None listed
Conditions
Brief summary
This project aims to compare the efficacy, acceptability and feasibility of three internet-delivered programs for adults with depression and/or anxiety symptoms: an internet-delivered cognitive behavioural therapy program versus an internet-delivered mindfulness-enhanced cognitive behavioural therapy program versus mindfulness skills training program, compared to usual care. Up to 200 people with elevated symptoms of depression and/or anxiety will be randomly assigned to one of the three treatment groups or the treatment as usual control group (TAU). All groups will commence their intervention immediately, except for the TAU group who will receive the mindfulness-enhanced iCBT program after the 14 week waiting period. The efficacy of the three programs will be compared at post-treatment (immediately after the treatment period finishes) and 3-month follow-up by comparing their symptoms of depression, anxiety and distress.
Interventions
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
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.
Sponsors
St Vincent's Hospital Sydney
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
* 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.
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.
Outcome results
None listed