Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001203640p
Ethics application status
Submitted, not yet approved
Date submitted
18/10/2023
Date registered
22/11/2023
Date last updated
22/11/2023
Date data sharing statement initially provided
22/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of Cognitive Processing Therapy for 18-35-year-olds with co-occurring post-traumatic stress and substance use disorders.
Scientific title
A randomized controlled trial of Cognitive Processing Therapy for 18-35-year-olds with co-occurring post-traumatic stress and substance use disorders in residential substance use treatment.
Secondary ID [1] 310542 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow-up from the studies registered as: ACTRN12621000296831 and ACTRN12621000492853.

Health condition
Health condition(s) or problem(s) studied:
post-traumatic stress disorder
 331365 0
substance use disorders 331953 0
other mental health disorders 331954 0
Condition category
Condition code
Mental Health 328112 328112 0 0
Addiction
Mental Health 328113 328113 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive processing therapy (CPT) is a 'gold-standard' cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters (Resick et al., 2016). CPT is a 12-session protocol that will be delivered by a team of trained clinicians (primarily case managers supervised by a board-approved, endorsed clinical psychologist) on an individual, twice-weekly basis, over 6 weeks, with 60-minute sessions. Sessions are delivered through telehealth (video-based) format.

Session 1 -
The goals for the first session of CPT are to engage the client in treatment and provide psychoeducation on the relationship between PTSD and substance use. The therapist also explains the rationale behind CPT: giving client’s tools to examine their thoughts and emotions, feeling the natural emotions arising from the trauma, and changing thoughts around trauma that are keeping client’s stuck (referred to as stuck points in CPT).

Sessions 1-3 -
Sessions 1-3 will focus on preparing the client for CPT and identifying stuck points that have interfered with the client’s recovery after their trauma(s), including the role of substance use. These sessions are foundational to developing the client’s association between thoughts and feelings and the client is taught to identify and self-monitor these associations.

Sessions 4- 5 -
The goal for these sessions are for the client to be able to label events, thoughts, and emotions and to understand the connections among them. These sessions will also introduce categorising thoughts objectively as well as challenging the client’s individual thoughts that can be related to the trauma or substance use behaviour.

Sessions 6-8 -
The first goal of these sessions are to teach the clients to become their own cognitive therapists based on the techniques learned thus far in therapy. Secondly, the clients are asked to identify their patterns of problematic thinking in relation to the traumatic event(s) and substance use. These sessions also begin to challenge core beliefs related to the traumatic event.

Sessions 9-12 -
The primary goals of the remainder of the sessions is to continue challenging the clients trauma related beliefs as well as examine the themes of Safety, Trust, Esteem, Intimacy and Power and Control related to the traumatic event. In addition, the client and therapist continue to integrate any unresolved ‘stuck points’ relevant to the index trauma. A modification which will be made at the end of treatment from the original protocol will be to add relapse prevention into the clients final sessions.

Treatment fidelity of the intervention will be monitored through: a) de-identified audio recordings which will be assessed at the end of treatment by independent CPT clinicians, b) session checklists for clinicians during sessions, and c) weekly supervision of clinicians by a trained, board-approved clinical supervisor specializing in the delivery of CPT.
Intervention code [1] 327137 0
Rehabilitation
Intervention code [2] 327322 0
Behaviour
Comparator / control treatment
The comparator condition will include a treatment-as-usual condition. Participants who are randomised to this condition will receive regular residential treatment offered as part of the standard service program and participate in the same outcome assessment as the intervention condition. Participants will be told their allocated condition in the first week of treatment by their case manager in the facility.

The standard service program is a residential, live-in service that includes a 6-week group program focused on substance use recovery, individual case management and counselling, and medical and psychiatric assistance.
Control group
Active

Outcomes
Primary outcome [1] 336240 0
PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5)
Timepoint [1] 336240 0
baseline, weekly and 1, 3, 6, and 12-months (primary timepoint) post-baseline
Primary outcome [2] 336241 0
Substance Use measured on The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) questionnaire
Timepoint [2] 336241 0
baseline and 1, 3, 6, and 12-months post-baseline
Primary outcome [3] 336634 0
Substance use measured using the Australian Treatment Outcomes Profile and Quality of Life (ATOP) questionnaire
Timepoint [3] 336634 0
baseline and 1, 3, 6, and 12-months post-baseline
Secondary outcome [1] 427489 0
Depression measured on the Patient Health Questionnaire (PHQ-9)
Timepoint [1] 427489 0
baseline and 1, 3, 6, and 12-months post-baseline
Secondary outcome [2] 427490 0
Anxiety measured on the Generalised Anxiety Disorder Scale (GADS-7).
Timepoint [2] 427490 0
baseline and 1, 3, 6, and 12-months post-baseline
Secondary outcome [3] 427491 0
Post-traumatic cognition as measured by the Posttraumatic Cognitions Inventory (PTCI)
Timepoint [3] 427491 0
baseline and 1, 3, 6, and 12-months post-baseline

Eligibility
Key inclusion criteria
1) Positive PTSD screen on the PCL-5 (+31). The PCL-5 is a measure used to assess PTSD symptomatology based on the DSM-5 criteria. This requires the client to need at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20) on the PCL-5.
2) Attendance at one of the participating Lives Lived Well residential facilities
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Following CPT protocol recommendations (Resick et al., 2016), participants will be excluded from therapy if they meet any of the following:
a) non-fluent in English
b) acutely suicidal
c) current diagnosis of schizophrenia, currently manic bipolar, or intellectual disability
d) Experienced a trauma that had occurred before the age of three (as there is an inability to remember the trauma)
e) the participant's cognitive capacity is limited such that they are unable to understand the therapeutic concepts and worksheets offered.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using simple randomisation coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For client sample size, a power calculation for the trial including two groups will require a total sample size of 128 participants for adequate power (.8) to detect a medium effect (f =.25, equivalent to a Cohen’s d medium effect size of 0.5) over two time points (calculated using G*Power 3.1). Using a medium effect and only two time points for the calculation was a conservative approach to calculate the sample size to maximise the likelihood to detect an effect, even though there will be more time points. A similar recent study that was run at the Lives Lived Well Mirikai facility recruited 118 clients over an 8-month period. Since the current project will be recruiting clients over a 12-month period, we envisage recruiting at least 177 clients over this time period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
177
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314744 0
Government body
Name [1] 314744 0
National Health and Medical Research Council (NHMRC)
Country [1] 314744 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 316724 0
None
Name [1] 316724 0
Address [1] 316724 0
Country [1] 316724 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313754 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 313754 0
Level 3, Brian Wilson Chancellery The University of Queensland St Lucia QLD 4072
Ethics committee country [1] 313754 0
Australia
Date submitted for ethics approval [1] 313754 0
09/10/2023
Approval date [1] 313754 0
Ethics approval number [1] 313754 0

Summary
Brief summary
There are disproportionately higher rates of lifetime trauma and Post-traumatic Stress Disorder (PTSD) among people with substance use disorders (SUDs), which can both precede, and occur as a consequence of substance use. Cognitive Processing Therapy (CPT) is a ‘gold-standard’ PTSD treatment, with a strong emphasis on processing and restructuring maladaptive beliefs around a traumatic event without employing exposure-based strategies. However, the effectiveness of CPT for individuals with co-occurring PTSD and SUD has not been extensively studied. The current project will be a randomized controlled parallel-group trial, which will determine the outcomes of CPT for young people with SUD/PTSD in the residential treatment setting for substance use. Participants will be randomised to receive either TAU or CPT alongside their usual residential treatment (CPT+TAU). Client outcomes on measures of substance use and PTSD, depression, anxiety symptoms will be evaluated at baseline, 1-, 3-, 6-, and 12-months follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129250 0
Prof Leanne Hides
Address 129250 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 129250 0
Australia
Phone 129250 0
+61 7 336 56398
Fax 129250 0
Email 129250 0
l.hides@uq.edu.au
Contact person for public queries
Name 129251 0
Miss Valeriya Mefodeva
Address 129251 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 129251 0
Australia
Phone 129251 0
+61 7 336 56398
Fax 129251 0
Email 129251 0
v.mefodeva@uq.edu.au
Contact person for scientific queries
Name 129252 0
Miss Valeriya Mefodeva
Address 129252 0
School of Psychology McElwain Building The University of Queensland St Lucia QLD 4072
Country 129252 0
Australia
Phone 129252 0
+61 7 336 56398
Fax 129252 0
Email 129252 0
v.mefodeva@uq.edu.au

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 de-identified baseline and follow up data collected
When will data be available (start and end dates)?
Within 12 months of the conclusion of the study
No end date specified
Available to whom?
Only researchers who provide a methodologically sound proposal will be provided with access to the data on a case-by-case basis
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
via University of Queensland Research Data Management System website
https://rdm.uq.edu.au/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20679Study protocol  v.mefodeva@uq.edu.au
20680Statistical analysis plan  v.mefodeva@uq.edu.au
20681Ethical approval  v.mefodeva@uq.edu.au



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.