An open evaluation trial of the iSleepWell digital health program for insomnia and stress-related symptoms.

• Register: ANZCTR
• Last refreshed on: 9 August 2022
• Main ID: ACTRN12617000575336
• Date of registration: 24/04/2017
• Prospective Registration: Yes
• Primary sponsor: Federation University
• Public title: An open evaluation trial of the iSleepWell digital health program for insomnia and stress-related symptoms.
• Scientific title: An open evaluation trial of the iSleepWell digital health program, offered through My Digital Health, for reducing insomnia, and related stress, anxiety and depression, in adults with insomnia symptoms.
• Date of first enrolment: 23/07/2017
• Target sample size: 70
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12617000575336.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia, Canada, New Zealand, United Kingdom, United States of America

Contacts

• Name: Prof Britt Klein

• Name: Prof Britt Klein

Key inclusion & exclusion criteria

Inclusion criteria: Participants must be 18 years or older and concerned about their sleep.

iSleepWell has been written for people with insomnia symptoms and therefore recruitment will focus on people with insomnia. However, people who have very minimal symptoms are able to register if they wish too. The program is also preventative in nature and therefore people with occasional sleeping difficulties may also benefit from the program
Exclusion criteria: No internet access, does not create a My Digital Health account (requires the provision of a valid email address), does not provide consent to study conditions.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Depression

Mental Health - Other mental health disorders

Mental Health - Anxiety

Insomnia;Stress;Anxiety;Depressive symptoms;
Insomnia
Stress
Anxiety
Depressive symptoms

Intervention(s)

A cognitive behavioural and biopsychosocially-based digital health program for decreasing symptoms of insomnia symptoms, as well as stress, depressive and anxiety symptoms (called iSleepWell), will be evaluated using a quasi-experimental trial design.

iSleepWell is a self-help digital health program designed to provide people with information and strategies to address their insomnia symptoms primarily, as well as stress, anxiety and depressive symptoms. iSleepWell contains five ‘core’ modules, plus an Introduction module, delivered over 7 weeks.

The five core iSleepWell digital health modules are:

1. Increasing Biological Flexibility: Discusses the effects of stress on sleep, sleep and the brain, and how to increase biological flexibility (e.g., stress reduction and relaxation techniques).
2. Increasing Sleep Flexibility: Looks at the techniques that can assist in improving sleep (stimulus control, sleep hygiene and sleep restriction).
3. Increasing Thinking Flexibility: Looks at how thinking can influence sleep and the techniques to improve thinking (e.g., identifying and challenging unhelpful thoughts, managing worry and rumination).
4. Increasing Wellness Flexibility: Looks at positive affect and strategies to increase wellness (e.g., self soothing, loving kindness, social connectedness).
5. Staying On Track: Looks back over the program, progress reflection and relapse prevention activities.

Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 30 minutes of offline activities each week. Offline activities involve applying the techniques discussed in each module such as self-monitoring sleep, applying the stimulus control and sleep hygiene rules,

Primary Outcome(s)

Insomnia symptoms using the ISI[Pre intervention (Week 0), during intervention (Week 2, 4, 6), post intervention (Week 8) and at the 1 (Week 12) and 3 month (Week 20) follow-up assessment.]

Secondary Outcome(s)

Mental Health Rating question - 6 point scale (self developed)[Pre, post and 1 and 3 month follow up]

Optimism using the LOT-R[Pre intervention, post and 1 and 3 month follow-up]

Chronic physical illness diagnosis questions (self developed)[Pre intervention]

Depressive symptoms using the PHQ9[Pre intervention, during intervention, post intervention and at the 1 and 3 month follow-up assessment.]

Anxiety subtype questions (self developed)[Pre, post and 1 and 3 month follow up]

Emotional regulation using the DERS[Pre intervention, post and 1 and 3 month follow-up]

Personality traits using the TIPI[Pre intervention]

Quality of Life Rating question - 6 point scale (self developed)[Pre, post and 1 and 3 month follow up]

Time perception using the TDT (Time Dilation Test - self-developed)[Pre-intervention, post and 1 and 3 month follow-up]

Anxiety symptoms using the GAD7[Pre intervention, during intervention, post intervention and at the 1 and 3 month follow-up assessment.]

Mental health condition diagnosis questions (self developed)[Pre intervention]

Use of services for a physical health condition questions (self developed) [Pre, post and 1 and 3 month follow up]

Physical Health Rating question - 6 point scale (self developed)[Pre, post and 1 and 3 month follow up]

Physical activity levels using single item questions (self developed)[Pre-intervention, post and 1 and 3 month follow-up]

Affective style using the ASQ[Pre-intervention, post and 1 and 3 month follow-up]

Current use of prescribed medication(s) question (self-developed)[Pre, post and 1 and 3 month follow up]

Mental wellness using the MHC-SF[Pre intervention, post and 1 and 3 month follow-up]

Treatment satisfaction, including engagement, will be measured using the TSQ[Post intervention]

Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated[Pre, post and 1 and 3 month follow up]

Use of mental health services questions (self developed)[Pre, post and 1 and 3 month follow up]

Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.[Pre, post and 1 and 3 month follow up]

Psychological distress symptoms using the K10[Pre intervention, post intervention and at the 1 and 3 month follow-up assessment.]

Quality of life using the EQ-5D[Pre-intervention, post and 1 and 3 month follow-up]

Social Connectedness Rating question using a 5 point scale (self developed)[Pre, post and 1 and 3 month follow up]

Treatment credibility using the TCS[Pre intervention]

Secondary ID(s)

None

Source(s) of Monetary Support

Federation University

Ethics review

Status: Approved
Approval date: 27/07/2016
Contact:

Federation University Higher Research Ethics Committee

Results

• Results available: Yes
• Date Completed: 12/06/2021