Condition category
Mental and Behavioural Disorders
Date applied
24/03/2017
Date assigned
27/03/2017
Last edited
27/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background & study aims
Bipolar disorder and psychosis are serious mental illnesses. People with bipolar disorder experience extreme changes in their mood. People with psychosis experience changes in their perceptions (like hearing or seeing things that other people cannot see or hear), and in their thoughts, feelings and behaviour. People often have bipolar disorder or symptoms and psychosis together. Managing these conditions can be very difficult for sufferers, and for their families and friends. People often have to give up work or study, and may need care from mental health services in the community or in a psychiatric hospital. Psychological therapy or ‘talking therapy’ is helpful for bipolar and psychosis, but is not widely available. Therapies also tend to focus mainly on bipolar or mainly on psychosis, rather than on both conditions. Better psychological therapies are needed for people with bipolar and psychosis together, that can be made available to more people in mental health services. A new group therapy has been developed especially for people with bipolar and psychosis. This is a small study to find out whether the new therapy could help people more than their usual treatment. This study will not provide a final answer, but will show whether the therapy should be developed and tested more, and how this could be done. The new therapy is a combination of two approaches: Acceptance and Commitment Therapy (ACT) and psychoeducation. ACT helps people find new, more helpful ways of reacting to upsetting experiences and symptoms. Psychoeducation helps people to understand their condition, recognise relapse signs and seek treatment early.

Who can participate?
People with an established psychotic illness, bipolar disorder or bipolar symptoms, in the boroughs of Lambeth and Southwark, in the South London and Maudsley NHS Foundation Trust

What does the study involve?
Participants complete questionnaires about how they are feeling, what they are doing, and recent treatment they have received. They are randomly allocated to be offered either the new group therapy alongside their usual treatment or just their usual treatment. The new group therapy involves ten two-hour sessions, held weekly, with a ‘booster’ session a month later (at 14 weeks). Sessions include talking about common experiences of bipolar and psychosis and ways to handle these. ‘Usual treatment’ is normally meetings with mental health professionals for a range of interventions, including medication, emotional and practical support, and help with housing, benefits, and day-to-day living, work and leisure activities. Participants complete the questionnaires again after 10 and 14 weeks. After 14 weeks, people who were only offered their usual treatment are able to complete the new group therapy if they like. Participants' quality of life is assessed, along with changes in how they are feeling, how they are reacting to upsetting experiences, how they are recovering, and much they use crisis services or are admitted to hospital.

What are the possible benefits and risks of participating?
It is hoped that the new group therapy will be helpful. The study may help improve future psychological treatments. No particular risks are expected, but talking therapies can involve uncomfortable or distressing conversations, and both the groups and questionnaires may bring upsetting experiences to mind. The staff involved in the study are all psychologists, and have training in how to respond if people do feel upset during the study.

Where is the study run from?
The study is running in Promoting Recovery services in the boroughs of Lambeth and Southwark in the Psychosis Clinical Academic Group of the South London and Maudsley NHS Foundation Trust, King’s Health Partners (UK)

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

Who is funding the study?
Guy’s and St. Thomas’ Charity (UK)

Who is the main contact?
Dr Emma O’Donoghue

Trial website

Contact information

Type

Public

Primary contact

Dr Emma O'Donoghue

ORCID ID

Contact details

SHARP
308-312 Brixton Road
London
SW9 6AA
United Kingdom

Type

Scientific

Additional contact

Dr Suzanne Jolley

ORCID ID

http://orcid.org/0000-0003-1622-0051

Contact details

King's College London
Institute of Psychiatry
Psychology & Neuroscience
Department of Psychology PO77
De Crespigny Park
16 Denmark Hill
London
SE5 8AF.
United Kingdom
+44 (0)20 7848 5028
suzanne.jolley@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Balancing ACT: evaluating the effectiveness of psychoeducation and acceptance and commitment therapy (ACT) groups for people with bipolar disorder: a randomised controlled trial

Acronym

Balancing ACT

Study hypothesis

Research questions:
1. Are primary and secondary clinical outcomes for people with psychosis and bipolar disorder/symptoms improved by the addition of ACT and psychoeducation groups? If so, to what extent?
2. Do the groups have an impact on mood, distress, recovery and psychological processes of change?
3. Is the intervention potentially cost-effective?

Ethics approval

London-Surrey Borders Research Ethics Committee, 23/03/2017, ref: 17/LO/0445

Study design

Single-centre Phase II two-arm interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

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

Condition

Psychosis with bipolar disorder/symptoms

Intervention

After agreeing to take part, participants will complete questionnaires about how they are feeling, what they are doing, and recent treatment they have received. Participants will be randomised through an independent web-based service provided by the UKCRC registered King’s Clinical Trials Unit (Reg No. 53). The randomisation procedure will employ random permuted blocks of random size, which will maintain pre-randomisation allocation concealment. The trialists will stratify by site (Lambeth or Southwark) for logistical reasons, so that treatment cases are equitably allocated across therapy groups. Participants will be randomised to be offered either the new group therapy alongside their usual treatment or just their usual treatment (waitlist control). The new group therapy involves ten two-hour sessions, held weekly, with a ‘booster’ session a month later (at 14 weeks). Sessions include talking about common experiences of bipolar and psychosis and ways to handle these. ‘Usual treatment’ is normally meetings with mental health professionals for a range of interventions, including medication, emotional and practical support, and help with housing, benefits, and day-to-day living, work and leisure activities. Participants will complete the questionnaires again after 10 weeks and 14 weeks. After 14 weeks, people who were only offered their usual treatment will be able to complete the new group therapy if they would like. The following outcomes are measured: changes in quality of life, how people are feeling, how they are reacting to upsetting experiences, how they are recovering, and much they use crisis services or are admitted to hospital.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Psychological wellbeing, assessed using the Brief Quality of Life in Bipolar Disorder (Brief QoL.BD) at 10 weeks

Secondary outcome measures

1. Mental health relapses, measured by service use as an average per month for the 12 months preceding baseline and the 3 months post-baseline (during the trial)
2. Psychological wellbeing, assessed by the Brief QoL BD at 14 weeks
3. Mood, assessed using a bespoke Mood Monitoring Measure (MMM) and the Internal States Scale (ISS)
4. Distress, assessed using the Clinical Outcomes in Routine Evaluation Measure (CORE-10)
5. Recovery, assessed using the Bipolar Recovery Questionnaire (BRQ)
6. Psychological processes of change, assessed using the Valuing Questionnaire (VQ8); the Acceptance and Action Questionnaire-II (AAQ-II); and the Southampton Mindfulness Questionnaire (SMQ)
Assessed at baseline, 10 and 14 weeks

Overall trial start date

01/05/2017

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Treated under Lambeth or Southwark Promoting Recovery Services
2. Diagnosis/symptoms of Bipolar Disorder
3. Available for the study duration
4. Sufficient English language ability to be able to complete assessment measures and therapy, without interpreter support (as this is not feasible in a group intervention).
5. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36 recruited, 24 completed with all data

Participant exclusion criteria

1. Inability to remain in a group setting, attend, understand and interact for up to 2 hours
2. Participants who are unable to consent for themselves (i.e. who lack capacity)

Recruitment start date

01/05/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
Psychosis Clinical Academic Group Promoting Recovery Pathway Lambeth and Southwark borough services
SW9 6AA

Sponsor information

Organisation

South London & Maudsley NHS Foundation Trust

Sponsor details

R&D Department
Room W1.11
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Guy's and St Thomas' Charity (ref: EFT 151106)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Suzanne Jolley (suzanne.jolley@kcl.ac.uk)

Intention to publish date

31/08/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes