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Trial registered on ANZCTR


Registration number
ACTRN12618001674224
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
10/10/2018
Date last updated
5/02/2021
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Attention Control Training In Veterans to Augment Treatment (ACTIVATE)
Scientific title
Attention training to augment post traumatic stress disorder treatment for veterans: A pilot RCT
Secondary ID [1] 295907 0
None
Universal Trial Number (UTN)
Trial acronym
ACTIVATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder 309605 0
Condition category
Condition code
Mental Health 308424 308424 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Attention control training (ACT)

In ACT, participants perform four computer-delivered attention training sessions, taking 7 minutes per training session, over a period of 4 weeks (once weekly). Attention training sessions are delivered in the hospital. In each session the dot-probe task is administered. The task consists of 128 trials. Each trial begins with a centrally-presented fixation cross that is then replaced by a pair of neutral and threat words. A target probe appears in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. In ACT, targets appear with equal probability at the location of threat and neutral stimuli, in order to modify the fluctuations in attention allocation. Reaction time duration and incorrect responses are reviewed post-hoc to assess adherence to the intervention.
Intervention code [1] 312393 0
Treatment: Other
Comparator / control treatment
Attention Bias Modification (ABM)

In ABM participants perform four computer-delivered attention training sessions, taking 7 minutes per training session, over a period of 4 weeks (once weekly). Attention training sessions are delivered in the hospital. In each session the dot-probe task is administered. The task consists of 128 trials. Each trial begins with a centrally-presented fixation cross that is then replaced by a pair of neutral and threat words. A target probe appears in the location previously occupied by the neutral word, and participants are requested to discriminate the probe type via button press. In ABM, the probe always appears in the location opposite to the threat word (i.e., replaces the location of the neutral word). Reaction time duration and incorrect responses are reviewed post-hoc to assess adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 307391 0
Severity of PTSD symptoms as measured by the PTSD Checklist (PCL-5). The PCL-5 is a 20-item self-report scale with scores ranging from 0 to 80, with higher scores reflecting more symptoms of PTSD (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).
Timepoint [1] 307391 0
Pre-attention training, post-attention training, post-treatment as usual (primary timepoint), 3 months follow-up, 9 months follow-up.
Secondary outcome [1] 351808 0
Symptoms of anxiety and depression will be measured using the The Hospital Depression Anxiety Scale (HADS; Zigmond & Snaith, 1983) with a total of 7 items for each subscale. Participants are asked to respond to 14 items on a 4-point Likert scale ranging from 0 to 3.
Timepoint [1] 351808 0
Pre-attention training, post-attention training, post-treatment as usual, 3 months follow-up, 9 months follow-up.
Secondary outcome [2] 351809 0
Psychological distress will be measued using the Kessler Psychological Distress Scale. This was developed by Kessler and others in 1992 as a screening instrument for mental health conditions and as a measure of non-specific psychological distress (Kessler et al, 2002).
Timepoint [2] 351809 0
Pre-attention training, post-attention training, post-treatment as usual, 3 months follow-up, 9 months follow-up.
Secondary outcome [3] 351810 0
Anger severity will be measured using the Dimensions of Anger Reactions (Forbes, Alkemade, Mitchell, et al., 2014). It comprised of 5 items relating to anger reactions and is a concise measure of anger severity. It has demonstrated strong psychometric properties in a combat veteran population (Forbes, Alkemade, Hopcraft, et al., 2014).
Timepoint [3] 351810 0
Pre-attention training, post-attention training, post-treatment as usual, 3 months follow-up, 9 months follow-up.
Secondary outcome [4] 351811 0
Pain will be measured using the Visual Analog Scale for Pain (Hawker, Mian, Kendzerska, & French, 2011), a unidimensional measure of pain intensity. It has been widely used in a diverse range of adult populations.
Timepoint [4] 351811 0
Pre-attention training, post-attention training, post-treatment as usual, 3 months follow-up, 9 months follow-up.
Secondary outcome [5] 351812 0
Attention Bias Variability (ABV) is a measure of the degree to which attention fluctuates between vigilance and avoidance. It is calculated using reaction time data from the dot-probe computer-based task. In this task, pairs of anger and neutral faces are simultaneously presented on the computer screen. Each stimulus pair is followed by a target probe appearing randomly at the location of either the angry face or the neutral face. Participants press a key indicating which probe appeared. The task consists of 64 items. Response latencies on the task provide a “snap-shot” of the distribution of the subject’s attention, with faster responses to probes presented in the attended relative to the unattended location. For example, attention bias toward threat is evident when participants are faster to respond to probes that replace threat stimuli rather than neutral stimuli. The reverse pattern indicates threat-related attentional avoidance.
Timepoint [5] 351812 0
Pre-attention training, post-attention training and post-treatment as usual.
Secondary outcome [6] 352591 0
Capacity for attention training to prepare an individual for standard treatment will be measured using the Readiness for Psychotherapy Index (Ogrodniczuk, Joyce, & Piper, 2009), which is a 20-item scale that assesses four aspects of readiness. An additional item measuring readiness to engage with the trauma memory was also added.
Timepoint [6] 352591 0
Pre and post attention training.

Eligibility
Key inclusion criteria
An ex-serving member of the Australian Defence Force
Have a diagnosis of PTSD, confirmed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Eligible for participation and consented to participate in the Toowong Hospital Trauma Recovery Program (TRP)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A currently serving member of ADF
Unable to use a computer keyboard
Unable or ineligible to participate in the Toowong TRP

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)
Allocation concealment will be used for this trial. Specifically, a central randomisation website will be utilised that assigns a participant to either condition 1 or 2. Neither participants nor the administering research assistant will know which is ABM and which is ACT.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a randomisation table created by computer software (i.e. computerised sequence generation),
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot RCT testing feasibility of the intervention in this population and in an augmentative capacity to standard treatment, no formal power analyses has been conducted. Our recruitment target of 50 participants (25 participants in each group) are similar to those used in previous studies that detected significant differences between the active and control groups.

Descriptive statistics will be used to summarise characteristics of intervention and control conditions, with regards to baseline characteristics and patterns of change over time. Differences between intervention and control conditions, on both primary and secondary outcomes, will be evaluated in a regression-based framework and in accordance with intention-to-treat (ITT) principles. Historical data previously collected in a sample of veterans with PTSD who received the Toowong TRP (i.e., this study's TAU) will be used to create a matched sample to further investigate change in PTSD scores between the intervention, control, and the historical sample.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID-19
Date of first participant enrolment
Anticipated
22/10/2018
Actual
1/11/2018
Date of last participant enrolment
Anticipated
30/10/2020
Actual
17/02/2020
Date of last data collection
Anticipated
30/07/2021
Actual
27/03/2020
Sample size
Target
50
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11838 0
Toowong Private Hospital - Toowong
Recruitment postcode(s) [1] 23975 0
4066 - Toowong

Funding & Sponsors
Funding source category [1] 300499 0
Charities/Societies/Foundations
Name [1] 300499 0
Centenary of Anzac Centre, Phoenix Australia - Centre for Posttraumatic Mental Health
Country [1] 300499 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Centenary of Anzac Centre, Phoenix Australia
Address
Department of Psychiatry, The University of Melbourne
Level 3, Alan Gilbert Building,
161 Barry Street
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 300459 0
None
Name [1] 300459 0
Address [1] 300459 0
Country [1] 300459 0
Other collaborator category [1] 280357 0
Hospital
Name [1] 280357 0
Toowong Private Hospital
Address [1] 280357 0
496 Milton Rd, Toowong QLD 4066
Country [1] 280357 0
Australia
Other collaborator category [2] 280358 0
University
Name [2] 280358 0
Tel Aviv University
Address [2] 280358 0
Laboratory for Research on Anxiety and Trauma
School of Psychological Sciences
Tel Aviv University
Tel Aviv, Israel 69978
Country [2] 280358 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301296 0
Department of Veterans’ Affairs Human Research Ethics Committee, the Departments of Defence and Veterans’ Affairs (DDVA HREC)
Ethics committee address [1] 301296 0
Ethics committee country [1] 301296 0
Australia
Date submitted for ethics approval [1] 301296 0
26/07/2018
Approval date [1] 301296 0
05/09/2018
Ethics approval number [1] 301296 0
050-18

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

Contacts
Principal investigator
Name 86534 0
Prof Meaghan O'Donnell
Address 86534 0
Phoenix Australia, Level 3, Alan Gilbert Building, 161 Barry Street Carlton VIC 3053
Country 86534 0
Australia
Phone 86534 0
+61 3 9035 5599
Fax 86534 0
Email 86534 0
mod@unimelb.edu.au
Contact person for public queries
Name 86535 0
Olivia Metcalf
Address 86535 0
Phoenix Australia, Level 3, Alan Gilbert Building, 161 Barry Street Carlton VIC 3053
Country 86535 0
Australia
Phone 86535 0
+61 3 9035 5599
Fax 86535 0
Email 86535 0
olivia.metcalf@unimelb.edu.au
Contact person for scientific queries
Name 86536 0
Olivia Metcalf
Address 86536 0
Phoenix Australia, Level 3, Alan Gilbert Building, 161 Barry Street Carlton VIC 3053
Country 86536 0
Australia
Phone 86536 0
+61 3 9035 5599
Fax 86536 0
Email 86536 0
olivia.metcalf@unimelb.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


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.