Cannabidiol enhancement of exposure therapy in patients with phobias.

Recruiting

Conditions: Phobic anxiety disorders, fobische angststoornissen

Registration Number: NL-OMON28305

Lead Sponsor: trecht University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

Patients will be invited to participate when they fulfill the diagnoses mentioned here-above, and provided that they have not or only partially responded to evidence-based treatment (either a full treatment with an SSRI (at least 12 weeks of sufficient dose) and/or at least 10 sessions of cognitive behavioural therapy) in the year preceding referral to the outpatient clinics.

Exclusion Criteria

Patients with co-morbid severe psychiatric disorders diagnosed with the SCID-I (severe major depressive or bipolar disorder, psychosis, dependence of alcohol and drugs), with mental deficiency (IQ<80) or inability to adequately read or speak Dutch will be excluded (assessed using a neuropsychological Test (NLV; Schmand et al. 1992), as well as persons with (a history of) epilepsy or brain damage, renal or liver abnormalities, and a history of allergies to medication (adverse reactions or rash).
Regular use of benzodiazepines and of antipsychotics will be an exclusion criterion, contunued use of SSRIs will be permitted, provided that dosages are kept constant during the study. Lastly pregnant or breastfeeding women will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the fear questionnaire (FQ, Marks and Mathews 1979).

Secondary Outcome Measures

Name	Time	Method
At all timepoints clinical questionnaires are administered: Beck Anxiety Inventory, Beck Depression Inventory, Body Sensations Questionnaire, Social Phobia and Anxiety Inventory, Treatment inventory of costs in Psychiatric patients, and EuroQol five dimensions. This also includes the Panic Disorder Severity Scale, Mobility Inventory and Agoraphobic Cognitions Questionnaire for patients with panic disorder with agoraphobia, and the Liebowitz Social Anxiety Scale for social phobia patients. The Clinical Global Impression, Subjective Units of Distress Scale and assessment of the quality of the sessions are administered weekly. Furthermore, an experimental assessment of fear learning using a fear conditioning paradigm is done, and blood is drawn twice to investigate CBD blood levels and (epi)genetics.