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Trial registered on ANZCTR


Registration number
ACTRN12615000241538
Ethics application status
Approved
Date submitted
9/03/2015
Date registered
17/03/2015
Date last updated
3/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Writing for Health: A randomised controlled trial of an online benefit-finding writing intervention for adults with type 1 or type 2 diabetes
Scientific title
The efficacy of an online benefit-finding writing intervention versus an online use-of-time writing intervention in reducing diabetes distress in adults with type 1 or type 2 diabetes mellitus
Secondary ID [1] 286332 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 and Type 2 diabetes mellitus
294440 0
Diabetes distress 294441 0
Diabetes self-care 294442 0
Depression 294443 0
Anxiety 294444 0
Condition category
Condition code
Mental Health 294745 294745 0 0
Other mental health disorders
Public Health 294746 294746 0 0
Other public health
Metabolic and Endocrine 294787 294787 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two web-based interventions on the Writing for Health online program:
Arm 1) Benefit-finding writing: Participants are asked to write online about any positive thoughts and feelings about their experience with diabetes.
Arm 2) Use of time writing (active control condition): Participants are asked to write in detail about how their time was spent that day and plans for how their time will be spent the following day and week.

Both interventions involve participants writing online, on the Internet-based Writing for Health program, for 15 minutes once a day, for three consecutive days.

Participants are asked to rate their current mood online immediately before and after each online writing session.

Participants will be sent automated emails reminding them to log on when they are due to complete a writing session or an online follow-up questionnaire.

The Writing for Health program involves an online information and consent procedure, online screening questionnaires with automatic feedback and online registration for eligible participants who provide informed consent to participate.
Participants will complete online questionnaires at pre-program, during the program, post-program and at one-month and three-month follow-up.

Participants in both arms are provided with feedback on their score categories (eg ‘mild’) on measures of symptoms of depression and anxiety, at baseline, one-month and three-month follow-up.
Intervention code [1] 291382 0
Treatment: Other
Intervention code [2] 291383 0
Behaviour
Comparator / control treatment
The comparator intervention is the active control condition of writing online about use of time. Participants are asked to write in detail about how their time was spent that day and plans for how their time will be spent the following day and week.

Both the intervention group and the active control group are asked to write online for 15 minutes per day, once a day, for three consecutive days.
Control group
Active

Outcomes
Primary outcome [1] 294509 0
Diabetes distress as measured by the Diabetes Distress Scale. The Diabetes Distress Scale is a 17-item self-report measure of psychosocial stress associated with diabetes and includes four reliable subscales: emotional burden, physician-related distress, regime-related distress and interpersonal distress.
Timepoint [1] 294509 0
Baseline, 1 month and 3 month follow-up.
Primary outcome [2] 294510 0
Benefit finding in diabetes, as measured by the Benefit Finding Scale-Diabetes. The 17-item Benefit Finding Scale was developed to assess benefit finding in women with breast cancer, and has previously been adapted for use in diabetes.
Timepoint [2] 294510 0
Baseline, 1 month and 3 month follow-up.
Secondary outcome [1] 313492 0
Diabetes self-care as measured by the Summary of Diabetes Self-Care measure.
Timepoint [1] 313492 0
Baseline, 1 month and 3 month follow-up.
Secondary outcome [2] 313493 0
Anxiety symptoms, measured by the GAD-7
Timepoint [2] 313493 0
Baseline, 1 month and 3 month follow-up.
Secondary outcome [3] 313494 0
Depression symptoms, measured by the PHQ-9
Timepoint [3] 313494 0
Baseline, 1 month and 3 month follow-up.
Secondary outcome [4] 313495 0
Health-care utilisation, assessed by asking participants to report the number of times they have visited a doctor or other healthcare professional over the past month.
Timepoint [4] 313495 0
Baseline, 1 month and 3 month follow-up.
Secondary outcome [5] 313496 0
Self-rated health, assessed by the single item ‘In general, how would you rate your health at present’, with responses rated on a five-point scale.
Timepoint [5] 313496 0
Baseline, 1 month and 3 month follow-up.
Secondary outcome [6] 313497 0
Positive and negative affect, as measured by the 10-item International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) – Immediate Version
Timepoint [6] 313497 0
Immediately before and after each of the three writing sessions (within intervention)
Secondary outcome [7] 313498 0
Intervention satisfaction, as measured by the Feedback Questionnaire, which was developed specifically for this study.
Timepoint [7] 313498 0
Post intervention

Eligibility
Key inclusion criteria
Participants must be aged 18 years or older, have ever received a diagnosis of type 1 or type 2 diabetes, live in Australia, have access to the Internet, provide informed consent and be able to register online using an email address.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have received a diagnosis of a psychotic or bipolar disorder or dementia; current significant symptoms of depression (scoring 10 or above on the PHQ-9) or anxiety (scoring 8 or above on the GAD-7); current suicidal ideation; history of self-harm or suicide attempt; current psychological therapy; difficulty reading or writing in English; inability to type for 15 minutes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested potential participants are invited on the Writing for Health website to read the Participant Information and to provide informed consent online in order to proceed.

Potential participants are then asked to complete online screening questionnaires, which provide automatic feedback as to whether they are eligible to participate.

Eligible participants can then register online and create an account with the Writing for Health program. This process includes an automatic email being sent to the participant requesting activation of their account and a further automatic email confirming when registration is complete.

Following registration, the participant is then asked to complete further online pre-intervention questionnaires. Once completed, the participant is then informed of the condition to which they have been randomly allocated when they commence their intervention (the first writing session). The Writing for Health program software, developed using the University of New South Wales eHealth Authoring Tool, randomly allocates participants using a block design method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block design method
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Repeated measures ANOVA/mixed modelling.

Data will be analysed on an intention-to-treat basis.

Previous research has reported effect sizes ranging from small to large. Assuming a medium effect size (i.e. GPower f(v) test = 0.40), power at 80%, significance set at 5% (p=.05), a sample of 73 will be required to demonstrate statistical significance. However, allowing for a 30% attrition rate, we will recruit 104 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290905 0
Hospital
Name [1] 290905 0
Faces in the Street: Urban Mental Health Research Institute, St Vincent’s Hospital, Sydney
Address [1] 290905 0
Level 6 O’Brien Centre, St Vincent’s Hospital, 390 Victoria St, Darlinghurst, Sydney, NSW 2010 AUSTRALIA
Country [1] 290905 0
Australia
Funding source category [2] 290906 0
University
Name [2] 290906 0
School of Psychiatry, University of New South Wales
Address [2] 290906 0
Black Dog Institute building, Hospital Rd, Prince of Wales Hospital, Randwick, Sydney, NSW 2031, AUSTRALIA
Country [2] 290906 0
Australia
Primary sponsor type
Hospital
Name
Faces in the Street: Urban Mental Health Research Institute, St Vincent’s Hospital
Address
Level 6 O’Brien Centre, St Vincent’s Hospital, 390 Victoria St, Darlinghurst, Sydney, NSW 2010, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 289586 0
None
Name [1] 289586 0
Address [1] 289586 0
Country [1] 289586 0
Other collaborator category [1] 278390 0
University
Name [1] 278390 0
School of Psychiatry, University of New South Wales
Address [1] 278390 0
Black Dog Institute building, Hospital Rd, Prince of Wales Hospital, Randwick, Sydney, NSW, 2031, AUSTRALIA
Country [1] 278390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292507 0
St Vincent’s Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 292507 0
Research Office, Level 6 deLacy Building, St Vincent’s Hospital, 390 Victoria St, Darlinghurst, NSW, 2010 AUSTRALIA
Ethics committee country [1] 292507 0
Australia
Date submitted for ethics approval [1] 292507 0
Approval date [1] 292507 0
19/02/2014
Ethics approval number [1] 292507 0
HREC/13/SVH/379

Summary
Brief summary
A randomised controlled trial will be conducted, using the online Writing for Health program, to examine the efficacy of Internet-based writing exercises focusing on benefit-finding in diabetes, versus an active control condition, in reducing diabetes distress and increasing perceived benefits of living with diabetes (primary outcomes) and reducing symptoms of depression and anxiety and increasing diabetes self-care and self-reported general health (secondary outomes).

Adults with type 1 or type 2 diabetes visiting the Writing for Health website, in response to advertisements, will be invited to participate in the study.

Following informed consent and an online screening procedure, participants will be randomly allocated to one of two interventions:
i) Benefit-finding: Writing about any positive thoughts of feelings about experiences with diabetes; or
ii) Use of time: Writing about how time has been spent this day and will be spent next week.

Both interventions in the Writing for Health program involve writing online for 15 minutes once a day, for three consecutive days.

Participants will complete online questionnaires at pre-intervention, during the program, post-intervention, and at one and three month follow-ups.
Trial website
https://writingforhealth.ehat.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55642 0
Prof Kay Wilhelm
Address 55642 0
Faces in the Street: Urban Mental Health Research Institute and Consultation Liaison Psychiatry, St Vincent's Hospital

Level 4, O'Brien Centre, St Vincent's Hospital, 390 Victoria St, Darlinghurst, Sydney, NSW 2010
Country 55642 0
Australia
Phone 55642 0
+61 2 8382 1540
Fax 55642 0
Email 55642 0
kay.wilhelm@svha.org.au
Contact person for public queries
Name 55643 0
Ms Joanna Crawford
Address 55643 0
Faces in the Street: Urban Mental Health Research Institute St Vincent's Hospital

Level 6, O'Brien Centre, St Vincent's Hospital, 390 Victoria St, Darlinghurst, Sydney, NSW 2010
Country 55643 0
Australia
Phone 55643 0
+61 2 8382 1660
Fax 55643 0
Email 55643 0
SVHS.WritingForHealth@svha.org.au
Contact person for scientific queries
Name 55644 0
Ms Joanna Crawford
Address 55644 0
Faces in the Street: Urban Mental Health Research Institute St Vincent's Hospital

Level 6, O'Brien Centre, St Vincent's Hospital, 390 Victoria St, Darlinghurst, Sydney, NSW 2010
Country 55644 0
Australia
Phone 55644 0
+61 2 8382 1660
Fax 55644 0
Email 55644 0
SVHS.WritingForHealth@svha.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary