Insomnia
Conditions
Keywords
Insomnia, ICBT, Factorial Experiment, Optimization, User Interface, Adaptive Treatment Strategy, Prompts, Digital Intervention
Brief summary
In a previous pilot study, a digital self-guided intervention for insomnia showed preliminary positive effects on insomnia symptoms. In order to optimize the digital self-guided format, this study will evaluate the added value of three treatment features on treatment engagement and insomnia symptoms. The participants will be adults with insomnia. The trial will be a 2x2x2 randomized factorial experiment, where the following features/factors will be manipulated: an optimized graphical user interface (yes or no), an adaptive treatment strategy (yes or no), and daily prompts to use the intervention (yes or no). The factorial experiment will create 8 equally large groups (1:1:1:1:1:1:1:1), who will receive the different combinations of features. The main outcome will be the effect on treatment engagement.
Interventions
BEHAVIORALDigital self-guided psychological intervention for insomnia
A four week digital self-guided intervention for insomnia, with content derived from Cognitive Behavioral Therapy for insomnia, and with a clinical interview before and after the intervention.
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to what condition they are randomized to, and will not receive information concerning what features are being manipulated in the experiment.
Intervention model description
A 2x2x2 randomized factorial experiment, where adult participants with insomnia get to use a digital self-guided intervention for insomnia. Three factors/treatment features will be manipulated in the experiment, namely: 1) an optimized graphical user interface (yes or no), 2) an adaptive treatment strategy (yes or no), and 3) daily prompts to use the intervention (yes or no). The factorial experiment will create 8 equally large groups (1:1:1:1:1:1:1:1), who will receive the different combinations of features.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age. 2. ≥ 15 points on Insomnia Severity Index. 3. Insomnia diagnosis, according to criteria in the Diagnostic and Statistical Manual of mental disorders-5 (somatic/psychiatric comorbidity is allowed). 4. Good understanding of the Swedish language. 5. No practical obstacles to participate in treatment and assessments. 6. Daily access to computer/smart-phone/tablet with Internet access. 7. Can receive phone calls and text messages during the study period.
Exclusion criteria
1. Sleep diseases, such as narcolepsy or sleep apnea. 2. Somatic or psychiatric illnesses that either are directly contraindicated for the treatment, require other treatment, or entail symptoms/a functional level making it too difficult to participate in the study. 3. Alcohol/drug abuse, or medication with side effects on sleep (however, sleep medication is allowed). 4. Working nights or night shifts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement with intervention method | Up to 12 months after treatment | Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia symptoms | Change from baseline (right before treatment start) up to 12 months after treatment | Insomnia Severity Index (self-rated), score range 0-28, lower is better |
| Change in Depression symptoms | Change from baseline (right before treatment start) up to 12 months after treatment | Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better |
| Change in Anxiety symptoms | Change from baseline (right before treatment start) up to 12 months after treatment | Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better |
| Change in Life quality | Change from baseline (right before treatment start) up to 12 months after treatment | Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better |
| Treatment credibility | 2 weeks after treatment start (mid-treatment) | Credibility/Expectancy Questionnaire (self-rated), score range 0-50, higher is better |
| Intervention/system usability | 2 weeks after treatment start (mid-treatment) | System Usability Scale (self-rated), score range 0-100, higher is better |
| Treatment satisfaction | Immediately after treatment (4 weeks after treatment start) | Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better |
| Change in Daily function | Change from baseline (right before treatment start) up to 12 months after treatment | World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinician time | Immediately after treatment (4 weeks after treatment start) | Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better |
Countries
Sweden
Outcome results
None listed