Condition category
Nervous System Diseases
Date applied
02/10/2017
Date assigned
12/10/2017
Last edited
25/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic fatigue syndrome (CFS) is a condition mainly associated with extreme tiredness that can cause significant levels of disability. Managing life with CFS can be challenging, and people with CFS are at increased risk of experiencing depression and anxiety, with their partners also reporting higher rates of emotional distress. Relationships can interact with physical and mental health in several ways. For example, distressed relationships can increase the risk of depression and other health problems. Conversely, partners and family members can offer valuable support both on an emotional level and in promoting health-related lifestyle changes. There is evidence that cognitive behavioral therapy (CBT) (a type of talking therapy) can help people with CFS to manage their symptoms. However, fatigue and other symptoms experienced by this patient group can make CBT, which is quite an ‘active’ therapy, quite difficult to engage in.For these reasons, it is believed that involving partners in a constructive manner in a psychological intervention for patients affected by CFS could enhance the effectiveness of the intervention and prove beneficial to partners. Therefore, the aim of this study is to develop a cognitive behavioural couple-based therapy (CBCT) for people with CFS and their partners to explore the effectiveness of the intervention in a group of 10 couples.

Who can participate?
Adults aged 18 and older who are diagnosed with chronic fatigue syndrome.

What does the study involve?
Patients referred to the service with a diagnosis of CFS and who are in a committed relationship will be invited to participate. After a telephone interview, eligible couples are offered a course of 12-15 sessions of CBCT. Participants are asked to complete questionnaire assessments before therapy starts and at the end of therapy, and also six months after the end of therapy.

What are the possible benefits and risks of participating?
Participants may benefit from participating in this study. It could help improve daily functioning and symptoms of fatigue in patients with CFS, and reduce symptoms of anxiety and depression as well as improving relationship satisfaction in both partners. Participants who enrol in the study will be offered a therapy start date within 2-3 weeks of assessment rather then being placed on a waiting list for treatment, so they will be able to access treatment very quickly. With regard to risk, participant wellbeing and safety will be monitored throughout the study, as is standard practice in Talking Therapies Southwark. Self-reported symptoms of anxiety, depression and general functioning will be collected at every contact, and deteriorations on any of these measures will be discussed as part of treatment and addressed as appropriate. Risk will be monitored throughout the study, and risk management plans will be made and amended as appropriate. This may include onward referral to other services.

Where is the study run from?
Talking Therapies Southwark (UK)

When is the study starting and how long is it expected to run for?
September 2019 to May 2018

Who is funding the study?
British Association for Behavioural and Cognitive Psychotherapies (UK)

Who is the main contact?
Dr Marion Cuddy
marion.cuddy@slam.nhs.uk

Trial website

n/a

Contact information

Type

Scientific

Primary contact

Dr Marion Cuddy

ORCID ID

http://orcid.org/0000-0002-5642-3163

Contact details

Talking Therapies Southwark
Middle House
Maudsley Hospital
London
SE5 8AZ
United Kingdom
+44
marion.cuddy@slam.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35029

Study information

Scientific title

A couple-based psychological intervention for chronic fatigue syndrome: a pilot study

Acronym

Study hypothesis

Research Questions:
1. Is a couple-based CBT intervention acceptable and useful to patients with CFS and their partners with regard to
helping them cope with CFS?
2. Can a couple-based CBT intervention improve fatigue, daily functioning, anxiety, and depression in patients with CFS?
3. Does this intervention improve relationship satisfaction in patients with CFS and their partners?

Ethics approval

London – Westminster Research Ethics Committee IRAS 221300, 17/07/2017, ref: 17/LO/1093

Study design

Non-randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Primary Care, Primary sub-specialty: Mental Health; UKCRC code/ Disease: Neurological/ Other disorders of the nervous system

Intervention

Patients referred to the service with a diagnosis of chronic fatigue syndrome (CFS) and who are in a committed relationship are invited to participate.

Participants referred or who self-refer to Talking Therapies Southwark, who have agreed to be contacted for research and who have a diagnosis of chronic fatigue syndrome are approached. They are sent an information sheet about the study by post, and invited to contact the chief investigator if they would like more information.

The initial letter is followed up by a telephone call one week later from the chief investigator, in order to answer any questions about the study. If the person is interested in taking part, a telephone screening appointment is arranged. Potentially suitable participants are then invited to a face to face appointment with their partner. If they are eligible and interested at that point, they are asked to consent to taking part in the study. It is made clear to participants (both partners) that they can withdraw from the study.

Participants (patients and their partners) are offered up to 12 sessions of a couple-based cognitive behavioural intervention. Therapy is delivered by experienced therapists who are trained in delivering couple-based interventions. Participants are invited to complete assessments at baseline, end of treatment, and six months after the end of treatment. A subgroup of five couples are also invited to provide qualitative feedback through semi-structured interviews at the end of treatment. Participants are in the study for approximately 12 months including the follow-up period.

Detailed outcome measures will be completed by both partners at the screening, assessment, and start of therapy appointments (pre-therapy), on the day of the final session (post-treatment), and 6 months after end of treatment (follow-up). These questionnaires will measure fatigue, depression, and relationship satisfaction. A small sample of couples will also be asked to take part in a brief interview concerning their experience of therapy. Routine measures of anxiety, depression and daily functioning will be completed at every appointment, as is standard practice in TTS.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Fatigue is measured using the Chalder Fatigue Scale at baseline, start of therapy, end of therapy and six months
2. Daily functioning is measured using the Work & Social Adjustment Scale at baseline, start of therapy, at every treatment session, the end of therapy and six month follow up
3. Anxiety and depression is measured using the Beck Depression Inventory at baseline, start of therapy, end of therapy and six month follow up; the Generalised Anxiety Disorder Assessment, and the Patient Health Questionnaire are administered at baseline, start of therapy, at every treatment session, the end of therapy and six month follow up
4. Relationship satisfaction is measured using the Couple Satisfaction Index at baseline, start of therapy, at every treatment session, the end of therapy and six month follow up

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

05/09/2017

Overall trial end date

01/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of chronic fatigue syndrome (CFS) made by a GP or other appropriate health professional. The research team will check that a) the participant has had the relevant medical tests to rule out alternative diagnoses in line with the NICE guidelines for CFS, and b) that the participant's symptoms meet the Oxford criteria for CFS.
2. Patient must be in a committed relationship with a duration of at least 6 months
3. Patient and partner must be willing to engage in a couple-based intervention
4. Over 18 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant exclusion criteria

1. Primary alcohol or drug misuse problem
2. Current psychotic illness
3. Insufficient command of the English language to be able to engage in therapy
4. Illness severity (CFS or other) that would prevent regular attendance of therapy sessions in an outpatient setting
5. Risk to self or others that would be difficult to manage in a primary care setting

Recruitment start date

01/11/2017

Recruitment end date

31/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Talking Therapies Southwark
Middle House Maudsley Hospital
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

South London and Maudsley NHS Foundation Trust

Sponsor details

Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

British Association for Behavioural and Cognitive Psychotherapies

Alternative name(s)

British Association for Behavioural & Cognitive Psychotherapies, BABCP

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of this pilot study will be disseminated in a number of ways:
1. Results will be presented to clinicians and managers in primary care and other relevant healthcare settings at a local and regional level
2. A newsletter will inform participants of outcomes, and the results will be disseminated through user groups
3. The results will be presented at the annual British Association for Behavioural and Cognitive Psychotherapy conference
4. A report will be submitted to a peer-reviewed journal

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/05/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

25/10/2017: The overall trial end date has been updated from 01/05/2018 to 01/12/2018. The recruitment start date has been updated from 27/09/2017 to 01/11/2017.