NightmareCBT-NCNCT04047277
Cognitive Behavioral Therapy for Nightmares in Children
A study testing Cognitive Behavioral Therapy in people with Nightmare, run by University of Oklahoma at 2 sites in United States.
Trial summary
Up to 50% of children experience nightmares annually. Nightmares interfere with sleep quality and quantity resulting in sleep deficiency, and are associated with negative mental health consequences. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Nightmare
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2019to 30 Oct 2020
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children must have a history of nightmares occurring approximately once or more per week over a minimum of one month.
- Children must have verbal comprehension of at least age 5 (determined by PPVT), and be fluent in English.
- If taking psychotropic medications, must be stable for one month.
- Children must have a parent or legal guardian who is able to participate in treatment assignments and be able to read and speak English.
Who cannot join
- Under age 5 or over age 17.
- No nightmares (or less than averaging one per week)
- Apparent psychosis
- Pervasive developmental disorder or mental retardation
- Not able to read and speak English.
- Sleep apnea
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Tulsa
Tulsa, Oklahoma, 74104
University of Oklahoma School of Community Medicine
Tulsa, Oklahoma, 74135
About this study
Official title: Clinical Outcomes of Cognitive Behavioral Therapy for Nightmares in Children
Up to 50% of children experience nightmares annually. Nightmares interfere with sleep quality and quantity resulting in sleep deficiency, and are associated with negative mental health consequences. Previous research has shown efficacy of manualized CBT treatment for reducing trauma related nightmares in adults, and preliminary evidence has shown efficacy in children. This study is the first randomized clinical trial to evaluate the effectiveness of the treatment for idiopathic, as well as trauma related nightmares in children. The treatment in a manualized CBT protocol (5 sessions) that teaches sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
- Conditions
- Nightmare
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Nightmares, Children, Trauma, CBT, Exposure, Relaxation, Rescripting, Cognitive, Behavioral, Therapy
- Medical subject headings
- Wounds and Injuries, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
The manualized CBT protocol is five sessions that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Right-Away | Experimental | Cognitive Behavioral Therapy using exposure, relaxztion, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring. Receives: Behavioral: Cognitive Behavioral Therapy |
| Waitlist Control | No intervention | Waitlist control group will complete pre and post assessments at beginning and end of wait period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Trauma Related Nightmare Survey (TRNS-C) - Child Version
The TRNS-C is a 14 item self report measure that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Nightmare Distress Questionnaire (NDQ)
The NDQ is a 13 item self report measure of nightmare related distress. Higher scores are significantly related to interest in therapy for nightmares.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Nightmare Locus of Control (NLOC)
The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Pittsburgh Sleep Quality Index - Modified (PSQI) - Child Version
The PSQI-M is a 10 item (with 2 items containing 23 sub items) self report measure of sleep quality and disturbance. It queries sleep quality and disturbances over the last month.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Children's Report of Sleep Patterns (CRSP)
The CRSP is a 62 item self report measure of children's sleep patterns, sleep hygiene, and sleep disturbances for children eight to 12 years of age
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Sleep Locus of Control (SLOC)
The SLOC is an 6 item self report measure perceived contingencies between sleep behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Epworth Sleepiness Scale (ESS)
The ESS is an 8 item self report. The test is a list of eight situations in which one rates his/her tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When the test is finished, response values are added up. The total score is based on a scale of 0 to 24. The scale estimates whether one is experiencing excessive sleepiness that possibly requires medical attention.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change in reports on Sleep Journal
6 question self report that patient assesses daily from home.
Measured: Participants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase, at Post treatment (for 1 week), at 3 month follow-up (for 1 week), and at 6 month follow-up (for 1 week).
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Children's Sleep Habits - Caregiver Report regarding child
To examine sleep habits and possible difficulties with sleep in preschool and school-aged children
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Adverse Childhood Experiences for CHILD - Caregiver Report regarding child
Assesses adverse experiences from infancy through early childhood
Measured: approximately 3 years.
Change on the Sleep Disturbances Scale for Children - Caregiver Report regarding child
SDSC is a 26-item inventory rated on a 5 point Likert-type scale. The instrument's purpose is to categorize sleep disorders in children
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Secondary outcomes (2)
Change on the Parental Stress Scale
18 item self report scale used for the assessment of parental stress for both mothers and fathers and for parents of children with and without clinical problems. • 5 - Point scale; strongly disagree, disagree, undecided, agree, strongly agree. A low score signifies a low level of stress, and a high score to signifies a high level of stress.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Adverse Childhood Experiences for SELF - Caregiver Report regarding self
Assesses adverse experiences from infancy through early childhood
Measured: approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start22 Mar 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NightmareStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded randomization into 2 groups: Treatment \& Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after 6 week wait.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tulsa
- Responsible party
- Sponsor
- Investigators
- Lisa M Cromer, PhD, Principal investigator, University of TulsaTara R Buck, MD, Principal investigator, University of Oklahoma School of Community Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047277
- Sponsor's protocol ID
- IRB9653
- Acronym
- CBT-NC
- Status last verified
- Nov 2022
- First submitted
- 5 Jun 2019
- Last updated
- 15 Nov 2022
- 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Cognitive Behavioral Therapy for Nightmares in Children
- ClinicalTrials.gov ID
- NCT04047277
- Acronym / sponsor ID
- CBT-NC / IRB9653
- Conditions
- Nightmare
- Keywords
- Nightmares, Children, Trauma, CBT, Exposure, Relaxation, Rescripting, Cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- University of Tulsa
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 6 Aug 2019 (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.
Up to 50% of children experience nightmares annually. Nightmares interfere with sleep quality and quantity resulting in sleep deficiency, and are associated with negative mental health consequences. Previous research has shown efficacy of manualized CBT treatment for reducing trauma related nightmares in adults, and preliminary evidence has shown efficacy in children. This study is the first randomized clinical trial to evaluate the effectiveness of the treatment for idiopathic, as well as trauma related nightmares in children. The treatment in a manualized CBT protocol (5 sessions) that teaches sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded randomization into 2 groups: Treatment \& Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after 6 week wait.
| Arm | Type | Receives |
|---|---|---|
| Treatment Right-Away | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy using exposure, relaxztion, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring. |
| Waitlist Control | No intervention | –Waitlist control group will complete pre and post assessments at beginning and end of wait period. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children must have a history of nightmares occurring approximately once or more per week over a minimum of one month.
- Children must have verbal comprehension of at least age 5 (determined by PPVT), and be fluent in English.
- If taking psychotropic medications, must be stable for one month.
- Children must have a parent or legal guardian who is able to participate in treatment assignments and be able to read and speak English.
Key exclusion criteria (6 listed)
- Under age 5 or over age 17.
- No nightmares (or less than averaging one per week)
- Apparent psychosis
- Pervasive developmental disorder or mental retardation
- Not able to read and speak English.
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 TherapyThe manualized CBT protocol is five sessions that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting. | Behavioural | Treatment Right-Away |
Primary outcome
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Change on the Trauma Related Nightmare Survey (TRNS-C) - Child Version
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The TRNS-C is a 14 item self report measure that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children.
Change on the Nightmare Distress Questionnaire (NDQ)
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The NDQ is a 13 item self report measure of nightmare related distress. Higher scores are significantly related to interest in therapy for nightmares.
Change on the Nightmare Locus of Control (NLOC)
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.
Change on the Pittsburgh Sleep Quality Index - Modified (PSQI) - Child Version
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The PSQI-M is a 10 item (with 2 items containing 23 sub items) self report measure of sleep quality and disturbance. It queries sleep quality and disturbances over the last month.
Change on the Children's Report of Sleep Patterns (CRSP)
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The CRSP is a 62 item self report measure of children's sleep patterns, sleep hygiene, and sleep disturbances for children eight to 12 years of age
Change on the Sleep Locus of Control (SLOC)
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The SLOC is an 6 item self report measure perceived contingencies between sleep behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.
Change on the Epworth Sleepiness Scale (ESS)
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The ESS is an 8 item self report. The test is a list of eight situations in which one rates his/her tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When the test is finished, response values are added up. The total score is based on a scale of 0 to 24. The scale estimates whether one is experiencing excessive sleepiness that possibly requires medical attention.
Change in reports on Sleep Journal
Time frame: Participants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase, at Post treatment (for 1 week), at 3 month follow-up (for 1 week), and at 6 month follow-up (for 1 week).
6 question self report that patient assesses daily from home.
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Change on the Children's Sleep Habits - Caregiver Report regarding child
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
To examine sleep habits and possible difficulties with sleep in preschool and school-aged children
Adverse Childhood Experiences for CHILD - Caregiver Report regarding child
Time frame: approximately 3 years.
Assesses adverse experiences from infancy through early childhood
Change on the Sleep Disturbances Scale for Children - Caregiver Report regarding child
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
SDSC is a 26-item inventory rated on a 5 point Likert-type scale. The instrument's purpose is to categorize sleep disorders in children
2 secondary outcomes
Change on the Parental Stress Scale
Time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Adverse Childhood Experiences for SELF - Caregiver Report regarding self
Time frame: approximately 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- 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.
Lisa M Cromer, PhD principal investigator
University of Tulsa
Tara R Buck, MD principal investigator
University of Oklahoma School of Community Medicine
2 sites 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 in people with Nightmare, run by University of Oklahoma at 2 sites 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?
The sponsor lists 4 inclusion and 6 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: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 on the Child Adolescent Trauma Screen (CATS) - Child Version (time frame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.). The study lists 13 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 15 Nov 2022.