Condition category
Mental and Behavioural Disorders
Date applied
26/01/2013
Date assigned
25/02/2013
Last edited
21/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The ACT for Recovery (ACTfR) study is an evaluation of Acceptance and Commitment Therapy (ACT) group workshops for users of community mental health recovery and early intervention psychosis services in South East London and their caregivers. ACT is a talking therapy that aims to help people to do the things that they value in life, by teaching them how to change the way they relate to their problems. ACT involves learning how to accept difficult feelings or thoughts when they happen, rather than getting caught up in trying to change or avoid them, which can lead to feeling more upset. People with psychosis often have upsetting experiences such as hearing voices, or worrying that other people may want to harm them in some way. Caregivers often feel upset by the day to day impact of psychosis on their lives and relationships. We would like to find out whether taking part in ACT group workshops improves wellbeing and reduces costs to the service. Group workshops will be delivered by experienced facilitators, alongside two trainee facilitators: a staff member and a service user peer supporter. We will evaluate whether co-facilitating a group is an effective way of training new facilitators to deliver ACT groups. We will compare people taking part in the ACT group workshops straight away, with people taking part after a three month wait (the ‘waitlist control’ group). We predict that service user and caregiver participants will find the intervention acceptable and will show improvements in wellbeing, compared to the waitlist control group. We predict that co-facilitators will show an improvement in knowledge and skills, compared to staff and peer supporters who wait three months before receiving the training. We also predict that service users will show improvements in recovery and reductions in service use.

Who can participate?
All service users and caregivers in Promoting Recovery or Early Intervention services in the Psychosis Clinical Academic Group of the South London & Maudsley NHS Foundation Trust can take part, providing they can participate in a group, and can understand spoken and written English well enough. Staff of mental health or related services and service user or caregiver peer supporters is eligible to participate in the training evaluation.

What does the study involve?
For service users and caregivers, taking part in the study will involve completing questionnaires measuring current wellbeing and coping. Participants will be offered the ACT group workshops straight away, or after a three month wait. Who joins in straight away and who has to wait will be decided randomly, by a process a bit like tossing a coin.
The ACT workshops will be four 2-hour sessions, taking place weekly, followed by two booster sessions, eight weeks later. We expect six to eight service users or caregivers to attend each workshop. We will use the questionnaires to measure change in service user and caregiver wellbeing from before the start of the groups (week 0), after the first four workshops (week 4) and after the booster sessions (week 12). We will compare people receiving the ACT intervention with people waiting for the intervention. For staff and peer supporter co-facilitators, taking part in the study will involve completing questionnaires measuring their knowledge of ACT. They will co-facilitate straight away or after a three month wait.

What are the possible benefits and risks of participating?
We hope that the ACT workshops will be helpful, and do not expect there to be any particular risks associated with taking part.

Where is the study run from?
The study is taking place in the Psychosis Clinical Academic Group in the South London and Maudsley NHS Foundation Trust, which is part of the Academic Health Sciences Centre, King’s Health Partners.

When is study starting and how long is it expected to run for?
We aim to deliver 16 ACT intervention groups to 48 service users and 48 caregivers, over a year. We will also train 16 members of the Community mental Health team staff and 16 service user peer supporters to facilitate ACT interventions. We will be recruiting participants from February 2013 until the end of December, 2013.

Who is funding the study?
The study is funded by a grant from the Maudsley Charity (ref. 764).

Who is the main contact?
Dr. Suzanne Jolley, Suzanne.jolley@kcl.ac.uk or
Dr. Louise Johns, Louise.Johns@slam.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Louise Johns

ORCID ID

Contact details

PICUP CLinic
PO Box 79
Institute of Psychiatry
King's College London
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 3228 3524
louise.johns@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1 081012

Study information

Scientific title

ACT for Recovery: A study of training to promote recovery through facilitated and peer support Acceptance and Commitment Therapy (ACT) courses for service users and caregivers in community services

Acronym

ACTfR

Study hypothesis

1. Service users and caregivers will find the intervention acceptable and will show improvements in wellbeing, compared to the waitlist control group.
2. Co-facilitators will show an improvement in knowledge and skills, compared to those not receiving the training.
3. Service users will show improvements in recovery and reductions in service use, compared to the waitlist control group.

Ethics approval

Camberwell St Giles NHS REC, 18/12/12, ref:12/LO/1789

Study design

Randomised waitlist controlled evaluation with two arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please contact suzanne.jolley@kcl.ac.uk to request a patient information sheet

Condition

Mental health

Intervention

Arm 1: ACT group workshops. Participants will take part in four sessions of Acceptance and Commitment therapy, each lasting two hours, delivered weekly, and two further 'booster' sessions taking place eight weeks later, delivered one week apart. Total duration of the intervention will be 12 hours, over a total of 12 weeks.

Arm 2: Waitlist control. Participants will receive their usual treatment. After completing the 12-week assessment, they will be able to join in with the ACT intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Service user and caregiver wellbeing: Warwick-Edinburgh Wellbeing Scale (Tennant et al., 2007), CORE-10 (Barkham et al., 2008)
2. Co-facilitator knowledge and skills

Comparison of change from 0 to 12 weeks between groups

Secondary outcome measures

1. Cost-effectiveness and service use:
1.1. Client service receipt inventory (Beecham & Knapp, 1992)
1.2. Service use in preceding 3 months
2. EQ5D (EuroQuol group, 1990)

Compared for week 12 to week 0, and from week 0 to week 12.

Overall trial start date

07/02/2013

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria are broad – any service user or caregiver within the Promoting Recovery service, with sufficient English to participate in the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Participants who are not users of the local service
2. Who do not have sufficient English to participate in a therapeutic group conducted in English
3. Whose clinical presentation makes participation in a moderate duration, moderately high demand group activity inappropriate

Recruitment start date

07/02/2013

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

PICUP CLinic
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

South London and Maudsley NHS Foundation Trust (UK)

Sponsor details

Ms Jenny Liebscher
Governance and Delivery Manager
Institute of Psychiatry/P005
R&D Office
16
De Crespigny Park
Denmark Hill
London
SE58AF
United Kingdom
+44 (0)20 7848 0251
jennifer.liebscher@kcl.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.kcl.ac.uk/iop/research/office/about/index.aspx

Funders

Funder type

Charity

Funder name

Maudsley Charity (UK) Ref: 764

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/06/2016: No publications found, verifying study status with principal investigator