Condition category
Mental and Behavioural Disorders
Date applied
24/02/2015
Date assigned
13/05/2015
Last edited
13/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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. We have a new brief psychological therapy to help people worry less. The aim of this initial study is to test how people find this therapy and whether it works. We 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 will received a ‘worry intervention’ in 6 sessions over 8 weeks, either at home or at the GP surgery. The worry reduction strategies will 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 will be homework exercises between sessions. At the end of the study, participants will be invited to take part in another interview to talk about their experience of the therapy sessions and suggest improvements. Participants will be paid £15 for each assessment session, and travel expenses will be paid.

What are the possible benefits and risks of participating?
The main possible burden is time taken to complete the questions. It is hoped that participants will benefit from the opportunity to engage in the worry intervention.

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

Who is the main contact?
Professor 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 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

A case series design will be used. 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.

Primary study design

Observational

Secondary study design

Case series

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Somatic Symptom Disorder

Intervention

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 measures

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

Eligibility

Participant inclusion criteria

Participants should be over 18 years old, and 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
United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

University of Southampton

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes