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Table 1 Primary and secondary measures to examine goal 1: investigate whether EMDR therapy + exposure therapy vs supportive counseling + exposure therapy improves treatment efficacy, tolerability, and adherence

From: Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder: study protocol for a multicenter randomized controlled trial (IMPROVE)

 

T1

Tp1

T2

Tp2

T3

FU1

FU2

Demographics and assessment of eligibility for inclusion

 Demographics (8)

X

-

-

-

-

-

-

 Mini-International Neuropsychiatric Interview Simplified (MINI-S-DSM-5)

X

-

-

-

-

X

-

Adherence rates

 Drop out and no-show

-

X

-

X

-

-

-

Primary outcome: Efficacy panic disorder symptomatology

 Panic Disorder Severity Scale (PDSS-SR)*(7)

X

X

X

X

X

X

X

 Panic Agoraphobia Scale (PAS) (14)

X

-

X

-

X

X

-

 Subtle Avoidance Frequency Examination- Agoraphobia (SAFE-A) (40)

X

-

X

-

X

X

X

 Fear Questionnaire- Agoraphobia (FQ-A) (5)

X

-

X

-

X

X

X

 Bodily Sensation Questionnaire (BSQ) (17)

X

-

X

-

X

X

X

Secondary outcomes: Tolerability of exposure therapy

 Exposure willingness (1)

-

X

-

X

-

X

X

 Intention to stop treatment (1)

-

-

X

-

X

-

-

 Behavioral avoidance task

-

-

-

X

-

-

-

Secondary outcomes: Related symptomatology and functional impairment

 General Anxiety Disorder 7 (GAD 7) (7)

X

X

X

X

X

X

X

 Patient Health Questionnaire (PHQ-9) (9)

X

X

X

X

X

X

X

 Work and Social Adjustment Scale (WSAS) (5)

X

-

X

-

X

X

X

Secondary outcomes: Treatment satisfaction

 Client Satisfaction Questionnaire (CSQ-8) (8) and Net Promotor Score (NPS) (1)

-

-

X

-

X

-

-

  1. Note: (nr.) number of items, T1 Baseline, Tp1 Treatment phase 1 (EMDR therapy or supportive counseling) T2 Between-treatments, Tp2 Treatment phase 2 (exposure therapy), T3 Post-treatments, FU1 follow-up 1, FU2 follow-up 2