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Trial registered on ANZCTR


Registration number
ACTRN12619001535167
Ethics application status
Approved
Date submitted
15/10/2019
Date registered
6/11/2019
Date last updated
6/11/2019
Date data sharing statement initially provided
6/11/2019
Date results information initially provided
6/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing Rumination and Worry: A pilot trial of an internet delivered intervention targeting repetitive negative thinking.
Scientific title
Developing and evaluating an internet-delivered treatment specifically targeting repetitive negative thinking in people with elevated repetitive negative thinking- A Pilot Study
Secondary ID [1] 299521 0
None
Universal Trial Number (UTN)
U1111-1241-7435
Trial acronym
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Depression 314760 0
Anxiety 314761 0
Condition category
Condition code
Mental Health 313090 313090 0 0
Anxiety
Mental Health 313091 313091 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 6weeks. It comprises psychoeducation about rumination and worry as well as techniques structured problem solving, attention shifting, activity planning and challenging positive and negative metacognitive beliefs about rumination and worry. 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, 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 homework tasks/ practicing the skills. Clinician guidance in the form of advice about the internet intervention will be provided in the form of email or phone contact from the clinician (registered clinical psychologist) after completion of the first two lessons, then as required. The participant is able to email or phone the clinician at any point during the trial. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations, 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 improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practicing skills.
Intervention code [1] 315768 0
Behaviour
Intervention code [2] 315897 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321632 0
Changes in repetitive negative thinking symptoms according to mean scores on the Repetitive Thinking Questionnaire- Repetitive Negative Thinking Subscale (RNT)
Timepoint [1] 321632 0
Baseline, before each lesson, one week post-treatment (week 7), and at 1-month post-treatment (week 11). Primary time-point is post-treatment (week 7).
Primary outcome [2] 321633 0
Changes in depression symptoms (according to mean scores on the Patient Health Questionnaire (PHQ-9)
Timepoint [2] 321633 0
Baseline, before each lesson, one week post-treatment (week 7), and at 1-month post-treatment (week 11). Primary time-point is post-treatment (week 7).
Primary outcome [3] 321634 0
Changes in anxiety symptoms according to mean scores on the Generalised Anxiety Disorder 7-item scale (GAD-7).
Timepoint [3] 321634 0
Baseline, before each lesson, one week post-treatment (week 7), and at 1-month post-treatment (week 11). Primary time-point is post-treatment (week 7).
Secondary outcome [1] 375679 0
Changes in psychological distress according to mean scores on the Kessler-10 (K10).
Timepoint [1] 375679 0
Baseline, before each lesson, one week post-treatment (week 7), and at 1-month post-treatment (week 11). Primary time-point is post-treatment (week 7).
Secondary outcome [2] 375680 0
Treatment Satisfaction according to the scores on the Treatment Satisfaction Questionnaire.
Timepoint [2] 375680 0
One week post-treatment (week 7).
Secondary outcome [3] 375681 0
Adherence, according to the number of lessons completed, and the number who complete 100% of the complete 3-lesson program within the 6-week treatment period.
Timepoint [3] 375681 0
One week post-treatment (Week 7)
Secondary outcome [4] 375682 0
Changes in metacognitive beliefs (both positive and negative) about RNT according to mean scores on the Metacognitions Questionnaire-30 (MCQ-30).
Timepoint [4] 375682 0
Baseline and 1-month follow up (Week 11)

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?
Yes
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
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)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot trial
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Linear mixed models will be used to analyse the data.

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
Recruitment postcode(s) [1] 28212 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 28213 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 304006 0
University
Name [1] 304006 0
University of New South Wales
Address [1] 304006 0
Mathews building UNSW Sydney Kensington Campus NSW, Australia, 2052
Country [1] 304006 0
Australia
Funding source category [2] 304014 0
Hospital
Name [2] 304014 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital
Address [2] 304014 0
Level 4, O’Brien Centre, St Vincent’s Hospital, 390 Victoria St, Darlinghurst NSW, 2010
Country [2] 304014 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] 304179 0
Hospital
Name [1] 304179 0
Clinical Research Unit for Anxiety and Depression
Address [1] 304179 0
Level 4, O’Brien Centre, St Vincent’s Hospital, 390 Victoria St, Darlinghurst NSW, 2010
Country [1] 304179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304500 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 304500 0
St Vincent's Hospital Research Office Translational Research Centre 97-105 Boundary St Darlinghurst, NSW 2010
Ethics committee country [1] 304500 0
Australia
Date submitted for ethics approval [1] 304500 0
30/08/2018
Approval date [1] 304500 0
03/10/2018
Ethics approval number [1] 304500 0
SVH 18/193

Summary
Brief summary
This pilot trial seeks to investigate the adherence rates and efficacy of an internet-delivered for repetitive negative thinking immediately following treatment and at 1-month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97162 0
Dr Jill Newby
Address 97162 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 97162 0
Australia
Phone 97162 0
+61293853425
Fax 97162 0
Email 97162 0
j.newby@unsw.edu.au
Contact person for public queries
Name 97163 0
Dr Jill Newby
Address 97163 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 97163 0
Australia
Phone 97163 0
+61293853425
Fax 97163 0
Email 97163 0
j.newby@unsw.edu.au
Contact person for scientific queries
Name 97164 0
Dr Jill Newby
Address 97164 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 97164 0
Australia
Phone 97164 0
+61293853425
Fax 97164 0
Email 97164 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
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary