Optimization of a Digital Self-guided Psychological Intervention for Insomnia: A Randomized Factorial Experiment

Karolinska Institute

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Digital self-guided psychological intervention for insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT05826002

2022-07226-01

Details and patient eligibility

About

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.

Enrollment: 447 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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447 participants in 8 patient groups

Digital insomnia intervention

Active Comparator group

Description:

This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (no).

Treatment:

Behavioral: Digital self-guided psychological intervention for insomnia

Digital insomnia intervention + optimized user interface

Active Comparator group

Description:

This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (no).

Treatment:

Behavioral: Digital self-guided psychological intervention for insomnia

Digital insomnia intervention + adaptive treatment strategy

Active Comparator group

Description:

This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (no).

Treatment:

Behavioral: Digital self-guided psychological intervention for insomnia

Digital insomnia intervention + optimized user interface, adaptive treatment strategy

Active Comparator group

Description:

This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (no).

Treatment:

Behavioral: Digital self-guided psychological intervention for insomnia

Digital insomnia intervention + daily prompts

Active Comparator group

Description:

This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (no), daily prompts (yes).

Treatment:

Behavioral: Digital self-guided psychological intervention for insomnia

Digital insomnia intervention + optimized user interface, daily prompts

Active Comparator group

Description:

This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (no), daily prompts (yes).

Treatment:

Behavioral: Digital self-guided psychological intervention for insomnia

Digital insomnia intervention + adaptive treatment strategy, daily prompts

Active Comparator group

Description:

This group receives the following combination of treatment features: optimized graphical user interface (no), adaptive treatment strategy (yes), daily prompts (yes).

Treatment:

Behavioral: Digital self-guided psychological intervention for insomnia

Digital insomnia intervention + optimized user interface, adaptive treatment strategy, daily prompts

Active Comparator group

Description:

This group receives the following combination of treatment features: optimized graphical user interface (yes), adaptive treatment strategy (yes), daily prompts (yes).

Treatment:

Behavioral: Digital self-guided psychological intervention for insomnia