Smartphone-delivered CBT-I

Smartphone-delivered CBT for Insomnia, a Randomised Controlled Trial

The overall purpose with this investigation was to increase access to cognitive behavioural therapy for insomnia (CBT-I) by examining CBT-I delivered through a smartphone application

The first aim that will be addressed is to explore the efficacy of the smartphone delivered CBT-I on overall insomnia and on nighttime symptoms by comparing CBT-I to a waitlist control in a randomised controlled trial.

The second aim is to investigate the effect smartphone delivered CBT-I compared to the waitlist on secondary outcomes related to insomnia, such as stress, anxiety, depression, quality of life and functional impairment.

The third aim that will be addressed is to examine what patient characteristics that CBT delivered to a smartphone depend on to be effective with a treatment-moderator strategy. To investigate moderators, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, somatic/psychiatric co-morbidity, and proposed behavioral mediators of sleep restriction and stimulus control will also be employed as moderators.

The fourth aim that will be addressed is to examine behavioural processes of sleep restriction and stimulus control as potential mediators of treatment outcome.

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholms Län
    • Stockholm, Stockholms Län, Sweden
      • Karolinska Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of insomnia more than three nights per week and for more than three months.
• Insomnia despite adequate opportunity to sleep.
• Insomnia severity typical for insomnia disorder, i.e. 11 points or more on the Insomnia Severity Index (ISI).
• Nighttime insomnia symptoms, i.e., two points or more on at least one of the first three ISI questions.
• Daytime insomnia symptoms, i.e. two points or more on one or both of the ISI distress and impairment items (numbers 5 and 7).
• Clinical insomnia symptoms from sleep diaries concerning three nighttime symptoms (difficulties with sleep initiation, difficulties with sleep maintenance, and early morning awakenings), i.e., thirty minutes or more on average on one or more of the symptoms.
• No current or past CBT-I treatment within the past 5 years.
• Time and opportunity to participate in treatment for six weeks.
• Time and opportunity to engage with the treatment content and execute homework assignments for six weeks.
• Access to a smart mobil telephone, email and internet.

Exclusion Criteria:

• Severe depression, i.e., more than 30 points on MADRS-S.
• Suicidal risk, i.e., 4 points or more on item 9 on MADRS-S.
• A high intake of alcohol or caffeine,
• Insomnia due to shiftwork or other sleep-disturbing events (e.g., pregnancy, small children, or animals in the sleep environment).
• Participants with a history of psychotic or bipolar disorder.
• If a somatic condition is reported, it is required that it is relatively stable and/or that the candidate is receiving treatment for the condition.
• When a candidate fulfills criteria for a psychiatric or somatic condition, it is required that insomnia is the disorder currently most distressing and disabling or that the insomnia remains despite treatment for the comorbid condition.
• Participants with the following primary sleep disorders will be excluded via the Duke Structured Interview for Sleep Disorders (DSISD): sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, and parasomnias.
• If sleep medication is used, it is required that the use has been relatively stable during three months.
• If Selective Serotonin Reuptake Inhibitors (SSRI) use is reported, it is required that the onset of the medication was at least three months prior to the telephone interview.
• Participants who regularly consume sleep-disturbing medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioural Therapy; Cognitive Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles and to a lesser extent some cognitive exercises. focused on handling sleep disturbing thought activities.	Behavioral: Cognitive Behavioural Therapy; Sleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts.
No Intervention: Waitlist; The waitlist serves as a passive control which will receive the same measures as the cognitive behaviour therapy group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia severity index	Global measure of insomnia severity, used for assessing change in insomnia severity from pretreatment to posttreatment.	Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6) and follow-up at 3 month after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work and Social Adjustment Scale	Score: 0-40, with higher scores indicating worse outcome.	Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment
Sleep onset latency (SOL)		Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Wake time after sleep onset (WASO).		Pretreatment (week 0), post-treatment (week 6).
Early morning awakenings (EMA).		Pretreatment (week 0), post-treatment (week 6).
Total sleep time (TST).		Pretreatment (week 0), post-treatment (week 6).
Depression, anxiety and stress scale-21	Score: 0-63, with higher scores indicating worse outcome.	Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Brunnsviken Brief Quality of life index	Score: 0-96, with higher scores indicating better quality of life.	Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Bed and rise time variability		Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Time in bed (TIB)		Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Pre sleep arousal scale	Score: 16-80, with higher scores indicating worse outcome.	Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6) and follow-up at 3 month after treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Credibility Expectancy Questionnaire.	Score: 4 items, 1-9, 2 items 0-10, with higher scores indicating higher credibility and expectancy.	During the first treatment module (first week of treatment).
Client Satisfaction Questionnaire.	Score: 8-32, with higher scores indicating higher satisfaction.	Post-treatment (week 6)
Activity and adherence with treatment protocol (self developed questionnaire assessing treatment activity and adherence relating to text, homework and therapist support).	Score ranging from 1-5, with higher scores indicating higher activity and adherence.	Post-treatment (week 6)
three items assessing sick-leave and other concomitant treatment (self developed questionns).	Item one assessing number of days on sick-leave. Item two assessing whether participants have sought other healthcare options. Item three assessing whether participants have received other treatments for their sleeping issues during the specified time frames.	Post-treatment (week 6) and at 3-month follow-up.
Adverse events (questionnaire from a previous similar study).		Post-treatment (week 6)
Changes in suicide risk (Item 9 from the MADRS).	Score: 0-6, with higher scores indicating a higher suicide risk.	Pretreatment (week 0), post-treatment (week 10) and follow-up at 6 month after treatment.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Rikard Sunnhed, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): November 20, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Efficacy; Cognitive behaviour therapy; Moderation; Mediation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: CBT-I - L2S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No