Clinical trial NCT06570954: Retraining and Control Therapy (ReACT)- Adults
Official title: Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Adult Functional Seizures (FS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Convulsion, Non-Epileptic
Keywords: ReACT
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants 19 years and older with PNES will be prospectively enrolled. Participants will be randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period after which they will receive 12 sessions of Retraining and Control Therapy (ReACT).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Patients with PNES who are treated at the UAB FND clinic will have the option to complete additional study procedures. Participants will come to our laboratory for a baseline visit and 4 follow-up visits. After the baseline visit, participants are randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period. After the assigned waiting period participants will receive 12 sessions of Retraining and Control Therapy (ReACT) as usual in the FND clinic. Therapy sessions are completed via telehealth.

During the baseline visit, participants complete several questionnaires assessing demographics, mood and suicidality, relationships with friends and family, as well as past and current PNES symptoms. They will also complete the childhood trauma questionnaire. The treatment targets (sense of control and catastrophic symptom expectations) are measured by the magic and turbulence computer task and pain tolerance, PCS and cortisol response to the CPT, respectively. PNES diaries are completed to assess PNES frequency over the previous 30 days. Participants randomized to the 3-month or 6-month waiting period conditions will log weekly PNES episodes until the start of therapy. Participants will also complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests. The baseline lab visit lasts about 2.5 hours. Saliva is collected over 1 time point before and 3 time points after the CPT to measure cortisol response to the CPT. Participants also collect 2 saliva samples 24 hours later to serve as a baseline outside of the laboratory setting. Participants will also be given a Respironics Actiwatch Spectrum Pro to track sleep and PNES episode severity and frequency for the 1 week following the baseline visit. 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.

After the baseline visit, participants are scheduled for the first of their 12 intervention sessions of ReACT depending on the waiting period they are assigned to. This first session lasts a maximum of two hours, and the following 11 sessions are scheduled weekly and last one hour. All 12 therapy sessions are conducted as telehealth visits via HIPAA-compliant platform. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 12th therapy session to track sleep and PNES episode severity and frequency for the 1 weeks between the 12th therapy session and the lab visit one week after the 12th treatment session.

Follow-up at 7 days after treatment is conducted to perform tasks and complete follow-up assessment of the targets (sense of control and catastrophic symptom expectations), PNES frequency, and questionnaires. Each of these sessions last 2 hours. Participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests at the lab visit at each of these visits. Participcants will complete 3 follow-up visits via Zoom at 2 months, 6 months and 12 months after treatment to assess long-term PNES outcomes and questionnaire data. These appointments will last 1 hour. PNES frequency will be measured from 30 days before treatment to 12 months after treatment through PNES diaries completed by the participant.

Eligibility criteria: Inclusion Criteria:

* 19 years and older.
* Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.

Exclusion Criteria:

* Comorbid Epilepsy
* Less than 4 PNES per month
* Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
* Participation in other therapy during the study
* Severe intellectual disability
* Severe mental illness (delusions/hallucinations)

Exclusion for CPT:

• Blood pressure \>130/80 mmHg

Primary outcomes:
measure: Magic and turbulence task
timeFrame: 6-12 months
measure: Pain catastrophizing scale- situation specific
timeFrame: 6-12 months
measure: Pain tolerance (time)
timeFrame: 6-12 months
measure: Salivary Cortisol
timeFrame: 6-12 months
measure: Pain Rating Scale
timeFrame: 6-12 months
measure: Stroop task
timeFrame: 6-12 months
Secondary outcomes:
measure: PNES Frequency
timeFrame: 16-22 months
measure: Pain Catastrophizing Scale (PCS)- General
timeFrame: 6-12 months
measure: Anxiety Sensitivity Index (ASI)
timeFrame: 16-22 months
measure: Shipley
timeFrame: At Baseline
measure: Quality of Life in Epilepsy (QOLIE-31)
timeFrame: 16-22 months
measure: Sense of Agency Question
timeFrame: 16-22 months
measure: LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire
timeFrame: 16-22 months
measure: WHO Disability Assessment Schedule (WHODAS2.0)
timeFrame: 16-22 months
measure: The Impact on Family Scale
timeFrame: 16-22 months
measure: Childhood Trauma Questionnaire
timeFrame: At baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 16-22 months
measure: The Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 16-22 months
measure: Healthcare Related Stigma Questionnaire
timeFrame: At baseline
measure: Flanker Inhibitory Control and Attention Subtest
timeFrame: 6-12 months
measure: List Sorting Working Memory Subtest
timeFrame: 6-12 months
measure: Pattern Comparison Processing Speed Subtest
timeFrame: 6-12 months
measure: Dimensional Change Card Sort Subtest
timeFrame: 6-12 months
measure: Picture Sequence Memory Subtest
timeFrame: 6-12 months
measure: Sleep Duration
timeFrame: 4-10 months
measure: Sleep Efficiency
timeFrame: 4-10 months
measure: Sleep Onset Latency
timeFrame: 4-10 months
measure: Sleep - Bed Time
timeFrame: 4-10 months
measure: Sleep - Wake Time
timeFrame: 4-10 months
measure: PNES Episode Duration
timeFrame: 4-10 months
measure: Rosenberg Self-esteem scale
timeFrame: 16-22 months
measure: Beaver's Self-Report Family Inventory
timeFrame: At Baseline
measure: FND Locus of Control: Multidimensional Health Locus of Control (MHLC) Scales
timeFrame: 16-22 months
measure: Dysfunctional Attitude Scale (DAS-9)
timeFrame: 16-22 months
measure: Mishel Uncertainty in Illness Questionnaire-Community Form (MUIS-C)
timeFrame: 16-22 months
measure: Revised Helping Alliance Questionnaire- II
timeFrame: 16-22 months
measure: The Credibility/Expectancy Questionnaire
timeFrame: 16-22 months
measure: Session Summary Sheet (SSS)
timeFrame: 6-12 months
measure: Illness Cognitions Scale
timeFrame: 16-22 months
measure: Other FND Symptoms Questionnaire
timeFrame: 16-22 months
measure: Dissociative Experiences Scale
timeFrame: 16-22 months
measure: Life Stress Inventory
timeFrame: 16-22 months
measure: Somatoform Dissociative Questionnaire
timeFrame: 16-22 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Aaron Fobian, PhD
role: PRINCIPAL_INVESTIGATOR
References: