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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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19 February 2018 |
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Main ID: |
ISRCTN73188383 |
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Date of registration:
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20/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The GOALS study: evaluation of a brief cognitive-behavioural therapy (CBT) treatment to support people with psychosis to reach personal goals
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Scientific title:
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The GOALS Study: a randomised controlled trial of a brief CBT intervention to promote recovery in psychosis |
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Date of first enrolment:
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01/02/2013 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN73188383 |
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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: Screening (Screening)
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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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Helen
Waller |
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Address:
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16 De Crespigny Park
SE5 8AF
London
United Kingdom |
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Telephone:
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- |
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Email:
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helen.waller@slam.nhs.uk |
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Affiliation:
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Name:
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Address:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psychosis ? early intervention and recovery
Mental and Behavioural Disorders
Unspecified nonorganic psychosis
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Intervention(s)
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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.
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Primary Outcome(s)
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Levels of daily activity, measured by the Time Budget Measure (Jolley et al., 2006) at the end of treatment and follow-up
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Research for Patient Benefit Programme; Grant Codes: PB-PG-0711-25010
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Ethics review
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Status:
Approval date:
Contact:
NRES Committee London, 19/12/2012, ref:12/LO/1523
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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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01/08/2015 |
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URL:
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