IMPROVE: Improving anxiety treatment by Modulating emotional memories PRiOr to in Vivo Exposure: A randomized controlled trial.

Phase 3

Recruiting

Conditions: panic disorder (involuntary reoccurring panic attacks)
10002861

Registration Number: NL-OMON52802

Lead Sponsor: niversiteit Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Treatment tolerability and adherence: actual drop-out during treatment (i.e.,<br /><br>EMDR/SC and CBT) and no show in CBT sessions, as well subjective measures:<br /><br>willingness to start exposure treatment, behavioral avoidance, and considered<br /><br>drop out (assessed after treatment).<br /><br>- Reductions in symptoms: anxiety (symptoms/diagnosis), related psychological<br /><br>problems (e.g., depression), functional impairments, quality of life, need for<br /><br>additional treatment after the trial.<br /><br><br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Predictors<br /><br>- Study parameters for patients are: extinction learning, intrusive memories<br /><br>from past and future events, clinical profiles, treatment expectancy,<br /><br>therapeutic alliance, intolerance of uncertainty, anxiety sensitivity, and<br /><br>worry.<br /><br><br /><br>- Study parameters for therapists are: demographics, trait anxiety, intolerance<br /><br>of uncertainty, attitudes towards evidence based practice and treatment<br /><br>manuals, treatment credibility, therapist prediction of clinical change and<br /><br>working alliance.<br /><br><br /><br>2. Mechanisms<br /><br>- Exposure process variables: threat expectancy and threat severity.<br /><br><br /><br>3. Cost-effectiveness<br /><br>- Direct and indirect cost within the healthcare system, as well as health<br /><br>related expenses for the patient and productivity losses. </p><br>