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 |
| Protocol serial number | Lambert HSR/0500/1 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Eastern (UK) |
- 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
Scientific
School of Occupational Therapy & Physiotherapy
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 (0)1603 593096 |
|---|---|
| r.lambert@uea.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) |
| Key secondary outcome measure(s) |
Self-completion diary sheets which will record: |
| Completion date | 01/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
School of Occupational Therapy & Physiotherapy
Norwich
NR4 7TJ
United Kingdom
NR4 7TJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
