Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof David Kingdon
ORCID ID
Contact details
University Department of Psychiatry
Academic Centre
College Keep
4-12 Terminus Terrace
Southampton
SO14 3DT
United Kingdom
+44 (0)2380718520
D.Kingdon@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12798
Study information
Scientific title
Reducing worry in patients with somatic symptom disorder using brief cognitive behavioural therapy
Acronym
REDRESS
Study hypothesis
To determine the acceptability and explore the clinical effectiveness of a worry-based intervention for severe and distressing health concerns.
Ethics approval
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
Study design
Observational case series
Primary study design
Observational
Secondary study design
Case series
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/01/2014
Overall trial end date
31/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Over 18 years old
2. Meet criteria for Somatic Symptom Disorder
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12
Participant 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
Recruitment start date
17/06/2014
Recruitment end date
07/01/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southern Health NHS Foundation Trust
SO40 2RZ
United Kingdom
Trial participating centre
Sussex Partnership NHS Foundation Trust
BN13 3EP
United Kingdom
Funders
Funder type
University/education
Funder name
University of Southampton
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
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
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list