Implementation of Transdx Group for POTS

NCT ID: NCT03185247

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-26
• Study Completion Date: 2019-09-01

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Intervention

10-week parent-child multi-family group

Group Type: EXPERIMENTAL

Transdiagnostic Group-Based Treatment

Intervention Type: BEHAVIORAL

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.

Interventions

Transdiagnostic Group-Based Treatment

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adolescent participants must be

1. between the ages of 13-18 years old,

2. english speaking, and

3. have been diagnosed with autonomic dysfunction, dysautonomia, orthostatic intolerance, and/or POTS.

• Participants must also:

1. endorse symptoms of autonomic dysfunction on the COMPASS 31 (measures are described below), and show

2. moderate functional impairment, and/or

3. 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.

Exclusion Criteria

• Adolescent participants;

1. wards of the state,

2. endorse active homicidal or suicidal ideation,

3. have an intellectual disability, a pervasive developmental disability or significant developmental delay,

4. endorse an active substance use disorder, and

5. are currently participating in individual or group psychotherapy.

6. do not have in-network health insurance that covers Health and Behavior interventions, or

7. are unable to self-pay.

• Parent/legal guardian(s) are

1. unwilling to participate in the study,

2. are non-English speaking, or

3. have an intellectual disability, a pervasive developmental disability or significant developmental delay, and/or

4. do not have legal custody of the adolescent participant.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Malmberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado/Children's Hospital Colorado

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

17-0470

Identifier Type: -

Identifier Source: org_study_id