None listed
Conditions
Brief summary
The project aims to explore the efficacy, acceptability and feasibility of an internet-delivered mindfulness-enhanced cognitive behavioural therapy (MEiCBT) program for depression and anxiety. Up to 30 people with elevated depression and/or anxiety will be assigned to the active treatment group. The treatment group will commence the Mindfulness-Based Program for Depression and Anxiety immediately. The efficacy of the program will be determined by comparing the depression and/or anxiety symptom levels before and after treatment, and at 3 month follow-up.
Interventions
The internet-delivered Mindfulness-Based Program comprises 7 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 released every 7 days (it will become available after the preceding lesson has been completed,
The internet-delivered Mindfulness-Based Program comprises 7 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 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 (14 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.
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
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 Disprder (MDD), Generalized Anxiety Disorder (GAD), Social Phobia (SP), Panic Disorder (PD), Agoraphobia (AG), or Obsessive-Compulsive Disorder (OCD) according to the Mini International Neuropsychiatric Interview Version 5.0.0 (MINI) * 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.
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 - 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.
Outcome results
None listed