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Trial registered on ANZCTR


Registration number
ACTRN12616001503415
Ethics application status
Approved
Date submitted
26/10/2016
Date registered
31/10/2016
Date last updated
16/10/2019
Date data sharing statement initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and effectiveness of trauma-focussed imaginal exposure for voice hearing following adverse life experiences: A pilot trial (The Recall study).
Scientific title
The feasibility and effectiveness of trauma-focussed imaginal exposure for voice hearing following adverse life experiences: A pilot trial (The Recall study).
Secondary ID [1] 290371 0
Nil known
Universal Trial Number (UTN)
U1111-1188-9792
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auditory hallucinations 300675 0
Condition category
Condition code
Mental Health 300524 300524 0 0
Schizophrenia
Mental Health 300525 300525 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Imaginal Exposure plus treatment as usual: The active intervention will be an 'imaginal exposure' intervention consisting of 6 weekly sessions of 90-minute duration. Imaginal exposure is a common element of several effective trauma-focussed treatments and involves repeated exposure to the trauma narrative through verbal recounting. The treatment will be delivered face to face in a mental health clinic by a doctoral level, registered Clinical Psychologist. Overall supervision will be provided by a senior Clinical Psychologist with extensive experience in psychological interventions for voice hearers. The intervention is manualised. The initial session will involve education regarding trauma and memory processing, a review and elaboration of the client’s trauma-voice link formulation established in the baseline assessment, and an explanation of the rationale for imaginal exposure. Sessions 2 – 6 will follow the protocol for imaginal exposures outlined in the Prolonged Exposure treatment manual (Foa, Hembree, & Rothbaum, 2007). Participants will also be required to listen to audio recordings of their in-session imaginal exposures for homework in sessions 2-5. This will be approximately 30-40 minutes of homework each day during this period. Ten percent of sessions will be randomly selected for adherence checks by a senior clinician using an adherence checklist. Participants in this group will also continue to receive standard psychiatric interventions such as case management and medication.
Intervention code [1] 296195 0
Behaviour
Intervention code [2] 296232 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299974 0
Acceptability and feasibility of the intervention - measured using a satisfaction questionnaire and uptake and retention rates. These measures will be used as a composite outcome.
Timepoint [1] 299974 0
Uptake and retention data collected at initial screening and throughout treatment. Satisfaction questionnaire completed at end of treatment (7 weeks following baseline) for the treatment group only.
Primary outcome [2] 299975 0
Voice hearing severity– measured using the Psychotic Symptom Rating Scales – Auditory Hallucinations Scale total score.
Timepoint [2] 299975 0
Baseline, 8 weeks following baseline, 12 weeks following baseline.
Primary outcome [3] 299976 0
Voice hearing intensity– measured ten times per day using ecological momentary assessment over a 6 day timeframe.
Timepoint [3] 299976 0
During week 1 and week 8 following baseline
Secondary outcome [1] 328625 0
Client experience of the intervention, measured using an adapted questionnaire version of Elliott’s change process interview.
Timepoint [1] 328625 0
End of treatment (7 weeks following baseline) - treatment group only.
Secondary outcome [2] 328626 0
PTSD symptom severity, measured using the CAPS -5.
Timepoint [2] 328626 0
Baseline, 8 weeks following baseline, 12 weeks following baseline.
Secondary outcome [3] 328627 0
Posttraumatic intrusion frequency, measured 10 times per day using ecological momentary assessment over a 6 day timeframe.
Timepoint [3] 328627 0
During week 1 and week 8 following baseline
Secondary outcome [4] 328628 0
Delusion severity, measured using the Psychotic Symptom Rating Scales – Delusions Scale total score.
Timepoint [4] 328628 0
Baseline, 8 weeks following baseline, 12 weeks following baseline.
Secondary outcome [5] 328629 0
Depression severity, measured using the Depression Anxiety and Stress Scale – 21.
Timepoint [5] 328629 0
Baseline, 8 weeks following baseline, 12 weeks following baseline.
Secondary outcome [6] 328630 0
Disorganisation of the trauma memory, measured using the Trauma Memory Questionnaire.
Timepoint [6] 328630 0
Baseline, 8 weeks following baseline, 12 weeks following baseline.
Secondary outcome [7] 328631 0
Posttraumatic cognitions, measured by the Posttraumatic Cognitions Inventory.
Timepoint [7] 328631 0
Baseline, 8 weeks following baseline, 12 weeks following baseline.
Secondary outcome [8] 328632 0
Sensory detail in the trauma memory, measured using transcribed trauma narratives from sessions 2 and 6 and analysed using Linguistic Inquiry and Word Count software.
Timepoint [8] 328632 0
Treatment session 2 and session 6, treatment group only.
Secondary outcome [9] 328749 0
Primary outcome 4: Voice hearing distress– measured 10 times per day using ecological momentary assessment over a 6 day timeframe.
Timepoint [9] 328749 0
During week 1 and week 8 following baseline
Secondary outcome [10] 328750 0
Primary outcome 5: Voice hearing frequency– measured 10 times per day using ecological momentary assessment over a 6 day timeframe.
Timepoint [10] 328750 0
During week 1 and week 8 following baseline
Secondary outcome [11] 328751 0
Posttraumatic intrusion distress, measured 10 times per day using ecological momentary assessment over a 6 day timeframe
Timepoint [11] 328751 0
During week 1 and week 8 following baseline
Secondary outcome [12] 328752 0
Anxiety severity, measured using the Depression Anxiety and Stress Scale – 21.
Timepoint [12] 328752 0
Baseline, 8 weeks following baseline, 12 weeks following baseline.
Secondary outcome [13] 328753 0
Intrusiveness of the trauma memory, measured using the Trauma Memory Questionnaire.
Timepoint [13] 328753 0
Baseline, 8 weeks following baseline, 12 weeks following baseline.
Secondary outcome [14] 328754 0
Cognitive processing in the trauma memory, measured using transcribed trauma narratives from sessions 2 and 6 and analysed using Linguistic Inquiry and Word Count software.
Timepoint [14] 328754 0
Treatment session 2 and session 6, treatment group only.

Eligibility
Key inclusion criteria
(a) aged 18-75
(b) persistent voice hearing that has been present for > 6 months and is currently occurring at least twice a week
(c) a history of criterion A traumatic events, childhood adversity or significant interpersonal victimisation (assessed by standardised trauma checklists)
(d) has made some conceptual links between their past adverse experiences and their experience of voice hearing and, for this reason, is motivated to undertake a trauma-focussed intervention
e) has a sufficient level of English language to participate in study requirements
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) recent (past month) or planned change in psychiatric medication
b) substance induced voices OR current substance dependence issues that would interfere with participation in the trial
c) Intellectual disability (Wechsler Test of Adult Reading estimated IQ < 70)
(d) Acute risk to self or others, defined by the presence of suicidal or homicidal thoughts with current intent.
e) Participant’s treating team report that undertaking the study treatment would pose a serious risk to the safety of the participant or the safety of other people.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None - this is now a single arm study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None - this is now a single arm study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Since this is a pilot study, the primary aim is to establish feasibility and acceptability as well as effect size estimates and confidence intervals for effectiveness outcomes. As such, a sample size of 15 was considered sufficient to meet these aims.

Repeated measures ANOVAs will be used to assess whether there is a significant change in scores for primary and secondary outcomes over the three assessment time points. Where there is a significant effect, paired t-tests will be used to examine differences between the time points. Hedges g will be used to calculate treatment effect sizes and confidence intervals will be established for these effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/11/2016
Actual
2/11/2016
Date of last participant enrolment
Anticipated
2/08/2019
Actual
18/06/2019
Date of last data collection
Anticipated
2/11/2019
Actual
17/09/2019
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6859 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment hospital [2] 12335 0
The Voices Clinic - Hawthorn
Recruitment postcode(s) [1] 14524 0
3004 - Melbourne
Recruitment postcode(s) [2] 24576 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 294767 0
University
Name [1] 294767 0
Swinburne University of Technology
Country [1] 294767 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John Street, Hawthorn, VIC, 3122
Country
Australia
Secondary sponsor category [1] 293612 0
Hospital
Name [1] 293612 0
Monash Alfred Psychiatry Research Centre
Address [1] 293612 0
Level 4, 607 St Kilda Road, Melbourne VIC 3004
Country [1] 293612 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296173 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 296173 0
Ethics committee country [1] 296173 0
Australia
Date submitted for ethics approval [1] 296173 0
05/08/2016
Approval date [1] 296173 0
11/10/2016
Ethics approval number [1] 296173 0
436/16

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

Contacts
Principal investigator
Name 69846 0
Dr Neil Thomas
Address 69846 0
Brain and Psychological Sciences Research Centre
Swinburne University of Technology
PO BOX 218
Hawthorn, VIC, 3122
Country 69846 0
Australia
Phone 69846 0
+613 9214 8742
Fax 69846 0
Email 69846 0
neilthomas@swin.edu.au
Contact person for public queries
Name 69847 0
Rachel Brand
Address 69847 0
Brain and Psychological Sciences Research Centre
Swinburne University of Technology
PO BOX 218
Hawthorn, VIC, 3122
Country 69847 0
Australia
Phone 69847 0
+613 9076 6564
Fax 69847 0
Email 69847 0
rbrand@swin.edu.au
Contact person for scientific queries
Name 69848 0
Rachel Brand
Address 69848 0
Brain and Psychological Sciences Research Centre
Swinburne University of Technology
PO BOX 218
Hawthorn, VIC, 3122
Country 69848 0
Australia
Phone 69848 0
+613 9076 6564
Fax 69848 0
Email 69848 0
rbrand@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this time we do not have ethical approval to share IPD for future research.


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.