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Trial registered on ANZCTR


Registration number
ACTRN12620000624987
Ethics application status
Approved
Date submitted
8/05/2020
Date registered
29/05/2020
Date last updated
2/07/2021
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Stepped care for adults with PTSD: A randomised controlled trial
Scientific title
Effectiveness of a stepped care approach for adults with posttraumatic stress disorder: A randomised controlled trial
Secondary ID [1] 301016 0
None
Universal Trial Number (UTN)
U1111-1250-4453
Trial acronym
Linked study record
Pilot Study -
An Effectiveness Trial of Online Stepped-Care for Adults with Posttraumatic Stress Disorder
ANZCTR Trial Id: ACTRN12619001141134

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder (PTSD) 317054 0
Condition category
Condition code
Mental Health 315221 315221 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a randomised control trial, the study aims to test the feasibility and effectiveness of a stepped care approach to treating posttraumatic stress disorder (PTSD) in adults that initially uses an intervention delivered online with modest clinician involvement, in comparison to a standard treatment approach (Cognitive Processing Therapy; CPT).

Following a comprehensive clinical, pre-treatment assessment via an online video call (90 minutes) and Qualtrics questionnaire (60 minutes), participants will be randomly allocated into either a Stepped condition or CPT.

All participants in the Stepped condition undertake Step 1 of the intervention.

Step 1: This Way Up (TWU)

TWU is an eight-week online cognitive-behavioural treatment program developed by the Clinical Research Unit for Anxiety and Depression (CRUfAD) at St Vincent’s Hospital in Sydney. Each week, participants will complete a self-guided 60-minute lesson in their own time. The lessons are delivered as comic-book stories and cover psychoeducation around PTSD, coping skills, cognitive therapy (i.e., teaching more adaptive ways to evaluate and interpret situations) and written and real-life exposure (e.g., a trauma account). In addition, participants complete homework exercises for one to three hours each week to practice the skills taught in lesson. To monitor progress and problem solve any issues, participants will consult with a therapist by video call for 15 minutes after each lesson is completed.

At the completion of TWU, particpants complete a post-treatment assessment via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes). Particpants who are 'stepped-up' before completing 7 sessions of TWU will only complete the 2-week version of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) via online video call before starting CPT.

Step 2: Cognitive Processing Therapy (CPT)

Participants are 'stepped-up' to CPT if (a) there is non-response in the first 5 sessions (i.e., no reliable change on PTSD self-report), (b) they fail to engage (e.g., complete session 1, but don’t progress immediately to session 2), (c) they complete TWU, but with minimal or moderate response (all assessed via reliability of change index analysed in conjunction with clinical cut-offs on the PCL-5), or (d) clinical issues arise that indicate more intensive therapy is required (e.g., reliable increase in symptoms associated with marked distress that does not remit by subsequent session).

CPT is an evidence-based cognitive behavioural therapy for PTSD (see Resick, Monson and Chard, 2016). In the current study, participants will be offered up to 18 weekly, 60-minute sessions on a one-to-one basis via online video call. CPT duration is estimated between 8 to 18 weeks depending on client's individual needs. Initial sessions provide a rationale for the approach, and psychoeducation about PTSD. Participants are asked to write an impact statement about how the trauma has impacted their life and beliefs about their self, others and the world. Subsequent sessions then focus upon learning to identify and label thoughts and feelings, and challenging unhelpful automatic thoughts through Socratic questioning. Therapist works with the participant to develop strategies for generating more useful and helpful thinking patterns. The final sessions focus on maladaptive beliefs surrounding safety, trust, power, esteem, intimacy (domains that are often impacted by PTSD). Before the final session of CPT, participants write a new impact statement which typically reflects treatments gains, and relapse prevention is discussed.

At the completion of CPT, participants complete another post-treatment assessment via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes).

Following therapy, regardless of treatment dose, participants complete a 3- and 6-month follow-up assessment via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes).

To ensure diagnostic reliability, all diagnostic interviews and therapy sessions will be video/audiotaped and will be coded by a research assistant to ensure that the therapist is adhering to the components of each treatment session. By adopting this design the proposed research conforms to the gold standard for conducting treatment outcome research with traumatised samples (Foa & Meadows, 1997), and ensures the methodological rigour of the proposed project. Assessors who have no knowledge of the participants or stage or treatment reached will be used at post and three-month follow up assessments.

Therapists involved are either registered psychologists, currently undertaking clinical psychology training or have recently completed this training and undertaking a placement in the Flinders University Posttraumatic Stress Clinic. All therapists will have training in the TWU and CPT protocol. Therapists will receive weekly supervision from Professor Nixon.
Intervention code [1] 317330 0
Treatment: Other
Comparator / control treatment
Cognitive processing therapy (CPT) will be used as the comparision treatment. A summary of this intervention is described in 'Step 2' of the Stepped condition detailed in the 'Description of intervention' field of the study ANZCTR registration record. In the CPT condition, following therapy, participants will be asked to complete a post-treatment assessment, 3-month follow-up assessment, and 6-month follow-up assessment via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes).
Control group
Active

Outcomes
Primary outcome [1] 323481 0
Change in PTSD symptom severity as measured on the Posttraumatic Stress Disorder Checklist (PCL-5).
Timepoint [1] 323481 0
At baseline, 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 3-months follow-up and 6-months follow-up.
Primary outcome [2] 323482 0
Change in PTSD symptom severity as measured on the Clinician Administered PTSD Scale (CAPS).
Timepoint [2] 323482 0
At baseline, 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 6-months follow-up.
Primary outcome [3] 323638 0
Proportion of participants who no longer meet the DSM-5 diagnostic criteria for PTSD on the Clinician Administered PTSD Scale (CAPS).
Timepoint [3] 323638 0
2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 6-months follow-up.
Secondary outcome [1] 382031 0
Change in depression severity as measured on the Depression Anxiety Stress Scale (DASS-21).
Timepoint [1] 382031 0
At baseline, 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 3-months follow-up and 6-months follow-up.
Secondary outcome [2] 382032 0
Cost effectiveness of the therapies measured by the Commonwealth Department of Health and Aged Care schedules with clinician time for both conditions (Stepped vs CPT) and therapy types (TWU vs CPT) recorded on a weekly basis. Clinician time will be measured by the length of recorded Zoom video calls.
Timepoint [2] 382032 0
At 2 weeks post This Way Up completion and 2 weeks post Cognitive Processing Therapy completion.
Secondary outcome [3] 382033 0
Change in quality of life scores as measured by the Assessment of Quality of Life (AQoL-8D).
Timepoint [3] 382033 0
At baseline, 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 3-months follow-up and 6-months follow-up.
Secondary outcome [4] 382542 0
Change in trauma-related cognition scores as measured by the Posttraumatic Cognitions Inventory (PTCI).
Timepoint [4] 382542 0
At baseline, 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 3-months follow-up and 6-months follow-up.
Secondary outcome [5] 382543 0
Change in alcohol and cannabis use as measured by the Alcohol Use Disorders Identification Test (AUDIT) and the Cannabis Use Disorders Identification Test – Revised (CUDIT-R).
Timepoint [5] 382543 0
At baseline, 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 3-months follow-up and 6-months follow-up.
Secondary outcome [6] 382544 0
Change in anger scores as measured by the Dimensions of Anger Reactions (DAR-5).
Timepoint [6] 382544 0
At baseline, 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 3-months follow-up and 6-months follow-up.
Secondary outcome [7] 382545 0
Change in emotion regulation scores as measured by the Difficulties in Emotion Regulation Scale (DERS).
Timepoint [7] 382545 0
At baseline, 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint), 3-months follow-up and 6-months follow-up.
Secondary outcome [8] 382550 0
Client satifaction of the online mode of service delievery measured by the Telehealth Satisfaction Measure (TSM).
Timepoint [8] 382550 0
At 2 weeks post This Way Up completion / 2 weeks post Cognitive Processing Therapy completion (primary timepoint).

Eligibility
Key inclusion criteria
All participants must have been directly or indirectly exposed to a Criterion A trauma, as defined by the DSM-5 and meet diagnostic criteria for PTSD or sub-threshold PTSD (APA, 2013). In the current study sub-threshold PTSD is defined as meeting 3 of 4 Criteria B-E, in addition to meeting Criteria F-H on the CAPS-5. Due to the online nature of the study, participants must have regular and secure access to a computer with a webcam and enough internet data to support video calls with a therapist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the study include scoring a sub-clinical level of PTSD as indicated by a cut off of 30 or below on the PCL-5 (as recommended by Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013). Additional exclusion criteria include illiteracy, current uncontrolled psychosis or substance dependence requiring supervised medical withdrawal, and/or significant cognitive impairment. These criteria are on the basis that individuals need to have a sufficient level of functioning to be able to participate in therapy. Further, individuals with a significant risk of harm (e.g., in a current abusive relationship or suicidality with intent) will be excluded as it is recommended that they engage in treatment to help minimise these risks before receiving treatment for PTSD.

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)
A researcher independent to the study and blind to the study's administration will allocate particpants to each treatment condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will use covariate-adaptive randomisation (Hu, Hu, Ma, & Rosenberger, 2014) that ensures comparable baseline characteristics for PTSD severity, gender, number of comorbid diagnoses and trauma type.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using IBM Statistical Package for the Social Sciences (SPSS). Linear mixed modeling (LMM) will be used for continuous data to determine treatment effects (i.e., pre-post and pre- to follow-up reductions) for both intent-to-treat and completer samples. Non-inferiority testing will also be used to test for equivalence on the CAPS at the 6-months follow-up between the two treatment conditions. For dichotomous outcomes (e.g., diagnostic outcomes), chi-square/Fishers Exact Test analyses will be used. Independent samples t-tests will be used to test other outcomes of interest (e.g., cost-effectiveness comparisons, etc.).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/06/2020
Actual
28/07/2020
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
120
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305420 0
University
Name [1] 305420 0
Flinders University
Country [1] 305420 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country
Australia
Secondary sponsor category [1] 305857 0
None
Name [1] 305857 0
Address [1] 305857 0
Country [1] 305857 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305741 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 305741 0
Ethics committee country [1] 305741 0
Australia
Date submitted for ethics approval [1] 305741 0
29/05/2019
Approval date [1] 305741 0
22/07/2019
Ethics approval number [1] 305741 0
HREC/19/SAC/134

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

Contacts
Principal investigator
Name 101426 0
Prof Reg Nixion
Address 101426 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 101426 0
Australia
Phone 101426 0
+61 8 8201 2748
Fax 101426 0
+61 8 8201 3877
Email 101426 0
reg.nixon@flinders.edu.au
Contact person for public queries
Name 101427 0
Larissa Roberts
Address 101427 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 101427 0
Australia
Phone 101427 0
+61 8 8201 5995
Fax 101427 0
Email 101427 0
traumaunit@flinders.edu.au
Contact person for scientific queries
Name 101428 0
Reg Nixion
Address 101428 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 101428 0
Australia
Phone 101428 0
+61 8 8201 2748
Fax 101428 0
+61 8 8201 3877
Email 101428 0
reg.nixon@flinders.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.