InsomniaNCT02051543
Investigating Affective Mechanisms of Behavioral Sleep Treatment
A study testing Brief Behavioral Treatment of Insomnia -Military Version in people with Insomnia, run by Minneapolis Veterans Affairs Medical Center.
Trial summary
Insomnia is a highly prevalent condition and costly national public health problem and a transdiagnostic risk factor for the development of a number of internalizing/emotional disorders, as well as associated functional impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Brief Behavioral Treatment of Insomnia -Military Version
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Aug 2016
- 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
- Adult, Older adult
Who may be able to join
- meeting Diagnostic and Statistical Manual of Mental Disorders-5 criteria for a diagnosis of insomnia
- a score above the clinical cut-off for insomnia on the Insomnia Severity Index (ISI).63 Participants using psychotropic or hypnotic medications will be eligible if the medication and dose was stable for 3 weeks prior to study entry, and no changes were expected over the course of treatment.
Who cannot join
- presence of an untreated sleep disorder other than insomnia (e.g., sleep breathing disorder, restless legs syndrome)
- report using drugs or alcohol at high levels
- report moderate or more levels of suicidal or homicidal ideation
- lifetime history of bipolar or psychotic disorder.
About this study
Insomnia is a highly prevalent condition and costly national public health problem and a transdiagnostic risk factor for the development of a number of internalizing/emotional disorders, as well as associated functional impairment. Interestingly, sleep treatments appear to reduce anxiety and depression in addition to improving sleep. Given the substantial individual and societal costs of insomnia and associated mental illness, there is an urgent need to better understand the mechanism through which sleep treatments improve daytime symptoms of depression and anxiety in order to enhance the efficacy of sleep treatments and ultimately prevent the development of depression and anxiety disorders following the onset of insomnia. Research suggests that sleep disruptions lead to emotional dysregulation, including increased negative affectivity and decreased positive affectivity. This affective reactivity may ultimately be related to the development of depression and anxiety. Despite the apparent link between sleep and emotion regulation, studies have not investigated the influence of sleep treatment on these affective dimensions. The investigators long term goal is to increase understanding of the mechanism of action in sleep treatments in relation to changes in positive and negative valence systems. The investigators immediate objective is to conduct a pilot study investigating changes in mean levels and day-to-day instability of affective dimensions following a brief behavioral intervention for insomnia tailored for veterans (Brief Behavioral Treatment for Insomnia-Military Version. The specific aims include developing a deeper understanding of the effects of behavioral sleep treatment on positive and negative valence systems and testing a model in which affective reactivity modulates the relation between sleep and internalizing symptoms. Both objective and subjective sleep data, as well as measures of affective states and depression/anxiety symptoms, will be collected pre and post-treatment in order to examine changes in sleep, affect and daytime symptoms over the course of treatment and to test a model in which affective changes mediate the relation between improvements in sleep and improvements in depression and anxiety. The investigators hypothesize that sleep treatment will improve sleep, daytime symptoms and affective reactivity and that changes in affect will mediate the relation between sleep and internalizing symptoms.
- Conditions
- Insomnia
- Being tested
- Brief Behavioral Treatment of Insomnia -Military Version
- 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.
Brief Behavioral Treatment of Insomnia -Military VersionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Treatment of Insomnia-Military Version | Experimental | Not described Receives: Behavioral: Brief Behavioral Treatment of Insomnia -Military Version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Measured: 1 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Erin Koffel, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051543
- Sponsor's protocol ID
- vamc-eak-1
- Status last verified
- Sep 2015
- First submitted
- 28 Jan 2014
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Affective Mechanisms of Behavioral Sleep Treatment
- ClinicalTrials.gov ID
- NCT02051543
- Acronym / sponsor ID
- vamc-eak-1
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Primary completion
- Aug 2016 (estimated)
- First posted
- 31 Jan 2014 (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.
Insomnia is a highly prevalent condition and costly national public health problem and a transdiagnostic risk factor for the development of a number of internalizing/emotional disorders, as well as associated functional impairment. Interestingly, sleep treatments appear to reduce anxiety and depression in addition to improving sleep. Given the substantial individual and societal costs of insomnia and associated mental illness, there is an urgent need to better understand the mechanism through which sleep treatments improve daytime symptoms of depression and anxiety in order to enhance the efficacy of sleep treatments and ultimately prevent the development of depression and anxiety disorders following the onset of insomnia. Research suggests that sleep disruptions lead to emotional dysregulation, including increased negative affectivity and decreased positive affectivity. This affective reactivity may ultimately be related to the development of depression and anxiety. Despite the apparent link between sleep and emotion regulation, studies have not investigated the influence of sleep treatment on these affective dimensions. The investigators long term goal is to increase understanding of the mechanism of action in sleep treatments in relation to changes in positive and negative valence systems. The investigators immediate objective is to conduct a pilot study investigating changes in mean levels and day-to-day instability of affective dimensions following a brief behavioral intervention for insomnia tailored for veterans (Brief Behavioral Treatment for Insomnia-Military Version. The specific aims include developing a deeper understanding of the effects of behavioral sleep treatment on positive and negative valence systems and testing a model in which affective reactivity modulates the relation between sleep and internalizing symptoms. Both objective and subjective sleep data, as well as measures of affective states and depression/anxiety symptoms, will be collected pre and post-treatment in order to examine changes in sleep, affect and daytime symptoms over the course of treatment and to test a model in which affective changes mediate the relation between improvements in sleep and improvements in depression and anxiety. The investigators hypothesize that sleep treatment will improve sleep, daytime symptoms and affective reactivity and that changes in affect will mediate the relation between sleep and internalizing symptoms.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Treatment of Insomnia-Military Version | Experimental | Behavioral: Brief Behavioral Treatment of Insomnia -Military Version |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- meeting Diagnostic and Statistical Manual of Mental Disorders-5 criteria for a diagnosis of insomnia
- a score above the clinical cut-off for insomnia on the Insomnia Severity Index (ISI).63 Participants using psychotropic or hypnotic medications will be eligible if the medication and dose was stable for 3 weeks prior to study entry, and no changes were expected over the course of treatment.
Key exclusion criteria (4 listed)
- presence of an untreated sleep disorder other than insomnia (e.g., sleep breathing disorder, restless legs syndrome)
- report using drugs or alcohol at high levels
- report moderate or more levels of suicidal or homicidal ideation
- lifetime history of bipolar or psychotic disorder.
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 |
|---|---|---|
| Brief Behavioral Treatment of Insomnia -Military Version | Behavioural | Brief Behavioral Treatment of Insomnia-Military Version |
Primary outcome
Insomnia Severity Index
Time frame: 1 week post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment of Insomnia -Military Version in people with Insomnia, run by Minneapolis Veterans Affairs Medical Center.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 25 Sep 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 1 week post-treatment). 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 25 Sep 2015.