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Trial registered on ANZCTR


Registration number
ACTRN12620000822987
Ethics application status
Approved
Date submitted
26/06/2020
Date registered
18/08/2020
Date last updated
8/10/2021
Date data sharing statement initially provided
18/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an Augmented Trauma-Focused Cognitive Behaviour Therapy on Posttraumatic Stress Disorder
Scientific title
Randomised Controlled Trial of Trauma-Focused Cognitive Behaviour Therapy versus Augmented Trauma-Focused Cognitive Behaviour Therapy on Posttraumatic Stress Disorder
Secondary ID [1] 301631 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 318040 0
Depression 318041 0
Condition category
Condition code
Mental Health 316071 316071 0 0
Anxiety
Mental Health 316072 316072 0 0
Depression
Mental Health 316358 316358 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Trauma-Focused Cognitive Behaviour Therapy. Arm 2: Augmented Trauma-Focused Cognitive Behaviour Therapy. Therapy is administered once-weekly 60 minute sessions by clinical psychologists over 11 weeks delivered. Trauma-Focused Cognitive Behaviour Therapy teaches the person skills in arousal reduction, exposure to trauma memories, restructuring of unrealistic thoughts, and relapse prevention. This will occur will via one-on-one sessions. All sessions will be audiotaped and fidelity checks of 10% of sessions for each treatment condition will be independently rated by independent experts. The duration of the study for any participant will conclude after a 2-year follow-up assessment, resulting in participation duration of 118 weeks.
Intervention code [1] 317937 0
Behaviour
Comparator / control treatment
The comparator condition is Augmented Trauma-Focused Cognitive Behaviour Therapy. This therapy is administered once-weekly 60 minute sessions by clinical psychologists over 11 weeks delivered. Augmented Trauma-Focused Cognitive Behaviour Therapy teaches the same skills in as Trauma-Focused Cognitive Behaviour Therapy. It also teaches skills in positive event scheduling, rehearsal in promoting pleasurable experiences, and training in imagining positive aspects of future events. This will occur will via one-on-one sessions. The duration of the study for any participant will conclude after a 2-year follow-up assessment, resulting in participation duration of 118 weeks.
Control group
Active

Outcomes
Primary outcome [1] 324265 0
Posttraumatic stress disorder as measured by the Clinician Administered PTSD Scale.
Timepoint [1] 324265 0
Pretreatment (week 1), posttreatment (week 12), primary follow-up (week 38), and long-term follow-up (week 118).
Secondary outcome [1] 384215 0
Depression as measured by the Beck Depression Inventory.
Timepoint [1] 384215 0
Pretreatment (week 1), posttreatment (week 12), primary follow-up (week 38), and long-term follow-up (week 118).
Secondary outcome [2] 384216 0
Alcohol use as measured by the Alcohol Use Disorder Identification Test.
Timepoint [2] 384216 0
Pretreatment (week 1), posttreatment (week 12), primary follow-up (week 38), and long-term follow-up (week 118).
Secondary outcome [3] 384217 0
Quality of life as measured by the WHO-QOL BREF.
Timepoint [3] 384217 0
Pretreatment (week 1), posttreatment (week 12), primary follow-up (week 38), and long-term follow-up (week 118).
Secondary outcome [4] 384218 0
Hedonia as measured by the Pleasure Scale.
Timepoint [4] 384218 0
Pretreatment (week 1), posttreatment (week 12), primary follow-up (week 38), and long-term follow-up (week 118).

Eligibility
Key inclusion criteria
• Satisfied PTSD criteria as defined by DSM-5 and measured by the Clinician-Administered
PTSD Scale
• Aged at least 18 years
• Sufficient English language ability
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current psychosis
• Imminent suicidal risk
• Current substance dependence

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)
Participants will be adults meeting diagnostic criteria for PTSD. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is independent from the trial centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will focus primarily on intent-to-treat analysis. Using SPSS version 24, hierarchical linear mixed models (HLM) will be used to study differential effects of each treatment condition because this method effectively handles missing data by calculating estimates of trajectories. For the folow-up analyses between the two conditions, analyses will focus on linear time effects, treatment conditions, and interactions. Fixed effects parameters were tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Cohen’s (d) effect size was calculated for all analyses. The primary outcome measure will be the Clinician-Administered PTSD Scale at 6 months . The primary outcome timepoint will be the 6 months assessment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
21/09/2020
Date of last participant enrolment
Anticipated
11/09/2023
Actual
Date of last data collection
Anticipated
17/11/2025
Actual
Sample size
Target
128
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16986 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 30648 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 306065 0
Government body
Name [1] 306065 0
NHMRC
Country [1] 306065 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Anzac Pde, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 306525 0
None
Name [1] 306525 0
NA
Address [1] 306525 0
NA
Country [1] 306525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306287 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 306287 0
UNSW HREC
UNSW Sydney
Sydney NSW 2052
Ethics committee country [1] 306287 0
Australia
Date submitted for ethics approval [1] 306287 0
18/05/2020
Approval date [1] 306287 0
14/09/2020
Ethics approval number [1] 306287 0

Summary
Brief summary
Posttraumatic stress disorder (PTSD) is the most common psychiatric disorder that develops following exposure to a traumatic event, such as interpersonal violence, combat, life-threatening accidents, or natural disasters. It is characterised by severe and persistent stress reactions including: intrusive memories and nightmares of the trauma, hypervigilance, difficulty sleeping, emotional withdrawal, pervasive negative emotions, and avoidance of places, activities, and situations that are reminiscent of their trauma. The treatment of choice for posttraumatic stress disorder (PTSD) is trauma-focused psychotherapy. Trauma-focused psychotherapy typically commences with psychoeducation about the trauma responses, and then focuses on three major strategies: anxiety management, exposure, and cognitive restructuring. Despite support for this therapeutic approach, meta-analyses indicate that at least one-third of patients do not respond to this treatment. Whilst extant treatments have shown success in reducing negative affect, they have had limited effect on increasing positive affect.This may be because extant treatments have focused solely on addressing symptoms reinforced by the withdrawal/defensive system and ignored the need to increase approach/appetitive responding, that results in increased positive affect. Modifying TF-CBT to include strategies that specifically target the approach/appetitive system may address a gap in available treatments that fail to address symptoms of dysphoria and anhedonia. Positive Affect Training aims to restore positive moods in participants alongside traditional extinction learning which reduces over-activation of the withdrawal/defensive motivation system associated with negative affect. To address the gap in augmenting the benefits of TF-CBT, this trial aims to test whether modifying TF-CBT to augment it with strategies to address anhedonia via Positive Affect Training will result in greater treatment gains relative to TF-CBT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103378 0
Prof Richard Bryant
Address 103378 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 103378 0
Australia
Phone 103378 0
+61 293853640
Fax 103378 0
+61 293853641
Email 103378 0
[email protected]
Contact person for public queries
Name 103379 0
Richard Bryant
Address 103379 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 103379 0
Australia
Phone 103379 0
+61 293853640
Fax 103379 0
+61 293853641
Email 103379 0
[email protected]
Contact person for scientific queries
Name 103380 0
Richard Bryant
Address 103380 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 103380 0
Australia
Phone 103380 0
+61 293853640
Fax 103380 0
+61 293853641
Email 103380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data acquired throughout the trial, including all assessments, as well as related data dictionaries will be available.
When will data be available (start and end dates)?
Data will be available following publication of the study outcomes. There is no end date for when this data will be available.
Available to whom?
Researchers wishing to conduct reanalyses of the data.
Available for what types of analyses?
Meta-analyses or reanalyses of subgroups
How or where can data be obtained?
By emailing the Principal Investigator (email: [email protected]


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.