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Implementation of Transdx Group for POTS

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Depression
Anxiety
Dysautonomia

Treatments

Behavioral: Transdiagnostic Group-Based Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03185247
17-0470

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

13 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Group Intervention
Experimental group
Description:
10-week parent-child multi-family group
Treatment:
Behavioral: Transdiagnostic Group-Based Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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