panic disorder (involuntary reoccurring panic attacks)
Conditions
Interventions
Two standardized interventions will be used before CBT: EMDR and SC. We will
use the standard Dutch EMDR 2020 protocol from the Dutch EMDR society. SC will
serve as a credible intervention that cont
Sponsors
Universiteit Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients of >18 years of age - Sufficient mastery of the Dutch language to complete questionnaires - Ability to understand questionnaires and written informed consent - Meeting DSM-5 criteria for primary panic disorder (with or without agoraphobia) (assessed with MINI-S-DSM-5) - Stable medication for at least six weeks and willingness by the patient and physician to keep the medication stable during the study period (until FU1). The use of sedating medication (e.g. benzodiazepines) is no contraindication, however participants are strongly advised not to use sedating medication prior to- or after treatment sessions and subsequent days. Use of sedating medication will be registered - Willingness and ability not to be under the influence of alcohol or drugs twenty-four hours before and after each session, general use will be discouraged as much as possible
Exclusion criteria
Exclusion criteria: - Neurological disorder - Acute or recent history of suicide attempts according to the M.I.N.I. section C - Self-reported visual or auditory impairments that could hinder treatment - Self-reported epilepsy, pregnancy, or heart disease (these are common exclusion criteria for using a fear conditioning task, see 8.3.3) - Not willing or able to fill in (online) questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Treatment tolerability and adherence: actual drop-out during treatment (i.e., EMDR/SC and CBT) and no show in CBT sessions, as well subjective measures: willingness to start exposure treatment, behavioral avoidance, and considered drop out (assessed after treatment). - Reductions in symptoms: anxiety (symptoms/diagnosis), related psychological problems (e.g., depression), functional impairments, quality of life, need for additional treatment after the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Predictors - Study parameters for patients are: extinction learning, intrusive memories from past and future events, clinical profiles, treatment expectancy, therapeutic alliance, intolerance of uncertainty, anxiety sensitivity, and worry. - Study parameters for therapists are: demographics, trait anxiety, intolerance of uncertainty, attitudes towards evidence based practice and treatment manuals, treatment credibility, therapist prediction of clinical change and working alliance. 2. Mechanisms - Exposure process variables: threat expectancy and threat severity. 3. Cost-effectiveness - Direct and indirect cost within the healthcare system, as well as health related expenses for the patient and productivity losses. | — |
Countries
Netherlands
Outcome results
None listed