insomnia remission, defined categorically as a score < 8 on the Insomnia Severity Index, will serve as the primary outcome for treatment comparisons. Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Study Aims include: (1) comparing the efficacy of CBT and Zolpidem for producing sustained insomnia remission when used as first line therapies; (2) comparing the efficacy of treatment switching and augmentation strategies for those who fail to remit with first line treatments; (3) comparing the responses of those with and without psychiatric comorbities to first and second line treatments; and (4) exploring the usefulness of selected biomarkers and trait measures as predictors of treatment outcomes. Our over-arching goal is to obtain new information that contributes to the development of clinical guidelines for PI and CMI management.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2015 ( Subtotal = $167,382 )
2015	2015	LAVAL UNIVERSITY	**	QUEBEC, QUEBEC				CAN	Mental Health Research Grants	000	5	2/28/2015	NON-COMPETING CONTINUATION	$167,382
														Subtotal = $167,382

Issue Date FY: 2014 ( Subtotal = $176,159 )
2014	2014	LAVAL UNIVERSITY	**	QUEBEC, QUEBEC				CAN	Mental Health Research Grants	000	4	3/6/2014	NON-COMPETING CONTINUATION	$176,159
														Subtotal = $176,159

Issue Date FY: 2013 ( Subtotal = $173,031 )
2013	2013	LAVAL UNIVERSITY	2705 Boul Laurler, room T -1-49	QUEBEC, QUEBEC				CAN	Mental Health Research Grants	000	3	2/20/2013	EXTENSION WITH OR WITHOUT FUNDS	$162,217
2013	2013	LAVAL UNIVERSITY	2705 Boul Laurler, room T -1-49	QUEBEC, QUEBEC				CAN	Mental Health Research Grants	001	3	5/15/2013	EXTENSION WITH OR WITHOUT FUNDS	$10,814
														Subtotal = $173,031

Issue Date FY: 2012 ( Subtotal = $181,376 )
2012	2012	LAVAL UNIVERSITY	2705 Boul Laurler, room T -1-49	QUEBEC, QUEBEC				CAN	Mental Health Research Grants	000	2	3/1/2012	NON-COMPETING CONTINUATION	$181,376
														Subtotal = $181,376

Issue Date FY: 2011 ( Subtotal = $183,694 )
2011	2011	LAVAL UNIVERSITY	2705 Boul Laurler, room T -1-49	QUEBEC, QUEBEC				CAN	Mental Health Research Grants	000	1	6/7/2011	NEW	$183,694
														Subtotal = $183,694

Grand Total All Awards = $881,642

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2/2-Sequenced Therapies for Comorbid and Primary Insomnias

Award Number: R01MH091053

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/07/2011

PERIOD OF PERFORMANCE END DATE: 02/28/2016

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