Reducing distress from somatic symptoms
| ISRCTN | ISRCTN11688040 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11688040 |
| Secondary identifying numbers | 12798 |
- Submission date
- 24/02/2015
- Registration date
- 13/05/2015
- Last edited
- 12/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Somatic symptom disorders are mental disorders characterized by physical symptoms that suggest physical illness but which cannot be explained fully by a general medical condition. A new brief psychological therapy may help people worry less. The aim of this study is to test how people find this therapy and whether it works. The researchers want to see whether it reduces worry, especially worries about health and illness. If it is shown to work then it will be possible to use the therapy in NHS services.
Who can participate?
Adults meeting criteria for somatic symptom disorders
What does the study involve?
Participants receive a ‘worry intervention’ in 6 sessions over 8 weeks, either at home or at the GP surgery. The worry reduction strategies include psycho-education about worry, reviewing of beliefs about worry, increasing awareness of the initiation of worry and identification of individual triggers, use of worry periods, substituting problem-solving in place of worry and relaxation exercises. There are homework exercises between sessions. At the end of the study, participants are invited to take part in another interview to talk about their experience of the therapy sessions and suggest improvements. Participants are paid £15 for each assessment session, and travel expenses are paid.
What are the possible benefits and risks of participating?
It is hoped that participants benefit from the opportunity to engage in the worry intervention. The main possible burden is time taken to complete the questions.
Where is the study run from?
South East England (UK)
When is the study starting and how long is it expected to run for?
June 2014 to August 2015
Who is funding the study?
University of Southampton (UK)
Who is the main contact?
Prof. David Kingdon
D.Kingdon@soton.ac.uk
Contact information
Scientific
University Department of Psychiatry
Academic Centre, College Keep
4-12 Terminus Terrace
Southampton
SO14 3DT
United Kingdom
| Phone | +44 (0)2380718520 |
|---|---|
| D.Kingdon@soton.ac.uk |
Study information
| Study design | Observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Reducing worry in patients with somatic symptom disorder using brief cognitive behavioural therapy |
| Study acronym | REDRESS |
| Study objectives | To determine the acceptability and explore the clinical effectiveness of a worry-based intervention for severe and distressing health concerns. |
| Ethics approval(s) | 1. University of Southampton Ethics and Research Governance Committee (ERGO12798) National Research Ethics Service, 17/02/2014, ref: 14/SC/0040 2. Southern Health NHS Foundation Trust, 27/05/2014, ref: SHT120 3. Sussex Partnership NHS Foundation Trust, 01/05/2014, ref: 5038-2014 |
| Health condition(s) or problem(s) studied | Somatic symptom disorder |
| Intervention | Patients with Somatic Symptom Disorder will be offered 6 sessions of individual manualised psychological intervention focussed on worry. A control group is not included in this design. The worry intervention will be provided in 6 sessions over 8 weeks. Intervention sessions will take place at home or at the participant's GP surgery, to minimise travel and burden for the participant. The worry reduction strategies included are indicated in the anxiety literature to be effective at reducing worry and do not challenge the illness interpretation. The main techniques are psycho-education about worry, reviewing of beliefs about worry, increasing awareness of the initiation of worry and identification of individual triggers, use of worry periods, substituting problem-solving in place of worry and relaxation exercises. Homework exercises are set between sessions. Written information is provided for patients (see appendix B). With patients’ consent, sessions will be taped for assessment of adherence and for competence. At the end of sessions, a consultation letter will be developed with the patient and shared with the patients’ referring clinician and their general practitioner. |
| Intervention type | Other |
| Primary outcome measure | Health Anxiety Inventory (Salkovskis, Rimes, Warwick & Clark, 2002). Assessments will take place at baseline and 8 weeks. |
| Secondary outcome measures | 1. Intolerance of Uncertainty Questionnaire (Freeston, Rheaume, Letarte, Dugas & Ladouceur (1994) 2. Penn State Worry Questionnaire (Meyer, Miller, Metzger & Borkovec, 1990) Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983) 3. EQ-5D (Rabin & de Charro, 2001) 4. Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS, Tennant, Hiller, Fishwick, Platt, Weich, Parkinson et al, 2007) 5. A question around the acceptability of a referral for psychological therapy, developed for this study 6. Number of attendences at A&E, 7. Outpatients and General Practice will also be recorded 8. New physical diagnoses will also be noted. The scales will provide comparative measures of symptoms, functioning and well being with some estimate of resource utilisation. Assessments will take place at baseline and 8 weeks. |
| Overall study start date | 01/01/2014 |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 |
| Key inclusion criteria | 1. Over 18 years old 2. Meet criteria for Somatic Symptom Disorder |
| Key exclusion criteria | 1. Under 18 years old 2. Not meeting criteria for Somatic Symptom Disorder 3. Having an insufficient understanding of English to read and complete the study questionnaires 4. Having a primary diagnosis of drug or alcohol misuse 5. Taking part in current Cognitive Behavourial Therapy |
| Date of first enrolment | 17/06/2014 |
| Date of final enrolment | 07/01/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
Sponsor information
University/education
Research Governance Office
University of Southampton
Building 37, Room 4055, University Road
Southampton
SO17 1BJ
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Southampton UK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | It is hoped to present results at the Annual BABCP conference 2015. Results will be also be submitted to a peer-review journal. In addition, results of this pilot study will be included in a grant application for a larger-scale study |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/08/2020: No publications found.
18/09/2017: No publications found, verifying study status with principal investigator.
