Families and Carers Training and Support Programme (FACTS) - for families of people with a Borderline Personality Disorder diagnosis
| ISRCTN | ISRCTN39303837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39303837 |
| Secondary identifying numbers | R&D ref: 131609 |
- Submission date
- 22/12/2014
- Registration date
- 14/01/2015
- Last edited
- 13/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Borderline Personality Disorder (BPD) is a serious mental illness characterized by pervasive instability in moods, volatile interpersonal relationships including sudden paranoid reactions, poor self-image, and self-destructive behaviours, which include suicide attempts and self-harm.
Families have a unique position of being able to support mental health treatment, but they can only do so if they are aware of what to do and how to manage common situations that present as a result of the illness. BPD is a particularly difficult condition for families to manage as the difficulties often present as a problem in the family relationships. As a result, families of patients with BPD struggle to cope with their own feelings, leaving them traumatized, disempowered and unsure how best to help their relative or loved one. Yet, support and advice for families is rarely available and, when it is, is often misleading, sometimes offensive, confusing, and generally unhelpful.
The Anna Freud Centre (AFC) proposes to evaluate a support programme known as the Families and Carers Training and Support programme, or FACTS programme. The programme is for families, friends, partners and others who are involved with people with BPD with the aim of reducing adverse incidents in the family whilst improving family well-being. It is suggested that these effects may lead to less use of crisis and other services by the person with BPD.
Who can participate?
Families, friends, partners and others who are involved with someone with a clinical diagnosis of BPD or emerging personality disorder can participate.
What does the study involve?
The FACTS programme consists of five group sessions, running one weekday evening per week for five weeks, and run by other family members who have received training to deliver the programme. Families who take part in the study will be randomly allocated to either a group which will receive the FACTS programme immediately, or to a waitlist group which will receive the programme a few months later. Throughout their involvement in the study, participants will submit weekly incident diaries to keep track of adverse incidents arising in the family.
What are the possible benefits and risks of participating?
Expected benefits of taking part in the FACTS programme include improved family well-being and reduced adverse incidents in the family. If a benefit is demonstrated, there could be a much wider potential benefit to health care systems and personality disorder services. FACTS could offer crucial support to families, improving their own mental health and well-being and enabling a reduction in crisis situations with their family member with BPD.
There are few risks. Families could fail to develop skills to manage the family member with BPD and feel more hopeless about their relationship. The implementation of the skills could be inadequate or misguided. However none of the 18 families in the pilot project reported this effect.
Where is the study run from?
The FACTS programme will be running at the Anna Freud Centre (AFC), London.
When is study starting and how long is it expected to run for?
December 2014 to July 2016
The first skills training group will run for five weeks from 12/01/2015. A further three groups will also follow. All four groups will be completed by June 2015. If the groups are found to be beneficial, families will be followed up for 6 months to provide information on the long-term effects of the programme. Recruitment will continue until all four courses are fully booked. It is anticipated that the courses will be fully booked by March 2015.
Who is funding the study?
The Lewis Trust (UK)
Who is the main contact?
Alice Wickersham
facts@annafreud.org
Contact information
Scientific
University College London
London
WC1E 6BT
United Kingdom
Public
The Anna Freud Centre
12 Maresfield Gardens
London
NW3 5SU
United Kingdom
| Phone | +44 (0)20 7443 2215 |
|---|---|
| facts@annafreud.org |
Study information
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Families and Carers Training and Support Programme (FACTS) - for families of people with a Borderline Personality Disorder diagnosis - a randomised controlled trial |
| Study acronym | FACTS |
| Study objectives | A psycho-educational and skills programme designed for families, friends, partners and others who are involved with people with BPD will reduce adverse incidents in the family whilst improving family well-being. It is suggested that these effects may lead to less use of crisis and other services by the person with BPD. This is a randomised controlled trial to test the feasibility of the method for a larger trial and to gather indicative data of the effectiveness of a psycho-educational and skills programme for families of a person with BPD in reducing incidents in the family and crises for the patient. This is a single-centre interventional study with a waitlist control, with the programme being delivered at the Anna Freud Centre in London. |
| Ethics approval(s) | National Research Ethics Service Committee London - City & East. Favourable ethical opinion letter received 07/10/2014, REC reference: 14/LO/1519 |
| Health condition(s) or problem(s) studied | Borderline Personality Disorder (BPD) |
| Intervention | Families of people with BPD will be randomised to the active intervention of 5 modules of a psycho-educational and skills programme or to waitlist control. All patients on waitlist control will be offered the intervention following a wait of 3-4 months. The programme will be delivered by family members of people with BPD who completed FACTS in 2013 and who have since received training to deliver the course. |
| Intervention type | Behavioural |
| Primary outcome measure | The primary outcome objective will be to reduce family incidents and increase family empowerment. It is hypothesised that this will lead to less crisis service use such as hospitalisation, police, A&E by the identified family member with BPD. Thus there will be improvements in the extent to which the family is able to cope with incidents. Incidents are defined as an emotional, behavioural, relationship, or other problems as reported in a weekly incident diary which are related to symptoms of borderline personality disorder and lead to family distress. They include any event which is usually recurrent that creates an interpersonal problem between family members such as withdrawal and refusal to speak, aggressive outbursts (verbal or physical), threats of self harm, suicide attempts. Weekly incident diaries will be completed by participants prior to starting the course and throughout their involvement in the trial. |
| Secondary outcome measures | The secondary objective will focus on the wellbeing of the family by: 1. Improving the well-being of the attendees; 2. Increasing their understanding of the condition; 3. Helping them support the family member to access and use appropriately available services; 4. Engendering greater empowerment These outcomes will be measured using a series of questionnaires before and after the intervention: 1. Beck Depression Inventory 2. Burden Assessment Scale 3. Family Empowerment Questionnaire 4. State Trait Anxiety Inventory (STAI) 5. SCORE 15 6.The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) |
| Overall study start date | 01/12/2014 |
| Completion date | 12/07/2016 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Must have a family member, friend, partner, or be otherwise involved with someone who has a clinical diagnosis of BPD or emerging personality disorder. |
| Key exclusion criteria | 1. Non-English speaking families 2. The family member with BPD has a history of schizoaffective disorder or schizophrenia 3. The family member with BPD has active psychosis 4. The family member with BPD has a severe substance addiction. |
| Date of first enrolment | 12/01/2015 |
| Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
NW3 5SU
United Kingdom
Sponsor information
Hospital/treatment centre
3rd Floor Bedford House
125-133 Camden High Street
London
NW1 7JR
England
United Kingdom
"ROR" |
https://ror.org/00d2v4e22 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Dissemination of the results will be through conference presentation initially and at family/user forums in personality disorder services. Publication of the initial outcomes of the data comparing the treated family group with the waiting list control will be in a peer reviewed journal. Follow-up data will be published either as a separate paper or as part of the main paper. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
