Phobic anxiety disorders
Conditions
Interventions
All patients receive exposure therapy following the treatment protocol. One
group will additional receive 300 mg cannabidiol before ERP, and one group
placebo.
cannabidiol
Cognitive Behavioral Therapy (CBT)
phobic anxiety disorders
Sponsors
Universiteit Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients will be invited to participate when they fulfill the DSM IV criteria for a diagnosis of either generalized social phobia or panic disorder with agoraphobia, and provided that they have not or only partially responded to treatment in the year preceding referral to the outpatient clinics. We will use the following definition of patients who only partially responded to treatment: a) having been treated in the past year for the same symptoms (psycho- or pharmacotherapy) and/or b) specifically referred to second-line treatment
Exclusion criteria
Exclusion criteria: Patients with co-morbid severe psychiatric disorders (severe major depressive or bipolar disorder, psychosis, dependence of alcohol and drugs), with mental deficiency (IQ32) or inability to adequately read or speak Dutch will be excluded, as well as persons with (a history of) epilepsy, cardiovascular disease or brain damage, renal or liver abnormalities, and a history of allergies on medication (adverse reactions or rash). Regular use of benzodiazepines and of antipsychotics will be an exclusion criterion, since benzodiazepine use might hamper the ERP effect. Use of serotonergic antidepressants will be permitted, provided that dosages are kept constant during the study. Use of drugs (among others THC, XTC, cocaine) of is not permitted from 2 months before the start of the treatment until the end of the study. Lastly pregnant or breastfeeding women will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main parameter regarding treatment effects on anxiety symptoms are measured at baseline, after every ERP-session, in the week after session 4 (at mid-treatment), in the week after session 8 (at post treatment) and at 3, and 6 months follow up. Secondary parameters (effects on other symptom questionnaires, on fear extinction in a laboratory assessment, learning and habituation and effects on health care use, costs, quality of life and loss of work productivity) are measured at baseline, and directly post treatment (one week after 8 exposure sessions), and a part of these are also monitored at 3, and 6 months follow-up. Further, 10 ml of blood to extract DNA will be drawn through venapuncture twice, before the first and the eight treatment session, in order to determine CBD-related genetic polymorphisms, to establish blood cannabidiol levels, and to perform epigenetic analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| n.a. | — |
Countries
The Netherlands
Outcome results
None listed