Condition category
Mental and Behavioural Disorders
Date applied
20/03/2014
Date assigned
20/03/2014
Last edited
28/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The standard treatment for psychosis is antipsychotic medication. Antipsychotics have been proven to be helpful in reducing symptoms of psychosis for some people, but evidence suggests that many people choose to discontinue their medication due to side effects. Several studies have concluded that having a talking therapy called Cognitive Behavioural Therapy (CBT) as well as medication can help reduce symptoms further. Furthermore, a recent study concluded that CBT can be acceptable and effective in reducing psychotic symptoms in those who choose not to take antipsychotics, especially among young people and those with a short duration of illness. Whilst CBT may reduce symptoms and quality of life in people who are currently taking antipsychotics and those who choose not to take antipsychotics, there is insufficient research to support one treatment over another in terms of symptom reduction. The National Institute of Clinical Excellence (NICE) currently recommend CBT and/or medication for the treatment of psychosis and suggest that treatment should include choice. Furthermore, a recent review of studies examining the effectiveness of antipsychotics versus placebo/psychosocial interventions found that there was too little information to assess the effects. Therefore, in this study we plan to explore the acceptability of CBT compared to antipsychotics and a combination of both in adults with psychosis.

Who can participate?
Men and women aged 16 or over with psychosis.

What does the study involve?
Anyone who wants to take part will be sent some more detailed information and given time to think about it. The researchers will also need to talk to the person’s care coordinator or doctor at this stage. The participant will then be given an appointment with the researcher to check in more detail that they can take part. This will involve answering some questions about their experiences and filling in some questionnaires with a research assistant. They will also be asked to have some physical checks such as weight and BMI and to provide a blood sample. This will be done by a trained professional. Following this the participant will be randomly allocated to one of three treatment options: antipsychotic medication prescribed by their own healthcare team, CBT, or a combination of both. If they are allocated to receive CBT, these sessions can be carried out at home or at another convenient location. Everyone who takes part in the study will also meet a research assistant four times during a 12-month period for follow-up appointments. They will be compensated £10 at the initial appointment and at the four follow-up appointments. They will also be compensated £10 if they are asked to take part in an interview about their experience at the end of the study. Participants are free to leave the study at any point if they change their mind and this will not affect the usual care they receive.

What are the possible benefits and risks of participating?
The current NICE guidelines recommend both CBT and medication for the treatment of psychosis so we would expect that the treatment participants receive will be helpful to them. It is possible that they will improve any mental health difficulties that the participant is experiencing. If the participant is allocated to receive CBT it is possible that talking about some of these issues may be upsetting. Similarly, if they are allocated to receive antipsychotics it is possible, as with any medication, that they will experience some side effects such as weight gain and an increased risk of the development of diabetes. Participants can talk to their CPN, GP or psychiatrist about participation in this study and any concerns they may have. They will also have the opportunity to discuss any concerns with the researcher.

Where is the study run from?
Prestwich Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2014 to July 2016

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Miss Heather Law
heather.law@gmw.nhs.uk

Trial website

http://www.psychosisresearch.com/research/compare/

Contact information

Type

Scientific

Primary contact

Miss Heather Law

ORCID ID

Contact details

Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
-
heather.law@gmw.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16388

Study information

Scientific title

A pilot study of a randomised controlled trial of antipsychotic medication in comparison to cognitive behaviour therapy and a combined treatment in adults with psychosis

Acronym

COMPARE (COgnitive behavioural therapy or Medication for Psychosis – A Randomised Evaluation)

Study hypothesis

The current NICE guidelines recommend a talking treatment called Cognitive Behavioural Therapy (CBT) and/or medication for people who are experiencing things like hearing voices or having very strong beliefs that others do not seem to share or agree with. These experiences are sometimes referred to using the term ‘psychosis’. Currently the evidence suggests that CBT and/or antipsychotic medication are equally helpful for people experiencing psychosis. Further research is needed to identify which of these treatment options is the most helpful in reducing symptoms or whether a combination of treatments is needed. Also, other important results of treatment have not been measured, such as recovery defined by service users themselves, or how well the person copes with daily life, relationships and the demands of a job or education.

Therefore, the COMPARE study will be a pilot randomised controlled trial to explore the feasibility and acceptability of CBT, APs and a combination in adults with psychosis. We will aim to recruit 75 participants who will be randomised to one of three treatment arms: CBT, APs or a combination of both. We will measure symptoms, functioning, quality of life and wellbeing, side effects and acceptability at four time points over a 12-month follow-up period. We will also conduct qualitative interviews with participants to examine their views of the different treatments. The data from this study will help to plan a large multisite trial that will examine clinical and cost-effectiveness.

Ethics approval

NRES Committee North West - Preston, 25/02/2014, 14/NW/0041

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.psychosisresearch.com/research/compare/

Condition

Topic: Mental Health Research Network; Subtopic: Schizophrenia, Psychosis; Disease: Schizophrenia, Psychosis

Intervention

Description: We aim to have usable data on 60 participants. If we recruit 75 participants (25 per condition) over the 28-month recruitment period this would allow for a dropout rate of 20%.

Antipsychotic medication: The APs will be selected from those commonly used in the treatment of psychosis, with dosages within recommended limits; the responsible consultant psychiatrists will choose the individual AP before randomisation.

Cognitive behaviour therapy: Up to 25 sessions will be delivered over the 6-month treatment period.

Combined treatment: antipsychotics plus cognitve behaviour therapy.

Follow Up Length: 6 month(s)
Study Entry : Single Randomisation only

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Positive and Negative Syndrome Scale (PANSS); Timepoint(s): 6 weeks, 12 weeks, 24 weeks, 52 weeks

Secondary outcome measures

1. Clinical Global Impression scales (CGI); Timepoint(s): 6 weeks, 12 weeks, 24 weeks, 52 weeks
2. Hospital Anxiety and Depression Scale (HADS); Timepoint(s): 24 weeks, 52 weeks
3. Personal and social performance scale (PSP); Timepoint(s): 24 weeks, 52 weeks
4. Questionnaire about the process of Recovery (QPR); Timepoint(s): 24 weeks, 52 weeks
5. WHOQOL- quality of life; Timepoint(s): 6 weeks, 12 weeks, 24 weeks and 52 weeks

Overall trial start date

01/04/2015

Overall trial end date

01/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 25/07/2014:
1. In contact with mental health care services (under the care of a consultant)
2. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis
3. Aged 16+
4. Competent and willing to provide written, informed consent
5. Score at least 4 on PANSS delusions or hallucinations or at least 5 on Suspiciousness/Grandiosity
6. Help seeking

Previous inclusion criteria:
1. Aged 18+
2. In contact with mental health services
3. Competent to provide written, informed consent.
4. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis
5. Score at least 4 on PANSS delusions or hallucinations or at least 5 on suspiciousness/grandiosity
6. Help seeking

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 75; UK Sample Size: 75

Participant exclusion criteria

Current exclusion criteria as of 25/07/2014:
1. Primary diagnosis of alcohol/substance misuse
2. Moderate or severe learning disability
3. Score 5+ on PANSS conceptual disorganisation
4. Non-English speaking
5. Current receipt of structured CBT from a qualified psychologist in accordance with NICE guideline recommendations (as opposed to more generic psychosocial interventions) OR receipt of antipsychotics, OR receipt of either within the past 3 months.
6. Immediate risk to self or others
7. Organic Impairment

Previous exclusion criteria:
1. Primary diagnosis of alcohol/substance dependence
2. Moderate or severe learning disability
3. Score 5+ on PANSS conceptual disorganisation
4. Non-English speaking
5. Current receipt of structured CBT or APs, or receipt within the last 3 months
6. Inpatient
7. Immediate risk to self or others
8. Organic Impairment

Recruitment start date

01/04/2015

Recruitment end date

01/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Prestwich Hospital
Manchester
M25 3BL
United Kingdom

Sponsor information

Organisation

Greater Manchester West Mental Health NHS Foundation Trust (UK)

Sponsor details

Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom

Sponsor type

University/education

Website

http://www.gmw.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-1112-29057

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

28/06/2016: Statistical analysis plan uploaded. 06/11/2015: the following changes were made to the trial record: 1. The target number of participants was changed from 60 to 75. 2. The overall trial start date was changed from 01/03/2014 to 01/04/2015. 3. The overall trial end date was changed from 01/07/2016 to 01/04/2017.