Phobia, Specific
Conditions
Brief summary
The purpose of this study is to evaluate whether valproic acid in combination with fear memory reactivation is useful to enhance treatment stability of exposure therapy for specific phobia.
Detailed description
* There will be one screening visit (visit 1), one intervention visit (visit 2) and one follow-up visit (90 days after visit 2) (visit 3). * On visit 2 all participants will undergo 30 min exposure therapy in virtual reality with pre-defined spider situations. * Duration for an individual participant will be at most 15 weeks depending on the time passing between screening (visit 1) and intervention visit (visit 2). * Change in phobic fear to baseline (visit 1) will be assessed on 90 day follow-up (visit 3). * Documentation of all study relevant source data of every study participant will be done by completing the study specific electronic case report forms (eCRF, SoSci Survey) and study specific case report forms on paper (Adverse Events, Serious Adverse Events and concomitant medication). Data in the eCRF can be validated for completeness and discrepancies automatically. An audit trail system maintains a record of initial entries and changes (reasons for changes, time and date of changes, user identification of entry and changes). * Quality insurance will be done by an external site monitoring (including study progress, accuracy and completeness of eCRF, fulfillment of protocol requirements, applicable local authority regulations and investigator's obligations). * Monitoring includes 100% of safety parameters, primary endpoints, informed consent documents and the Trial Master File on the Initiation Visit and on Close Out. * Standard Operating Procedures to address study activities such as patient recruitment, informed consent, study interventions, data collection, data management, data analysis, and reporting for adverse events exist.
Interventions
DRUGValproic Acid
Once oral administration of 500mg before exposure therapy.
DRUGPlacebo
Once oral administration of 500mg before exposure therapy.
BEHAVIORALFear reactivation
Fear reactivation before exposure therapy.
BEHAVIORALNo fear reactivation
No fear reactivation before exposure therapy.
Sponsors
Prof. Dominique de Quervain, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* DSM-IV diagnosis of specific phobia (animal type: spider) * BAT score (at screening) between 1 and 7 points * Physically healthy * Normotensive (90/60-140/90 mmHg) * Male or female * Aged between 18 and 40 years * Native or fluent German-speaking * Females have to be on effective birth control
Exclusion criteria
* Other axis I disorder except a further comorbid phobic disorder * Concurrent psychotherapy or pharmacotherapy * Previous exposure-based therapy for specific phobia * Parallel participation in another study * Body weight less than 50kg * Long-term medication intake * Substance abuse * 5 or more cigarettes a day and/or inability of being abstinent for at least 5 hours * Pregnancy or breast-feeding * Kinetosis * History of coagulation disease * History of gastrointestinal disease * Laboratory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in performance in Behavioral Approach Test (BAT) in real-life (in vivo) | Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention |
Secondary
| Measure | Time frame |
|---|---|
| Performance in working and recognition memory of pictures task | Follow up (visit 3: 90 days after visit 2: intervention) |
| Change in performance during exposure in virtuo quantified by eye tracking | Intervention (visit 2: 7-21 days after visit 1: baseline) |
| Change in subjective reactions during exposure in virtuo quantified by subjective units of discomfort (SUD) ratings | Intervention (visit 2: 7-21 days after visit 1: baseline) |
| Change in psychophysiological reactions during exposure in virtuo quantified by EDA and HR | Intervention (visit 2: 7-21 days after visit 1) |
| Change in clinical relevance of phobic symptoms measured by Diagnostic Interview for Psychiatric Disorders (DIPS), section for specific phobia | Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention) |
| Change in performance in BAT in virtual reality (in virtuo) | Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention |
| Change in subjective reactions in BAT in virtual reality (in virtuo) | Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention |
| Change in psychophysiological reactions in BAT in virtual reality (in virtuo) | Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention |
| Change in subjective reactions to fear-related picture cue presentation quantified by visual analog scales (VAS) for valence, arousal and fear | Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention |
| Change in psychophysiological reactions to fear-related picture cue presentation quantified by electrodermal activity (EDA), heart rate (HR), startle response | Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention |
| Valence, arousal, and mood ratings of pictures of working and recognition memory of pictures task | Follow up (visit 3: 90 days after visit 2: intervention) |
| Change in strength of phobic fear quantified by self-report questionnaires | Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention) |
| Change in mood and state-anxiety quantified by self-report questionnaires | Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention) |
Other
| Measure | Time frame |
|---|---|
| Heart rate | Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention) |
| VAS of headache, stomach pain, nausea, fatigue, dizziness, drowsiness muscle fatigue, and motivation. | Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention) |
| Blood pressure | Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention) |
| Adverse Events | Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention) |
Countries
Switzerland
Outcome results
None listed