Clinical trial NCT05826002: Optimization of a Digital Self-guided Psychological Intervention for Insomnia: A Randomized Factorial Experiment
Official title: Optimization of a Digital Self-guided Psychological Intervention for Insomnia: A Randomized Factorial Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
ICBT
Factorial Experiment
Optimization
User Interface
Adaptive Treatment Strategy
Prompts
Digital Intervention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2023-04-24
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Engagement with intervention method
timeFrame: Up to 12 months after treatment
measure: Engagement with intervention method
timeFrame: Immediately after treatment (4 weeks after treatment start)
Secondary outcomes:
measure: Change in Insomnia symptoms
timeFrame: Change from baseline (right before treatment start) up to 12 months after treatment
measure: Change in Insomnia symptoms
timeFrame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
measure: Change in Depression symptoms
timeFrame: Change from baseline (right before treatment start) up to 12 months after treatment
measure: Change in Depression symptoms
timeFrame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
measure: Change in Anxiety symptoms
timeFrame: Change from baseline (right before treatment start) up to 12 months after treatment
measure: Change in Anxiety symptoms
timeFrame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
measure: Change in Life quality
timeFrame: Change from baseline (right before treatment start) up to 12 months after treatment
measure: Change in Life quality
timeFrame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
measure: Change in Daily function
timeFrame: Change from baseline (right before treatment start) up to 12 months after treatment
measure: Change in Daily function
timeFrame: Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
measure: Treatment credibility
timeFrame: 2 weeks after treatment start (mid-treatment)
measure: Intervention/system usability
timeFrame: 2 weeks after treatment start (mid-treatment)
measure: Treatment satisfaction
timeFrame: Immediately after treatment (4 weeks after treatment start)
Other outcomes:
measure: Clinician time
timeFrame: Immediately after treatment (4 weeks after treatment start)
Locations:
city: Stockholm
country: Sweden
facility: Centre for Psychiatry Research
Study officials:
References: