Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000708752
Ethics application status
Approved
Date submitted
2/05/2022
Date registered
17/05/2022
Date last updated
17/05/2022
Date data sharing statement initially provided
17/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new online psychological treatment for depression and anxiety: the Acceptance and Commitment Therapy (ACT) Course.
Scientific title
The Acceptance and Commitment Therapy (ACT) Course for depression and anxiety in adults: a feasibility trial
Secondary ID [1] 307040 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 326181 0
Anxiety Disorders 326182 0
Condition category
Condition code
Mental Health 323486 323486 0 0
Depression
Mental Health 323487 323487 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ACT Course (the intervention) is comprised of five modules delivered online over 8 weeks. Each module takes up to 30mins to complete. The intervention provides psychoeducation about the nature of anxiety and depression, identification of personal values and related goals, acceptance as an alternative to control, cognitive distancing (defusion), and mindfulness. The ACT Course contains interactive exercises, activities between modules, meditation audio activities and illustrations. It also includes optional weekly contact with a registered clinical psychologist over the phone or via private secure message, to support and apply understanding the of the treatment content, encouragement to complete activities when motivation is low, and monitoring of symptoms. The online platform monitors module engagement and questionnaire completion, and the psychologist is able to offer assistance to complete the intervention.
Intervention code [1] 323496 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331234 0
Symptom outcome feasibility using the Primary Health Questionnaire (PHQ9)
Timepoint [1] 331234 0
Baseline (pre-intervention), then weekly for 8 weeks
Primary outcome [2] 331235 0
Disability outcome feasibility using the World Health Organisation Disability Assessment Scale (WHODAS-2)
Timepoint [2] 331235 0
Baseline (pre-intervention), then weekly for 8 weeks
Primary outcome [3] 331236 0
Quality of Life outcome feasibility, using the Quality of Life Scale (QoL).
Timepoint [3] 331236 0
Baseline (pre-intervention), then midway (week 4) and end treatment after completion of 5th module (week 8).
Secondary outcome [1] 409267 0
Treatment satisfaction and acceptability feasibility (primary outcome), using the Treatment Satisfaction Questionnaire (TSQ), a composite measure which asks questions about level of overall satisfaction, confidence in recommending to others, being worth the time, degree of improvement or worsening in symptoms noticed (patient perspectives on improvement), and free text about what was liked and disliked about the treatment (acceptability), and any other feedback about the treatment.
Timepoint [1] 409267 0
Midway (week 4 post treatment commencement) and at the end of treatment (week 8 after completion of the 5th module).
Secondary outcome [2] 409571 0
Symptom outcome feasibility (primary outcome) using the Generalised Anxiety Disorder Questionnaire (GAD7)
Timepoint [2] 409571 0
Baseline (pre-intervention), then weekly for 8 weeks

Eligibility
Key inclusion criteria
(a) Australian resident
(b) Are aged 18 years or older
(c) Report primary difficulties with anxiety and/or depression
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Actively suicidal or unable to keep themselves safe
(b) Living outside of Australia
(c) Unable to read and understand English.

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)
Nil
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
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All analyses will be carried out using conservative intention-to-treat principles to provide unbiased estimates in the case of missing data. Under the assumption that data will not be missing at random, multiple imputation will be used to account for missing cases. Generalized Estimating Equations will be used to analyse the change in outcome measures across time between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/05/2022
Actual
Date of last participant enrolment
Anticipated
27/06/2022
Actual
Date of last data collection
Anticipated
31/08/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311351 0
Other Collaborative groups
Name [1] 311351 0
MindSpot
Country [1] 311351 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
1 Innovation Dr, Macquarie Park, Macquarie Park, NSW 2109
Country
Australia
Secondary sponsor category [1] 312738 0
None
Name [1] 312738 0
Address [1] 312738 0
Country [1] 312738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310844 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 310844 0
Ethics committee country [1] 310844 0
Australia
Date submitted for ethics approval [1] 310844 0
14/03/2022
Approval date [1] 310844 0
14/04/2022
Ethics approval number [1] 310844 0
520221150437289

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

Contacts
Principal investigator
Name 119070 0
A/Prof Shane Cross
Address 119070 0
Macquarie University, 1 Innovation Dr, Macquarie Park, NSW 2109
Country 119070 0
Australia
Phone 119070 0
+61 02 9850 8724
Fax 119070 0
Email 119070 0
[email protected]
Contact person for public queries
Name 119071 0
Shane Cross
Address 119071 0
Macquarie University, 1 Innovation Dr, Macquarie Park, NSW 2109
Country 119071 0
Australia
Phone 119071 0
+61 02 9850 8724
Fax 119071 0
Email 119071 0
[email protected]
Contact person for scientific queries
Name 119072 0
Shane Cross
Address 119072 0
Macquarie University, 1 Innovation Dr, Macquarie Park, NSW 2109
Country 119072 0
Australia
Phone 119072 0
+61 02 9850 8724
Fax 119072 0
Email 119072 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
SourceTitleYear of PublicationDOI
EmbaseAn open trial of the feasibility of brief internet-delivered acceptance and aommitment therapy (iACT) for chronic anxiety and depression.2023https://dx.doi.org/10.1016/j.invent.2023.100655
N.B. These documents automatically identified may not have been verified by the study sponsor.