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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05826002
• Other study ID #: 2022-07226-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 447
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Digital 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.

Locations

Country	Name	City	State
Sweden	Centre for Psychiatry Research	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinician time	Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better	Immediately after treatment (4 weeks after treatment start)
Primary	Engagement with intervention method	Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better	Up to 12 months after treatment
Primary	Engagement with intervention method	Treatment engagement questionnaire (self-rated study-specific questionnaire), score range 0-21 (0-7 per item), higher is better	Immediately after treatment (4 weeks after treatment start)
Secondary	Change in Insomnia symptoms	Insomnia Severity Index (self-rated), score range 0-28, lower is better	Change from baseline (right before treatment start) up to 12 months after treatment
Secondary	Change in Insomnia symptoms	Insomnia Severity Index (self-rated), score range 0-28, lower is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Secondary	Change in Depression symptoms	Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better	Change from baseline (right before treatment start) up to 12 months after treatment
Secondary	Change in Depression symptoms	Patient Health Questionnaire-9 (self-rated), score range 0-27, lower is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Secondary	Change in Anxiety symptoms	Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better	Change from baseline (right before treatment start) up to 12 months after treatment
Secondary	Change in Anxiety symptoms	Generalized Anxiety Disorder-7 (self-rated), score range 0-21, lower is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Secondary	Change in Life quality	Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better	Change from baseline (right before treatment start) up to 12 months after treatment
Secondary	Change in Life quality	Brunnsviken Brief Quality of life scale (self-rated), score range 0-96, higher is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Secondary	Change in Daily function	World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better	Change from baseline (right before treatment start) up to 12 months after treatment
Secondary	Change in Daily function	World Health Organization Disability Assessment Schedule (self-rated), score rang 0-100, lower is better	Change from baseline (right before treatment start) to immediately after treatment (4 weeks after treatment start)
Secondary	Treatment credibility	Credibility/Expectancy Questionnaire (self-rated), score range 0-50, higher is better	2 weeks after treatment start (mid-treatment)
Secondary	Intervention/system usability	System Usability Scale (self-rated), score range 0-100, higher is better	2 weeks after treatment start (mid-treatment)
Secondary	Treatment satisfaction	Client Satisfaction Questionnaire-8 (self-rated), score range 8-32, higher is better	Immediately after treatment (4 weeks after treatment start)