None listed
Conditions
Brief summary
The aims of the current study are to evaluate the efficacy of a validated internet-based cognitive behavioural therapy (iCBT) program (CRUfAD's Sadness Program) for depression when delivered to individuals who meet criteria for a major depressive episode comorbid with osteoarthritis (OA). This study will recruit 100 people with depression and OA and randomly allocate them to 1 of 2 conditions: OA treatment as usual (TAU) + iCBT for depression or OA TAU + delayed iCBT for depression (TAU waitlist control). The primary outcomes will be to determine the impact of online CBT for MDD on depression symptoms and remission rates, as well as on OA-specific outcomes. We will also measure adherence to the course material and satisfaction with the intervention generally.
Interventions
All intervention participants will separately complete 6 lessons of Internet based cognitive behavioural therapy (iCBT) about the management of symptoms of depression over 10 weeks. 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. Participants will have access to summaries of each lesson, homework exercises, extra resources, email contact from the Clinician (Registered 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 contact with the participant either by phone or email is initiated. 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 practising skills.
Sponsors
St Vincent's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of current Major Depressive Disorder (MDD) based on the Mini International Neuropsychiatric Interview Version 5.0.0. Diagnosis of symptomatic Osteoarthritis based upon radiographic criteria and pain on most days. The recruitment pathway ensures all potential participants (i.e., those who are informed about the study) meet this eligibility criterion. Age 50+ Prepared to provide name, phone number and address, and to provide the name and address of a local general practitioner, and to provide informed consent. English language skills equivalent to a School Certificate level. Have access to a phone and a computer with regular Internet access and a printer.
Exclusion criteria
Severe depression (PHQ-9 >23) and/ or current suicidality (PHQ-9 Q9=2 or 3). If taking medication for anxiety or depression, has been taking the same dose for less than 1 month or intended to change the dose during the course of the program. Currently receiving CBT for depression or completed an iCBT or CBT program for depression in the past 6 months or intention to commence CBT for depression. Psychosis, bipolar disorder, substance abuse or dependence. Taking antipsychotics or benzodiazepines.
Outcome results
None listed