Plain English Summary
Background and study aims
The aim of the study is to run a small trial of a new, recovery-focused, brief cognitive behavioural therapy (CBT) treatment for people with psychosis: the GOALS study (Getting On top of Anxiety and Low mood and So achieving your goals). The therapy will be delivered by frontline mental health staff over eight weekly sessions, following brief training and ongoing supervision with a clinical psychologist. The intervention (treatment) aims to improve recovery, social inclusion and social functioning and reduce distress, and in this study, will be evaluated in comparison to a treatment as usual control group. The will inform the further development of the treatment and training and will provide information for a larger multi-centre trial.
Who can participate?
The GOALS study aims to recruit around 65 adults with a diagnosis of psychosis and who have difficulties in their daily functioning due to anxiety-related avoidance and/or depression. Participants will be recruited from early intervention and recovery teams within the local National Health Service Trust.
What does the study involve?
Participants who give their consent to take part in the study will meet with a researcher three times to complete a number of questionnaires asking about thoughts, feelings, beliefs and experiences. Each meeting will last around 1.5 hours and will be at the beginning of the study, 8 weeks later and 16 weeks later.
After the first meeting, half of the people taking part will be randomly chosen to receive the therapy straight away and half will be offered therapy in four months. Everybody will be asked to complete all of the questionnaires in order to compare the therapy with usual treatment.
Those who have therapy straight away will meet with a trained staff member at their clinical team for 8 weekly one-to-one meetings and one follow-up meeting a month later. The therapy aims to support participants to work towards a personal goal which they are finding difficult to complete due to anxiety or depression.
Those who are allocated to the control group will continue to receive their usual care, but will be offered the therapy once they have completed all of the questionnaires.
In addition we will ask a quarter of people taking part to give some additional feedback on how they found the meetings with staff and how they could be improved.
What are the possible benefits and risks of participating?
In a pilot study almost all participants achieved their goals and many showed improvements in mood and wellbeing. All participants will be offered the intervention including those allocated to the treatment as usual group should they wish, after completion of the measures. It is not expected that participation in the study has any risks. The staff who will be delivering the therapy are trained in managing patient distress and will be working within participants clinical teams. Participants will be free to take a break at any point during the meetings and are free to withdraw from the study at any point.
Where is the study run from?
The study has been set up by the Institute of Psychiatry and will be conducted within the South London and Maudsley NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
The study is due to begin in February 2013 and the end date for the project is August 2015.
Who is funding the study?
The study is funded by the National Institute for Health Research, Research for Patient Benefit funding stream.
Who is the main contact?
Dr Helen Waller
helen.waller@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Helen Waller
ORCID ID
Contact details
16 De Crespigny Park
London
SE5 8AF
United Kingdom
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helen.waller@slam.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13538
Study information
Scientific title
The GOALS Study: a randomised controlled trial of a brief CBT intervention to promote recovery in psychosis
Acronym
GOALS
Study hypothesis
It is hypothesised that, in comparison to those receiving treatment as usual, people who receive the brief CBT treatment will reach their personal goal and show improvements in their levels of activities, symptoms of anxiety and depression, and general well-being. In addition it is hypothesised that the brief CBT treatment will be cost-effective. Although the treatment is not aimed at directly intervening with psychotic symptoms, it is hypothesised that the intervention will also have a beneficial indirect impact on delusions and hallucinations.
Those who have therapy straight away will meet with a trained staff member at their clinical team for 8 weekly one-to-one meetings and one follow-up meeting a month later. The therapy aims to support participants to work towards a personal goal.
Ethics approval
NRES Committee London, 19/12/2012, ref:12/LO/1523
Study design
Randomised interventional; Design type: Screening
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Psychosis early intervention and recovery
Intervention
Treatment as Usual Group: Participants in the TAU group will continue to receive all the treatment and support they currently receive, including input from their GP and psychiatrist and will be seen by their care co-ordinator at least monthly.
Treatment Group: Participants allocated to the treatment group will receive the brief CBT intervention. The manualised intervention comprises two evidence-based CBT interventions, which have been adapted for people with psychosis graded exposure (GE) for anxious avoidance and behavioural activation (BA) for depression. Participants will meet with a trained member of staff for nine hour-long sessions (8 weekly sessions and 1 booster session at 1 month post-intervention). The intervention aims to support participants to achieve personal recovery goals (increasing activity and social engagement), through targeting symptoms of depression or anxiety.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Levels of daily activity, measured by the Time Budget Measure (Jolley et al., 2006) at the end of treatment and follow-up
Secondary outcome measures
1. Global distress (Clinical Outcomes in Routine Evaluation - Outcome Measure, Evans et al., 2000); Timepoint(s): 0, 8 and 16 weeks
2. Patient-reported outcomes (CHOICE Measure, Greenwood et al., 2010); Timepoint(s): 0, 8 and 16 weeks
3. Psychotic symptoms (Positive and Negative Syndromes Scale, Kay et al., 1987; Psychotic Rating Scal; Timepoint(s): 0, 8 and 16 weeks
4. Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale, Zigmond & Snaith, 2003); Timepoint(s): 0, 8 and 16 weeks
5. Well-being (Warwick-Edinburgh Mental Well-being Scale, Tennant et al., 2007); Timepoint(s): 0, 8 and 16 weeks
6. Anxious avoidance (Mobility Inventory, Chambless et al., 1985); Timepoint(s): 0, 8 and 16 weeks
Overall trial start date
01/02/2013
Overall trial end date
01/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male & Female; Upper Age Limit 65 years ; Lower Age Limit 18 years
2. Diagnosis of a Schizophrenia Spectrum Disorder or currently experiencing positive psychotic symptoms (e.g. with diagnosis of personality disorder, bipolar affective disorder or psychotic depression)
3. Accessing adult community mental health services (both early intervention or longer-term)
4. Symptoms of anxiety-related avoidance and / or depression (above clinical cut-offs)
5. Sufficient command of the English language to complete questionnaires
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 65; Description: Randomised 1:1, therapy and control group
Participant exclusion criteria
1. Currently refusing all medication
2. Currently or recently (in last 3 months) receiving psychological therapy (CBT)
3. Primary diagnosis of an organic mental health problem
4. Primary diagnosis of substance dependency
5. Clients under the care of staff who are trained in the intervention will be excluded in order to reduce the potential for leakage of delivery of the intervention to the treatment of usual condition, should they be allocated to the control group. However, we will ensure that any eligible clients are offered access to the intervention following completion of the trial follow-up should they wish
Recruitment start date
01/02/2013
Recruitment end date
01/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
16 De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute Of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Research for Patient Benefit Programme; Grant Codes: PB-PG-0711-25010
Alternative name(s)
NIHR Research for Patient Benefit Programme, RfPB
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24973026
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29351861
Publication citations
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Protocol
Waller H, Craig T, Landau S, Fornells-Ambrojo M, Hassanali N, Iredale C, Jolley S, McCrone P, Garety P, The effects of a brief CBT intervention, delivered by frontline mental health staff, to promote recovery in people with psychosis and comorbid anxiety or depression (the GOALS study): study protocol for a randomized controlled trial., Trials, 2014, 15, 255, doi: 10.1186/1745-6215-15-255.