DysautonomiaNCT03185247
Implementation of Transdx Group for POTS
A study testing Transdiagnostic Group-Based Treatment in people with Dysautonomia and Anxiety, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The proposed intervention is focused on developing and implementing a psychological approach incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysautonomia, Anxiety, Depression
- What is being tested?
- Transdiagnostic Group-Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 1 Sep 2019
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent participants must be
- between the ages of 13-18 years old,
- english speaking, and
- have been diagnosed with autonomic dysfunction, dysautonomia, orthostatic intolerance, and/or POTS.
- Participants must also:
- endorse symptoms of autonomic dysfunction on the COMPASS 31 (measures are described below), and show
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- moderate functional impairment, and/or
- some psychiatric symptoms in the domains of anxiety and/or depression.
- FDI scores must be greater than 12 (see Kashikar-Zuck et al., 2011 for an empirical rationale).
- Must have attended at least one day of school per week during the past month.
- On the measures of anxiety (SCARED) and depression (CDI), the adolescent's scale score must be above the "average" range based on T scores (CDI) or within the "clinical" range (SCARED).
- Each participant must have at least one English-speaking parent/legal guardian who can provide informed consent for the adolescent, as well as participate in the study.
- Each adolescent and their parent/legal guardian(s) must be English-speaking.
Who cannot join
- Adolescent participants;
- wards of the state,
- endorse active homicidal or suicidal ideation,
- have an intellectual disability, a pervasive developmental disability or significant developmental delay,
- endorse an active substance use disorder, and
- are currently participating in individual or group psychotherapy.
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- do not have in-network health insurance that covers Health and Behavior interventions, or
- are unable to self-pay.
- Parent/legal guardian(s) are
- unwilling to participate in the study,
- are non-English speaking, or
- have an intellectual disability, a pervasive developmental disability or significant developmental delay, and/or
- do not have legal custody of the adolescent participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Implementation of a Transdiagnostic Psychological Group Intervention for Pediatric Autonomic Dysfunction
The proposed intervention is focused on developing and implementing a psychological approach incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction. The investigators hypothesize that their intervention will result in improvements in the transdiagnostic mechanisms specifically targeted by components of their intervention including sleep, information processing, and youth/parent experiential avoidance.
- Conditions
- Dysautonomia, Anxiety, Depression
- Being tested
- Transdiagnostic Group-Based Treatment
- Keywords
- Transdiagnostic, POTS (Postural Orthostatic Tachycardia Syndrome), Therapy
- Medical subject headings
- Autonomic Nervous System Diseases, Anxiety Disorders, Depression, Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Group-Based TreatmentBehavioural
10 week 90-minute weekly therapy sessions including both the adolescent and caregiver. Treatment will consist of psychoeducation about dysautonomia, motivational interviewing techniques to promote readiness for change, support around lifestyle and behavioral changes, core CBT components (e.g., relaxation training, linking thoughts, feelings, and behaviors, minimizing catastrophizing thoughts, cognitive coping, and exposure), and components of ACT aiming to increase cognitive flexibility (e.g., mindfulness, experiential avoidance, values, cognitive defusion, committed action), and relapse prevention and maintenance. Most sessions will involve homework assigned to the adolescent and their parent/legal guardian(s) to encourage practice at home.
| Study group | Role | What they receive |
|---|---|---|
| Group Intervention | Experimental | 10-week parent-child multi-family group Receives: Behavioral: Transdiagnostic Group-Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Autonomic Symptom Score (self-report)
This is a 31 item self-report measure developed to assess autonomic symptoms (e.g., dizziness, orthostatic intolerance, nausea, sweating).
Measured: Baseline, 10 weeks, and 6-months
Change in Functional Disability Inventory (caregiver and self-report)
This is a measure that evaluates children's difficulty in physical and psychosocial functioning due to their physical health. The instrument consists of 15 items that assess self-perceptions of activity limitations during the past 2 weeks.
Measured: Baseline, 10 weeks, and 6-months
Change in Children's Depression Inventory (caregiver and self-report)
This is a 27-item self-report measure designed to assess cognitive, behavioral, and affective symptoms of depression.
Measured: Baseline, 10 weeks, and 6-months
Change in Screen for Childhood Anxiety Related Emotional Disorders (caregiver and self-report)
This measure is used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school refusal. The SCARED consists of 41 items.
Measured: Baseline, 10 weeks, and 6-months
Change in Transdiagnostic Youth/Parent Questionnaire
Our team developed these comprehensive questionnaires to assess transdiagnostic mechanisms in the present study. These questionnaires comprise full measures and/or subscales drawn from several well-validated and psychometrically-sound measures that are available as part of the public domain and/or that were provided for open access by the developers of the measure, and that have been previously designed and validated to measure each of the mechanisms of interest. These mechanisms include emotion regulation, experiential avoidance, sleep, peer acceptance/rejection, parenting, and information processing.
Measured: Baseline, 10 weeks, and 6-months
Change in Pain Coping Questionnaire (caregiver and self-report)
For the current study, this measure has been adapted to ask about "physical illness symptoms" rather than pain. The adapted measure asks adolescents/caregivers to indicate how often (1 = never to 5 = very often) they/their child used each of 39 coping strategies when responding to prompts such as, "When I am experiencing autonomic symptoms for a few hours or days, I…"
Measured: Baseline, 10 weeks, and 6-months
Satisfaction Questionnaire (caregiver and self-report)
This is an 8-item measure intended to assess satisfaction, perceived benefits, and likelihood of recommending the program. Items, which include "How would you rate the quality of care you have received?" are rated on a 1 to 4 Likert-scale.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start26 May 2017
- Primary completion1 Mar 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysautonomiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Malmberg, PhD, Principal investigator, University of Colorado/Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185247
- Sponsor's protocol ID
- 17-0470
- Status last verified
- Sep 2019
- First submitted
- 8 Jun 2017
- Last updated
- 26 Sep 2019
- 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 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Transdiagnostic Psychological Group Intervention for Pediatric Autonomic Dysfunction
- ClinicalTrials.gov ID
- NCT03185247
- Acronym / sponsor ID
- 17-0470
- Conditions
- Dysautonomia, Anxiety, Depression
- Keywords
- Transdiagnostic, POTS (Postural Orthostatic Tachycardia Syndrome), Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 14 Jun 2017 (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 proposed intervention is focused on developing and implementing a psychological approach incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction. The investigators hypothesize that their intervention will result in improvements in the transdiagnostic mechanisms specifically targeted by components of their intervention including sleep, information processing, and youth/parent experiential avoidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Intervention | Experimental | Behavioral: Transdiagnostic Group-Based Treatment10-week parent-child multi-family group |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Adolescent participants must be
- Participants must also:
- FDI scores must be greater than 12 (see Kashikar-Zuck et al., 2011 for an empirical rationale).
- Must have attended at least one day of school per week during the past month.
- On the measures of anxiety (SCARED) and depression (CDI), the adolescent's scale score must be above the "average" range based on T scores (CDI) or within the "clinical" range (SCARED).
Key exclusion criteria (13 listed)
- Adolescent participants;
- Parent/legal guardian(s) are
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 |
|---|---|---|
| Transdiagnostic Group-Based Treatment10 week 90-minute weekly therapy sessions including both the adolescent and caregiver. Treatment will consist of psychoeducation about dysautonomia, motivational interviewing techniques to promote readiness for change, support around lifestyle and behavioral changes, core CBT components (e.g., relaxation training, linking thoughts, feelings, and behaviors, minimizing catastrophizing thoughts, cognitive coping, and exposure), and components of ACT aiming to increase cognitive flexibility (e.g., mindfulness, experiential avoidance, values, cognitive defusion, committed action), and relapse prevention and maintenance. Most sessions will involve homework assigned to the adolescent and their parent/legal guardian(s) to encourage practice at home. | Behavioural | Group Intervention |
Primary outcome
Change in Composite Autonomic Symptom Score (self-report)
Time frame: Baseline, 10 weeks, and 6-months
This is a 31 item self-report measure developed to assess autonomic symptoms (e.g., dizziness, orthostatic intolerance, nausea, sweating).
Change in Functional Disability Inventory (caregiver and self-report)
Time frame: Baseline, 10 weeks, and 6-months
This is a measure that evaluates children's difficulty in physical and psychosocial functioning due to their physical health. The instrument consists of 15 items that assess self-perceptions of activity limitations during the past 2 weeks.
Change in Children's Depression Inventory (caregiver and self-report)
Time frame: Baseline, 10 weeks, and 6-months
This is a 27-item self-report measure designed to assess cognitive, behavioral, and affective symptoms of depression.
Change in Screen for Childhood Anxiety Related Emotional Disorders (caregiver and self-report)
Time frame: Baseline, 10 weeks, and 6-months
This measure is used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school refusal. The SCARED consists of 41 items.
Change in Transdiagnostic Youth/Parent Questionnaire
Time frame: Baseline, 10 weeks, and 6-months
Our team developed these comprehensive questionnaires to assess transdiagnostic mechanisms in the present study. These questionnaires comprise full measures and/or subscales drawn from several well-validated and psychometrically-sound measures that are available as part of the public domain and/or that were provided for open access by the developers of the measure, and that have been previously designed and validated to measure each of the mechanisms of interest. These mechanisms include emotion regulation, experiential avoidance, sleep, peer acceptance/rejection, parenting, and information processing.
Change in Pain Coping Questionnaire (caregiver and self-report)
Time frame: Baseline, 10 weeks, and 6-months
For the current study, this measure has been adapted to ask about "physical illness symptoms" rather than pain. The adapted measure asks adolescents/caregivers to indicate how often (1 = never to 5 = very often) they/their child used each of 39 coping strategies when responding to prompts such as, "When I am experiencing autonomic symptoms for a few hours or days, I…"
Satisfaction Questionnaire (caregiver and self-report)
Time frame: 10 weeks
This is an 8-item measure intended to assess satisfaction, perceived benefits, and likelihood of recommending the program. Items, which include "How would you rate the quality of care you have received?" are rated on a 1 to 4 Likert-scale.
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 26 Sep 2019.
- 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.
Jessica Malmberg, PhD principal investigator
University of Colorado/Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Group-Based Treatment in people with Dysautonomia and Anxiety, run by University of Colorado, Denver 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?
The sponsor lists 13 inclusion and 13 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 26 Sep 2019. 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 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 in Composite Autonomic Symptom Score (self-report) (time frame: Baseline, 10 weeks, and 6-months). The study lists 7 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 Sep 2019.