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Online Cognitive Behavioural Therapy (CBT) versus mindfulness for depression and anxiety: a randomised controlled trial

A randomised controlled trial to compare the efficacy of online CBT versus mindfulness for reducing symptoms of depression and anxiety in adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001538336
Enrollment
128
Registered
2017-11-06
Start date
2018-04-17
Completion date
2019-02-01
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

This randomised controlled trial seeks to compare the adherence rates and efficacy of internet-delivered cognitive behavioural therapy and internet-delivered mindfulness skills training for the treatment of adult depression and anxiety disorders immediately following treatment and at 6-month follow-up.

Interventions

The internet-delivered Cognitive Behavioural Therapy Program comprises 6 lessons completed over 10 weeks. It comprises psychoeducation about depression and anxeity as well as CBT techniques including thought challenging, behavioural activation, graded exposure and relapse prevention. 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

The internet-delivered Cognitive Behavioural Therapy Program comprises 6 lessons completed over 10 weeks. It comprises psychoeducation about depression and anxeity as well as CBT techniques including thought challenging, behavioural activation, graded exposure and relapse prevention. 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 (10 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

UNSW Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Self-identified as experiencing depression and/or anxiety. * Meet criteria for one or more of the following diagnoses: Major Depressive Disprder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), Agoraphobia (AG), or Obsessive-Compulsive Disorder (OCD) according to the ADIS-5 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 2 months 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 - Current Post traumatic stress disorder (PTSD) - Currently suicidal and/or 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

Source: ANZCTR · Data processed: Feb 4, 2026