Plain English Summary
Background and study aims
Schizophrenia is a mental illness which occurs in around 1 in 100 people. About half will also suffer from depression, and around 1 in 20 will commit suicide. The NHS spends over £2 billion a year on the treatment of schizophrenia. Medication does not work well for everyone, and a lot of service users prefer talking therapies. Several studies have shown that psychological therapies work, and can help to save the NHS money by keeping people out of hospital. Unfortunately, current psychological therapies for schizophrenia are quite long (at least 6 months) and do not specifically target the treatment of depression. Our research team has developed a new psychological intervention to meet this need. It is relatively short-term (3 months) and is very structured. This makes it easy to train NHS staff to be able to deliver it. There have been encouraging results with this new therapy in previous studies. Given the potential benefit to patients diagnosed with schizophrenia, it is important to test whether this intervention will work for them. We plan to conduct a study to find out whether this treatment is effective and good value for money in treating depression in this group of patients.
Who can participate?
Individuals diagnosed with schizophrenia/schizo-affective disorder can participate.
What does the study involve?
Individuals who give consent and are eligible are allocated into one of two groups: either 'treatment as usual' or 'treatment as usual plus 3 months of positive memory training'. We will assess people at several times during the study. We will also develop a measure to use with people when they finish the study, to check whether they found it acceptable. We will compare the level of depression within the two groups in order to see whether those who received the treatment became less depressed than those who did not.
What are the possible benefits and risks of participating?
Those allocated to receive positive memory training may benefit from enhanced self-esteem and improved mood. There are no known risks associated with taking part in this study.
Where is the study run from?
Berkshire Healthcare Foundation Trust (UK) and Southern NHS Foundation Trust (UK) in collaboration with the University of Reading (UK).
When is the study starting and how long is it expected to run for?
Recruitment will commence in April 2014 for a period of 19 months, with follow-up assessments lasting a further 9 months.
Who is funding the study?
National Institute for Health Research (NIHR), UK.
Who is the main contact?
Dr Craig Steel
c.steel@reading.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Craig Steel
ORCID ID
Contact details
Department of Psychology
University of Reading
PO Box 238
Reading
RG6 6AL
United Kingdom
-
c.steel@reading.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15976
Study information
Scientific title
Positive Memory Training for the treatment of depression in schizophrenia: a randomised controlled trial
Acronym
PoMeT
Study hypothesis
The main hypothesis to be tested is that Positive Memory Training (PoMeT), delivered to patients with co-morbid schizophrenia and depression, in addition to standard psychiatric care will result in a reduced level of depressed symptomatology. The subsidiary hypothesis is that reduction in the symptoms of depression will mediate a reduction in psychotic symptomatology and service use.
Ethics approval
13SC0634; First MREC approval date 13/02/2014
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Mental Health Research Network; Subtopic: Schizophrenia; Disease: Schizophrenia
Intervention
Individuals who give consent and are eligible for the study will undergo an assessment at the start and 3 months, 6 months and 9 months after the first assessment. After the initial assessment, participants are allocated into one of two groups: either 'treatment as usual' or 'treatment as usual plus 3 months of positive memory training'. Those who receive positive memory training will have access to 8-12 one-hour sessions of the intervention within a 3-month period. The intervention trains people to increase their accessibility to feelings of positive self-esteem, initially within sessions and then in their day to day lives.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Depression: self-report, assessed through the Beck Depression Inventory-II at 3, 6 and 9 months
Secondary outcome measures
1. Schizophrenia symptoms (0, 3 and 9 months only). Assessed by clinical interview using the Positive and Negative Symptom Scale (PANSS).
2. Mood and Quality of Life. Assessed using the Generalised Anxiety Disorder Assessment (GAD7), the Work and Social Adjustment scale and the Warwick-Edinburgh Mental Well-Being Scale.
3. Self-Esteem. Measured using the Rosenberg self-esteem scale.
4. Mental Imagery (0, 3 and 9 months only). . Assessed using the Spontaneous Use of Imagery Scale.
5. Therapy Satisfaction (end of treatment only). Assessed using the newly developed measure.
6. Level of Service Use and Costs. Using a version of the Client Service Receipt Inventory (CSRI) which has been adapted for use in the current study and termed the Health Economic Questionnaire (0, 3 and 9 months).
7. Generic health-related quality of life and broader well-being of patients. EuroQol EQ-5D-5L, ICECAP-A and OxCAP-MH (0, 3, 6, 9 months).
8. Generic health-related quality of life and broader well-being of primary carers. EuroQol EQ-5D-5L and Carer Experiences Scale (CES) (0 and 9 months).
Overall trial start date
01/04/2014
Overall trial end date
01/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants will be included if:
1. They consent and have a current DSM-IV diagnosis of schizophrenia or schizo-affective disorder
2. Present with symptoms consistent with at least a mild level of depression, as indicated by a score of 14 or above on the BDI-II
3. They will be aged between 18 and 65
4. They will be able to read and write in English to a level required to participate in a talking therapy
5. Have a fixed abode: Operationalised as having a current address (including B&B or open access hostel)
6. Evidence (e.g., from key worker) indicating that the person is more likely than not to have a reliable address throughout the 12 months study duration
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant exclusion criteria
Not be suffering from an organic disorder which is associated with psychotic symptoms or have a learning disability.
Recruitment start date
01/04/2014
Recruitment end date
01/11/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Reading
Reading
RG6 6AL
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0712-28021
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
Basic results (scientific)
Publication list
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/25886265