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Trial registered on ANZCTR


Registration number
ACTRN12617001538336
Ethics application status
Approved
Date submitted
20/10/2017
Date registered
6/11/2017
Date last updated
4/02/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Cognitive Behavioural Therapy (CBT) versus mindfulness for depression and anxiety: a randomised controlled trial
Scientific title
A randomised controlled trial to compare the efficacy of online CBT versus mindfulness for reducing symptoms of depression and anxiety in adults
Secondary ID [1] 293177 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 305164 0
Generalised anxiety disorder 305165 0
Social anxiety disorder 305166 0
Panic disorder 305167 0
Agoraphobia 305168 0
Obsessive Compulsive Disorder 305169 0
Condition category
Condition code
Mental Health 304486 304486 0 0
Anxiety
Mental Health 304487 304487 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Cognitive Behavioural Therapy Program comprises 6 lessons completed over 10 weeks. It comprises psychoeducation about depression and anxeity as well as CBT techniques including thought challenging, behavioural activation, graded exposure and relapse prevention. 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 each lesson (10 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 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] 299424 0
Treatment: Other
Intervention code [2] 299425 0
Behaviour
Comparator / control treatment
The internet-delivered Mindfulness Skills Program comprises 6 lessons completed over 10 weeks. It comprises formal and informal mindfulness exercises (including guided mindfulness meditations (provided on a CD, or downloadable audio file) and written instruction for using mindfulness in daily life). 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 each lesson (10 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 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.
Control group
Active

Outcomes
Primary outcome [1] 303722 0
Changes in depression symptoms (according to mean scores on the Patient Health Questionnaire (PHQ-9)
Timepoint [1] 303722 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 11), and at 6-month post-treatment (week 34). Primary time-point is post-treatment (week 11).
Primary outcome [2] 303723 0
Changes in anxiety symptoms according to mean scores on the Generalised Anxiety Disorder 7-item scale (GAD-7).
Timepoint [2] 303723 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 11), and at 6-month post-treatment (week 34). Primary time-point is post-treatment (week 11).
Secondary outcome [1] 339960 0
Changes in psychological distress according to mean scores on the Kessler-10 (K10).
Timepoint [1] 339960 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 11), and at 6-month post-treatment (week 34)
Secondary outcome [2] 339961 0
Changes in in functional impairment and disability according to mean scores on the Work and Social Adjustment Scale (WSAS)
Timepoint [2] 339961 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 11), and at 6-month post-treatment (week 34)
Secondary outcome [3] 339963 0
Changes in mindfulness according to mean scores on the Five-Factor Mindfulness Questionnaire (FFMQ)
Timepoint [3] 339963 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 11), and at 6-month post-treatment (week 34)
Secondary outcome [4] 339964 0
Treatment Satisfaction according to the scores on the Treatment Satisfaction Questionnaire.
Timepoint [4] 339964 0
One week post-treatment (week 11).
Secondary outcome [5] 339965 0
Adherence, according to the number of lessons completed, and the number who complete 100% of the complete 6-lesson program within the 10-week treatment period.
Timepoint [5] 339965 0
Week 11.
Secondary outcome [6] 353157 0
Changes in self compassion according to the Self Compassion scale - short form.
Timepoint [6] 353157 0
Baseline, mid-treatment (before Lesson 4), one-week post-treatment (week 11) and 6-month follow-up (week 34)

Eligibility
Key inclusion criteria
* Self-identified as experiencing depression and/or anxiety.
* Meet criteria for one or more of the following diagnoses: Major Depressive Disprder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), Agoraphobia (AG), or Obsessive-Compulsive Disorder (OCD) according to the ADIS-5 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 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
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 depresison and/or anxiety in the past year
- Current Post traumatic stress disorder (PTSD)
- 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)
Random numbers will be generated by an independent researcher using random.org random number generation. Random allocation numbers will be concealed from the interviewer using opaque sealed envelopes, which will be opened once an offer of treatment is made. Due to the nature of the treatments, allocation cannot be concealed from the participant once they have been allocated to the group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers will be generated by an independent researcher using random.org random number generation. Random allocation numbers will be concealed from the interviewer using opaque sealed envelopes, which will be opened once an offer of treatment is made. Due to the nature of the treatments, allocation cannot be concealed from the participant once they have been allocated to the group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Simple randomisation, parallel Randomised Controlled trial comparing two treatment groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models will be used to analyse the data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/03/2018
Actual
17/04/2018
Date of last participant enrolment
Anticipated
1/02/2019
Actual
1/02/2019
Date of last data collection
Anticipated
18/10/2019
Actual
Sample size
Target
120
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 9216 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 17871 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 17872 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 297805 0
University
Name [1] 297805 0
University of New South Wales
Country [1] 297805 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Mathews building
UNSW Sydney
Kensington Campus
NSW, Australia, 2052
Country
Australia
Secondary sponsor category [1] 296848 0
None
Name [1] 296848 0
N/A
Address [1] 296848 0
N/A
Country [1] 296848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298864 0
University of New South Wales Human Research Ethics Commitee
Ethics committee address [1] 298864 0
Ethics committee country [1] 298864 0
Australia
Date submitted for ethics approval [1] 298864 0
Approval date [1] 298864 0
13/10/2017
Ethics approval number [1] 298864 0
HC17792

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

Contacts
Principal investigator
Name 78478 0
Dr Jill Newby
Address 78478 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 78478 0
Australia
Phone 78478 0
+61293853425
Fax 78478 0
Email 78478 0
j.newby@unsw.edu.au
Contact person for public queries
Name 78479 0
Jill Newby
Address 78479 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 78479 0
Australia
Phone 78479 0
+61403759122
Fax 78479 0
Email 78479 0
j.newby@unsw.edu.au
Contact person for scientific queries
Name 78480 0
Jill Newby
Address 78480 0
Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Country 78480 0
Australia
Phone 78480 0
+61403759122
Fax 78480 0
Email 78480 0
j.newby@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.