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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Prof David Kingdon
Scientific

University Department of Psychiatry
Academic Centre, College Keep
4-12 Terminus Terrace
Southampton
SO14 3DT
United Kingdom

Phone +44 (0)2380718520
Email D.Kingdon@soton.ac.uk

Study information

Study designObservational case series
Primary study designObservational
Secondary study designCase series
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleReducing worry in patients with somatic symptom disorder using brief cognitive behavioural therapy
Study acronymREDRESS
Study objectivesTo 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) studiedSomatic symptom disorder
InterventionPatients 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 typeOther
Primary outcome measureHealth Anxiety Inventory (Salkovskis, Rimes, Warwick & Clark, 2002). Assessments will take place at baseline and 8 weeks.
Secondary outcome measures1. 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 date01/01/2014
Completion date31/08/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants12
Key inclusion criteria1. Over 18 years old
2. Meet criteria for Somatic Symptom Disorder
Key exclusion criteria1. 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 enrolment17/06/2014
Date of final enrolment07/01/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Southern Health NHS Foundation Trust
SO40 2RZ
United Kingdom
Sussex Partnership NHS Foundation Trust
BN13 3EP
United Kingdom

Sponsor information

University of Southampton
University/education

Research Governance Office
University of Southampton
Building 37, Room 4055, University Road
Southampton
SO17 1BJ
England
United Kingdom

ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

University/education

University of Southampton
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 shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planIt 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.