Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001316897
Ethics application status
Approved
Date submitted
28/07/2021
Date registered
28/09/2021
Date last updated
3/04/2024
Date data sharing statement initially provided
28/09/2021
Date results provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptance Commitment Therapy (ACT) for distress associated with inflammatory bowel disease
Scientific title
Acceptance Commitment Therapy (ACT) for distress associated with inflammatory bowel disease: A feasibility trial of the ACTforIBD program
Secondary ID [1] 304904 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACTforIBD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
crohn's disease 323035 0
ulcerative colitis 323036 0
indeterminate colitis 323037 0
inflammatory bowel disease 323038 0
distress 323039 0
anxiety 323040 0
depression 323041 0
Condition category
Condition code
Oral and Gastrointestinal 320608 320608 0 0
Inflammatory bowel disease
Mental Health 320609 320609 0 0
Anxiety
Mental Health 320610 320610 0 0
Depression
Oral and Gastrointestinal 320801 320801 0 0
Crohn's disease
Oral and Gastrointestinal 320802 320802 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 320803 320803 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our intervention is consistent with the core principles of acceptance and commitment therapy (ACT) and tailored to IBD. The ACTforIBD program includes eight fully-scripted modules, each addressing a different ACT theme or principle. Module 1 introduces ACT and explores the client’s experiences and struggles. Module 2 explores the client’s avoidance behaviours. Module 3 focuses on exploring the personal values the client holds. Module 4 introduces mindfulness practice. Module 5 explores cognitive fusion and defusion. Module 6 focuses on willingness and acceptance. Module 7 revisits the client’s values and establishes goals. Module 8 focuses on commitment and overcoming barriers moving forward. ACTforIBD has a blended design: the first three sessions and the last session are therapist-led (via Zoom/Skype), and the between sessions are self-led (using a website designed specifically for this study). The website includes interactive modules consisting of text, short videos and audio recordings. It also has in-built website analytics, including participant login times to monitor adherence. The sessions occur weekly for 8 weeks and take 1 hour (duration established as effective). The goals of treatment with this program broadly include: assisting clients to define valued directions and take committed action in the direction of their identified values, increasing understanding and insight into the client’s personal experiences by promoting presence and increasing cognitive defusion; improved coping with physical symptoms through the process of acceptance and cognitive defusion; and increasing psychological flexibility around psychological distress associated with IBD. The specific goals of treatment with each person will vary depending on their symptoms, life experiences and importantly, what they want to gain from therapy.
Intervention code [1] 321299 0
Behaviour
Intervention code [2] 321300 0
Prevention
Intervention code [3] 321434 0
Treatment: Other
Comparator / control treatment
The active control group will be asked to utilise the website collating the Centre for Clinical Interventions materials (https://www.cci.health.wa.gov.au/Resources/Looking-After-Yourself). The duration of the control condition will mirror what happens in the experimental group with 8-weeks of 1-hour involvement with the website recommended. This group will also be facilitated in a similar fashion to the ACT group, with the therapist present during 4 sessions. However, the therapist will be asked to not use any active therapy techniques beyond psychoeducation and focus on answering the participant’s queries regarding the content of the website.
Control group
Active

Outcomes
Primary outcome [1] 328419 0
Feasibility of recruitment assessed based on data from study database
Timepoint [1] 328419 0
8 weeks after starting treatment
Primary outcome [2] 328420 0
Feasibility of retention in the study based on data from study database
Timepoint [2] 328420 0
8 weeks after starting treatment
Secondary outcome [1] 398951 0
Change in patient distress level based on Depression Anxiety Stress Scale (DASS)
Timepoint [1] 398951 0
8 weeks and 3 months after starting treatment
Secondary outcome [2] 398952 0
Change in patient disease activity based on PRO2
Timepoint [2] 398952 0
8 weeks and 3 months after starting treatment
Secondary outcome [3] 398953 0
Change in patient quality of life based on EQ5D5L
Timepoint [3] 398953 0
8 weeks and 3 months after starting treatment
Secondary outcome [4] 398954 0
Change in patient fatigue based on Fatigue Symptom Inventory
Timepoint [4] 398954 0
8 weeks and 3 months after starting treatment
Secondary outcome [5] 398955 0
Change in patient pain based on Pain Numeric Rating Scale
Timepoint [5] 398955 0
8 weeks and 3 months after starting treatment
Secondary outcome [6] 398956 0
Change in patient resilience based on Brief Resilience Scale
Timepoint [6] 398956 0
8 weeks and 3 months after starting treatment
Secondary outcome [7] 398957 0
Change in patient self-efficacy based on General Self-efficacy Scale
Timepoint [7] 398957 0
8 weeks and 3 months after starting treatment
Secondary outcome [8] 398958 0
Preliminary cost-effectiveness based on healthcare utilisation resource questionnaire designed specifically for this study
Timepoint [8] 398958 0
8 weeks and 3 months after starting treatment
Secondary outcome [9] 398959 0
Patient satisfaction based on a Satisfaction Numeric Rating Scale
Timepoint [9] 398959 0
8 weeks after starting treatment
Secondary outcome [10] 401006 0
Change in patient disease activity based on PRO3
Timepoint [10] 401006 0
8 weeks and 3 months after starting treatment
Secondary outcome [11] 401007 0
Change in patient disease activity based on the Manitoba Index
Timepoint [11] 401007 0
8 weeks and 3 months after starting treatment
Secondary outcome [12] 401008 0
Change in patient disease activity based on the IBD Control Scale
Timepoint [12] 401008 0
8 weeks and 3 months after starting treatment
Secondary outcome [13] 401009 0
Patient satisfaction assessed by one to one semi-structured interviews with a purposive selection (representatives of different genders, age groups, urban/rural location, IBD types, group allocation) of 20 participants
Timepoint [13] 401009 0
8 weeks and 3 months after starting treatment

Eligibility
Key inclusion criteria
Diagnosis of IBD: Crohn’s disease, ulcerative colitis or indeterminate colitis established by a health professional using standard criteria (evidence can include a letter from a doctor, results of endoscopy or any other medical document confirming the diagnosis);
Distress: scores 16-29 on K10 (screening for distress will take place after consent has been obtained);
Age: 18 years and older;
Language: Able to read and write in English;
Residence: Live in Australia or New Zealand;
Other: Access to the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No distress (scores <16 on K10);
Severe distress (scores 30-50 on K10) as it is anticipated that these participants would require a more intensive therapeutic approach before benefiting from the current intervention.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer-generated random sequences will be embedded in the Redcap platform ensuring allocation concealment.
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
An RCT design is a gold standard to establish effectiveness of interventions. However, since psychological interventions for IBD designed and tested to date have not been co-designed with consumers and offer only limited efficacy, we will incorporate a comprehensive qualitative evaluation alongside the quantitative data collection. Participants will be randomly allocated to one of two groups: the ACTforIBD program or active control. Randomisation will be stratified by IBD activity.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analysis. Analyses will be carried out on an intention-to-treat basis. As feasibility trials cannot establish efficacy, the analysis will be largely descriptive. However, we will attempt to run a group comparison on the main outcome measures with linear mixed effects models which enable retention of participants with missing waves of data, under the assumption that data are missing at random. In these models, the dependent variable is the outcome measure, with predictors being Time, Group and the Interaction between Time and Group - the coefficient for Interaction being the formal test of preliminary efficacy. Primary analyses will be conducted unadjusted, with significance tests will be two-sided at the 5% level. No adjustment for multiple testing will be made to p-values; however, effect sizes for each outcome measure will be presented. These will facilitate the power calculation for the future full-scale trial. A trial-based cost-utility analysis will evaluate the incremental resource use and cost of ACTforIBD program compared to control group at 8 weeks and 3-months follow up. Mean costs will be estimated using: costs of the ACTforIBD program; outpatient and emergency department visits; hospitalizations; medication use; diagnostic and investigation use; general practitioner visits; and quality-adjusted life years (calculated using AQOL).

Qualitative analysis. Longitudinal qualitative data collected during semi-structured interviews with participants will be transcribed and analysed thematically, following the main procedural steps of Template Thematic Analysis: 1) becoming familiar with the transcripts, noting any a priori themes; 2) Preliminary data coding and theme extraction across a subset of the data to capture a good cross-section of the issues and experiences covered in the data as a whole; 3) Emerging themes organized into meaningful clusters in a hierarchical structure; 4) An initial coding template is developed and applied to further data, modified where necessary; 5) The comprehensive template is applied to the full dataset; 6) Finally, a refinement of what each theme represents will occur to ensure it informs the research question and the literature. Half of the transcripts will be additionally coded and analysed by a researcher not involved in data collection. Any disagreements between coders will be resolved with a third researcher.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2021
Actual
18/11/2021
Date of last participant enrolment
Anticipated
30/04/2023
Actual
20/04/2023
Date of last data collection
Anticipated
31/10/2023
Actual
28/10/2023
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24010 0
New Zealand
State/province [1] 24010 0
all country

Funding & Sponsors
Funding source category [1] 309277 0
Charities/Societies/Foundations
Name [1] 309277 0
Crohn's & Colitis Foundation of America
Country [1] 309277 0
United States of America
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood 3125 VIC
Country
Australia
Secondary sponsor category [1] 310249 0
None
Name [1] 310249 0
Address [1] 310249 0
Country [1] 310249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309116 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309116 0
Ethics committee country [1] 309116 0
Australia
Date submitted for ethics approval [1] 309116 0
28/07/2021
Approval date [1] 309116 0
10/09/2021
Ethics approval number [1] 309116 0
2021-263

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

Contacts
Principal investigator
Name 113030 0
A/Prof Antonina Mikocka-Walus
Address 113030 0
School of Psychology, Deakin University, 221 Burwood Highway, 3125 Burwood, VIC
Country 113030 0
Australia
Phone 113030 0
+61392468575
Fax 113030 0
Email 113030 0
[email protected]
Contact person for public queries
Name 113031 0
Antonina Mikocka-Walus
Address 113031 0
School of Psychology, Deakin University, 221 Burwood Highway, 3125 Burwood, VIC
Country 113031 0
Australia
Phone 113031 0
+61392468575
Fax 113031 0
Email 113031 0
[email protected]
Contact person for scientific queries
Name 113032 0
Antonina Mikocka-Walus
Address 113032 0
School of Psychology, Deakin University, 221 Burwood Highway, 3125 Burwood, VIC
Country 113032 0
Australia
Phone 113032 0
+61392468575
Fax 113032 0
Email 113032 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
We do not plan data sharing with the exception of providing descriptive statistics for any systematic reviews/meta-analyses. We do not plan to share raw data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13219Ethical approval    382493-(Uploaded-15-09-2021-19-07-51)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcceptance commitment therapy (ACT) for psychological distress associated with inflammatory bowel disease (IBD): protocol for a feasibility trial of the ACTforIBD programme.2022https://dx.doi.org/10.1136/bmjopen-2021-060272
N.B. These documents automatically identified may not have been verified by the study sponsor.