Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001141134
Ethics application status
Approved
Date submitted
18/07/2019
Date registered
16/08/2019
Date last updated
16/08/2019
Date data sharing statement initially provided
16/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Effectiveness Trial of Online Stepped-Care for Adults with
Posttraumatic Stress Disorder
Scientific title
An Effectiveness Trial of Online Stepped-Care for Adults with
Posttraumatic Stress Disorder
Secondary ID [1] 298650 0
Nil Known
Universal Trial Number (UTN)
U1111-1236-4038
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 313540 0
Condition category
Condition code
Mental Health 311970 311970 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In an open trial, the study aims to test the feasibility and effectiveness of a stepped-care approach to treating posttraumatic stress disorder (PTSD) in adults, using online and telehealth technology.

Following a comprehensive clinical, pre-treatment assessment (T1) via an online video call (90 minutes) and Qualtrics questionnaire (60 minutes), all participants 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, and at a matched time point for those who are 'stepped-up' early, participants complete a post-treatment assessment (T2) via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes).

Step 2: Cognitive Processing Therapy (CPT)

Following the pragmatic trial design, 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 developed by Resick, Monsoon and Chard (2016). In the current study, participants will be offered up to 15 weekly, 60-minute sessions on a one-to-one basis via online video call. CPT duration is estimated between 8 to 15 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.

Following CPT, participants complete a post-treatment assessment (T3) via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes). At this time point we will also assess those who only completed TWU as a comparator. Approximately 9 months after enrolment into the study, all participants will be assessed again via an online video call and Qualtrics questionnaire (this will reflect a 3-month follow-up for those who needed CPT, and a matched time interval for those who completed TWU only). Additional funding success permitting, we would also like to include a 6-month follow-up.

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 or currently undertaking clinical psychology training or have recently completed this training and undertaking a placement in the Flinders University Posttraumatic Stress Research Unit. All therapists will have training in the TWU and CPT protocol. Therapists will receive weekly supervision from Professor Nixon.
Intervention code [1] 314913 0
Treatment: Other
Comparator / control treatment
Study is an open trial - there is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320630 0
Proportion of participants with a change in PTSD symptom severity as measured on the Post traumatic stress disorder checklist (PCL-5) and the Clinician Administered PTSD Scale (CAPS).
Timepoint [1] 320630 0
At baseline, 2 weeks post This Way Up completion (T2 Assessment), 2 weeks post Cognitive Processing Therapy completion (T3 Assessment) and 3 months post Cognitive Processing Therapy completion (T4 Follow-up Assessment).
Primary outcome [2] 320632 0
The proportion of participants who dropout of each therapy. Dropout will be measured via a record of participants who withdraw from each therapy before completion in comparison to therapy completers.
Timepoint [2] 320632 0
At baseline, 2 weeks post This Way Up completion (T2 Assessment), 2 weeks post Cognitive Processing Therapy completion (T3 Assessment) and 3 months post Cognitive Processing Therapy completion (T4 Follow-up Assessment).
Secondary outcome [1] 372259 0
Proportion of participants with a change in levels of depression, stress and anxiety as measured on the DASS-21.
Timepoint [1] 372259 0
At baseline, 2 weeks post This Way Up completion (T2 Assessment), 2 weeks post Cognitive Processing Therapy completion (T3 Assessment) and 3 months post Cognitive Processing Therapy completion (T4 Follow-up Assessment).
Secondary outcome [2] 372260 0
Cost effectiveness of the therapies measured by the Commonwealth Department of Health and Aged Care schedules with clinician time for both interventions recorded on a weekly basis. Clinician time will be measured by the length of recorded Zoom video calls.
Timepoint [2] 372260 0
At 2 weeks post This Way Up completion (T2 Assessment) and 2 weeks post Cognitive Processing Therapy completion (T3 Assessment).
Secondary outcome [3] 372261 0
Quality of life as measured by the Assessment of Quality of Life (AQoL-8D) .
Timepoint [3] 372261 0
At baseline, 2 weeks post This Way Up completion (T2 Assessment), 2 weeks post Cognitive Processing Therapy completion (T3 Assessment) and 3 months post Cognitive Processing Therapy completion (T4 Follow-up Assessment).
Secondary outcome [4] 372262 0
Participants' credibility judgement of treatment as measured by the Credibility/Expectancy Questionnaire (CEQ).
Timepoint [4] 372262 0
At baseline, 2 weeks post This Way Up completion (T2 Assessment), 2 weeks post Cognitive Processing Therapy completion (T3 Assessment) and 3 months post Cognitive Processing Therapy completion (T4 Follow-up Assessment).

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 (APA, 2013). 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-threshold 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, 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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. For dichotomous outcomes (e.g., diagnostic outcomes), chi-square/Fishers Exact Test analyses will be used. T-tests will be used to test other outcomes of interest (e.g., cost-effectiveness comparisons, treatment credibility etc.).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/04/2019
Date of last participant enrolment
Anticipated
1/11/2019
Actual
Date of last data collection
Anticipated
28/08/2020
Actual
Sample size
Target
30
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303188 0
Charities/Societies/Foundations
Name [1] 303188 0
Break Through Mental Health Research Foundation
Country [1] 303188 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] 303202 0
None
Name [1] 303202 0
Address [1] 303202 0
Country [1] 303202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303752 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 303752 0
Ethics committee country [1] 303752 0
Australia
Date submitted for ethics approval [1] 303752 0
Approval date [1] 303752 0
10/01/2019
Ethics approval number [1] 303752 0
HREC/18/SAC/366

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

Contacts
Principal investigator
Name 94670 0
Prof Reg Nixon
Address 94670 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 94670 0
Australia
Phone 94670 0
+61 8 8201 2748
Fax 94670 0
+61 8 8201 3877
Email 94670 0
[email protected]
Contact person for public queries
Name 94671 0
Reg Nixon
Address 94671 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 94671 0
Australia
Phone 94671 0
+618 8201 2748
Fax 94671 0
+61 8 8201 3877
Email 94671 0
[email protected]
Contact person for scientific queries
Name 94672 0
Reg Nixon
Address 94672 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 94672 0
Australia
Phone 94672 0
+61 8 8201 2748
Fax 94672 0
+61 8 8201 3877
Email 94672 0
[email protected]

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.