panic disorder with agoraphobia/panic attacks with phobia in open spaces
Conditions
Interventions
All patients receive exposure therapy (following a protocol) and part of the
patients will get additional study medication (DCS), the other part placebo.
Sponsors
Universiteit Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - adult patients (between 18 and 55 years old) with panic disorder with agoraphobia (PD+AGO), according to DSM IV diagnoses as established using a standardized interview. - patients are referred to the outpatient clinic of one of the three participating centers.
Exclusion criteria
Exclusion criteria: Patients with - comorbid psychiatric disorder (severe major depressive disorder, bipolar disorder, psychosis, dependence and/or abuse of alcohol/drugs during the past three months) - mental deficiency - inability to adequately read or speak Dutch - (a history of) neurological disease (i.e. neurovascular disease, movement disorders, seizures, dementia), renal or liver abnormalities - a history of allergies, adverse reactions or rash on medication - currently taking benzodiazepines during the day since benzodiazepines might hamper therapy effect (use of stable dosage of evening medication is allowed) - pregnancy or breastfeeding at the time of the study (in case of possible pregnancy, a pregnancy test will be offered) - use of isoniazide - use of variable dosages of antidepressiva (SSRI's or TCA's). (The use of a fixed dosage is NOT an exclusion criterium, but will be registered) - a unsuccessful evidence based behavioral therapy for panic disorder during the past 12 months (therapy resistant patients)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - PDSS scores (the Panic Disorder Severity Scale, Shear et al. 1997), measure will be taken before sessions 4 and 8, after session 12 and after 3 and 6 months follow up. - SUDS scores (the Subjective Unit of Distress Scale, Wolpe 1969), measured weekly during the session. | — |
Secondary
| Measure | Time frame |
|---|---|
| De secondary outcome measurements will be taken before sessions 4 and 8, after session 12 and after 3 and 6 months follow up: - Fawcett side effects checklist (Fawcett, 1987). - Positive and Negative Affect Shedule (PANAS). - Mobility Inventory (MI; Chambless, 1985). - Agoraphobis Cognitions Questionnaire (ACQ; Chambless, 1985) - Beck anxiety Inventory (BAI; Becl. 1990) - EQOL (Quality of Life; WHOQOL Group, 1996). - Beck depression inventory II (BDI-II, 1987). - Outcome questionnaire (OQ). - Body symptoms Questionnaire (BSQ,Chambless, 1985). - Sheenhan Disability Scales (SDS; Sheehan, 1998). - TiC-P (Hakkaart-van Rooijen, 2002) - The degree of extinction during the extinction task. | — |
Countries
Netherlands
Outcome results
None listed