Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001263785
Ethics application status
Approved
Date submitted
14/09/2022
Date registered
21/09/2022
Date last updated
14/05/2024
Date data sharing statement initially provided
21/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing an Online Intervention for Inflammatory Bowel Disease (IBD) Patients
Scientific title
Internet Acceptance and Commitment Therapy For Inflammatory Bowel Disease (iACT4IBD): Testing the effect of an Online Intervention on the Psychological Wellbeing of IBD Patients – A Two-armed Randomised Controlled Trial
Secondary ID [1] 307900 0
None
Universal Trial Number (UTN)
U1111-1282-2334
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 327547 0
stress 327548 0
anxiety 327549 0
inflammatory bowel disease 327550 0
Crohn’s disease 327551 0
ulcerative colitis 327552 0
Condition category
Condition code
Mental Health 324646 324646 0 0
Depression
Oral and Gastrointestinal 324733 324733 0 0
Inflammatory bowel disease
Mental Health 324757 324757 0 0
Anxiety
Mental Health 324758 324758 0 0
Other mental health disorders
Oral and Gastrointestinal 324759 324759 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a parallel two-arm randomised controlled trial (RCT) with a 1:1 allocation ratio comparing an intervention group to a waitlist control group—designed following the CONSORT guidelines. The proposed study will examine the effects of a seven-day online Acceptance and Commitment Therapy (ACT) intervention (iACT4IBD) on depression, stress, and anxiety levels in adult IBD patients residing in Aotearoa New Zealand. After the intervention, up to 15 participants from the intervention group will be invited to attend focus groups or interviews to explore their views of the ACT intervention and explore gaps in current psychosocial support services for patients with IBD.

Potential participants will be directed from the study website to REDCap (a secure web application for managing online surveys and databases) to review the Participant Information Sheet (which will be available for download), read and complete an online screening questionnaire for eligibility. If eligible for the study, participants will complete an online consent form and then fill out baseline questionnaires on REDCap. The consent form and questionnaires will link to the intervention website via a URL for participants to access. The ACT modules will be secured with password protection on the iACT4IBD website. Upon completion of the consent form and baseline questionnaires on REDCap, participants will be randomised into either the intervention group or waitlist control group by a researcher outside the study team using an online random number generator.

Participants in the intervention group will receive an email with a link to the intervention website and the password to access the ACT modules. Intervention group participants will be instructed to log onto the iACT4IBD website daily for one week at a location of their choice. They will spend approximately 20 minutes daily on an ACT module for seven consecutive days. Throughout the intervention, participants will receive emails to remind them to complete a module each day. Four weeks after completing the baseline questionnaires, intervention group participants will receive an email with a link to complete follow-up questionnaires on REDCap.

The intervention is a brief online therapeutic intervention based on the core processes of ACT and designed to be completed in seven days. Daily modules guide participants through the six core processes within the ACT model to increase psychological flexibility: (1) awareness of the present moment, (2) cognitive defusion, (3) self as context, (4) acceptance of unpleasant experiences, (5) recognition of personal values, and (6) committed action to living meaningfully according to one’s values. Each daily module is self-directed and will take approximately 20 minutes to complete.

The content of the modules are as follows: introduction to the intervention; being mindful and aware of the present moment; cognitive defusion; self as context; acceptance of unpleasant experiences or thoughts; recognition of personal values; and taking value-driven committed action. Exercises within the modules include relaxation techniques, mindfulness exercises, goal setting, self-compassion exercises, and gratitude. Content will be delivered within the modules through written information, audio recordings, short videos, and basic graphics/iconography and animations.

At the end of the intervention, participants will be asked to select a statement that represents the extent that they adhered to the intervention. For example, “I completed all modules”, “I completed one module”, “I completed two modules” or “I completed no modules”. An acceptable adherence rate requires the completion of five out of seven modules (Hayes et al., 1980). Participants will also rate the extent to which they found each module helpful upon module completion by answering the question “how helpful did you find this module?”. Participants will indicate that the module was either very helpful, somewhat helpful, only a little helpful, or not helpful. This question will be asked at the end of each module and represent another indicator of adherence to the intervention and provide feedback on the most helpful/unhelpful modules.
Intervention code [1] 324367 0
Lifestyle
Intervention code [2] 324368 0
Behaviour
Comparator / control treatment
Participants in the waitlist control group will continue with their usual IBD care once the baseline questionnaires have been completed. Four weeks after completing the baseline questionnaires, the waitlist control group will be emailed access to the online intervention.

Usual IBD care is described as the prescribed course of medical treatment that participants receive from their general practitioner and gastroenterologist.
Control group
Active

Outcomes
Primary outcome [1] 332460 0
Depression scores are assessed by the brief Depression, Anxiety, and Stress Scale (DASS; Lovibond & Lovibond, 1995).
Timepoint [1] 332460 0
Baseline, 4 weeks post-baseline (for both the intervention and control groups), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [1] 413589 0
Anxiety scores are assessed by the brief Depression, Anxiety, and Stress Scale (DASS; Lovibond & Lovibond, 1995).
Timepoint [1] 413589 0
Baseline, 4 weeks post-baseline (for both the intervention and control groups), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [2] 413590 0
Stress scores are assessed by the brief Depression, Anxiety, and Stress Scale (DASS; Lovibond & Lovibond, 1995).
Timepoint [2] 413590 0
Baseline, 4 weeks post-baseline (for both the intervention and control groups), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [3] 413591 0
Wellbeing is measured by the World Health Organisation Well-being Index (WHO-5; World Health Organization, 1998).
Timepoint [3] 413591 0
Baseline, 4 weeks post-baseline (for both the intervention and control groups), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [4] 413592 0
Psychological flexibility will be measured by the Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011).
Note: this questionnaire was not administered in full due to an error made on REDCap.
Timepoint [4] 413592 0
Baseline, 4 weeks post-baseline (for both the intervention and control groups), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [5] 413593 0
Crohn’s disease activity will be assessed using the Harvey-Bradshaw Index (Harvey & Bradshaw, 1980).
Timepoint [5] 413593 0
Baseline, 4 weeks post-baseline (for both the intervention and control groups), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [6] 413594 0
Ulcerative colitis disease activity will be measured using the Simple Clinical Colitis Activity Index (SCCAI) (Walmsley et al., 1998).
Timepoint [6] 413594 0
Baseline, 4 weeks post-baseline (for both the intervention and control groups), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [7] 413595 0
Adherence will be measured by the feedback questionnaire at the end of each module so the completion of this questionnaire will indicate adherence for that module. The feedback questionnaire was designed specifically for this study.
Timepoint [7] 413595 0
Daily from baseline to the end of the intervention period (7 days post-baseline for the intervention group), and then daily from intervention commencement until 7 days post-intervention commencement (for the control group).
Secondary outcome [8] 413597 0
Adherence will be measured by question in the final follow-up questionnaire consisting of one question asking participants to report the number of modules they completed—from zero modules to seven modules. This questionnaire has been specifically designed for this study.
Timepoint [8] 413597 0
4 weeks post-baseline (post-intervention completion for the intervention group), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [9] 413888 0
Quality of Life is measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). (Irvine et al., 1996).
Timepoint [9] 413888 0
Baseline, 4 weeks post-baseline (for both the intervention and control groups), and 8 weeks post-baseline (post-intervention completion for the control group).
Secondary outcome [10] 413889 0
The feedback questionnaire will also ask participants to rate the extent they found the module helpful as another adherence indicator. The feedback questionnaire has been designed specifically for this study and will consist of a single question that asks participants to rate the extent that they found the module helpful on a 4-point scale.
Timepoint [10] 413889 0
Daily from baseline to the end of the intervention period (7 days post-baseline for the intervention group), and then daily from intervention commencement until 7 days post-intervention commencement (for the control group).
Secondary outcome [11] 413890 0
15 participants from the intervention group will be invited to attend semi-structured, online or face-to-face focus groups or one-on-one interviews with a member of the research team to explore their views of the ACT intervention and explore gaps in current psychosocial support services for patients with IBD. The focus groups or interviews may be conducted either in-person or remotely by video-conference and facilitated by a member of the research team. There will be no more than five participants in each focus group. The decision to attend a focus group or an interview will be determined by the participant's preference and the participant's availability.
Timepoint [11] 413890 0
Within 8 weeks post-baseline (post-intervention completion for the intervention group), and within 12 weeks post-baseline (post-intervention completion for the control group).

Eligibility
Key inclusion criteria
The inclusion criteria for this study require participants to:
1. be diagnosed with IBD (either Crohn’s disease or ulcerative colitis),
2. be a minimum of 18 years of age,
3. reside in Aotearoa New Zealand,
4. be able to give informed consent,
5. be able to understand, read and write English, and
6. be able to access an electronic device that can connect to the internet (e.g. computer, mobile phone, tablet).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
This study will exclude participants that are currently:
1. hospitalised,
2. seeing a mental health professional, and
3. practising mindfulness or meditation regularly.

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)
Participants will be randomised into either the intervention group or waitlist control group. A researcher outside the study team will randomise the participants into their respective groups (intervention or waitlist) using an online random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated number sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will consist of mixed model ANOVAs (2 groups by 2 time points) and independent t-tests that will evaluate differences between the intervention and waitlist groups over two time points (baseline and four weeks after baseline assessments).

Pearson’s correlations will examine relationships between demographic and psychosocial variables and depression, stress, and anxiety.

The qualitative data will be analysed using Directed Content Analysis (Hsieh & Shannon, 2005), a deductive approach where exploring the data is guided by predetermined research questions or categories.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2022
Actual
3/02/2023
Date of last participant enrolment
Anticipated
Actual
12/04/2023
Date of last data collection
Anticipated
Actual
21/06/2023
Sample size
Target
70
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 24994 0
New Zealand
State/province [1] 24994 0
Auckland

Funding & Sponsors
Funding source category [1] 312173 0
University
Name [1] 312173 0
University of Auckland
Country [1] 312173 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 313699 0
None
Name [1] 313699 0
Address [1] 313699 0
Country [1] 313699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311559 0
Health and Disability Ethics Committee (specific committee TBC)
Ethics committee address [1] 311559 0
Ethics committee country [1] 311559 0
New Zealand
Date submitted for ethics approval [1] 311559 0
25/08/2022
Approval date [1] 311559 0
02/12/2022
Ethics approval number [1] 311559 0

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

Contacts
Principal investigator
Name 121538 0
Dr Anna Serlachius
Address 121538 0
Department of Psychological Medicine
The University of Auckland
22-30 Park Avenue
Grafton, Auckland 1023
New Zealand
Country 121538 0
New Zealand
Phone 121538 0
+64 9 923 3073
Fax 121538 0
Email 121538 0
[email protected]
Contact person for public queries
Name 121539 0
Anna Serlachius
Address 121539 0
Department of Psychological Medicine
The University of Auckland
22-30 Park Avenue
Grafton, Auckland 1023
New Zealand
Country 121539 0
New Zealand
Phone 121539 0
+64 9 923 3073
Fax 121539 0
Email 121539 0
[email protected]
Contact person for scientific queries
Name 121540 0
Anna Serlachius
Address 121540 0
Department of Psychological Medicine
The University of Auckland
22-30 Park Avenue
Grafton, Auckland 1023
New Zealand
Country 121540 0
New Zealand
Phone 121540 0
+64 9 923 3073
Fax 121540 0
Email 121540 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
Participants have not consented to sharing IPD


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.