Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes