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Trial registered on ANZCTR


Registration number
ACTRN12623000097640
Ethics application status
Approved
Date submitted
7/11/2022
Date registered
27/01/2023
Date last updated
27/01/2023
Date data sharing statement initially provided
27/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Randomised Controlled Trial Comparing Cognitive Behaviour Therapy-Standard vs Cognitive Behaviour Therapy-Memory Reconsolidation for Inpatients with Post-Traumatic Stress Disorder
Scientific title
A Pilot Randomised Controlled Trial Comparing CBT-S vs CBT-MR for Inpatients with PTSD for Symptom Severity in Inpatients with PTSD
Secondary ID [1] 308359 0
Nil known.
Universal Trial Number (UTN)
U1111-1284-8088
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 328152 0
Condition category
Condition code
Mental Health 325207 325207 0 0
Anxiety
Mental Health 325792 325792 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention involves a 4-week inpatient program that includes group therapy and individual therapy. All participants will receive the same group therapy experience. The group therapy involves psychoeducation, motivational interviewing and cognitive behaviour therapy targeting maladaptive beliefs about emotions. The group therapy will be delivered 4 times a week over 4 weeks, with each session lasting approximately 1.5 hours. The group therapy will be delivered by a registered or probationally registered psychologist with either another registered or probationally registered psychologist or mental health professional attending as a co-therapist. The groups will include between 4 to 10 participants. The participants will self-monitor attendance by rating a session attendance checklist.

The individual therapy involves one of two conditions. The intervention condition is a modified version of standard prolonged exposure therapy modified according to memory reconsolidation therapy principles (CBT-MR). Each participant will receive 2 x 1.5 hour sessions a week over 4 weeks. These sessions will be administered one-on-one and face-to-face with a probationally registered or registered psychologist. Attendance will be measured using a self-rated session attendance checklist. The first session will involve developing a fear hierarchy of traumatic memories. The subsequent sessions will involve recalling the next traumatic memory on the fear hierarchy for a few minutes. The participant will then be invited to engage in detached mindfulness for the next 20 minutes. Following this, the participant will be asked to recall the traumatic memory again and will engage in imaginal exposure therapy until the participants subjective unit of distress has significantly reduced. The participant will then be advised on helpful aftercare. The individual therapy sessions will be spaced out so that there is at least one day between each session.
Intervention code [1] 324810 0
Treatment: Other
Comparator / control treatment
The control group will receive the same experience with the group therapy sessions as the intervention group. However, rather than receiving the modified individual therapy sessions, they will receive standard prolonged exposure therapy for traumatic memories (CBT-S). Each participant will receive 2 x 1.5 hour sessions a week over 4 weeks. These sessions will be administered one-on-one and face-to-face with a probationally registered or registered psychologist. Attendance will be measured using a self-rated session attendance checklist. The first session will involve developing a fear hierarchy of traumatic memories. The subsequent sessions will involve recalling the next traumatic memory on the fear hierarchy for a few minutes. Following this, the participant will be asked to engage in imaginal exposure therapy until the participants subjective unit of distress has significantly reduced. The participant will then be advised on helpful aftercare. The individual therapy sessions will be spaced out so that there is at least one day between each session.
Control group
Active

Outcomes
Primary outcome [1] 333041 0
Changes in symptoms of PTSD as measured by the participants' self-rating on the PCL-5
Timepoint [1] 333041 0
PCL-5 is measured at basesline, end of weeks 1-4 and 1 month follow-up.
Primary outcome [2] 333637 0
This is an additional primary outcome measure. The participants will interviewed by a psychiatrist, psychiatric registrar, registered psychologist or probationary registered psychologist using the CAPS-5 structured clinical interview.
Timepoint [2] 333637 0
CAPS-5 is measured at the start of week 1 and the end of week 4
Secondary outcome [1] 415592 0
Beliefs about Emotions Questionnaire
Timepoint [1] 415592 0
Baseline, end of weeks 1-4 post-commencement of intervention and at 1 month follow-up post-completion of intervention.
Secondary outcome [2] 415593 0
Post-traumatic Maladaptive Beliefs Scale (PMBS; Vogt et al., 2012).
Timepoint [2] 415593 0
Baseline, end of weeks 1-4 post-commencement of intervention and at 1 month follow-up post-completion of intervention.
Secondary outcome [3] 415594 0
Depression will be assessed using the self-report Patient Health Questionnaire 9
Timepoint [3] 415594 0
Baseline, end of weeks 1-4 post-commencement of intervention and at 1 month follow-up post-completion of intervention.
Secondary outcome [4] 415595 0
Anxiety will be measured using the self-report Generalized Anxiety Disorder Scale (GAD7)
Timepoint [4] 415595 0
Baseline, end of weeks 1-4 post-commencement of intervention and at 1 month follow-up post-completion of intervention.
Secondary outcome [5] 415596 0
Acceptability of Intervention Measure (AIM)
Timepoint [5] 415596 0
At end of week 4 post-commencement of intervention.
Secondary outcome [6] 415597 0
Attendance as measured by the participants self-rating their attendance at each therapy session.
Timepoint [6] 415597 0
Daily during the 4 week inpatient program.
Secondary outcome [7] 417835 0
Intervention Appropriateness Measure (IAM)
Timepoint [7] 417835 0
Competed at the end of week 4 post-commencement of the intervention.
Secondary outcome [8] 417836 0
Feasibility of Intervention Measure (FIM; Weiner et al., 2017).
Timepoint [8] 417836 0
Completed at the end of week 4 post-commencement of the intervention.
Secondary outcome [9] 417837 0
Attrition will be measured by the research team recording the date that a participant decided to drop out of the study.
Timepoint [9] 417837 0
This will be recorded any day from the first day following randomisation to the follow-up date.

Eligibility
Key inclusion criteria
>= 18 years and a diagnosis of Post-Traumatic Stress Disorder (PTSD)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Psychosis, due to the lack of reality testing inherent to this disorder.
- Intellectual Disability or any evidence of cognitive impairment that would interfere with the course of treatment.
- Complex PTSD, Borderline Personality Disorder, Narcistic Personality Disorder, or Histrionic Personality Disorder due to poor emotion regulation interfering with the ability to engage in group therapy.
- Bipolar Disorder, due to the potentially confounding effects of rapid mood swings.
- Alcohol Use Disorder and/or Substance Use Disorder, due to the potential to interfere with the patient’s ability to engage in exposure-based treatment and mentalise in the group CBT.
- Anorexia Nervosa, because severe restrictive eating practices can reduce cognitive capacity, and reduce the effectiveness of cognitive therapy.
- High Suicide Risk

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)
Sealed opaque envelopes
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
Open (masking not used)
Who is / are masked / blinded?



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






Sampe Size
o Given the novelty of this study, a direct estimation of sample size based upon a similar previous study is not possible. However, using the change in pre-post PTSD symptom scores (Impact of Events Scale-Revised) combined from the two previous published case series studies that the intervention arm is based upon (Kerswell, et al, 2020; Vivian et al, 2022), and using published treatment standard deviation score for the IES-R we have an estimated effect size of d = 1.72 for CBT-MR. This compares with published effect size of CBT for PTSD compared with waitlist control groups of d=1.39 (Cusack, et al., 2016). The difference in these effect sizes is small (f=0.165). Using this effect size in GPower 3.1 for an ANOVA between-within group comparison and alpha =.05, power =.80, number of groups = 2 and number of measurements = 5 results in a total sample size of 46.
o A similar 30-day inpatient treatment for PTSD experienced a 16% drop-out rate (Menefee, et al., 2016). Assuming a similar drop-out rate in our study, we will need 55 participants to start the intervention.
o We plan to recruit an average of 7 participants per month (starting with 5 per month and increasing to 10 per month) over a 10-month period. This will yield a sample size of 70 participants for this study.

Statistical Analyses
• Group descriptive data will be presented using means and standard deviations for continuous data and frequencies for categorical data.
• The two conditions will be compared on the baseline continuous variables and the acceptability measures using Analysis of Variance.
• The two conditions will be compared on the baseline categorical variables using Chi-square.
• The two conditions will be compared on the outcome variables using a Repeated Measures Analysis of Variance. If baseline differences are detected between the two conditions on any continuous or ordinal demographic variable, then these will be included as covariates in these analyses.
• These analyses will be repeated in Mixed Models using biological targets as covariates. If significant correlations are established between the biological targets (that make sense theoretically) then Structural Equation Models will be used in place of Mixed Models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2023
Actual
Date of last participant enrolment
Anticipated
22/12/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23515 0
New Farm Clinic - New Farm
Recruitment postcode(s) [1] 38923 0
4005 - New Farm

Funding & Sponsors
Funding source category [1] 312599 0
University
Name [1] 312599 0
Queensland University of Technology
Country [1] 312599 0
Australia
Funding source category [2] 313050 0
Hospital
Name [2] 313050 0
New Farm Clinic
Country [2] 313050 0
Australia
Primary sponsor type
Hospital
Name
New Farm Clinic
Address
New Farm Clinic
22 Sargent Street,
New Farm, 4005
Queensland
Country
Australia
Secondary sponsor category [1] 314214 0
University
Name [1] 314214 0
Queensland University of Technology
Address [1] 314214 0
Queensland University of Technology
School of Psychology and Counselling
Victoria Park Road
Kelvin Grove 4059
Queensland
Country [1] 314214 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311926 0
Ramsay Health Human Research Ethics Commitee
Ethics committee address [1] 311926 0
Ethics committee country [1] 311926 0
Australia
Date submitted for ethics approval [1] 311926 0
07/11/2022
Approval date [1] 311926 0
18/01/2023
Ethics approval number [1] 311926 0
2022/ETH/0119

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

Contacts
Principal investigator
Name 122862 0
Dr Wole Akosile
Address 122862 0
New Farm Clinic
22 Sargent Street
New Farm 4005
Queensland
Country 122862 0
Australia
Phone 122862 0
+61 07 3254 9111
Fax 122862 0
Email 122862 0
AkosileW@ramsayhealth.com.au
Contact person for public queries
Name 122863 0
Wole Akosile
Address 122863 0
New Farm Clinic
22 Sargent Street
New Farm 4005
Queensland
Country 122863 0
Australia
Phone 122863 0
+61 07 3254 9111
Fax 122863 0
Email 122863 0
nfcsreception@ramsayhealth.com.au
Contact person for scientific queries
Name 122864 0
Esben Strodl
Address 122864 0
School of Psychology and Counselling
Queensland University of Technology
Victoria Park Rd
Kelvin Grove 4059
Queensland
Country 122864 0
Australia
Phone 122864 0
+61731388416
Fax 122864 0
Email 122864 0
e.strodl@qut.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.