Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000440628
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
20/09/2005
Date last updated
15/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Resistant Command Hallucinations
Scientific title
A randomised controlled trial to evaluate the efficacy of a mindfulness-based cognitive behavioural therapy in reducing distress and compliance in medication-resistant command hallucinations in psychotic disorders.
Universal Trial Number (UTN)
Trial acronym
TORCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Command hallucinations in psychotic disorders 552 0
Condition category
Condition code
Mental Health 630 630 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Auditory hallucinations (AHs), often described as voices, are a common symptom of schizophrenia and related psychoses. Command hallucinations (CHs) are a type of auditory hallucinations in which the voice heard by the patient commands him or her to perform a particular action. When heard, such commands often impose great pressure for obedience. CHs frequently urge dangerous acts and are associated with greater levels of disability and distress compared to patients with non-command AHs. Although anti-psychotic medication is helpful in preventing compliance, it is not fully effective. We are conducting a randomised controlled trial evaluating the efficacy of a mindfulness-based cognitive behavioural treatment for CHs (TORCH: Treatment of Resistant Command Hallucinations). The aim of TORCH is to reduce the distress, worry and harmful or self-defeating behaviour associated with CHs. Treatment comprises 15 sessions with a psychologist, normally conducted at weekly intervals.
Intervention code [1] 485 0
Treatment: Other
Comparator / control treatment
The evaluation of TORCH is being undertaken by comparing TORCH with a control condition, Befriending. In Befriending, participants receive an equal amount of therapist contact, in the form of positive and enjoyable social conversation and activity, but not the specific components of TORCH. Participants in both groups are offered an additional 2 follow-up therapy sessions in the 6 months following completion of their therapy. A subset of participants have been randomised to a 4-month wait-list condition in order to permit a comparision of both TORCH and Befriending with standard treatment.
Control group
Active

Outcomes
Primary outcome [1] 738 0
Compliance with CHs
Timepoint [1] 738 0
Assessments compared to baseline occur as soon as possible after completing therapy and at 6 months follow-up.
Primary outcome [2] 739 0
Compliace with distress
Timepoint [2] 739 0
Assessments compared to baseline occur as soon as possible after completing therapy and at 6 months follow-up.
Secondary outcome [1] 1519 0
Beliefs about voices, general psychopathology (illness severity), depression, psychological adaptation to psychosis, insight, quality of life.
Timepoint [1] 1519 0
Assessments compared to baseline occur as soon as possible after completing therapy and at 6 months follow-up.

Eligibility
Key inclusion criteria
Current diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or mood disorder with psychotic features; have experienced command hallucinations over previous 6 months that have cause distress or dysfuntion despite receiving treatment with anti-psychotic medication at doses in therapeutic range.
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; premorbid IQ below 70; insufficient conversational English for meaningful participation.

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)
Assessments are conducted by research assistants who are kept blind to treatment allocation. Participants are given written and verbal instructions not to say which group they are in or refer to their treatment in any way. Research assistants are located in a different office to therapists to help maintain blindness.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was by variable length blocks. Sequences of fix length blocks were generated using the first random generator available at www.randomization.com. Switching between blocks was determined by an additional random sequence generated by the same method. A similar procedure was used to generate assignments to treatments for participants initially assigned to the wait-list condition. All seeds were recorded so that sequences could be replicated if necessary. Assignment of participants to conditions was done by the study statistician who worked independently of staff involved in the recruitment, assessment and management of participants in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
3/04/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
43
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 688 0
Government body
Name [1] 688 0
National Health & Medical Research Council
Country [1] 688 0
Australia
Funding source category [2] 689 0
Other
Name [2] 689 0
The Mental Health Research Institute of Victoria
Country [2] 689 0
Australia
Primary sponsor type
Government body
Name
The Mental Health Research Institute of Victoria
Address
155 Oak Street, Parkville, Vic 3052 Australia
Country
Australia
Secondary sponsor category [1] 576 0
None
Name [1] 576 0
nil
Address [1] 576 0
Country [1] 576 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1883 0
Austin Health (North East Area Mental Health Service)
Ethics committee address [1] 1883 0
Ethics committee country [1] 1883 0
Australia
Date submitted for ethics approval [1] 1883 0
Approval date [1] 1883 0
Ethics approval number [1] 1883 0
Ethics committee name [2] 1884 0
Bendigo Health Care Group (Loddon Area Mental Health Service)
Ethics committee address [2] 1884 0
Ethics committee country [2] 1884 0
Australia
Date submitted for ethics approval [2] 1884 0
Approval date [2] 1884 0
Ethics approval number [2] 1884 0
Ethics committee name [3] 1885 0
Department of Human Services (Forensicare - Community Operations)
Ethics committee address [3] 1885 0
Ethics committee country [3] 1885 0
Australia
Date submitted for ethics approval [3] 1885 0
Approval date [3] 1885 0
Ethics approval number [3] 1885 0
Ethics committee name [4] 1886 0
Goulburn Valley Health (Goulburn Valley Area Mental Health Service)
Ethics committee address [4] 1886 0
Ethics committee country [4] 1886 0
Australia
Date submitted for ethics approval [4] 1886 0
Approval date [4] 1886 0
Ethics approval number [4] 1886 0
Ethics committee name [5] 1887 0
Mercy Health & Aged Care (South West Area Mental Health Service)
Ethics committee address [5] 1887 0
Ethics committee country [5] 1887 0
Australia
Date submitted for ethics approval [5] 1887 0
Approval date [5] 1887 0
Ethics approval number [5] 1887 0
Ethics committee name [6] 1888 0
North Western Mental Health (Inner West, Mid West, Northern and North West Area Mental Health Services)
Ethics committee address [6] 1888 0
Ethics committee country [6] 1888 0
Australia
Date submitted for ethics approval [6] 1888 0
Approval date [6] 1888 0
Ethics approval number [6] 1888 0
Ethics committee name [7] 1889 0
Peninsula Health (Peninsula Area Mental Health Service)
Ethics committee address [7] 1889 0
Ethics committee country [7] 1889 0
Australia
Date submitted for ethics approval [7] 1889 0
Approval date [7] 1889 0
Ethics approval number [7] 1889 0
Ethics committee name [8] 1890 0
St. Vincent's Health (Inner Urban East Area Mental Health Service)
Ethics committee address [8] 1890 0
Ethics committee country [8] 1890 0
Australia
Date submitted for ethics approval [8] 1890 0
Approval date [8] 1890 0
Ethics approval number [8] 1890 0
Ethics committee name [9] 1891 0
Southern Health (Dandenong & Middle South Area Mental Health Services)
Ethics committee address [9] 1891 0
Ethics committee country [9] 1891 0
Australia
Date submitted for ethics approval [9] 1891 0
Approval date [9] 1891 0
Ethics approval number [9] 1891 0

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

Contacts
Principal investigator
Name 36285 0
Address 36285 0
Country 36285 0
Phone 36285 0
Fax 36285 0
Email 36285 0
Contact person for public queries
Name 9674 0
Dr Fran Shawyer
Address 9674 0
School of Psychological Science
La Trobe University
Vic 3086 Australia
Country 9674 0
Australia
Phone 9674 0
+61 3 9479 1421
Fax 9674 0
+ 61 3 9479 1956
Email 9674 0
[email protected]
Contact person for scientific queries
Name 602 0
Dr Fran Shawyer
Address 602 0
School of Psychological Science
La Trobe University
Vic 3086 Australia
Country 602 0
Australia
Phone 602 0
+61 3 9479 1421
Fax 602 0
+ 61 3 9479 1956
Email 602 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.