Insomnia, PrimaryNCT03014960
Effects of Leader Sleep Improvement on Leadership
A study testing Online Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Insomnia, Primary and Chronic Insomnia, run by University of Washington.
Trial summary
The purpose of the study is to investigate the effects of sleep improvement in leaders on leader outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Primary, Chronic Insomnia
- What is being tested?
- Online Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Working adults who have at least one direct report (i.e., subordinate).
Who cannot join
- Non-working adults/ adults who do not have at least one direct report (i.e., subordinate).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Leader Sleep Improvement on Leadership
The purpose of the study is to investigate the effects of sleep improvement in leaders on leader outcomes.
Read the detailed description
The investigators seek to extend the findings of a recent research which demonstrated that treating insomnia has several beneficial effects on employee work outcomes (Barnes, Miller, \& Bostock, in press). In the present study, the investigators propose that the treatment of leader insomnia would beneficially influence leadership, specifically abusive supervision, charismatic leadership, and laissez-faire leadership.
- Conditions
- Insomnia, Primary, Chronic Insomnia
- Being tested
- Online Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Cognitive Behavioral Therapy for Insomnia (CBT-I)Other
CBT-I is a psychological treatment designed to break the patterns of maladaptive thinking and behavior that maintain insomnia. CBT-I includes a range of techniques including a behavioral component (stimulus control, sleep restriction, relaxation) combined with a cognitive component (managing sleep related worries, the racing mind and intrusive thoughts) and an educational (sleep hygiene) component.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Condition | Experimental | Online Cognitive Behavioral Therapy for Insomnia Intervention Receives: Other: Online Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Control Condition | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Control Scale
Rate self-control over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
Measured: 2 weeks
Abusive Supervision Scale
Rate abusive supervision over the past 2 weeks. Each item is scored 1-5:
- - I cannot remember him/her ever using this behavior with me
- - He/she very seldom uses this behavior with me
- - He/she occasionally uses this behavior with me
- - He/she uses this behavior moderately often with me
- - He/she uses this behavior very often with me
Measured: 2 weeks
Emotional Labor Scale
Rate emotional labor over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
Measured: 2 weeks
Charismatic Leadership Scale
Rate charismatic leadership over the past 2 weeks. Each item is scored 1-5 (1 = to a very little extent; 2 = to a little extent; 3 = to a moderate extent; 4 = to a great extent; 5 = to a very great extent).
Measured: 2 weeks
Emotional Exhaustion Scale
Rate emotional exhaustion over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
Measured: 2 weeks
Laissez-Faire Leadership Scale
Rate laissez-faire leadership over the past 2 weeks. Each item is scored 1-5 (1 = to a very little extent; 2 = to a little extent; 3 = to a moderate extent; 4 = to a great extent; 5 = to a very great extent).
Measured: 2 weeks
Secondary outcomes (1)
Insomnia Scale
Rate insomnia over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Very much)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia, PrimaryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Tse Heng, University of Washington
- Investigators
- Yu Tse Heng, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014960
- Sponsor's protocol ID
- STUDY00000461-B
- Status last verified
- Oct 2017
- First submitted
- 5 Jan 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Leader Sleep Improvement on Leadership
- ClinicalTrials.gov ID
- NCT03014960
- Acronym / sponsor ID
- STUDY00000461-B
- Conditions
- Insomnia, Primary, Chronic Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the effects of sleep improvement in leaders on leader outcomes.
Detailed description
The investigators seek to extend the findings of a recent research which demonstrated that treating insomnia has several beneficial effects on employee work outcomes (Barnes, Miller, \& Bostock, in press). In the present study, the investigators propose that the treatment of leader insomnia would beneficially influence leadership, specifically abusive supervision, charismatic leadership, and laissez-faire leadership.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition | Experimental | Other: Online Cognitive Behavioral Therapy for Insomnia (CBT-I)Online Cognitive Behavioral Therapy for Insomnia Intervention |
| Control Condition | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Working adults who have at least one direct report (i.e., subordinate).
Key exclusion criteria (1 listed)
- Non-working adults/ adults who do not have at least one direct report (i.e., subordinate).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Cognitive Behavioral Therapy for Insomnia (CBT-I)CBT-I is a psychological treatment designed to break the patterns of maladaptive thinking and behavior that maintain insomnia. CBT-I includes a range of techniques including a behavioral component (stimulus control, sleep restriction, relaxation) combined with a cognitive component (managing sleep related worries, the racing mind and intrusive thoughts) and an educational (sleep hygiene) component. | Other | Experimental Condition |
Primary outcome
Self-Control Scale
Time frame: 2 weeks
Rate self-control over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
Abusive Supervision Scale
Time frame: 2 weeks
Rate abusive supervision over the past 2 weeks. Each item is scored 1-5: 1. - I cannot remember him/her ever using this behavior with me 2. - He/she very seldom uses this behavior with me 3. - He/she occasionally uses this behavior with me 4. - He/she uses this behavior moderately often with me 5. - He/she uses this behavior very often with me
Emotional Labor Scale
Time frame: 2 weeks
Rate emotional labor over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
Charismatic Leadership Scale
Time frame: 2 weeks
Rate charismatic leadership over the past 2 weeks. Each item is scored 1-5 (1 = to a very little extent; 2 = to a little extent; 3 = to a moderate extent; 4 = to a great extent; 5 = to a very great extent).
Emotional Exhaustion Scale
Time frame: 2 weeks
Rate emotional exhaustion over the past 2 weeks. Each item is scored 1-5 (1 = Very slightly or not at all, 2 = A little, 3 = Moderately, 4 = Quite a bit, 5 = Extremely).
Laissez-Faire Leadership Scale
Time frame: 2 weeks
Rate laissez-faire leadership over the past 2 weeks. Each item is scored 1-5 (1 = to a very little extent; 2 = to a little extent; 3 = to a moderate extent; 4 = to a great extent; 5 = to a very great extent).
1 secondary outcome
Insomnia Scale
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Tse Heng principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Online Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Insomnia, Primary and Chronic Insomnia, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Tse Heng (412-517-2941, yutse@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Control Scale (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.