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Trial registered on ANZCTR


Registration number
ACTRN12620000959976
Ethics application status
Approved
Date submitted
3/08/2020
Date registered
25/09/2020
Date last updated
25/09/2020
Date data sharing statement initially provided
25/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing Rumination and Worry: A randomised controlled trial of an internet delivered intervention targeting repetitive negative thinking.
Scientific title
A randomised controlled trial to compare the efficacy of a clinician-guided internet delivered intervention for repetitive negative thinking versus internet-delivered intervention without clinician guidance versus waitlist control.
Secondary ID [1] 301197 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12619001535167

This current study is a larger-scale follow-up to the initial pilot trial.

Health condition
Health condition(s) or problem(s) studied:
Depression 317344 0
Anxiety 317345 0
Condition category
Condition code
Mental Health 315451 315451 0 0
Anxiety
Mental Health 315452 315452 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Rumination and Worry program comprises 3 comic-style lessons completed over 6 weeks. It comprises psychoeducation about rumination and worry as well as techniques such as structured problem solving, attention shifting, activity planning and shifting into a more specific thinking style. One lesson will be released every 7 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons), with each participant taking between one and two weeks to complete each lesson (6 weeks in total). Each lesson will take approximately 30-40 minutes to complete. Participants will have access to summaries of each lesson, homework exercises (e.g., self-monitoring, planning and engaging in distracting activities, practicing structured problem solving), and extra resources for each lesson. Participants are advised to spend at least 3-4 hours per week working through the lesson material, revisiting the content, and practicing the skills.

Clinician guidance in the form of advice about the skills covered in the program will be provided to participants randomly allocated to the clinician-guided group. This will be in the form of email or phone contact from a clinician (provisional psychologist or registered clinical psychologist) after the completion of each lesson. It is expected that the duration of each clinical guidance session will be between 10 - 20 minutes per participant. Participants in the self-help group will complete the intervention in a self-help format and will not receive any additional clinical support or guidance. Participants in the self-help group and waitlist-control group can contact research staff for technical assistance at any point via phone or email.

Participants in the two intervention groups will complete a measure of psychological distress before each lesson. Participants in the control group will complete this same measure at three time points across the trial as part of a larger questionnaire battery. Across all groups, if their scores increase by one or more standard deviation, the clinician is automatically alerted and initiates contact with the participant by phone or email. This mode of contact is dependent on what is clinically indicated in terms of the participant's distress score and or what the participant may have communicated (in the form of phone or email contact) to the clinician. The mode of contact (email or phone or both) therefore is dependent on the clinician's clinical judgement of the situation in hand.

Strategies used to improve adherence to intervention protocols include standardised automated email and SMS reminders sent to participants whenever a new lesson or questionnaire is available, if they have not completed a lesson or questionnaire 4 and 8 days after it was released, and reminders to complete homework tasks 3 days after lesson completion. Strategies used to assess adherence to the intervention include monitoring the downloading of homework and collection of data on how long participants spent reading lessons and practicing skills.
Intervention code [1] 317500 0
Behaviour
Intervention code [2] 317501 0
Treatment: Other
Comparator / control treatment
Participants in the waitlist control condition will receive access to the intervention program in a self-help format after an 18-week waiting period. Participants will be asked to complete questionnaires at three time points during this waiting period. During this waiting period, participants can continue to contact their GP, local Psychologist, and other mental health professionals and services as they would have done if they were not completing the study.
Control group
Active

Outcomes
Primary outcome [1] 323697 0
Changes in repetitive negative thinking symptoms according to mean scores on the Repetitive Thinking Questionnaire- Repetitive Negative Thinking Subscale (RNT)
Timepoint [1] 323697 0
Baseline, before each lesson, one week post-treatment (week 7), and at 3-months post-treatment (week 18). Primary time-point is post-treatment (week 7).
Secondary outcome [1] 382647 0
Changes in psychological distress according to mean scores on the Kessler-10 (K10).
Timepoint [1] 382647 0
Baseline, before each lesson, one week post-treatment (week 7), and at 3-months post-treatment (week 18).
Secondary outcome [2] 382648 0
Treatment Satisfaction according to the scores on the Treatment Satisfaction Questionnaire designed for this study.
Timepoint [2] 382648 0
One week post-treatment (week 7).
Secondary outcome [3] 382649 0
Adherence according to the number of lessons completed.
Timepoint [3] 382649 0
One week post-treatment (Week 7) (intervention groups only)
Secondary outcome [4] 385255 0
Changes in depression symptoms (according to mean scores on the Patient Health Questionnaire (PHQ-9)
Timepoint [4] 385255 0
Baseline, before each lesson, one week post-treatment (week 7), and at 3-months post-treatment (week 18).
Secondary outcome [5] 385256 0
Changes in anxiety symptoms according to mean scores on the Generalised Anxiety Disorder 7-item scale (GAD-7).
Timepoint [5] 385256 0
Baseline, before each lesson, one week post-treatment (week 7), and at 3-months post-treatment (week 18).
Secondary outcome [6] 386294 0
Adherence according to the number who complete 100% of the complete 3-lesson program within the 6-week treatment period.
Timepoint [6] 386294 0
One week post-treatment (Week 7) (intervention groups only)

Eligibility
Key inclusion criteria
* Score above 27 on Repetitive Negative Thinking Questionnaire.
* Australian resident status
* At least 18 years of age
* Access to a computer, printer, and the internet
* If taking medication, must have been taking the same dose for at least 2 months and not intend to change that dose during the course of the program.
* Prepared to provide name, phone number, and address, and to provide the name and phone number of a local general practitioner.
* Willing to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently experiencing severe depression symptoms (score of 23 or above on the PHQ-9).
- Regularly using illicit drugs or regularly consuming more than three standard drinks per day
- Current regular use of benzodiazepines
- Current use of atypical anti-psychotics
- Currently experiencing a psychotic mental illness or bipolar disorder
- Completed an online program for depression and/or anxiety in the past year
- Currently suicidal and/or severe symptoms of suicidal ideation (defined as responding 3 to the PHQ-9 question 9 item that assesses the frequency of suicidal ideation over the past fortnight).
-Those scoring 1 or 2 on the Patient Health Questionnaire-9 Item (PHQ-9) item 9 will require risk assessment with the responsible clinician before being admitted into the study.

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)
Following assessment and offer of treatment, the participant will log into the online portal that delivers the internet-based intervention, at which point the portal will randomly assign them to a condition (clinician-guided, self-help, or control). That is, the assessor will have no role in randomizing the participant, and randomization will not take place until the participant has been accepted into the trial. Due to the nature of the treatments, allocation cannot be concealed form the participant once they have been allocated to any of the three groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online portal used for this trial generates a random number sequence to allocate participants to condition when they sign in (the random sequence has been developed based on random number generators using random.org). Randomization occurs after a participants is accepted into the trial and is therefore concealed from the interviewer.
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
Linear mixed models will be used to analyse the data.

Recruitment
Recruitment status
Recruiting
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
Recruitment hospital [1] 16605 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 30202 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 305648 0
University
Name [1] 305648 0
University of New South Wales
Address [1] 305648 0
Mathews building UNSW Sydney Kensington Campus NSW, Australia, 2052
Country [1] 305648 0
Australia
Funding source category [2] 305650 0
Hospital
Name [2] 305650 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital
Address [2] 305650 0
Level 4, O’Brien Centre, St Vincent’s Hospital, 390 Victoria St, Darlinghurst NSW, 2010
Country [2] 305650 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Mathews building UNSW Sydney Kensington Campus NSW, Australia, 2052
Country
Australia
Secondary sponsor category [1] 306055 0
Hospital
Name [1] 306055 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital
Address [1] 306055 0
Level 4, O’Brien Centre, St Vincent’s Hospital, 390 Victoria St, Darlinghurst NSW, 2010
Country [1] 306055 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305932 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 305932 0
St Vincent's Hospital Research Office Translational Research Centre 97-105 Boundary St Darlinghurst, NSW 2010
Ethics committee country [1] 305932 0
Australia
Date submitted for ethics approval [1] 305932 0
24/03/2020
Approval date [1] 305932 0
16/04/2020
Ethics approval number [1] 305932 0
2019/ETH03309

Summary
Brief summary
This randomised controlled trial seeks to investigate the adherence rates and efficacy of an internet-delivered program for repetitive negative thinking immediately following treatment and at 3-months follow-up, and compare outcomes for clinician-guided versus self-guided online program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102114 0
A/Prof Jill Newby
Address 102114 0
The Black Dog Institute
Hospital Road, Randwick
NSW, 2031
Australia
Country 102114 0
Australia
Phone 102114 0
+61293824217
Fax 102114 0
Email 102114 0
j.newby@unsw.edu.au
Contact person for public queries
Name 102115 0
A/Prof Jill Newby
Address 102115 0
The Black Dog Institute
Hospital Road, Randwick
NSW, 2031
Australia
Country 102115 0
Australia
Phone 102115 0
+61293824217
Fax 102115 0
Email 102115 0
j.newby@unsw.edu.au
Contact person for scientific queries
Name 102116 0
A/Prof Jill Newby
Address 102116 0
The Black Dog Institute
Hospital Road, Randwick
NSW, 2031
Australia
Country 102116 0
Australia
Phone 102116 0
+61293824217
Fax 102116 0
Email 102116 0
j.newby@unsw.edu.au

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 other documents available
Summary results
No Results