Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000662662
Ethics application status
Approved
Date submitted
19/01/2023
Date registered
20/06/2023
Date last updated
15/05/2024
Date data sharing statement initially provided
20/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Online single-session positive psychology interventions for youth with chronic conditions: A pilot study
Scientific title
Feasibility and acceptability of single-session positive psychology interventions for youth with chronic conditions: A pilot study
Secondary ID [1] 308744 0
None
Universal Trial Number (UTN)
U1111-1286-9984
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Chronic Conditions 328685 0
Mental health 328686 0
Depression 330291 0
Anxiety 330292 0
Condition category
Condition code
Mental Health 325695 325695 0 0
Depression
Mental Health 325696 325696 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions are three online, brief (<60 minute) positive psychology modules. Each module is designed to be stand-alone and completed in one sitting. Participants will choose which of the three modules they would like to complete. The modules will be delivered using the Qualtrics platform, which will track intervention completion rates. Each module focuses on a different positive psychology skill that has been linked to mental health and adaptive emotion regulation in youth with chronic conditions: self-compassion, optimism, self-efficacy. The intervention is self-guided, and participants are free to complete the intervention in their own home, or any environment where they have access to a computer.
Intervention Format
A generic introductory section will be consistent across the three modules and will explain the concept of emotion regulation and its importance for mental health when dealing with a chronic condition. Self-compassion, optimism, and self-efficacy will be introduced as adaptive emotion regulation strategies. After reading an overview of each module, participants will choose which of the three modules they want to complete.
Each of the three modules will contain psychoeducation in the form of short videos and written text. This will include what the target skill is, why it is important for emotion regulation, why it is relevant for youth with chronic conditions, and how it can be modified. Following this, each module will contain a series of activities that have been designed by the co-design group or theoretically and empirically linked to the target skill in the current literature. Activities will demonstrate content through audio recordings of stories shared by the intervention co-designers, before guiding participants through a series of self-reflection exercises using free-text responses. For example, the self-compassion module will ask participants to reflect on the way they treat themselves compared to the way they treat their friends in times of hardship. Each module will conclude with a summary of the module content and tips for translating the lessons into the real world contexts.
Co-design process
Modules were co-designed with 10 young people living with chronic conditions to ensure relevance. Over 6 months, co-designers were engaged via several individually completed surveys and generative activities (e.g. creating graphic design boards) as well as five 90-120 minute online group workshops with all co-designers working together. In addition to these planned processes, to ensure all co-designers felt like they were meaningfully able to share their perspective, the facilitator offered individual consultations with co-designers if requested (e.g. if a co-designer was unable to attend a group workshop due to illness or wanted further assistance with an individual co-design activity).
Initial stages of the co-design used group workshops and anonymous brainstorm boards to explore participants’ ideas about the target skills, including what each skill is, how it could be improved, and specific barriers to each skill faced by young people with chronic conditions. In the next survey and workshop, co-designers provided feedback on potential intervention activities from the current literature base, before working as a group to design new activities that would be more relevant for the target population. Next, anonymous brainstorm boards were used to explore what information should be provided before choosing a module, language preferences, and the most important messages within the intervention. In the subsequent group workshop, the co-design group worked together to design introduction sections based on these preferences. In another workshop, a member of the research team facilitated a story generation workshop, where co-designers generated content for the intervention based on their own experiences of living with a chronic condition. Finally, intervention prototypes were created, with each participant individually and anonymously providing feedback on the prototypes. A final group workshop was used to re-design elements of the intervention to appropriately address the feedback.

Intervention code [1] 325205 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333549 0
Program Acceptability: program acceptability will be assessed using the Program Feedback Scale. This instrument includes 5 items that relate to program ease of use, engagement, and relevance. Participants rate the items on 4 point scale from ‘really disagree’ to ‘really agree’. It also includes two free-text questions asking participants to share what the liked and what they would change about the program.
Timepoint [1] 333549 0
Scale will be implemented at post-test (T1), immediately after module completion.
Primary outcome [2] 333550 0
Program Feasibility: Detailed tracking of rates at which (a) participants consent to participate; (b) each individual module is selected, started, and completed, (c) attrition is present in follow-up measurement. This will be tracked using Qualtrics analytics.

Qualitative feedback: Individual interviews will be conducted with participants to determine feasibility of the intervention. Questions will focus on how participants selected which module to complete, their experience working through the module content, and any ongoing changes they perceived in the period after module completion. Interviews will be conducted by a member of the research team and will be audio-recorded to facilitate transcription and analysis. Interviews are expected to take approximately 45 minutes.
Timepoint [2] 333550 0
Quantitative data will be collected at the conclusion of the study, four weeks post-intervention commencement (T3). Participants will be invited to completed interviews at four weeks post-intervention commencement (T3).
Secondary outcome [1] 417490 0
Perceived change in target skills: Participants will complete a measure to assess whether they perceive changes in their ability to perform the targeted skill (optimism, self-efficacy, self-compassion, or emotion regulation), from before to after module completion. The item will differ across modules to ask about the specific target skill from the intervention ( e.g., “To what extent are you able to be self-compassionate, compared to before you completed the program?”) and will ask participants to compare how they are currently feeling with how they felt before completing the module on a 5-point Likert-Type scale from -2 (“Much less able to be self-compassionate”) to 2 (“Much more able to be self-compassionate”).

This question was based of previously established methods of evaluating perceived change in single-session interventions (See Schleider et al., 2020; Shroff et al., 2023).
Timepoint [1] 417490 0
Assessed immediately after intervention completion (T1).
Secondary outcome [2] 417491 0
Perceived change in emotions: Participants will complete a measure to assess whether they perceive changes in their emotion from before to after module completion. Each item ( e.g., “Right now, how much more happy are you feeling, compared to before you did the program?”) will ask participants to compare how they are currently feeling with how they felt before completing the module on a 5-point Likert-Type scale from -2 (“Much less happy”) to 2 (“Much more happy”)


One item each will assess perceived changes in the emotions or states (e,g., happy, sad, positive, negative, inspired, frustrated, proud, ashamed.) Thistechnique is based of previously established methods of evaluating perceived change in single-session interventions (See Schleider et al., 2020; Shroff et al., 2023).


Descriptive statistics including frequencies and mean will be calculated for each item. This outcome will be assessed for each module individually, and mean scores >0 will suggest that overall, there was a subjectively detectable change in emotions from pre to post intervention for participants in the module.
Timepoint [2] 417491 0
Assessed immediately after intervention completion (T1).
Secondary outcome [3] 417687 0
Wellbeing: Wellbeing will be assessed using the Emotional Well-being Subscale of the Mental Health Continuum - Short-Form.
Timepoint [3] 417687 0
Measure will be assessed at two weeks (T2) and four weeks (T3) post intervention commencement.
Secondary outcome [4] 422750 0
Distress. Distress will be assessed using the Short Mood and Feelings Questionnaire.
Timepoint [4] 422750 0
Measure will be assessed at two weeks (T2) and four weeks (T3) post-intervention commencement.
Secondary outcome [5] 422751 0
Perceived change in ability to cope: Participants will complete a measure to assess whether they perceive changes in their ability to cope from before to after module completion. This item ( “Right now, to what extent are you to cope with difficulties, compared to before you did the program?”) will ask participants to compare how they are currently feeling with how they felt before completing the module on a 5-point Likert-Type scale from -2 (“Much less able to cope”) to 2 (“Much more able to cope”).

Descriptive statistics including frequencies and mean will be calculated. This outcome will be assessed for each module individually, and a mean score >0 will suggest that overall, there was a subjectively detectable change in ability to cope from pre to post intervention for participants in the module.
Timepoint [5] 422751 0
Assessed immediately after intervention completion (T1).
Secondary outcome [6] 435116 0
Emotion Regulation Difficulties. Emotion Regulation Difficulties will be measured using the 18-item version of the Difficulties in Emotion Regulation Scale (DERS-18).
Timepoint [6] 435116 0
Secondary outcome [7] 435117 0
Emotion Regulation Difficulties. Emotion Regulation Difficulties will be measured using the 18-item version of the Difficulties in Emotion Regulation Scale (DERS-18).
Timepoint [7] 435117 0
Measure will be assessed at baseline and two weeks (T2) and four weeks (T3) post intervention commencement.

Eligibility
Key inclusion criteria
Participants must currently reside in Australia and self-report being diagnosed with a chronic physical condition; a chronic physical condition will be defined as any medical condition that (a) persists for over six months, (b) requires medical management, and (c) impacts an individual’s functioning.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they do not have regular access to internet to complete the module and the surveys.

Study design
Purpose of the study
Prevention
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary outcomes 1 and 2 and secondary outcomes 1, 2, and 5 will be evaluated using descriptive statistics for the entire sample and individual modules. In addition, qualitative data from interviews will also be used to evaluate primary outcomes 1 and 2. Analysis of variance will assess whether there are differences in secondary outcomes for secondary outcomes across interventions, with post-hoc tests used to evaluate the nature and extend of any differences.

For secondary outcomes 1, 2, and 5. Descriptive statistics including frequencies and mean will be calculated for each item, with a mean score >0 will suggest that overall, participant's experienced a subjectively detectable change in the outcome from pre to post intervention.

Secondary outcomes 3, 4, and 6 will be evaluated using linear mixed models to determine changes in outcomes across timepoints. If the sample size is sufficient, this analysis will compare changes in outcomes across timepoints for each of the four interventions. If sample size is insufficient for this aim, participants will be analysed as one group, regardless of which intervention they completed.

Analysis of variance will assess whether there are differences in secondary outcomes across interventions, with post-hoc tests used to evaluate the nature and extend of any differences.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/01/2024
Actual
31/01/2024
Date of last participant enrolment
Anticipated
30/07/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
108
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312966 0
Government body
Name [1] 312966 0
Healthway WA
Country [1] 312966 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
15 Hospital Avenue, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 314693 0
None
Name [1] 314693 0
Address [1] 314693 0
Country [1] 314693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312238 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 312238 0
Kent St, Bentley, 6102, WA
Ethics committee country [1] 312238 0
Australia
Date submitted for ethics approval [1] 312238 0
09/02/2023
Approval date [1] 312238 0
03/05/2023
Ethics approval number [1] 312238 0
HRE2023-0213

Summary
Brief summary
This study aims to investigate whether 3 newly developed brief online interventions are acceptable to young people with chronic health conditions, and pilot the methods for a larger scale randomized control trial. Young people (aged 18-25) with chronic conditions will choose one of three modules to complete and provide feedback on.

Each module teaches a different skill (self-compassionate, self-efficacy, and optimism) that has been linked to healthy emotion regulation and mental health in young people with chronic conditions. Modules run for less than 60 minutes, are self-guided and designed to be completed in a single setting. Modules contain a mixture of video content, stories from other young people, psychoeducation on the targeted skills, and interactive activities including guided self-reflection.

The trial will assess whether young people perceive changes in their skills and emotions from pre-to-post module completion, as well as their feedback on the module content. It will also explore which modules young people choose to complete, rates of completion across modules, and changes in mental health using validated measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123946 0
Dr Amy Finlay-Jones
Address 123946 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 123946 0
Australia
Phone 123946 0
+61863191808
Fax 123946 0
Email 123946 0
amy.finlay-jones@telethonkids.org.au
Contact person for public queries
Name 123947 0
Dr Amy Finlay-Jones
Address 123947 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 123947 0
Australia
Phone 123947 0
+61863191808
Fax 123947 0
Email 123947 0
amy.finlay-jones@telethonkids.org.au
Contact person for scientific queries
Name 123948 0
Dr Amy Finlay-Jones
Address 123948 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 123948 0
Australia
Phone 123948 0
+61863191808
Fax 123948 0
Email 123948 0
amy.finlay-jones@telethonkids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval has been given for the team to make de-identified data available on request from researchers. Due to the sentence nature of the raw data, including free-text responses and interviews that are likely to be identifiable, we do not currently have plans to deposit raw IPD on an open-access data repository.


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.