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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 January 2021 |
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Main ID: |
ISRCTN34966555 |
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Date of registration:
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12/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Active Assistance for Psychological Therapy (Actissist): Using mobile technology to deliver cognitive behaviour therapy for psychosis
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Scientific title:
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Active Assistance for Psychological Therapy (Actissist): Using mobile technology to deliver cognitive behaviour therapy for psychosis: a randomised controlled trial |
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Date of first enrolment:
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01/03/2015 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN34966555 |
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Study type:
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Interventional |
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Study design:
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Randomised; Interventional; Design type: Treatment (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Sandra
Bucci |
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Address:
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School of Psychological Sciences
Zochonis Building
Oxford Road
M13 9PL
Manchester
United Kingdom |
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Telephone:
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- |
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Email:
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sandra.bucci@manchester.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. In current contact with Early Intervention Services
2. At least 4 week stabilisation of positive symptoms (score <3 on the PANSS items)
3. Mental capacity to provide informed consent
4. Sufficient English language proficiency to complete questionnaires and respond to written material
5. Aged 16 years or older
Exclusion criteria:
1. Anyone less than 16 years old at the point of recruitment
2. Anyone incapable of giving informed consent
3. Non-English proficient
4. Score >3 on the PANSS items for positive psychotic symptoms
5. Any service user >35 years
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Mental Health; Subtopic: Psychosis; Disease: Psychosis
Mental and Behavioural Disorders
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Intervention(s)
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Participants will be randomly assigned to the intervention and control groups in a ratio of 2:1, respectively (24:12).
Mobile CBT: Cognitive Behavioural Therapy administered via a mobile phone.
The control group will receive ClinTouch; a mobile phone application developed to monitor the symptoms of psychosis (Palmier-Claus et al., 2012).
Follow Up Length: 10 month(s); Study Entry : Single Randomisation only
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Primary Outcome(s)
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Acceptability and feasibility; Timepoint(s): Uptake and drop-out rates will be assessed throughout. Patient feedback is taken at follow-up.
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Secondary Outcome(s)
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1. Number of social interactions, measured by the Personal and and Social Performance Scale (Morosini et al., 2000)
2. Drug use frequency, measured by the Timeline FollowBack (TLFB; Sobell & Sobell, 1992)
3. Perceived criticism, measured by the perceived criticism scale (Hooley & Teasdale, 1989)
4. Positive psychotic symptoms, measured by the Positive and Negative Syndrome Scale (PANSS; Kay,Opler & Fiszbein, 1987)
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK); Grant Codes: R116690
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Ethics review
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Status:
Approval date:
Contact:
14/WM/0118; First MREC approval date 28/04/2014
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/06/2016 |
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URL:
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