Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000507684
Ethics application status
Approved
Date submitted
30/04/2023
Date registered
17/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
17/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The INTEGRATE program: A group-based therapeutic intervention for relational functioning in individuals with complex traumatic stress disorder (CTSD).
Scientific title
The INTEGRATE program: A feasibility implementation trial of a manualised group-based psychotherapeutic intervention for relational functioning in individuals with complex traumatic stress disorder (CTSD).
Secondary ID [1] 308177 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
complex traumatic stress disorder 327969 0
emotional dysregulation 327970 0
interpersonal dysregulation 327971 0
intrapersonal dysregulation 327972 0
work/social functional impairment 327973 0
Condition category
Condition code
Mental Health 325030 325030 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the INTEGRATE program, which is a 12-week manualised group-based psychotherapeutic intervention. The manualised approach has opportunity for some flexibility to suit the group dynamic, while still maintaining the integrity of the core components of the protocol.

The INTEGRATE program is novel and has been designed for the specific purpose of this project. It is not publicly available and the content will remain confidential until such time IP is appropriately protected; however, the following information is provided as a summary overview of the program. The core components are tailored towards therapeutic intervention of the Disturbances of Self Organisation (DSO) triad of affect regulation, self-concept, and interpersonal relating. Accordingly, the program is underpinned by evidence-based cognitive, behavioural, and interpersonal therapeutic techniques. The program combines psychoeducation, facilitator-led activities, interactive group activities and discussions, self-reflective activities, and a between-session self-reflective journaling activity. This between-session activity is anticipated to take between 20 - 30 minutes/week to complete and is intended to both consolidate learning/experience from the past session as well providing continuity of self-reflection practice that is a foundation component of the entire program.

Each session duration is 2-hours in total with a half-time 10-minute comfort break. Sessions will run 1x/week for 12 consecutive weeks. INTEGRATE functions as a closed group, meaning all participants commence at week 1 and no additional participants can join the group once it has commenced. The target sample size for a group is 8 – 12 participants. It is planned to run 4 x groups throughout the duration of the feasibility trial. Actual sample size for the first of group is 9 participants.

Participants for the current study will be recruited from a Northern Territory (NT) government supported local community service for people who have experienced sexual assault, the Sexual Assault Recovery Centre (SARC). In addition to sexual assault, most clients who present to this service have complex trauma histories and experience of domestic and/or family violence. As such this client group is most representative of the people that might benefit from engagement in the INTEGRATE program. In addition, the information gathered from the SARC service and staff, will provide feasibility and implementation insights from a service that is highly representative of future services who might employ the INTEGRATE program.

Delivery of INTEGRATE will be in face-to-face format by two facilitators. Co-facilitation is considered integral for INTEGRATE program to ensure client and facilitator safety. For the current study the two group-facilitators will be provisionally registered psychologists in the final stages of their Master of Psychology (Clinical) program. The facilitators will be supervised by the primary investigator, who is a registered Clinical Psychologist and who is also a PsyBA board approved supervisor. The INTEGRATE program will be conducted at the Charles Darwin University Wellness Centre Psychology Service (CDU-WCPS), which is a university-based psychology training facility that provides psychological services to members of the public. The CDU-WCPS is appropriately resourced to house the feasibility implementation trial of INTEGRATE and provides a neutral environment to assess feasibility elements, as it is separate to SARC, the local support service collaborating in this research.

There are two versions of the INTEGRATE program manual, a client version and a facilitator version. The facilitator version mirrors the client manual but also contains scripts, prompts, activity guidelines, that supports a standardised administration. At sections where it is anticipated some flexibility in delivery might be required, facilitators are provided with parameters within which they can flex as required while ensuring the core component of that section holds integrity. Facilitators will be asked to complete a brief fidelity checklist at the end of each session to monitor adherence to core components of the manualised protocol.

Each client receives a hard copy spiral bound INTEGRATE manual at commencement of the group, and they use the manual as an interactive therapeutic tool for the duration of the group. As weekly homework is part of the program, with an aim to consolidate therapeutic gains across the weeks, participants are encouraged to take the manual home each week at the end of the session; however, provision is also made to store a client's manual on-site if there are concerns about bringing the manual home. In this case, alternative options for homework will be negotiated as suits the client's needs.

Intervention code [1] 324693 0
Treatment: Other
Intervention code [2] 324694 0
Behaviour
Comparator / control treatment
This is a feasibility implementation trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332878 0
Functioning as measured by change in Work and Social Adjustment Scale (WSAS; Mundt et al., 2002) scores.
Timepoint [1] 332878 0
Baseline, Week 6, Week 13 (Primary Timepoint) and 3-months post-intervention.
Primary outcome [2] 332879 0
Trauma symptom profile as measured by change in the Trauma Symptom Checklist-40 (TSC-40; Elliott & Briere, 1992)
Timepoint [2] 332879 0
Baseline, Week 13 (Primary Timepoint), and 3-months post-intervention.
Secondary outcome [1] 414930 0
Resilience as measured by change in Conner-Davison Resilience Scale-10 (CD-RISC-10; Campbell-Sills & Stein, 2007) scores.
Timepoint [1] 414930 0
Baseline, Week 13, and 3-months post-intervention.
Secondary outcome [2] 414931 0
Emotion regulation as measured by change in Perth Emotion Regulation Competence Inventory (PERCI; Preece et al, 2018) scores from baseline to post-intervention
Timepoint [2] 414931 0
Baseline, Week 13, and 3-months post-intervention.
Secondary outcome [3] 414932 0
Emotional reactivity as measured by change in Perth Emotional Reactivity Scale - Short Form (PERS-S; Preece et al., 2019) scores.
Timepoint [3] 414932 0
Baseline, Week 13, and 3-months post-intervention.
Secondary outcome [4] 414933 0
Posttraumatic cognitions as measured by change in Post-Traumatic Cognitions Inventory-9 (PTCI-9; Wells et al., 2019) scores.
Timepoint [4] 414933 0
Baseline, Week 13, and 3-months post-intervention.
Secondary outcome [5] 415120 0
Client responses to feasibility questions in a semi-structured interview.
Timepoint [5] 415120 0
Week 13 post-intervention
Secondary outcome [6] 415121 0
Facilitator responses to feasibility questions in a semi-structured interview.
Timepoint [6] 415121 0
Week 13 post-intervention
Secondary outcome [7] 415122 0
Service provider responses to feasibility questions in a semi-structured interview.
Timepoint [7] 415122 0
Week 13 post-intervention
Secondary outcome [8] 415185 0
The Group Session Rating Scale (GSRS; Duncan & Miller, 2007) will be used to monitor clinical alliance for the duration of the intervention. The GSRS is a brief 4-item measure that uses a visual analogue scale for response.
Timepoint [8] 415185 0
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, post-intervention.
Secondary outcome [9] 421387 0
International Trauma Questionnaire (ITQ; Hyland et al., 2017)
Timepoint [9] 421387 0
Baseline, Week 13, and 3-months post-intervention.

Eligibility
Key inclusion criteria
Participants report at least one (1) experience of adversity in childhood as measured by score of => 1 on the Revised Adverse Childhood Experiences (R-ACEs; Finkelhor et al., 2015) and/or participant reports as least one potentially traumatic experience during their lifetime as measured by a score of => 1 on Life Events Checklist for DSM-5 (LEC-5; Weathers et al., 2013).

1 = Yes and 0 = No
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with high suicide risk as measured by the Suicide Risk Screener from the Suicide Assessment Kit (SAK; Ross et al., 2012).

Individuals who have been hospitalised in the past 6-months for self-harm or who are assessed at screening to be at a level of active harming that is not appropriate for participation in this research; according to a clinical risk formulation based on the current National Institute for Health and Care Excellence (NICE, 2022) guidelines for self-harm assessment, management and prevention.

Individuals with current problematic substance use issues as determined by the Alcohol, Smoking and Substance Involvement Screening - Lite (ASSIST-Lite; Ali et al., 2013)

Individuals with active psychosis or who have had a psychotic episode within the past 6-months.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
A mixed method research design informs this feasibility implementation trial as is recommended best practice (Donald, 2018; Orsmond & Cohn, 2015). The data collection for this project is to be undertaken by two independent researchers (i.e., not the group facilitators or staff from the service provider) and will be overseen and supported by the principal investigator and the senior associate investigator.

All baseline data will be interrogated for descriptive information about the participants presentation prior to commencement of the INTEGRATE program.

As a feasibility implementation trial, the primary focus of quantitative data will be Reliable Change analysis (Jacobson & Traux, 1991) of the two primary outcomes, the WSAS and the TSI-2, which will provide the necessary data for progression into the next trial phase. This analysis will be conducted at the individual participant level as group mean analysis is not appropriate at this early trial phase.

The primary reason for inclusion of the additional secondary outcomes measures is to evaluate the feasibility of the proposed measures protocol for future trials; however, a preliminary inspection of change scores pre-post-intervention will be conducted to ensure the data is trending in the expected direction, i.e., improvement not deterioration. Additionally, post-intervention scores will be compared with follow-up scores to gain cursory insight into stability of change across time. IBM SPSS Statistics V26 will be used in quantitative analyses.

The qualitative data will be analysed using Reflective Thematic Analysis and the six-phase recursive process (Braun & Clarke, 2006, 2021; Pistrang & Barker, 2012). Results will be presented in a narrative synthesis that is shaped to address the main objectives of this feasibility implementation trial. NVivo 12 (Windows) statistical package will be employed to support thematic analysis.

Inspection of weekly GSRS trends across the 12-weeks of the intervention, will also be used to inform feasibility implementation evaluation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/04/2023
Date of last participant enrolment
Anticipated
1/05/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
20
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment postcode(s) [1] 38817 0
0800 - Darwin

Funding & Sponsors
Funding source category [1] 312434 0
University
Name [1] 312434 0
Charles Darwin University
Country [1] 312434 0
Australia
Primary sponsor type
Individual
Name
Dr Carol Keane
Address
Charles Darwin University
7 Ellengowan Drive
Brinkin 0810
NT
Country
Australia
Secondary sponsor category [1] 314011 0
None
Name [1] 314011 0
Address [1] 314011 0
Country [1] 314011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311782 0
Charles Darwin University Human Research Ethics Committee
Ethics committee address [1] 311782 0
Ethics committee country [1] 311782 0
Australia
Date submitted for ethics approval [1] 311782 0
28/11/2022
Approval date [1] 311782 0
22/03/2023
Ethics approval number [1] 311782 0
H22103

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

Contacts
Principal investigator
Name 122342 0
Dr Carol Keane
Address 122342 0
Charles Darwin University
7 Ellengowan Drive
Brinkin 0810
NT
Country 122342 0
Australia
Phone 122342 0
+61889467246
Fax 122342 0
Email 122342 0
[email protected]
Contact person for public queries
Name 122343 0
Carol Keane
Address 122343 0
Charles Darwin University
7 Ellengowan Drive
Brinkin 0810
NT
Country 122343 0
Australia
Phone 122343 0
+61889467246
Fax 122343 0
Email 122343 0
[email protected]
Contact person for scientific queries
Name 122344 0
Carol Keane
Address 122344 0
Charles Darwin University
7 Ellengowan Drive
Brinkin 0810
NT
Country 122344 0
Australia
Phone 122344 0
+61889467246
Fax 122344 0
Email 122344 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
This is a feasibility implementation trial. As such, sharing of individual participant data is not deemed appropriate at this early stage.


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.