InsomniaNCT04920630
TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
A study testing Cognitive Behavioral Therapy - Insomnia (CBT-I) in people with Insomnia and Chronic Pain, run by Indiana University at 1 site in United States.
Trial summary
The primary aim of this study is to understand how insomnia contributes to chronic pain in youth. Specifically, the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the body's ability to efficiently modulate pain, either to increase or decrease pain perception. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Insomnia, Chronic Pain
- What is being tested?
- Cognitive Behavioral Therapy - Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 5 May 2023
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Youth Inclusion Criteria:
- Aged 12 to 17 years.
- Meets criteria for insomnia with or without comorbid chronic musculoskeletal pain.
- Parent/guardian available to provide consent.
- Patient and a primary caregiver are able to independently read and understand English well enough to provide informed consent and complete study procedures.
- Access to email, internet, and audio and video call capabilities.
Parent/Guardian Inclusion Criteria:
- Parent/legal guardian of a child meeting above eligibility criteria
- Able to independently read and understand English well enough to provide informed consent and complete study questionnaires.
Youth Exclusion Criteria:
- History of cardiac or neuromuscular disorder
- Parent-report of child's use of Opioid medications (i.e., fentanyl, morphine, hydromorphone, methadone, hydrocodone, oxycodone) that cannot be discontinued for 7 days prior to study visits.
- Inadequate proficiency in English or a developmental disability that interferes with informed consent/assent or completion of study procedures.
- History of obstructive sleep apnea, restless leg syndrome, or narcolepsy.
- History of bipolar disorder and/or manic episodes
- Diagnosis of epilepsy.
- Currently in foster care or considered a ward of the state.
- History of Raynaud Syndrome.
- Active suicidal ideation, intent or plan in the past month.
Parent Exclusion Criteria:
- Inadequate proficiency in English or a developmental disability that interferes with informed consent or completion of questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Childre
Indianapolis, Indiana, 46202
About this study
Official title: TRAIN Your Sleep: Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
The primary aim of this study is to understand how insomnia contributes to chronic pain in youth. Specifically, the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the body's ability to efficiently modulate pain, either to increase or decrease pain perception. It is hypothesized that insomnia is associated with increased negative emotional states and impaired pain modulation, which will improve after treatment of insomnia. In this project, the objectives are to 1) evaluate the role of pain modulation as a potential mechanism through which insomnia impacts pain symptoms, and 2) evaluate the role of negative affect as mediators of the impact of insomnia on pain modulation.
Study participation will consist of a baseline assessment, a 5 session (once per week) virtual group cognitive behavioral therapy for insomnia (CBT-I) intervention, and a follow-up assessment. Investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits. Assessment visits will consist of two types of assessments, questionnaires and quantitative sensory testing (QST). Participating parents and teens will complete questionnaires (both child and parent report) assessing the child's pain, sleep, and psycho-social variables. QST will assess pain inhibition via conditioned pain modulation (CPM) and pain facilitation via temporal summation (TS).
- Conditions
- Insomnia, Chronic Pain
- Being tested
- Cognitive Behavioral Therapy - Insomnia (CBT-I)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy - Insomnia (CBT-I)Behavioural
Also called CBT-I
CBT-I will be delivered via 5 weekly virtual group therapy sessions. Session content is manualized and adapted from existing CBT-I protocols to be relevant to a virtual adolescent group and will include: Session 1 - Introduction of group members, group rules, psychoeducation regarding sleep, and instructions on completion of sleep log. Session 2 - Review sleep log, sleep hygiene, relaxation training, and stimulus control. Session 3 - Review sleep log, sleep restriction, and cognitive strategies (positive self-statements, worry management). Session 4 - Review sleep log and sleep restriction, and problem-solving barriers. Session 5 - Maintenance and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | 5-weekly Cognitive Behavioral Therapy for Insomnia group therapy sessions conducted virtually. Receives: Behavioral: Cognitive Behavioral Therapy - Insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Conditioned Pain Modulation (CPM)
Heat pain threshold (test stimulus) will be assessed on the volar surface of the dominant forearm twice before before, during, and after immersion (for 1 minute) of the non-dominant hand in a circulated cold-water bath (conditioning stimulus) maintained at 5˚C ±1˚C. Heat pain threshold will be assessed via the method of limits. Subjects will be instructed to push a button as soon as the heat feels painful, which will stop the trial. Immediately before and after the CPM assessment, the subjects' non-dominant hand will be placed in a room-temperature water bath (20-25˚C) for 2 minutes. The CPM effect will be calculated as a difference score: heat pain threshold during conditioning stimulus minus baseline. A negative score indicates pain inhibition.
Measured: 1-4 weeks post-treatment
Change from baseline Temporal Summation of Pain (TS)
Temporal summation will be assessed via a series of 10 brief (~0.5s duration for peak, total time for heating, peak, and cooling <1.5s) heat pulses (48˚C) delivered via a Medoc Thermal Sensory Analyzer-2 thermode positioned on the volar surface of the forearm. Time between each peak will be 3 seconds. Subjects will provide a verbal pain rating immediately after the first and last heat pulse is delivered. Pain ratings will be made on a 0-100 numerical rating scale (0=no pain, 100=most pain imaginable), which will be displayed during the assessment. Temporal summation will be calculated as a difference score (i.e., pain during final stimulus minus pain during initial stimulus), with a positive score indicating pain facilitation due to temporal summation.
Measured: 1-4 weeks post-treatment
Secondary outcomes (4)
Change from baseline score on Generalized Anxiety Disorder -7
Generalized Anxiety Disorder - 7 (GAD-7). The GAD-7 is a 7 item screener for anxiety focused on symptoms of anxiety over the past week. Each item is scores on a 0-3 scale and summed to create a total score that ranges from 0-21.
Measured: 1-4 weeks post-treatment
Change from baseline score on Patient Health Questionnaire - 9 Adolescent Form (PHQ9-A).
The PHQ9-A is a validated 9 item self-report scale (4-point Likert scale) assessing symptoms of depression. Scores range from 0-27 with 0-4 indicating no or minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
Measured: 1-4 weeks post-treatment
Change from Baseline Score on Positive and Negative Affect Schedule (PANAS)
he PANAS is a 20-item self- and parent-report measure assessing positive and negative affect. Responses are made on a 5-point Likert scale. A separate score is calculated for negative (10 items) and positive (10 items) affect and higher scores reflect higher levels of experienced affect.
Measured: 1-4 weeks post-treatment
Change from baseline score on Pediatric Insomnia Severity Index (PISI)
The PISI is a 6-item parent- and child-report scale measuring insomnia severity. Total scores range from 0-30 with higher scores reflecting greater insomnia severity.
Measured: 1-4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start10 May 2021
- Primary completion5 May 2023
- Study completion5 May 2023
Why it stopped: Research team members no longer employed. Determination made to utilize pilot data already obtained and close study to enrollment.
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.
- More trials run by Indiana UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute
- Responsible party
- Principal investigator, Amy E. Williams, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920630
- Sponsor's protocol ID
- 2009842860
- Status last verified
- Aug 2023
- First submitted
- 27 May 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAIN Your Sleep: Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
- ClinicalTrials.gov ID
- NCT04920630
- Acronym / sponsor ID
- 2009842860
- Conditions
- Insomnia, Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research team members no longer employed. Determination made to utilize pilot data already obtained and close study to enrollment.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute
- Study start
- 10 May 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 10 Jun 2021 (actual)
- 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 primary aim of this study is to understand how insomnia contributes to chronic pain in youth. Specifically, the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the body's ability to efficiently modulate pain, either to increase or decrease pain perception. It is hypothesized that insomnia is associated with increased negative emotional states and impaired pain modulation, which will improve after treatment of insomnia. In this project, the objectives are to 1) evaluate the role of pain modulation as a potential mechanism through which insomnia impacts pain symptoms, and 2) evaluate the role of negative affect as mediators of the impact of insomnia on pain modulation.
Study participation will consist of a baseline assessment, a 5 session (once per week) virtual group cognitive behavioral therapy for insomnia (CBT-I) intervention, and a follow-up assessment. Investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits. Assessment visits will consist of two types of assessments, questionnaires and quantitative sensory testing (QST). Participating parents and teens will complete questionnaires (both child and parent report) assessing the child's pain, sleep, and psycho-social variables. QST will assess pain inhibition via conditioned pain modulation (CPM) and pain facilitation via temporal summation (TS).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy - Insomnia (CBT-I)5-weekly Cognitive Behavioral Therapy for Insomnia group therapy sessions conducted virtually. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Cognitive Behavioral Therapy - Insomnia (CBT-I)Also: CBT-ICBT-I will be delivered via 5 weekly virtual group therapy sessions. Session content is manualized and adapted from existing CBT-I protocols to be relevant to a virtual adolescent group and will include: Session 1 - Introduction of group members, group rules, psychoeducation regarding sleep, and instructions on completion of sleep log. Session 2 - Review sleep log, sleep hygiene, relaxation training, and stimulus control. Session 3 - Review sleep log, sleep restriction, and cognitive strategies (positive self-statements, worry management). Session 4 - Review sleep log and sleep restriction, and problem-solving barriers. Session 5 - Maintenance and relapse prevention. | Behavioural | CBT-I |
Primary outcome
Change from baseline Conditioned Pain Modulation (CPM)
Time frame: 1-4 weeks post-treatment
Heat pain threshold (test stimulus) will be assessed on the volar surface of the dominant forearm twice before before, during, and after immersion (for 1 minute) of the non-dominant hand in a circulated cold-water bath (conditioning stimulus) maintained at 5˚C ±1˚C. Heat pain threshold will be assessed via the method of limits. Subjects will be instructed to push a button as soon as the heat feels painful, which will stop the trial. Immediately before and after the CPM assessment, the subjects' non-dominant hand will be placed in a room-temperature water bath (20-25˚C) for 2 minutes. The CPM effect will be calculated as a difference score: heat pain threshold during conditioning stimulus minus baseline. A negative score indicates pain inhibition.
Change from baseline Temporal Summation of Pain (TS)
Time frame: 1-4 weeks post-treatment
Temporal summation will be assessed via a series of 10 brief (~0.5s duration for peak, total time for heating, peak, and cooling <1.5s) heat pulses (48˚C) delivered via a Medoc Thermal Sensory Analyzer-2 thermode positioned on the volar surface of the forearm. Time between each peak will be 3 seconds. Subjects will provide a verbal pain rating immediately after the first and last heat pulse is delivered. Pain ratings will be made on a 0-100 numerical rating scale (0=no pain, 100=most pain imaginable), which will be displayed during the assessment. Temporal summation will be calculated as a difference score (i.e., pain during final stimulus minus pain during initial stimulus), with a positive score indicating pain facilitation due to temporal summation.
4 secondary outcomes
Change from baseline score on Generalized Anxiety Disorder -7
Time frame: 1-4 weeks post-treatment
Change from baseline score on Patient Health Questionnaire - 9 Adolescent Form (PHQ9-A).
Time frame: 1-4 weeks post-treatment
Change from Baseline Score on Positive and Negative Affect Schedule (PANAS)
Time frame: 1-4 weeks post-treatment
Change from baseline score on Pediatric Insomnia Severity Index (PISI)
Time frame: 1-4 weeks post-treatment
Results and safety
The study was stopped early (reason given: Research team members no longer employed. Determination made to utilize pilot data already obtained and close study to enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy - Insomnia (CBT-I) in people with Insomnia and Chronic Pain, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Research team members no longer employed. Determination made to utilize pilot data already obtained and close study to enrollment.). Results are not available in the source record.
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?
Change from baseline Conditioned Pain Modulation (CPM) (time frame: 1-4 weeks post-treatment). The study lists 2 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 23 Aug 2023.