None listed
Conditions
Brief summary
The primary purpose of this trial is to compare the efficacy of an internet program for insomnia to an internet program for anxiety in individuals with comorbid anxiety and insomnia. . Insomnia frequently co-occurs with anxiety and mood disorders, and gives rise to more complications and greater burden than any disorder alone. Internet cognitive behavioural therapy (iCBT) for insomnia has been found to be more effective than iCBT for depression in reducing insomnia symptoms, and equally effective in reducing depression symptoms. This suggests that in the case of comorbid insomnia and depression, it may be particularly valuable to target the insomnia symptoms, at least in the first instance. To the best of our knowledge, this same question has not been examined in the case of comorbid insomnia and anxiety. Thus the aim of the current study is to compare the efficacy of our online iCBT insomnia course to our online iCBT course for anxiety in a sample of individuals with comorbid insomnia and anxiety. Study details All participants enrolled in this study will be randomly allocated (by chance) to either a cognitive behavioural program for insomnia or anxiety. For the internet-based cognitive behavioural program for insomnia, there are four lessons to complete over up to 8 weeks. It includes psycho-education about insomnia and how it is maintained, as well as specific strategies to manage insomnia and change unhelpful behaviours and thinking patterns which maintain poor sleep. For the internet-based cognitive behavioural program for anxiety, there are four lessons to complete over up to 8 weeks. It includes psycho-education about anxiety and how it is maintained, as well as specific strategies to manage anxiety and change unhelpful behaviours and thinking patterns which maintain anxiety. Participants will complete a number of questionnaires to assess their insomnia, anxiety, depression and sleep difficulties among other psychological factors, at the beginning of the program, mid-way through, at the end of the program, and 3 months after finishing the program. Participants will undergo a diagnostic telephone interview prior to treatment. Participants will also be asked to complete a sleep diary before and after the program. It is hoped that the findings of this trial will provide information regarding the relative efficacy of internet interventions for insomnia and anxiety in reducing these symptoms in a comorbid sample.
Interventions
Eligible participants that apply for the study will be randomised in equal proportions to one of two active treatment groups:
1. Internet cognitive behavioural therapy for insomnia (iCBT-I)
2. Internet cognitive behavioural therapy for anxiety (iCBT-A)
iCBT-I
Group 1 will receive the online insomnia CBT program (iCBT-I), which is a 4-lesson program that includes psycho-education about insomnia and how it is maintained, as well as specific strategies to manage insomnia (e.g., changing unhelpful
Eligible participants that apply for the study will be randomised in equal proportions to one of two active treatment groups: 1. Internet cognitive behavioural therapy for insomnia (iCBT-I) 2. Internet cognitive behavioural therapy for anxiety (iCBT-A) iCBT-I Group 1 will receive the online insomnia CBT program (iCBT-I), which is a 4-lesson program that includes psycho-education about insomnia and how it is maintained, as well as specific strategies to manage insomnia (e.g., changing unhelpful behaviours, managing worries about sleep and catastrophic thinking about the consequences of poor sleep, and monitoring sleep schedules). The program comprises online lessons/modules, supplemented with homework activities to complete between lessons to consolidate the key skills taught in the program. In addition, this program includes a sleep diary for participants to keep track of their sleep schedules and monitor progress throughout the program. iCBT-A Group 2 will receive the online anxiety CBT program (iCBT-A), which is a 4-lesson program including psycho-education about anxiety and how it is maintained, and specific anxiety management strategies including relaxation (controlled breathing), cognitive therapy techniques to challenge worries and catastrophic thinking styles, and graded exposure to overcome behavioural avoidance and safety behaviours that maintain anxiety. Similar to the insomnia program. The program comprises online lessons/modules, supplemented with homework activities to complete between lessons to consolidate the key skills taught in the program. The groups will be matched on the length, style, and format, but the key differences will be the content of the program, and targeted symptoms (i.e., insomnia or anxiety). Both groups will have access to the 4 online lessons for up to 8 weeks, and will be encouraged to complete one lesson every 5-10 days. Each lesson is estimated to take 3-4 hours, including lesson slides and homework activities over the week. Homework activities build on the skills taught in the lesson slides, including stimulus control exercises, creating a wind down routine, and relaxation (for the iCBT-I group) and thought challenging, problem solving, and exposure step ladders (for the iCBT-A group). Adherence to the program is assessed by how many lessons a participant completes, where a lesson is marked as complete when the homework activities for that lesson are downloaded.
Sponsors
St Vincent's Hospital, Sydney
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
Individuals aged over 18 years old with online questionnaire scores indicating a clinical level of anxiety on the GAD-7 (> 9) and insomnia on the ISI (> 14). Participants must be prepared to provide their own name, phone number and address, and details of their general practitioner (GP). Participants are also required to have English language skills equivalent to a School Certificate level, access to a phone and computer with a printer, and must provide electronic informed consent.
Exclusion criteria
Mental health exclusion criteria will include self-reported diagnosis of psychosis, bipolar disorder, substance abuse or dependence, current PTSD, severe depression (PHQ-9 >23), current suicidality, and/or a PHQ-9 Item 9 score above 1, and/or BDI Item 9 score above 1. Additional exclusion criteria will include presence of untreated sleep disorder other than insomnia, engagement in shift work/presence of commitments that interfere with regular night-time sleep patterns, bed times outside of 8pm-2am more than twice a week not primarily due to insomnia, previous participation in a This Way Up course for insomnia or anxiety, and changes in/initiation of psychological or pharmacological treatment in the previous 2 months to application. Participants who do not complete 7 sleep diaries within a 10-day period will not be eligible to participate.
Outcome results
None listed