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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.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000502730
Enrollment
270
Registered
2013-05-07
Start date
2013-05-22
Completion date
2015-02-26
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many people with depression do not access treatment. Internet-based therapies are proven in efficacy and effectiveness. Bibliotherapy may provide an easier way to deliver self-guided treatment, but efficacy is rarely established. A trial comparing internet CBT, CBT via a self help book, and meditation via a self help book has not been performed to our knowledge. This research will allow the community to make a more informed choice about what form of readily available treatment to choose from for depression.

Interventions

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 base

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.

Sponsors

St Vincent's Hospital, Sydney
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026