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Sleep Restriction Treatment for Insomnia

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
sleep restriction treatment
sleep diary monitoring
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring insomnia, behavioral treatment, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Insomnia Severity Index Score ≥ 10
  • 18 years or older
  • Self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months
  • Daytime problems related to sleep complaints
  • Sleep efficiency < 85%
  • Dutch speaking

Exclusion Criteria:

  • (1) No acces to internet
  • (2) Pregnant or breastfeeding
  • (3) working in night shifts
  • (4) currently in psychological treatment (started < 6 months) or on wait-list for treatment
  • (5) cognitive behavioral treatment for insomnia in last 12 months
  • (6) concrete suicidal ideation
  • (7) schizophrenic or psychotic disorder
  • (8) high level of depressive complaints (BDI-II > 28)
  • (9) Instable medication use (medication should not be tampered in last 6 weeks) incidental sleep-medication use is allowed

Sites / Locations

  • University of AmsterdamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sleep restriction treatment

Sleep monitoring

Arm Description

In this condition participants receive a behavioral sleep restriction intervention for six weeks

In this control condition people fill out a sleep diary for six weeks

Outcomes

Primary Outcome Measures

Insomnia Severity Index
The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.

Secondary Outcome Measures

Sleep diary: sleep onset latency
Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).
Sleep diary: sleep onset latency
Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).
Sleep diary: wake after sleep onset
Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset).
Sleep diary: wake after sleep onset
Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset )
Sleep diary: terminal wakefulness
Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
Sleep diary: terminal wakefulness
Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
Sleep diary: sleep efficiency
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Sleep diary: sleep efficiency
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Sleep diary: total sleep time
Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).
Sleep diary: total sleep time
Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).
Sleep diary: time in bed
Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).
Sleep diary: time in bed
Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).
Cognitive arousal
cognitive arousal is measured daily with a visual analogue scale
Somatic arousal
Somatic arousal is measured daily with a visual analogue scale
Current sleepiness
Sleepiness is measured daily with a visual analogue scale
Insomnia Severity
The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
Sleep safety
Sleep safety behaviors are measured with the Dutch translation of the 32-item Sleep-Related Behaviors Questionnaire-SRBQ (Ree & Harvey, 2004). The total score ranges from 0 (no safety behaviors) to 128 (severe safety behaviors).
Sleep safety
Sleep safety behaviors are measured with the Dutch translation of the 32-item Sleep-Related Behaviors Questionnaire-SRBQ (Ree & Harvey, 2004). The total score ranges from 0 (no safety behaviors) to 128 (severe safety behaviors).
Epworth Sleepiness Scale
To assess daytime sleepiness the Epworth Sleepiness Scale (ESS) is used. The ESS consists of 8-items on a 4-point Likert scale (range 0-24) with higher scores indicating more sleepiness.
Epworth Sleepiness Scale
To assess daytime sleepiness the Epworth Sleepiness Scale (ESS) is used. The ESS consists of 8-items on a 4-point Likert scale (range 0-24) with higher scores indicating more sleepiness.
Pre-sleep arousal
Sleep-related arousal was measured with the Pre-sleep Arousal Scale (PSAS) (Nicassio et al. 1985). The PSAS consists of 16 items that range from 1 ('not at all') to 5 ('extremely'), higher scores indicating more arousal (range 16-80).
Pre-sleep arousal
Sleep-related arousal was measured with the Pre-sleep Arousal Scale (PSAS) (Nicassio et al. 1985). The PSAS consists of 16 items that range from 1 ('not at all') to 5 ('extremely'), higher scores indicating more arousal (range 16-80).
Sleep-bed association
Sleep-bed association is measured with a newly constructed scale of 5 items on a 7-point Likert scale (0-6). Higher scores indicating a stronger sleep-bed association (range 0-30)
Sleep-bed association
Sleep-bed association is measured with a newly constructed scale of 5 items on a 7-point Likert scale (0-6). Higher scores indicating a stronger sleep-bed association (range 0-30)
Dysfunctional beliefs
Dysfunctional beliefs about sleep are measured using the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) (Morin et al. 2017). Items are scored on an 11-point Likert scale (0-10). Higher scores indicating more dysfunctional beliefs (range 0-160).
Dysfunctional beliefs
Dysfunctional beliefs about sleep are measured using the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) (Morin et al. 2017). Items are scored on an 11-point Likert scale (0-10). Higher scores indicating more dysfunctional beliefs (range 0-160).
Depression
Depression is measured with the Dutch version of a nine-item depression scale, the Patient Health Questionnaire-9 (PHQ-9; range 0-27, Cronbach's α = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.
Depression
Depression is measured with the Dutch version of a nine-item depression scale, the Patient Health Questionnaire-9 (PHQ-9; range 0-27, Cronbach's α = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.
Anxiety
Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's α = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.
Anxiety
Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's α = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.
Acceptance
Acceptance is measured with 10-items of the 'flexibiliteits index test'. Items are scored on a 7-point Likert scale (0-6) and higher scores indicate more acceptance (range 0-60).
Acceptance
Acceptance is measured with 10-items of the 'flexibiliteits index test'. Items are scored on a 7-point Likert scale (0-6) and higher scores indicate more acceptance (range 0-60).
Adverse events
Participants asked to report adverse events ("Did anything unpleasant happen to you that was related to your sleep or participation in the trial?"
Treatment quality
Treatment quality is rated with a single question 'how do you rate the treatment'. This is rated on an 11-point Likert scale (0-10) with higher scores indicating more satisfaction (intervention only)
Rating coach
Coaches are rated with a single question 'how satisfied were you with your coach during the treatment'. This is rated on an 11-point Likert scale (0-10) with higher scores indicating more satisfaction

Full Information

First Posted
September 6, 2022
Last Updated
May 8, 2023
Sponsor
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT05548907
Brief Title
Sleep Restriction Treatment for Insomnia
Official Title
Sleep Restriction Treatment for Insomnia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
With a prevalence of about 10% chronic insomnia is a common problem. The standard treatment for insomnia is cognitive behavioral therapy. According to many, the core element within this treatment is sleep restriction. This element has been examined separately in a couple of studies and also appears to be effective in isolation. In the current study the aim is to get more information about the effectiveness of this core element of the treatment. For this reason, a randomized study is conducted to compare sleep restriction with a diary control condition. The second aim in this study is to determine mechanisms behind treatments. Network intervention analysis will be used to determine which specific symptoms are associated with therapy success. This is the reason that throughout the study weekly and daily measures will be conducted. The expectations are that: Participants in the sleep restriction condition will improve more on insomnia complaints than the sleep diary control condition (primary outcome) Participants in the sleep restriction condition will improve more on sleep diary outcomes and other secondary outcomes compared to the sleep diary control condition (secondary outcome)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
insomnia, behavioral treatment, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial where participants are allocated to either a sleep restriction treatment condition or a sleep monitoring control condition. All participants keep a daily sleep diary and fill out weekly questionnaires
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep restriction treatment
Arm Type
Experimental
Arm Description
In this condition participants receive a behavioral sleep restriction intervention for six weeks
Arm Title
Sleep monitoring
Arm Type
Placebo Comparator
Arm Description
In this control condition people fill out a sleep diary for six weeks
Intervention Type
Behavioral
Intervention Name(s)
sleep restriction treatment
Intervention Description
Treatment consists of sleep restriction treatment for insomnia. In this treatment, participants limit their bedtimes to the time they actually sleep. If they sleep most of the time in bed again then bedtimes are slowly built up again. This treatment technique has already been studied in several trials and found to be effective. Mode of delivery is an online booklet, online exercises and weekly telephone support
Intervention Type
Behavioral
Intervention Name(s)
sleep diary monitoring
Intervention Description
As an active control condition people monitor their sleep with a sleep diary (also included in the sleep restriction intervention)
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
Time Frame
Change from baseline to six weeks post-randomization
Secondary Outcome Measure Information:
Title
Sleep diary: sleep onset latency
Description
Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).
Time Frame
Change from baseline to six-weeks post-randomization
Title
Sleep diary: sleep onset latency
Description
Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Sleep diary: wake after sleep onset
Description
Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset).
Time Frame
Change from baseline to six-weeks post-randomization
Title
Sleep diary: wake after sleep onset
Description
Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset )
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Sleep diary: terminal wakefulness
Description
Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
Time Frame
Change from baseline to six-weeks post-randomization
Title
Sleep diary: terminal wakefulness
Description
Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Sleep diary: sleep efficiency
Description
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Time Frame
Change from baseline to six-weeks post-randomization
Title
Sleep diary: sleep efficiency
Description
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Sleep diary: total sleep time
Description
Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).
Time Frame
Change from baseline to six-weeks post-randomization
Title
Sleep diary: total sleep time
Description
Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Sleep diary: time in bed
Description
Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).
Time Frame
Change from baseline to six-weeks post-randomization
Title
Sleep diary: time in bed
Description
Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Cognitive arousal
Description
cognitive arousal is measured daily with a visual analogue scale
Time Frame
Change from baseline to six weeks post randomization
Title
Somatic arousal
Description
Somatic arousal is measured daily with a visual analogue scale
Time Frame
Change from baseline to six weeks post randomization
Title
Current sleepiness
Description
Sleepiness is measured daily with a visual analogue scale
Time Frame
Change from baseline to six weeks post randomization
Title
Insomnia Severity
Description
The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Sleep safety
Description
Sleep safety behaviors are measured with the Dutch translation of the 32-item Sleep-Related Behaviors Questionnaire-SRBQ (Ree & Harvey, 2004). The total score ranges from 0 (no safety behaviors) to 128 (severe safety behaviors).
Time Frame
Change from baseline to six weeks post-randomization
Title
Sleep safety
Description
Sleep safety behaviors are measured with the Dutch translation of the 32-item Sleep-Related Behaviors Questionnaire-SRBQ (Ree & Harvey, 2004). The total score ranges from 0 (no safety behaviors) to 128 (severe safety behaviors).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Epworth Sleepiness Scale
Description
To assess daytime sleepiness the Epworth Sleepiness Scale (ESS) is used. The ESS consists of 8-items on a 4-point Likert scale (range 0-24) with higher scores indicating more sleepiness.
Time Frame
Change from baseline to six weeks post-randomization
Title
Epworth Sleepiness Scale
Description
To assess daytime sleepiness the Epworth Sleepiness Scale (ESS) is used. The ESS consists of 8-items on a 4-point Likert scale (range 0-24) with higher scores indicating more sleepiness.
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Pre-sleep arousal
Description
Sleep-related arousal was measured with the Pre-sleep Arousal Scale (PSAS) (Nicassio et al. 1985). The PSAS consists of 16 items that range from 1 ('not at all') to 5 ('extremely'), higher scores indicating more arousal (range 16-80).
Time Frame
Change from baseline to six weeks post-randomization
Title
Pre-sleep arousal
Description
Sleep-related arousal was measured with the Pre-sleep Arousal Scale (PSAS) (Nicassio et al. 1985). The PSAS consists of 16 items that range from 1 ('not at all') to 5 ('extremely'), higher scores indicating more arousal (range 16-80).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Sleep-bed association
Description
Sleep-bed association is measured with a newly constructed scale of 5 items on a 7-point Likert scale (0-6). Higher scores indicating a stronger sleep-bed association (range 0-30)
Time Frame
Change from baseline to six weeks post-randomization
Title
Sleep-bed association
Description
Sleep-bed association is measured with a newly constructed scale of 5 items on a 7-point Likert scale (0-6). Higher scores indicating a stronger sleep-bed association (range 0-30)
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Dysfunctional beliefs
Description
Dysfunctional beliefs about sleep are measured using the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) (Morin et al. 2017). Items are scored on an 11-point Likert scale (0-10). Higher scores indicating more dysfunctional beliefs (range 0-160).
Time Frame
Change from baseline to six weeks post-randomization
Title
Dysfunctional beliefs
Description
Dysfunctional beliefs about sleep are measured using the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) (Morin et al. 2017). Items are scored on an 11-point Likert scale (0-10). Higher scores indicating more dysfunctional beliefs (range 0-160).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Depression
Description
Depression is measured with the Dutch version of a nine-item depression scale, the Patient Health Questionnaire-9 (PHQ-9; range 0-27, Cronbach's α = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.
Time Frame
Change from baseline to six weeks post-randomization
Title
Depression
Description
Depression is measured with the Dutch version of a nine-item depression scale, the Patient Health Questionnaire-9 (PHQ-9; range 0-27, Cronbach's α = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Anxiety
Description
Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's α = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.
Time Frame
Change from baseline to six weeks post-randomization
Title
Anxiety
Description
Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's α = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Acceptance
Description
Acceptance is measured with 10-items of the 'flexibiliteits index test'. Items are scored on a 7-point Likert scale (0-6) and higher scores indicate more acceptance (range 0-60).
Time Frame
Change from baseline to six weeks post-randomization
Title
Acceptance
Description
Acceptance is measured with 10-items of the 'flexibiliteits index test'. Items are scored on a 7-point Likert scale (0-6) and higher scores indicate more acceptance (range 0-60).
Time Frame
Change from baseline to six-month follow-up (intervention only)
Title
Adverse events
Description
Participants asked to report adverse events ("Did anything unpleasant happen to you that was related to your sleep or participation in the trial?"
Time Frame
Six-weeks post-randomization
Title
Treatment quality
Description
Treatment quality is rated with a single question 'how do you rate the treatment'. This is rated on an 11-point Likert scale (0-10) with higher scores indicating more satisfaction (intervention only)
Time Frame
Six-weeks post-randomization
Title
Rating coach
Description
Coaches are rated with a single question 'how satisfied were you with your coach during the treatment'. This is rated on an 11-point Likert scale (0-10) with higher scores indicating more satisfaction
Time Frame
Six-weeks post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Insomnia Severity Index Score ≥ 10 18 years or older Self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months Daytime problems related to sleep complaints Sleep efficiency < 85% Dutch speaking Exclusion Criteria: (1) No acces to internet (2) Pregnant or breastfeeding (3) working in night shifts (4) currently in psychological treatment (started < 6 months) or on wait-list for treatment (5) cognitive behavioral treatment for insomnia in last 12 months (6) concrete suicidal ideation (7) schizophrenic or psychotic disorder (8) high level of depressive complaints (BDI-II > 28) (9) Instable medication use (medication should not be tampered in last 6 weeks) incidental sleep-medication use is allowed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaap Lancee, PhD
Phone
+31 (0) 20 525 8609
Email
j.lancee@uva.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap Lancee, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Amsterdam
City
Amsterdam
State/Province
Noord Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaap Lancee

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon requests

Learn more about this trial

Sleep Restriction Treatment for Insomnia

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