Smartphone-delivered CBT-I

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Smartphone-delivered CBT for Insomnia, a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065242
• Other study ID #: CBT-I - L2S
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: November 20, 2022

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 20, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioural Therapy
Sleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts.

Locations

Country	Name	City	State
Sweden	Karolinska institute	Stockholm	Stockholms Län

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	Client Satisfaction Questionnaire.	Score: 8-32, with higher scores indicating higher satisfaction.	Post-treatment (week 6)
Other	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)
Other	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.
Other	Adverse events (questionnaire from a previous similar study).		Post-treatment (week 6)
Other	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.
Primary	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	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
Secondary	Sleep onset latency (SOL)		Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Secondary	Wake time after sleep onset (WASO).		Pretreatment (week 0), post-treatment (week 6).
Secondary	Early morning awakenings (EMA).		Pretreatment (week 0), post-treatment (week 6).
Secondary	Total sleep time (TST).		Pretreatment (week 0), post-treatment (week 6).
Secondary	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.
Secondary	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.
Secondary	Bed and rise time variability		Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Secondary	Time in bed (TIB)		Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Secondary	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.