Condition category
Mental and Behavioural Disorders
Date applied
04/01/2017
Date assigned
23/01/2017
Last edited
13/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Psychosis is a serious mental disorder in which thought and emotions are impaired, causing a person to lose touch with reality. The main symptoms of psychosis are experiencing hallucinations (hearing and/or seeing things that aren’t there) and delusions (holding strong beliefs that aren’t shared by others, such as believing people are trying to harm them). People experiencing psychosis need help with their mental and physical health and daily activities (e.g. shopping, finances). Care is mostly provided by family/friends, often in their 70s or 80s. Caregiving limits caregivers’ own leisure activities and availability to work/volunteer, causing additional stress, poor health and financial problems. The Department of Health recognise that supporting caregivers ultimately also helps the people they care for, but current recommendations are hard to access and time-consuming. Positive Written Disclosure (PWD) is a type of therapy which involves writing about positive life experiences. Studies have shown that it can reduce health/complaints and feelings of anxiety depression in many different groups of people. The aim of this study is to find out whether PWD is helpful in older adult caregivers of people experiencing psychosis, and if the therapy is acceptable.

Who can participate?
Caregivers over 50 years old who are caring for someone with psychosis.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group take part in PWD. This involves spending 20 minutes a day for three days engaging in positive writing exercises. Instructions are provided to help guide people through the activity, in which participants are asked to think of a positive memory, and write about their deepest thoughts and emotions in relation to this memory. Those in the second group take part in a writing task that does not involve PWD for 20 minutes a day for three days. This involves looking at a series of images and writing down what can be seen in the pictures factually. Those in the third group are asked to continue as normal and do not take part in a writing activity. At the start of the study and then again after one, three and six months, participants in all groups complete a number of questionnaires to assess their mood and mental wellbeing.

What are the possible benefits and risks of participating?
Participants may benefit from trying a new treatment, and all participants will have the opportunity to provide their feedback on the study and interventions. This feedback will inform the next steps of the research programme. There is a small risk of participants not finding any benefit from the intervention; and participating in the study will involve participants giving up some of their own time i.e. to complete the questionnaires.

Where is the study run from?
Sussex Partnership NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2017 to October 2018

Who is funding the study?
The Dunhill Medical Trust (UK)

Who is the main contact?
Miss Cassie Hazell
C.Hazell@bsms.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Cassie Hazell

ORCID ID

http://orcid.org/0000-0001-5868-9902

Contact details

Brighton and Sussex Medical School
Mayfield House
Village Way
Falmer
Brighton
BN1 9PH
United Kingdom
+44 1273 643921
C.Hazell@bsms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32688

Study information

Scientific title

Caring For Carers (C4C): Pilot randomised controlled trial of Positive Written Disclosure for Older Adult Carers of people with psychosis

Acronym

C4C

Study hypothesis

The aim of this pilot randomised controlled feasibility trial is to investigate the feasibility of conducting a definitive trial looking at the efficacy of Positive Written Disclosure (PWD) for older adult carers of people with psychosis.

Ethics approval

North West - Lancaster Research Ethics Committee, 24/11/2016, ref: 16/NW/0757

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Physical

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

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: Mental Health, Primary sub-specialty: Study not assigned to a MH Clinical Studies Group; UKCRC code/ Disease: Other/ General symptoms and signs

Intervention

At the start of the study, the statistician responsible for randomisation will generate a group allocation sequence that will link participant IDs to either positive written disclosure (PWD), writing control activity (WC) or no writing task (NWC). Block randomisation will be used, and will be carried out by a statistician independent of the research team. The statistician will not have access to any of the personal information of the participants and will randomise using the participant identification numbers. Members of the research team will be blind to the size of the blocks. Randomisation will be carried out using a 1:1:1 ratio. The group allocation will be concealed from participants until after the baseline assessment is completed. The researcher responsible for carrying out the assessments will be blinded to the group allocation.

Positive Written Disclosure (PWD): Participants take part in Positive Written Disclosure (PWD), which is a self-directed and time-limited therapy. PWD will require participants to take 20 minutes out of their day, for three consecutive days to write continuously about a positive memory or experience. Participants will be encouraged to describe this positive event in a lot of detail, focussing on the subjective experience. Participants will be provided with a workbook and a set of writing instructions within which to complete the PWD writing tasks. The PWD workbook and instructions are based on the materials used in similar research studies that were found to be acceptable to participants. It is hoped that taking some time to focus on this positive experience or memory will help to improve the wellbeing of our participants (older adult caregivers of people experiencing psychosis).

Writing Control (WC) task: Participants are asked to complete a non-emotive writing task. The participants allocated to this group will also receive a workbook and a set of writing instructions. The writing task will require participants to look at images of different rooms within a house and describe them as accurately and in as much detail as possible. The images were selected to be neutral (not provoke any strong positive or negative feelings) and also rich in detail – so that participants have enough to write about. The final images were selected by our lived experience advisory panel. Participants will be asked to write about these images continuously for 20 minutes over three consecutive days. The instructions for the writing task encourage participants to not give their feelings or opinions towards the images, and instead stick to the facts.

Non-Writing Control (NWC) task: Participants will not be asked to complete any writing tasks over the course of the study, and will receive no intervention. Participants in this group will be encouraged to carry on with their usual activities, as if they were not part of the research study. So as to maintain researcher blinding, this group will receive a writing pack that is empty.

Quantitative data will be collected at baseline (before randomisation), and 1, 3 and 6 months post randomisation. Participants in the writing conditions (PWD or WC) will be invited to complete an exit interview discussing their experiences of the study and the writing tasks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Mood is measured using the Positive and Negative Affect Scale (PANAS) at baseline, 1, 3 and 6 months.

Secondary outcome measures

1. Symptoms of anxiety and depression are measured using the Depression Anxiety and Stress Scale (DASS 21) at baseline, 1, 3 and 6 months
2. Self-efficacy is measured using the General Self-Efficacy Scale (GSES) at baseline, 1, 3 and 6 months
3. Wellbeing is measured using the Caregiver Wellbeing and Support Scale (CWSv2) at baseline, 1, 3 and 6 months
4. Alexithymia is measured using the Toronto Alexithymia Scale (TAS 20) at baseline only
5. General health and health economics is measured using the EQ-5D at baseline, 1, 3 and 6 months
6. Satisfaction with leisure activities is measured using the Leisure Time Satisfaction Measure (LTS) at baseline, 1, 3 and 6 months

Feasibility outcomes:
1. Recruitment rate is measured as the proportion of participant who provide consent, compared to those who are referred, at baseline.
2. Retention rate is measured as the percentage of participants that provide data at all time points (baseline, and 1, 3 and 6 months) at the end of the study
3. Adherence to the intervention is measured as the percentage of participants that complete writing on all three days, the percentage of participants that write for 20 minutes each day, and the percentage of participants that complete their writing on the three consecutive days, at the end of the study

Overall trial start date

01/01/2017

Overall trial end date

01/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Classified as a primary caregiver as defined by the Royal College of General Practitioners (2011, p. 9): “any person who provides unpaid support to a partner, child, relative or friend who couldn’t manage to live independently or whose health or wellbeing would deteriorate without this help.”
2. Aged 50 years or over
3. Providing care for someone with a psychosis diagnosis - psychosis is defined here as including the following diagnoses:
3.1. Schizophrenia
3.2. Schizoaffective disorder
3.3. Schizotypal Personality Disorder
3.4. Delusional disorder
3.5. Psychosis not otherwise specified
3.6. Bipolar
3.7. Depression with psychotic features
4. Able to read, write and communicate in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

Currently receiving or have confirmed plans to engage in psychological therapy of any form (including family therapies).

Recruitment start date

09/01/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
Headquarters Swandean Arundel Road
Worthing
BN13 3EP
United Kingdom

Sponsor information

Organisation

University of Sussex

Sponsor details

Medical Teaching Building
Brighton and Sussex Medical School
University of Sussex
Brighton
BN1 9PX
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Dunhill Medical Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. All participants taking part in the study will receive a summary of the research findings once data have been analysed
2. Presentations will be made to clinical management groups within Sussex Partnership NHS Foundation Trust and publish summaries of findings within their “Research Magazine” and through their “Research Network”. Dissemination nationally will be augmented through our links with Rethink, FACTOR and McPin (when the project is adopted into a CLRN portfolio). Planned presentation of findings in caregiver organisation publications (e.g. “Your Voice” by Rethink).
3. Research findings will also be presented at caregivers’ groups (e.g. The Caregivers Centre) with the support of the caregiver representatives and a summary included in caregivers’ newsletters
4. Study results will be shared through high impact, academic peer-reviewed journals, using open access journals where possible (e.g. BMJ Open Access). Investigators have a good track record of publication in high impact mental health, psychology and general practice journals. Results will be presented at internal and external seminars. If PWD therapy is found to be feasible and acceptable to caregivers of people with psychosis, a grant to fund a fully scaled RCT to determine therapy effectiveness will be developed and submitted to an appropriate funder (e.g. NIHR).

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

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting. 08/08/2017: Internal review. 02/08/2017: The inclusion criteria age criteria has been updated from 60 years of age to be 50 years old age.