Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000603213
Ethics application status
Not yet submitted
Date submitted
23/03/2009
Date registered
21/07/2009
Date last updated
27/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treating acute psychotic symptoms in an inpatient service using Acceptance and Commitment Therapy
Scientific title
Treating acute psychotic symptoms in an inpatient service using Acceptance and Commitment Therapy, measuring acceptance-based attitudes and actions, health outcomes and level of disability.
Secondary ID [1] 289778 0
study has been withdrawn
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute psychotic symptoms 4520 0
Condition category
Condition code
Mental Health 4804 4804 0 0
Schizophrenia
Mental Health 239628 239628 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acceptance and Commitment Therapy (ACT) incorporates acceptance, mindfulness, values clarification and committing to behavioural oriented goals. ACT is based on the view that many maladaptive behaviors are produced by unhealthy attempts to avoid or suppress thoughts, feelings, or bodily sensations (Hayes, Luoma, Bond, Masuda, & Lillis, 2006; Hayes, Wilson, Gifford, Follette & Strosahl, 1996).
The brief (4 session) form of ACT intervention used in this study (Guadiano & Herbert, 2006) will follow the following specifications:
a) the duration of therapy sessions; one hour;
b) the frequency of therapy sessions: 2- 3 per week;
c) the mode of administration: one-on-one therapy sessions with a psychologist;
d) total duration of the therapy program: 4 sessions.
Intervention code [1] 4274 0
Treatment: Other
Comparator / control treatment
Treatment as usual (TAU) varies for each individual patient, but can include medication, participation in the ward groups and activities, individual sessions with a psychologist (average duration of sessions 60 minutes, frequency of sessions ranging 1-3 times per week); the average duration of the usual treatment program 14 days. After discharge, TAU includes case-management services.
Control group
Active

Outcomes
Primary outcome [1] 5663 0
Increase in score on the Voices Actions and Acceptance Scale, which measures the participants attitudes to their voices.
Timepoint [1] 5663 0
1. At the completion of treatment
2. At 6 months follow-up
Secondary outcome [1] 241550 0
Decrease of score on Health of the Nation Outcome Scale (HoNOS) scale, which measures the severity (on a 5 point likerd scale) of the 12 types of problem commonly presented by patients/clients in mental health care settings, including behavioural problems, impairment, symptomatic problems, and social problems
Timepoint [1] 241550 0
1. At the completion of treatment
2. At 6 months follow-up
Secondary outcome [2] 241551 0
Decrease of score on the Sheehan Disability Scale , which measures the self-reported level of impairment caused by psychiatric symptoms in work/school, social and family life, using a 10 point visual analog scale.
Timepoint [2] 241551 0
1. At the completion of treatment
2. At 6 months follow-up

Eligibility
Key inclusion criteria
Adult, aged 18-65; meeting criteria for a Psychotic Diosorder; case managed/will be case managed by by St Vincent's Mental Health Service; fluent in English
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychotic symptoms are part of delirium, dementia or medical condition; experiencing withdrawal symptoms; have a diagnosis of intellectual disability

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
staff left - project was never commenced this was updated in 2012
Date of first participant enrolment
Anticipated
8/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4705 0
Self funded/Unfunded
Name [1] 4705 0
Country [1] 4705 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Mental Health
Address
46 Nicholson Street, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 4250 0
None
Name [1] 4250 0
Address [1] 4250 0
Country [1] 4250 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6739 0
Ethics committee address [1] 6739 0
Ethics committee country [1] 6739 0
Date submitted for ethics approval [1] 6739 0
22/10/2008
Approval date [1] 6739 0
Ethics approval number [1] 6739 0
1/08/0132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29429 0
Dr study has been withdrawn
Address 29429 0
study has been withdrawn
Country 29429 0
Australia
Phone 29429 0
study has been withdrawn
Fax 29429 0
Email 29429 0
study has been withdrawn
Contact person for public queries
Name 12676 0
Dr Maria Ftanou
Address 12676 0
Acute Inpatient Service - Mental Health
St Vincent's Hospital
46 Nicholson Street
Fitzroy VIC 3065
Melbourne
Country 12676 0
Australia
Phone 12676 0
+61 3 92882366
Fax 12676 0
Email 12676 0
[email protected]
Contact person for scientific queries
Name 3604 0
Dr Maria Ftanou
Address 3604 0
Acute Inpatient Service - Mental Health
St Vincent's Hospital
46 Nicholson Street
Fitzroy VIC 3065
Melbourne
Country 3604 0
Australia
Phone 3604 0
+61 3 92882366
Fax 3604 0
Email 3604 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.