The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (RESTING)

The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy

This project aims to compare the effectiveness and implementation potential of two primary care friendly approaches to delivering an effective non-pharmacological intervention - cognitive behavioral therapy - for insomnia to middle aged and older adults.

All participants will receive cognitive behavioral therapy for insomnia, either through an online program or through visit with a therapist specializing in behavioral sleep medicine, and is some cases both. Participants will be randomized with equal probability to an ONLINE ONLY treatment arm or to a STEPPED CARE arm, whereby they will be assigned to on line or therapist-led treatment, based on their clinical presentation; but those assigned to this arm who start treatment with an online program and do not have sufficient response after 2 months will be switched over to a therapist-led treatment.

Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors

A two step treatment that starts with either an online or therapist led cognitive behavioral therapy for insomnia, depending on a decision algorithm. Those with insufficient progress to the online treatment after 8 weeks are switched to a therapist-led treatment

Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity

the number of minimal effective doses of a given sleep medication over 7 nights; A greater number means that a person is taking more sleep medication, with a value of 0 meaning that the person is not taking any sleep medication.

Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) - sleep related impairment questionnaire

Questionnaire measuring sleep related impairment. The range of scores is 8 to 40, with higher score representing greater perceived impairment in function related to sleep.

A validated questionnaire measuring depressive and anxiety symptom severity. The total score ranges between 0 and 12. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).

Inclusion Criteria: insomnia disorder Exclusion Criteria: Unable to be consented in English without an interpreter In poor physical or mental that limits capacity to participate in study treatment (e.g., Mini-Mental State Examination score < 25) Unable to use the internet Study physician determines participation is not medically advised for any reason

The researchers will share fully de-identified data on: the two primary outcomes, allocation to arm, and demographic.

Data will become available 2 years after the publication of the results pertaining to the primary aims. Data will be available for 2 years after its release

Data will be shared only with investigators who have a clear and rigorous analytic plan and who sign a data use agreement with Stanford University.

Manber R, Tully IA, Palaniappan L, Kim JP, Simpson N, Zulman DM, Goldhaber-Fiebert JD, Rangel E, Dietch JR, Rosas LG. RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol. Contemp Clin Trials. 2022 May;116:106749. doi: 10.1016/j.cct.2022.106749. Epub 2022 Mar 30.