The investigators have powered the study to detect a small effect size, recognizing that the effect size of s-zopiclone is larger ( 0.5) in a small short-term pilot study in PTSD but that the effect size of s-zopiclone declines over time in a well-powered study of primary insomnia, stabilizing at 12 weeks of treatment at a level that is sustained over subsequent months of treatment. Thus, this study is powered to detect significant differences between trazodone, eszopiclone, and gabapentin versus placebo. This study is designed to serve as a well-powered "screen" for efficacious medications for the treatment of PTSD-related insomnia from among the medications already widely prescribed for this purpose within VA. Other secondary outcomes include brief questionnaire secondary measures of comorbid depression (PHQ-9), anxiety (GAD-7), quality of life (WHOQOL-BREF), treatment satisfaction questionnaire for medication (TSQM-9), anger and aggression (DAR-5), smoking and alcohol consumption (Timeline Follow-Back, or TLFB), clinical global change (CGI-S), resource utilization (an abbreviated subset of the Service Utilization and Resources Form, or SURF), Columbia Suicide Severity Rating Scale (C-SSRS), optional wearable device (Actiwatch Spectrum Plus by Philips) to measure actigraphy. Other secondary outcomes that measure PTSD and sleep include the PTSD Checklist (PCL-5) and Pittsburgh Sleep Quality Index Scale-Addendum for PTSD (PSQI-A). The Clinician Administered PTSD Scale for DSM-V (CAPS-5) will be the primary secondary outcome measuring change in PTSD symptoms. The Insomnia Severity Index (ISI) is the primary outcome for this study. Study drug dose will be increased using a flexible dose titration schedule over a period of up to 3 weeks and continued for up to 12 weeks. Otherwise, the study will continue and the remaining sample size will be allocated to the remaining study arms with equal randomization probabilities. If all active treatment arms are dropped at the interim analysis, the study is stopped at that time. A mid-point interim analysis will be conducted wherein active treatment arms meeting futility early stopping criteria will be dropped. Permuted blocks randomization will be used within each participating site. Veterans who meet inclusion and exclusion criteria will be randomized within each site to receive trazodone hydrochloride, eszopiclone, gabapentin or placebo. Participants will be approximately 1224 male and female Veterans with PTSD and moderate levels of insomnia as measured on the ISI. VA Cooperative Studies Program #2016 is a double-blind four-arm adaptive clinical trial to compare the efficacy of trazodone hydrochloride, eszopiclone, and gabapentin to placebo, as adjunctive therapies in the treatment of insomnia symptoms among Veterans with military related PTSD, as measured by statistically significant difference in change from baseline in Insomnia Severity Index (ISI) total score at Week 12. Why Should I Register and Submit Results?.Thank you to the developers of this app for providing a way for people with chronic insomnia to help themselves. Lack of sleep had taken me to a very dark place. It was amazing, and I am so thankful for this VA program! I truly feel like it saved my life. I was going to sleep, staying asleep, and feeling 100% better within 2 days. After getting through the first week of logging my sleep schedule, the sleep coach made sleep and wake time recommendations. I found this app and did not have high hopes that it could help me. I was so desperate for help and sleep and feeling so terrible. I tried to get an appointment with sleep clinics, counselors, therapists, etc and all told me they weren’t taking new patients. I consulted my doctor who prescribed Trazodone which didn’t help me sleep any better and made me feel even worse the next day. Lack of sleep made me feel miserable, and I began having anxiety and panic attacks. This went on for 5 months prior to finding this app. Sometimes I would go 2-3 days without sleeping at all and rarely slept more than 6 hours per night. I suddenly began having issues staying asleep after Covid.
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |