A randomised controlled trial of occupational therapy led lifestyle treatment routine general practitioner treatment of panic disorder presenting in primary care

ISRCTN	ISRCTN51562655
DOI	https://doi.org/10.1186/ISRCTN51562655
Secondary identifying numbers	Lambert HSR/0500/1

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 11/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Rod Lambert
Scientific

School of Occupational Therapy & Physiotherapy
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Phone	+44 (0)1603 593096
Email	r.lambert@uea.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2000
Completion date	01/03/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Key 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
Key exclusion criteria	No identifiable lifestyle factors above a stated baseline level.
Date of first enrolment	01/05/2000
Date of final enrolment	01/03/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Occupational Therapy & Physiotherapy

Norwich
NR4 7TJ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Eastern (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/04/2007		Yes	No