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ID
Source
Brief title
Health condition
Panic disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be severity of PD at follow up, measured with the Agoraphobic Cognitions Questionnaire (ACQ, Dutch version) and the Body Sensations Questionnaire (BSQ, Dutch version).
Secondary outcome
The secondary outcome measure will be severity of symptomatology and stressors of psychopathology, measured with the Symptom Questionnaire-48 (SQ-48) and related aspects as impact of future events (IFES).
Background summary
An estimated 2-3% of the general population suffers from a panic disorder (PD). A PD is characterized by recurrent, unexpected panic attacks followed fear of physical sensations, catastrophic interpretations of these sensations, and avoidance behavior because of the concern about their possible reappearance (American Psychiatric Association, 2013).
Nowadays, cognitive behavioral therapy (CBT) is considered to be the most effective intervention for patients with a panic disorder with or without agoraphobia. Response rates range from 38% to 90%, so a substantial part of patients do not respond to CBT. Unfortunately, there is little information which psychological treatment is needed if this CBT is not resulting in a clinical relevant symptom reduction during treatment.
In the current guidelines (Van Balkom et al., 2013), no clear suggestions are made which available treatment options there are when a patient does not respond to CBT. Eye Movement Desensitization and Reprocessing (EMDR) is a treatment method for patients who suffer from past traumatic experiences . It can be argued that EMDR can be helpful in the treatment of PD because: 1) panic attacks can be experienced as life threatening and therefore traumatic; 2) panic memories specific to PD resemble traumatic memories seen in posttraumatic stress disorder and 3) PD can develop after one or more distressing life events.
The evidence for EMDR as first choice treatment for PD is scarce but EMDR as second step intervention might be effective for people suffering from PD and who do not respond to CBT as first step treatment. This study examines EMDR as second step intervention for patients who do not respond to CBT.
The aim of this naturalistic uncontrolled pilot study treatment project is to generate knowledge about the incremental effect of EMDR, for patients who do not respond significantly to an outpatient CBT for panic disorder.
Study objective
The aim of this study is to critically examine the effect of EMDR added as a second step intervention to CBT in patients with PD.
Study design
Using a multiple baseline single case series design, 15 patients with panic disorder first enter a baseline phase (CBT treatment according to treatment guidelines), followed by a 4 weeks phase wherein no treatment is given (control phase). Hereafter patients start the active treatment phase (6 sessions EMDR), followed by a 12 weeks follow up. Panic disorder severity is weekly assessed using the ?? (primary outcome measure) from start baseline to end of follow up phase. Secondary outcome measures (ACQ; BSQ; OCI-R, SQ-48) are completed at start baseline, after treatment, and after 3 months FU. Finally, actual drop-out is monitored.
Intervention
Step 1: CBT
Step 2: EMDR
Inclusion criteria
1. a PD (with or without agoraphobia) as main classification according to DSM-5 based on the SCID-5-S (APA, 2017)
2. age above 18 years
3. sufficient mastery of Dutch to complete the questionnaires
4. less than 33.33 % symptom reduction after nine treatment sessions of CBT
5. stable medication use (type and dosage) for at least four weeks and willingness of both patient and treating physician/psychiatrist to keep it stable during the study period
6. use of anxiolytic medication is allowed, even reduction in intake this medication to engage better in treatment attending any other psychological treatment during the study is not allowed.
Exclusion criteria
1. very severe depression (QIDS-C ≥ 20)
2. acute suicidality
3. current Post Traumatic Stress Disorder (DSM-5)
4. severe alcohol or substance dependence (DSM-5)
5. lifetime psychotic disorder (DSM-5).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7591 |
| Other | HSK/UU : FETC18-043 |