Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
NCT05096273, Not applicable, Recruiting, University of Alabama at Birmingham
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES | ClinicalTrials.gov |
| NCT number | NCT05096273 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 68 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Alabama at Birmingham | ClinicalTrials.gov |
| Conditions | Convulsion, Non-Epileptic | ClinicalTrials.gov |
| Interventions | ReACT | ClinicalTrials.gov |
| First posted | 2021-10-27 | ClinicalTrials.gov |
| Last updated | 2026-08-26 | ClinicalTrials.gov |
Registered outcomes 36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Magic and turbulence task | 7 months | Measure of perceived sense of control in response to tasks in which control is manipulated; Greater negative numbers indicate improved understanding of control. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Primary | Pain catastrophizing scale for children- situation specific | 7 months | Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done after performing Cold Pressor Test. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Primary | Pain tolerance (time) | 7 months | Measures catastrophic symptom expectations. Measured by the total time the participant can keep their hand in cool water during the Cold Pressor Test. Shorter time indicates less pain tolerance. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Primary | Salivary cortisol response to Cold Pressor Test | 7 months | Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Primary | Pain Rating Scale | 7 months | Measures perceived pain severity after the CPT; score ranges from 0-100. Higher scores indicate greater perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Primary | Stroop task | 7 months | Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | PNES Frequency | 16 months | Measured by Psychogenic Non-epileptic Seizures (PNES) diary, including frequency, premonitory symptoms, description of PNES symptoms and duration. Assessed 30 days before treatment to 12 months after the 12th treatment session (about 16 months total). Frequency and severity also measured by Respironics Actiwatch Spectrum Pro. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total). | ClinicalTrials.gov |
| Secondary | Pain Catastrophizing Scale for Children (PCS-C)- General | 16 months | Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done before performing Cold Pressor Test. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | Children's Somatic Symptoms Inventory (CSSI-24) | 16 months | General somatic symptom complaints, higher scores indicate greater somatic complaints. Scores range from 0-140. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | Anxiety Sensitivity Index (ASI) | 16 months | Assesses catastrophic symptom expectations; higher scores indicate greater anxiety. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | Shipley | At baseline | Assesses verbal IQ; higher scores indicate greater verbal IQ. Completed by participant at the baseline visit. | ClinicalTrials.gov |
| Secondary | Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) | 16 months | Assesses health-related quality of life for children with epilepsy (used in PNES participants by instructing them to consider their PNES when asked about "seizures"); score ranges from 0-100, higher scores indicate better functioning and well-being. Completed by participant. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | Sense of Agency Scale | 16 months | Single question which asks "How much control do you believe you have over your PNES?". Completed by participant. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire Physical Symptoms | 16 months | Measures symptom severity in children; higher scores indicate greater symptom severity. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | Functional Disability Inventory (FDI) | 16 months | Completed by child and parent to measure physical functioning and disability in children with chronic pain; score ranges from 0-60, higher scores indicate greater perceived functional disability. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | The Impact on Family Scale | 16 months | Assesses parental perceptions of the impact of a child's medical condition on the family; higher scores indicate greater financial burden on the family. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | Childhood Trauma Questionnaire | At Baseline | History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect. Completed by participant at baseline visit. | ClinicalTrials.gov |
| Secondary | The Revised Children's Anxiety and Depression Scale (RCADS) | 16 months | Measures anxiety and depression symptoms in children; higher scores indicate increased symptom severity. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | The Columbia Suicide Severity Rating Scale (C-SSRS) | 16 months | Measure that addresses the full range of suicidal thoughts and behaviors that suggest a person is at heightened risk of committing suicide. Completed by trained research study coordinator. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total). | ClinicalTrials.gov |
| Secondary | Healthcare Related Stigma Questionnaire | At Baseline | Measures stigma in patients and their parents related to their interaction with health care providers; higher scores indicate greater stigma. Completed by participant and parent. Assessed at baseline visit. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41769205 | DERIVED | PubMed |
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R61MH127155 | Retraining and Control Therapy (ReACT): Sense of control and catastrophic symptom expectations as targets of a cognitive behavioral treatment for pediatric psychogenic non-epileptic seizures (PNES) | FOBIAN, AARON D | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL INSTITUTE OF MENTAL HEALTH | 2021 to 2022 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Dimensional Change Card Sort | Secondary outcome | ConductCognition |
| Pattern and Letter Comparison | Secondary outcome | ConductCognition |
| Picture Order Memory Test | Secondary outcome | ConductCognition |
| Size Order Memory Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)