Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000502730
Ethics application status
Approved
Date submitted
26/04/2013
Date registered
7/05/2013
Date last updated
23/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing Internet based cognitive behavioural therapy (CBT) versus a cognitive behavioural therapy (CBT) self help book versus a meditation self help book versus a waitlist control condition for adults with depression on severity of symptoms and depression.
Scientific title
A randomised controlled trial comparing an Internet based Cognitive Behavioural Therapy (CBT) treatment versus a Cognitive Behavioural Therapy (CBT) self help book versus a meditation self help book versus a waitlist control condition for Adults with Depression on severity of symptoms of depression.
Secondary ID [1] 282400 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 288981 0
Condition category
Condition code
Mental Health 289323 289323 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of four groups: 1) Treatment with clinician-assisted Internet based Cognitive Behavioural Therapy (iCBT) for depression, 2) CBT self help book for depression, 3) Meditation self help book, or 4) Waitlist control (treatment as usual). All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for Major depressive disorder.

All group 1 participants will separately complete 6 lessons of Internet based treatment about the management of symptoms of depression. One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 7 days between lessons and a maximum of 14 days). Each lesson will take about 15 minutes to complete. Group 1 participants will have access to summaries of each lesson, homework exercises, extra resources, weekly reminder emails, and one-on-one contact with the Clinician (Clinical Psychologist) by telephone or email in the first 2 weeks, then as required. We’ve found that people who get the most out of our programs spend about 3-4 hours a week completing the homework tasks and applying the new skills they’re learning on a daily basis. The treatment materials are based on cognitive behavioural techniques.

The CBT self help book group (Group 2) will have 12 chapters to read over the 12 week period. This leading Australian book designed to help people with depression and will be given free to the people in this group. They will be asked to work through each of the 12 chapters over the given time. The book is self-guiding in describing specialised ways of looking at your thoughts and what you do when you’re feeling low. The 12 chapters are arranged in an organised manner beginning with Understanding Depression and working through multiple topics including Our Thinking Habits and Looking After Your Needs. We recommend approximately 1 hour per week reading the chapters (total approximately 12 hours). There are various activities for participants to complete throughout the book, varying from Chapter to Chapter. We recommend participants spend 3-4 hours a week completing the homework tasks and applying the new skills they’re learning on a daily basis.

The Meditation self help book group (Group 3) will have 7 sections (including 13 chapters) to read over the 12 week period. This leading Australian book designed to help people improve their mental health will be given free to the people in this group. They will be asked to work through each of the 13 chapters over the given time. The book is self-guiding in describing an approach to meditation called mental silence. The chapters are arranged in an organised manner, working through multiple topics including How to Meditate: How to begin and Stress – the noise in the mind. We recommend approximately 1 hour per week reading the chapters (total approximately 12 hours). There are various activities for participants to complete throughout the book, varying from chapter to chapter. We recommend participants spend 3-4 hours a week applying the new skills they’re learning on a daily basis.

The duration of the program is 12 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-treatment, mid-treatment, post-treatment, at 3 months post-treatment, and the K10 pre-each lesson for those in group 1 (iCBT group). These will take about 20 minutes to complete.

Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: Group 1 - receive automated email reminders, monitor downloading of homework, collect data on how long participants spent reading lessons and practising skills; Groups 2, 3 receive mid term email reminders, collect data on how long participants spent reading the books and practising new skills.
Intervention code [1] 287032 0
Treatment: Other
Intervention code [2] 287033 0
Behaviour
Comparator / control treatment
Waitlist control group (receiving treatment as usual). These participants remain on the waitlist until the treatment groups have completed their treatment (12 weeks). At that time (12 weeks) the waitlist group will be offered the choice of whichever treatment they would like after being advised which mode appears to be better. The person will be given free access to either the CBT book, the meditation book, or the computer course.
Control group
Active

Outcomes
Primary outcome [1] 289433 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 289433 0
Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [1] 302464 0
Psychological distress is measured by the Kessler-10 (K-10).
Timepoint [1] 302464 0
Administered at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment. Also administered pre each lesson for group 1 (iCBT).
Secondary outcome [2] 302465 0
Generalised Anxiety Disorder is measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire.
Timepoint [2] 302465 0
Administered at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [3] 302466 0
Rumination is measured with the RTQ: The Repetitive Thinking Questionnaire - 10 items
Timepoint [3] 302466 0
Administered at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [4] 302467 0
Rumination is also measured by the Beliefs about Thinking Scale 18 item
Timepoint [4] 302467 0
Administered at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [5] 302468 0
Distress Tolerance is measure by the DTS - Distress Tolerance Scale
Timepoint [5] 302468 0
Administered at pre-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [6] 302469 0
Service use and days out of role are measure by the SUDOR questionnaire.
Timepoint [6] 302469 0
Administered at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [7] 302470 0
Credibility/Expectancy Questionnaire (CEQ)
Timepoint [7] 302470 0
Administered at pre-treatment and post-treatment.

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of the American Psychiatric Association-4th Edition (DSM-IV) criteria for Major Depressive Disorder, Internet access + printer access, Australian citizen.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current substance abuse/dependence, Psychotic mental illness (Bipolar or Schizophrenia), change of psychological treatment in last month, change in medications during last 1 month, use of Benzodiazepines, Suicidal.

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)
The sealed opaque envelope (described in the next section) will be taken at the beginning of the phone call and opened after the informed consent is received and after the patient meets criteria on the MINI diagnostic interview completed by the research staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization to four groups will be generated by www.random.org and each choice will be placed in a sealed opaque envelope by staff not involved in the research 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
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: 100 subjects in each cell had an 80% chance or showing a significance p< 0.5 if the difference between the iCBT and the books was greater than 0.4 SD or the difference between the books and waitlist control (treatment as usual) was greater than 0.4 SD.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2013
Actual
22/05/2013
Date of last participant enrolment
Anticipated
31/05/2015
Actual
26/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 954 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 287174 0
Hospital
Name [1] 287174 0
St Vincent's Hospital, Sydney
Country [1] 287174 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 285939 0
None
Name [1] 285939 0
Address [1] 285939 0
Country [1] 285939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289170 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 289170 0
Ethics committee country [1] 289170 0
Australia
Date submitted for ethics approval [1] 289170 0
Approval date [1] 289170 0
16/04/2013
Ethics approval number [1] 289170 0
HREC/13/SVH/29

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

Contacts
Principal investigator
Name 39574 0
Prof Gavin Andrews
Address 39574 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 39574 0
Australia
Phone 39574 0
+612 8382 1400
Fax 39574 0
+612 8382 1401
Email 39574 0
[email protected]
Contact person for public queries
Name 39575 0
Gavin Andrews
Address 39575 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 39575 0
Australia
Phone 39575 0
+612 8382 1400
Fax 39575 0
+612 8382 1401
Email 39575 0
[email protected]
Contact person for scientific queries
Name 39576 0
Gavin Andrews
Address 39576 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 39576 0
Australia
Phone 39576 0
+612 8382 1400
Fax 39576 0
+612 8382 1401
Email 39576 0
[email protected]

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
EmbaseHelp from home for depression: A randomised controlled trial comparing internet-delivered cognitive behaviour therapy with bibliotherapy for depression.2017https://dx.doi.org/10.1016/j.invent.2017.05.001
N.B. These documents automatically identified may not have been verified by the study sponsor.