Retraining and Control Therapy (ReACT)- Adults

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06570954
Status
Recruiting
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Conditions

  • Convulsion, Non-Epileptic

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not 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. ReACT consists of 12 sessions of therapy focused on teaching patients to regain control of their body through managing thoughts and behaviors that reinforce the PNES and return to previous activities. The PNES is explained as behaviors learned through classical and operant conditioning.

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 adult psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 19 years and older participants diagnosed with PNES who are treated at UAB FND clinic will engage in twelve sessions of ReACT. Participants will be randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period. 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 (PCS), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment and 7 days after the 12th treatment session. Participants randomized to the 3-month and 6-month waiting period will also complete these measures one additional time immediately before the beginning of their waiting period. Long term follow-up assessments will occur at 2 months, 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment. Participants randomized to the 3-month or 6-month waiting period conditions will log weekly PNES episodes until the start of therapy.

Key Dates

Start date
Apr 10, 2025
Status verified
Jun 2026
Primary completion
Aug 1, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Active Comparator: No waiting period
    At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) with no waiting period.
  • Active Comparator: 3-month waiting period
    At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) after a waiting period of 3 months.
  • Active Comparator: 6-month waiting period
    At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) after a waiting period of 6 months.

Primary Outcome Measure

Magic and turbulence task [ Time Frame: 6-12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Michelle Bumpers
[email protected]
205-996-6425

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By research site
University of Alabama at Birmingham· Birmingham, AL

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