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Trial registered on ANZCTR


Registration number
ACTRN12615000927527
Ethics application status
Approved
Date submitted
16/08/2015
Date registered
7/09/2015
Date last updated
5/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing internet-delivered Cognitive Behavioural Therapy (iCBT), internet-delivered Mindfulness-Enhanced Cognitive Behavioural Therapy, internet-delivered Mindfulness Skills Training versus usual care for adults with depression and/or anxiety.
Scientific title
A randomised controlled trial comparing internet-delivered Cognitive Behavioural Therapy (iCBT), internet-delivered Mindfulness-Enhanced Cognitive Behavioural Therapy, internet-delivered Mindfulness Skills Training versus usual care for adults with depression and/or anxiety on the severity of symptoms of depression and anxiety.
Secondary ID [1] 287131 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder 295673 0
Major Depressive Disorder 295674 0
Panic Disorder with or without Agoraphobia 295675 0
Social Anxiety Disorder 295676 0
Anxiety Disorder not Otherwise Specified 295677 0
Obsessive Compulsive Disorder 296087 0
Condition category
Condition code
Mental Health 295948 295948 0 0
Anxiety
Mental Health 295949 295949 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete one of the three interventions described below.

The internet-delivered Mindfulness-Enhanced Cognitive Behavioural Therapy Program comprises 6 lessons completed over 14 weeks. It includes all treatment components typically seen in face-to-face cognitive behavioural therapy (CBT), as well as a number of formal and informal mindfulness exercises (including guided mindfulness meditations (provided on a CD) and written instruction for using mindfulness in daily life). One lesson will be completed every 7-14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons). 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. Clinician guidance will be provided in the form of email and/or phone contact from the clinician (registered clinical psychologist) after completion of the first two lessons, then as required. The participant is also able to email or phone the clinician at any point during the trial as required. 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.

The internet-delivered Cognitive Behavioural Therapy Program comprises 6 lessons completed over 14 weeks. It includes all treatment components typically seen in face-to-face cognitive behavioural therapy (CBT). One lesson will be completed every 7-14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons). 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. Clinician guidance will be provided in the form of email and/or phone contact from the clinician (registered clinical psychologist) after completion of the first two lessons, then as required. The participant is also able to email or phone the clinician at any point during the trial as required. 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.

The internet-delivered Mindfulness Skills Training Program comprises 6 lessons completed over 14 weeks. It includes a number of formal and informal mindfulness exercises (including guided mindfulness meditations (provided on a CD) and written instruction for using mindfulness in daily life).
One lesson will be completed every 7-14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons).
Each lesson will take approximately 30-40 minutes to complete. Participants will have access to summaries of each lesson, homework exercises, and mindfulness recordings. Clinician guidance will be provided in the form of email and/or phone contact from the clinician (registered clinical psychologist) after completion of the first two lessons, then as required. The participant is also able to email or phone the clinician at any point during the trial as required. 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.


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] 292386 0
Treatment: Other
Intervention code [2] 292387 0
Behaviour
Comparator / control treatment
The Treatment as Usual Control Group/usual care control group (TAU) will receive care as usual for a 14 week period until the treatment groups have completed their intervention. Usual care refers to any treatments the participant would typically receive (e.g., counselling, psychology sessions). That is. the TAU group will not be restricted from receiving any treatments during the waiting period. At that time (14 weeks), the TAU group will be offered the opportunity to take part in the Mindfulness-Enhanced CBT program.
Control group
Active

Outcomes
Primary outcome [1] 295626 0
Changes in depression symptoms (according to mean scores on the Patient Health Questionnaire (PHQ-9)
Timepoint [1] 295626 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Primary outcome [2] 295627 0
Changes in anxiety symptoms according to mean scores on the Generalised Anxiety Disorder 7-item scale (GAD-7).
Timepoint [2] 295627 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Primary outcome [3] 295628 0
Changes in well-being according to mean scores on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Timepoint [3] 295628 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Secondary outcome [1] 316035 0
Changes in in functional impairment and disability according to mean scores on the World Health Organisation Disability Assessment Schedule (WHODAS-II).
Timepoint [1] 316035 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Secondary outcome [2] 316036 0
Changes in repeptitive thinking frequency according to mean scores on the Repetitive Thinking Questionnaire (RTQ-10)
Timepoint [2] 316036 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Secondary outcome [3] 316039 0
Changes in experiential avoidance according to the Brief Experiential Avoidance Questionnaire (BEAQ)
Timepoint [3] 316039 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Secondary outcome [4] 316040 0
Changes in in emotion regulation according to mean scores on the Difficulties with Emotion Regulation Scale (DERS)
Timepoint [4] 316040 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Secondary outcome [5] 316041 0
Changes in mindfulness according to mean scores on the Five-Factor Mindfulness Questionnaire (FFMQ)
Timepoint [5] 316041 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Secondary outcome [6] 316043 0
Treatment Satisfaction according to the scores on the Treatment Satisfaction Questionnaire.
Timepoint [6] 316043 0
One week after the final lesson is completed (post-treatment: 14 weeks).
Secondary outcome [7] 316044 0
Changes in severity of social anxiety according to mean scores on the Social Phobia Inventory (SPIN).
Timepoint [7] 316044 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Secondary outcome [8] 316045 0
Changes in the severity of panic disorder symptoms according to mean scores on the Panic Disorder Severity Scale (PDSS).
Timepoint [8] 316045 0
Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)
Secondary outcome [9] 316712 0
Changes in psychological distress according to mean scores on the Kessler-10 (K10).
Timepoint [9] 316712 0
Baseline, prior to each lesson, one week post-treatment (14 weeks), and at 3-months post-treatment (week 26).
Secondary outcome [10] 316713 0
Changes in wellbeing according to scores on the World Health Organisation 5-item wellbeing scale.
Timepoint [10] 316713 0
Baseline, before each lesson, mid-treatment (before lesson 4), post-treatment (14 weeks) and at 3-month follow-up (26 weeks).
Secondary outcome [11] 316714 0
Changes in the frequency of avoidance and safety behaviours according to the Worry Behaviours Inventory.
Timepoint [11] 316714 0
Baseline, post-treatment (14 weeks), and at 3-months post-treatment (26 weeks).
Secondary outcome [12] 316715 0
Unwanted/negative side effects of the internet program as defined as the self-reported number of unwanted problems or events that participant reported occurring due to participation in the program.
Timepoint [12] 316715 0
After each lesson and at post-treatment (14 weeks).

Eligibility
Key inclusion criteria
* Self-identified as suffering from depression and/or anxiety.
* Meet criteria for either Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Phobia (SP), Panic Disorder (PD), Agoraphobia (AG), Disorder or Obsessive-Compulsive Disorder (OCD) according to the Anxiety Disorders Interview Schedule for DSM-5
* 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 1 month 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.
* Willing to be randomised to one of the three treatment conditions or usual care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Does not meet diagnostic criteria for an anxiety or depressive disorder.
- 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
- 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.
- current diagnosis of PTSD.

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)
Participants apply online, followed by a telephone interview to confirm diagnosis via the Anxiety Disorders Interview Schedule for DSM-5, a structured clinical interview.

Once the participant meets criteria for inclusion into the study, they will be randomly allocated to one of the four conditions. Random allocation will be concealed in an opaque envelope, which will only be opened once the offer of treatment is made.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation numbers will be generated via www.random.org by a member of the research team who is independent from the study.
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
A pre-to-post-treatment improvement of effect size (ES) 1.0 is expected for the CBT and Mindfulness-based CBT treatment groups on the primary depression and anxiety measures. A between-groups effect size greater than 0.6 is expected between the intervention groups and the usual care control group.


All analyses will be undertaken using mixed-model repeated measures (MMRM) ANOVA with measurement occasion as a within-groups factor and intervention as a between-groups factor. Relationships between observations at different occasions will be modelled with an unstructured covariance matrix. For each experimental group, planned contrasts will be used to compare changes from baseline to post-test and 3 month follow-up. At each measurement occasion, participants will be asked whether they are currently undertaking any adjunctive treatment for their depression, and this variable will be included as a covariate in the regression models.
How number of participants needed to achieve study objectives was determined: 50 subjects in each cell had an 80% power to detect a significance p< 0.5 if the difference between the treatment groups and the usual care control group of 1.0, and of a 0.6 ES difference between ME-iCBT and iCBT.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2015
Actual
3/09/2015
Date of last participant enrolment
Anticipated
11/03/2016
Actual
25/02/2016
Date of last data collection
Anticipated
30/09/2016
Actual
30/09/2016
Sample size
Target
200
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 4075 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 291689 0
Self funded/Unfunded
Name [1] 291689 0
Country [1] 291689 0
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria Street, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 290364 0
None
Name [1] 290364 0
Address [1] 290364 0
Country [1] 290364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293216 0
St Vincent's Hospital HREC
Ethics committee address [1] 293216 0
Ethics committee country [1] 293216 0
Australia
Date submitted for ethics approval [1] 293216 0
28/05/2014
Approval date [1] 293216 0
19/06/2014
Ethics approval number [1] 293216 0
HREC/14/SVH/170

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

Contacts
Principal investigator
Name 58942 0
Prof Gavin Andrews
Address 58942 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Level 4 O'Brien Centre, 390 Victoria St Darlinghurst NSW 2010
Country 58942 0
Australia
Phone 58942 0
+61 2 8382 1405
Fax 58942 0
Email 58942 0
gavina@unsw.edu.au
Contact person for public queries
Name 58943 0
Jill Newby
Address 58943 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Level 4 O'Brien Centre, 390 Victoria St Darlinghurst NSW 2010
Country 58943 0
Australia
Phone 58943 0
+61283821433
Fax 58943 0
Email 58943 0
j.newby@unsw.edu.au
Contact person for scientific queries
Name 58944 0
Jill Newby
Address 58944 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Level 4 O'Brien Centre, 390 Victoria St Darlinghurst NSW 2010
Country 58944 0
Australia
Phone 58944 0
+61283821433
Fax 58944 0
Email 58944 0
j.newby@unsw.edu.au

No information has been provided regarding IPD availability


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
EmbaseTransdiagnostic internet-delivered CBT and mindfulness-based treatment for depression and anxiety: A randomised controlled trial.2020https://dx.doi.org/10.1016/j.invent.2020.100310
N.B. These documents automatically identified may not have been verified by the study sponsor.