Positive Memory Training for the treatment of depression in schizophrenia
| ISRCTN | ISRCTN99485756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99485756 |
| Secondary identifying numbers | 15976 |
- Submission date
- 13/03/2014
- Registration date
- 13/03/2014
- Last edited
- 10/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Department of Psychology
University of Reading
PO Box 238
Reading
RG6 6AL
United Kingdom
| c.steel@reading.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Positive Memory Training for the treatment of depression in schizophrenia: a randomised controlled trial |
| Study acronym | PoMeT |
| Study objectives | 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(s) | 13SC0634; First MREC approval date 13/02/2014 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2014 |
| Completion date | 01/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Total final enrolment | 100 |
| Key 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 |
| Key exclusion criteria | Not be suffering from an organic disorder which is associated with psychotic symptoms or have a learning disability. |
| Date of first enrolment | 01/04/2014 |
| Date of final enrolment | 01/11/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
RG6 6AL
United Kingdom
Sponsor information
Hospital/treatment centre
Fitzwilliam House
Skimped Hill Lane
Berkshire
Bracknell
RG12 1BQ
England
United Kingdom
"ROR" |
https://ror.org/03t542436 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/04/2015 | Yes | No | |
| Results article | 01/12/2020 | 10/05/2021 | Yes | No |
Editorial Notes
10/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
26/11/2018: No publications found, verifying study status with principal investigator.
21/10/2015: Publication reference added.
