A Randomized Controlled Trial to Examine the Feasibility and Preliminary Efficacy of a Digital Mindfulness-Based Therapy for Improving Insomnia Symptoms.

"Declarations Ethics ApprovalEthics approval was obtained from Monash University Human Research Ethics Committee (project ID: 18774). Informed ConsentWritten informed consent was obtained from all participants prior to undertaking the study. Conflict of Interest The research was supported by A Mindful Way Training, who provided access to the program for research participants. The authors have no other conflicts of interest to declare.Research performed at Monash University, Melbourne, Australia. Conflict of Interest The research was supported by A Mindful Way Training, who provided access to the program for research participants. The authors have no other conflicts of interest to declare. Research performed at Monash University, Melbourne, Australia."

"Declarations: Ethics ApprovalEthics approval was obtained from Monash University Human Research Ethics Committee (project ID: 18774).: Informed ConsentWritten informed consent was obtained from all participants prior to undertaking the study.: Conflict of Interest The research was supported by A Mindful Way Training, who provided access to the program for research participants. The authors have no other conflicts of interest to declare.Research performed at Monash University, Melbourne, Australia. Conflict of Interest : The research was supported by A Mindful Way Training, who provided access to the program for research participants. The authors have no other conflicts of interest to declare.: Research performed at Monash University, Melbourne, Australia."

"This study was a randomized waitlist control trial of an online MBTI intervention compared to a waitlist control condition with a 1:1 allocation ratio, utilizing a two (group) by three (time) repeated measures design. Ethics approval was obtained from Monash University Human Research Ethics Committee prior to the study. The study was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12620000398909). Eligibility was determined by screening questionnaires, including the STOP-BANG and ISI during a subsequent telephone interview, and written informed consent was obtained from all participants. All participants completed the ISI, PSAS, and PANAS at baseline via Qualtrics. Participants were then randomly allocated to either the intervention or waitlist groups, via random number generation using block randomization. Participants were not blinded to group allocation. The intervention group accessed the program online via a link, and asked to complete one module of the program per week, for 6 weeks. Waitlist participants were asked to not commence any insomnia treatment during the study and were given free access to the program post-study. Participants were also asked to refrain from completing any other treatment during the study. Participants were provided a link to the Qualtrics survey to complete at the end of module three/week 3 (mid) and at the end of the study (week 6; post). The KIMS was delivered at the end of treatment. Recruitment commenced in April 2019, and data was collected from May 2019 and June 2020. Participants in the intervention group completed an exit interview at the conclusion of the study, and program usage data was obtained from A Mindful Way. Participants received a $A50 gift voucher upon completion. Conclusions: This study provides preliminary evidence of the feasibility and efficacy of a digital MBTI, which may assist in the broader dissemination of insomnia treatment.: Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12620000398909"