Contact information
Type
Scientific
Primary contact
Mr Rod Lambert
ORCID ID
Contact details
School of Occupational Therapy & Physiotherapy
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 593096
r.lambert@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Lambert HSR/0500/1
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the cost-effectiveness of an Occupational Therapists led lifestyle treatment for patients presenting with panic disorder, compared with routine GP care. It will be monitored by a project board consisting of experts in clinical trials, panic disorder, general practice, occupational therapy and health economics, from Norfolk, Cambridgeshire and Oxford. The subject group will be patients presenting with panic disorder, with or without agoraphobic symptoms, at participating GP surgeries, between the ages of 16 and 65 years. Following a pilot study of 10 patients in each study arm, the main sample size followed through to analysis will be 85 in each arm of the study.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Panic disorder
Intervention
1. Occupational therapy led lifestyle treatment that assesses, plans and monitors lifestyle change over 10 intervention sessions
2. Routine GP care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
2. Self-report diary sheets recording frequency and severity of panic attacks
3. Beck Depression Inventory ll
4. Beck Anxiety Inventory
5. Lifestyle Behaviour Index
6. 36-item short form health survey (SF-36)
7. Fear Questionnaire
Secondary outcome measures
Self-completion diary sheets which will record:
1. Fluid intake
2. Diet
3. Smoking
4. Exercise
5. Mood
Overall trial start date
01/05/2000
Overall trial end date
01/03/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients presenting with panic disorder between 16 and 65 years of age
2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for panic disorder (from Anxiety Disorders Interview Schedule [ADIS-IV])
3. Panic is not considered secondary to another health problem
4. Stable medication for anxiety/depression for one month prior to referral
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
No identifiable lifestyle factors above a stated baseline level.
Recruitment start date
01/05/2000
Recruitment end date
01/03/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Occupational Therapy & Physiotherapy
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Eastern (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/17014912
Publication citations
-
Results
Lambert RA, Harvey I, Poland F, A pragmatic, unblinded randomised controlled trial comparing an occupational therapy-led lifestyle approach and routine GP care for panic disorder treatment in primary care., J Affect Disord, 2007, 99, 1-3, 63-71, doi: 10.1016/j.jad.2006.08.026.