To evaluate the effectiveness of the cognitive based behavioral psychotherapy as given by the VALK Foundation by means of psychophysiological measures.
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
By means of the electrocardiogram (ECG) and the impedance cardiogram (ICG) it
is possible to assess heart rate (HR), heart rate variability (HRV),
respiratory sinus arrythmia (RSA) and the pre-ejection period (PEP). From these
variables, sympathetic and parasympathetic nervous system activity can be
derived. These measures are well suited to show the physiological responses to
fear and anxiety.
Secondary outcome
A secondary point in question in this study is if the relation between
subjective experience and psychophysiological measures, especially during in
vivo exposure, is modulated by personality, cognitive coping style and worry
behavior. For this purpose two additional questionnaires will be added. The
PSWQ measures the tendency for excessive and uncontrollable worry. The BIS/BAS
questionnaire measures two personality traits.
Background summary
The VALK Foundation is a collaborative venture by the University of Leiden, KLM
Royal Dutch Airlines and Amsterdam Airport Schiphol. The foundation was set up
in 1989, and is devoted to treating fear of flying on the basis of many years
of scientific research.
Study objective
To evaluate the effectiveness of the cognitive based behavioral psychotherapy
as given by the VALK Foundation by means of psychophysiological measures.
Study design
This study is a randomized controlled trial in combination with a correlational
design.
70 persons with fear of flying will after a diagnostic assesment randomly be
assigned to either the normal waiting period between intake and therapy or to a
'fast track' in which the normal waiting period between intake and first
therapy session is reduced from 5 to 6 weeks to 1 to 2 weeks. Both groups
receive exactly the same therapy normally used at VALK, i.e intake, a couple of
individual therapy sessions followed by a two-day grouptherapy.
Subjective and physiological responses to several flying related videos will be
measured just before and after the therapy. The people in the normal waiting
period group will receive an extra pretreatment measurement just before the
first individual therapy session. Therefore the normal waiting period group
members have measurement before and after the waiting period in which no
therapy is given. Any changes in this waiting period can be compared to changes
(due to therapy) found in the 'fast track' therapy group.
Study burden and risks
There is no risk associated with participating in this study. The burden is
mainly the extra time involved. Generally the apparatus used does not hinder
the client.
Sandifortdreef 1a
2333 ZZ Leiden
Nederland
Sandifortdreef 1a
2333 ZZ Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Fear of Flying
Exclusion criteria
Beta blockers
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL13905.058.07 |