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.
- Conditions
- Generalised Anxiety DisorderMajor Depressive DisorderPanic Disorder with or without AgoraphobiaSocial Anxiety DisorderAnxiety Disorder not Otherwise SpecifiedObsessive Compulsive DisorderMental Health - AnxietyMental Health - Depression
- Registration Number
- ACTRN12615000927527
- Lead Sponsor
- St Vincent's Hospital Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
* 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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in depression symptoms (according to mean scores on the Patient Health Questionnaire (PHQ-9) [Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)];Changes in anxiety symptoms according to mean scores on the Generalised Anxiety Disorder 7-item scale (GAD-7).[Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)];Changes in well-being according to mean scores on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)[Baseline, mid-treatment (before lesson 4), one week post-treatment (14 weeks), and at 3-month post-treatment (week 26)]
- Secondary Outcome Measures
Name Time Method