None listed
Conditions
Brief summary
The present study will examine whether open-label placebos (OLP) can enhance an existing online treatment for insomnia. OLP involves administering a placebo treatment with full disclosure that the treatment is, in fact, a placebo. The absence of deception in OLP may enable patients to receive the benefits of placebos without violating informed consent. Our primary hypothesis is that participants who receive the OLP augmented treatment (SHUTi+OLP) will show greater improvements in subjective sleep parameters, sleep quality and self-reported insomnia symptoms, compared with standard treatment groups. Furthermore, it is also hypothesised that the SHUTi+OLP group will show greater adherence to digital internet treatment compared with the SHUT-i only group.
Interventions
There will be one face-to-face session (1 x 30 minutes) for all participants with the researcher. In this session, participants will be randomly assigned to one of three treatment groups;
Arm 1:
The first group will be given access to the SHUTi (Sleep Healthy Using the Internet) online treatment program. SHUT-i is an interactive and tailored web-based program that requires participants to complete a weekly 25-40 minute module for six weeks. These modules include 1) Psychoeducation, 2) sleep re
There will be one face-to-face session (1 x 30 minutes) for all participants with the researcher. In this session, participants will be randomly assigned to one of three treatment groups; Arm 1: The first group will be given access to the SHUTi (Sleep Healthy Using the Internet) online treatment program. SHUT-i is an interactive and tailored web-based program that requires participants to complete a weekly 25-40 minute module for six weeks. These modules include 1) Psychoeducation, 2) sleep restriction, 3) stimulus control, 4) cognitive restructuring, 5) sleep hygiene and 6) relapse prevention. These modules are based on the well-established face-to-face cognitive behavioural therapy for insomnia (CBT-i). Adherence will be monitored by website analytics and module completion data. Participants in this group will also receive a 20mL plastic bottle labelled ‘Placebos’ containing 84 placebo tablets, with instructions to take two tablets every night before sleep. A placebo tablet is an inert or inactive tablet that does not contain any active drug ingredient. The placebo tablets are composed of microcrystalline cellulose which is an inert substance. Adherence will be measured by asking participants how many tablets they have left at the end of their intervention period. Arm 2: The second group will be given access to the SHUTi (Sleep Healthy Using the Internet) online treatment program only. SHUT-i is an interactive and tailored web-based program that requires participants to complete a weekly 25-40 minute module for six weeks. These modules include 1) Psychoeducation, 2) sleep restriction, 3) stimulus control, 4) cognitive restructuring, 5) sleep hygiene and 6) relapse prevention. These modules are based on the well-established face-to-face cognitive behavioural therapy for insomnia (CBT-i). Adherence will be monitored by website analytics and module completion data.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria To participate, individuals must: 1.Reported Insomnia Severity Index (ISI) score of >7. 2.Have ability to read/speak English. 3.Be 18 years and older. 4.Have Internet access, computer access and an active email address.
Exclusion criteria
Exclusion Criteria Participants will be excluded from the study if they: 1.Have irregular sleep schedules that prevent the ability to follow intervention recommendations including night shift work, bedtimes outside of 8pm-2am or awakenings outside of 4am-10am. 2.Have uncontrolled or certain medical conditions deemed to interfere with the study procedures or put the participant at undue risk. 3.Are pregnant. 4.Have current psychological treatment for insomnia. 5.Are currently taking medications that interfere with sleep e.g. Steroids, Dexedrine, Ritalin, Adderall, and Provigil.
Outcome results
None listed