Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05096273
Status
Recruiting
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Conditions

  • Convulsion, Non-Epileptic

Eligibility Criteria

Sex
ALL
Age
11 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • ReACT — BEHAVIORAL
    ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations

Study Details

The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.

Key Dates

Start date
Oct 28, 2021
Status verified
Aug 2025
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CPT- Pain relief lotion
    During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectations. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.
  • Experimental: CPT- Pain sensitivity lotion
    During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectation. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.
  • Active Comparator: ReACT for PNES- Booster therapy sessions
    After completing the 12 therapy sessions, half of the participants will be randomized to receive 2 booster therapy sessions, 3 months and 9 months after the 12th ReACT treatment session.
  • Experimental: ReACT for PNES- No Booster therapy sessions
    After completing the 12 ReACT treatment sessions, half of the participants will be randomized to not receive the 2 booster therapy sessions.
  • No Intervention: Healthy Control
    Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.

Primary Outcome Measure

Magic and turbulence task [ Time Frame: 7 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sparks Center Office of Psychiatric ResearchBirminghamAlabama35294
Badhma Valaiyapathi, MD
[email protected]
2059754205
Aaron Fobian, PhD
[email protected]
2059342241

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By research site
Sparks Center Office of Psychiatric Research· Birmingham, AL

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