Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000210370
Ethics application status
Approved
Date submitted
10/04/2008
Date registered
18/04/2008
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Date results information initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Acceptance and Commitment Therapy as a psychological treatment for schizophrenia
Scientific title
Evaluating the efficacy of Acceptance and Commitment Therapy as a psychological treatment for schizophrenia
Secondary ID [1] 299928 0
Nil
Universal Trial Number (UTN)
Trial acronym
lifengage project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 3031 0
Condition category
Condition code
Mental Health 3184 3184 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acceptance and Commitment Therapy
Manualised psychological treatment, invovling the use of questioning, metaphors, experiential exercises and homework tasks, designed to promote distancing from psychotic symptoms and orientation towards acting in line with personal values and goals.
8 x 50 min one-to-one sessions, held weekly to fortnightly
Intervention code [1] 2776 0
Treatment: Other
Intervention code [2] 2777 0
Behaviour
Comparator / control treatment
Befriending
Manualised psychosocial intervention, involving talking about day-to-day events and topics of interest to the person, and avoiding discussion of psychotic symptoms or other areas of difficulty.
8 x 50 min one-to-one sessions, held weekly to fortnightly
Control group
Active

Outcomes
Primary outcome [1] 4073 0
Positive and Negative Syndrome Scale (PANSS)
Timepoint [1] 4073 0
Pre-treatment
Post-treatment
6 months post-treatment
Secondary outcome [1] 6857 0
Psychotic Symptom Rating Scales (PSYRATS)
Timepoint [1] 6857 0
Pre-treatment
Post-treatment
6 months post-treatment
Secondary outcome [2] 6858 0
Social Functioning Scale
Timepoint [2] 6858 0
Pre-treatment
Post-treatment
6 months post-treatment
Secondary outcome [3] 6859 0
Psychiatric service utilisation (outpatient consultations and inpatient admissions)
Timepoint [3] 6859 0
6 month period prior to treatment
6 month period post-treatment

Eligibility
Key inclusion criteria
Diagnosis of schizophrenia or schizoaffective disorder (using Structured Clinical Interview for DSM-IV - SCID)
Current residual hallucinations of delusions (score 4 or greater on Positive and Negative Syndrome Scale items P1 or P3)
Residual symptoms present continuously for past six months
On antipsychotic medication with dose in therapeutic range for past six months
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological disorder affecting cognitive function
IQ less than 70
Insufficient spoken English for participation
Change in antipsychotic medication in last eight weeks or planned at time of intake
Currently receiving other formal psychological treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
31/10/2011
Date of last data collection
Anticipated
Actual
30/11/2012
Sample size
Target
106
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3286 0
Government body
Name [1] 3286 0
National Health and Medical Research Council
Country [1] 3286 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora Campus
Victoria 3086
Country
Australia
Secondary sponsor category [1] 2941 0
None
Name [1] 2941 0
n/a
Address [1] 2941 0
n/a
Country [1] 2941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5272 0
Melbourne Health MHREC
Ethics committee address [1] 5272 0
Royal Melbourne Hospital
Grattan Street
Parkville
Victoria 3050
Ethics committee country [1] 5272 0
Australia
Date submitted for ethics approval [1] 5272 0
Approval date [1] 5272 0
01/01/2008
Ethics approval number [1] 5272 0
MHREC 2007.39

Summary
Brief summary
Study examining how effective a psychological therapy called acceptance and commitment therapy is for people with persisting symptoms of severe mental illnesses such as schizophrenia.
Trial website
Trial related presentations / publications
Shawyer, F., Thomas, N., Morris, E.M.J., & Farhall, J. (2013). Theory of voices. In E.M.J. Morris, L.C. Johns & J.E. Oliver (Eds.), Acceptance and commitment therapy and mindfulness for psychosis (pp. 12-32). Chichester, England: Wiley-Blackwell. doi:10.1002/9781118499184.ch2

Farhall, J., Shawyer, F., Thomas, N., & Morris, E.M.J. (2013). Clinical assessment and assessment measures. In E.M.J. Morris, L.C. Johns & J.E. Oliver (Eds.), Acceptance and commitment therapy and mindfulness for psychosis (pp. 47-63). Chichester, England: Wiley-Blackwell. doi:10.1002/9781118499184.ch4

Thomas, N., Morris, E.M.J., Shawyer, F., & Farhall, J. (2013). Acceptance and commitment therapy for voices. In E.M.J. Morris, L.C. Johns & J.E. Oliver (Eds.), Acceptance and commitment therapy and mindfulness for psychosis (pp. 95-111). Chichester, England: Wiley-Blackwell. doi:10.1002/9781118499184.ch7

Thomas, N., Shawyer, F., Castle, D., Copolov, D., Hayes, S., & Farhall, J. (2014). A randomised controlled trial of acceptance and commitment therapy (ACT) for psychosis: Study protocol. BMC Psychiatry, 14, e198. doi:10.1186/1471-244X-14-198

Shawyer, F., Farhall, J., Thomas, N., Hayes, S. C., Gallop, B., Copolov, D., & Castle, D. (2017). A randomised controlled trial of acceptance and commitment therapy for psychosis. British Journal of Psychiatry, 210, 140-148. doi:10.1192/bjp.bp.116.182865
Public notes

Contacts
Principal investigator
Name 28517 0
Dr John Farhall
Address 28517 0
School of Psychological Science
La Trobe University
Bundoora
VIC 3086
Country 28517 0
Australia
Phone 28517 0
+61 3 9479 1626
Fax 28517 0
Email 28517 0
[email protected]
Contact person for public queries
Name 11674 0
Dr Dr Neil Thomas
Address 11674 0
School of Psychological Science
La Trobe University
Bundoora
Victoria 3086
Country 11674 0
Australia
Phone 11674 0
03 9479 5045
Fax 11674 0
Email 11674 0
[email protected]
Contact person for scientific queries
Name 2602 0
Dr Dr John Farhall
Address 2602 0
School of Psychological Science
La Trobe University
Bundoora
Victoria 3086
Country 2602 0
Australia
Phone 2602 0
03 9479 1626
Fax 2602 0
Email 2602 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcceptance and commitment therapy for psychosis: Randomised controlled trial.2017https://dx.doi.org/10.1192/bjp.bp.116.182865
EmbaseA randomised controlled trial of acceptance and commitment therapy (ACT) for psychosis: study protocol.2014https://dx.doi.org/10.1186/1471-244X-14-198
N.B. These documents automatically identified may not have been verified by the study sponsor.