The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001198718
Ethics application status
Approved
Date submitted
28/10/2013
Date registered
30/10/2013
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Online treatment for depression in people with diabetes: a randomised controlled trial
Scientific title
A randomised controlled trial comparing Internet based cognitive behaviour therapy (iCBT) for depression in patients with Type 1 and Type 2 diabetes versus treatment as usual on depression symptoms.
Secondary ID [1] 283466 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 290380 0
Type 1 Diabetes 290403 0
Type 2 Diabetes 290404 0
Condition category
Condition code
Mental Health 290770 290770 0 0
Depression
Metabolic and Endocrine 290795 290795 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 or Psychiatrist) 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 practicing skills.

For all study participants, their diabetes treatment will not change and will continue as usual. For example, they will continue to receive regular monitoring from the appropriate Diabetes service and medication management for their diabetes.
Intervention code [1] 288174 0
Behaviour
Comparator / control treatment
Treatment as usual (TAU) waitlist control group. These participants remain on the waitlist and receive their usual treatment for diabetes until the immediate treatment group has completed their treatment and post-treatment assessment (11 weeks). At that time (11 weeks) the waitlist control group will be offered the same iCBT program for depression.

For all study participants, their diabetes treatment will not change and will continue as usual ('treatment as usual". For example, as part of usual treatment, participants will continue to receive regular monitoring from the appropriate Diabetes service and medication management for their diabetes.
Control group
Active

Outcomes
Primary outcome [1] 290766 0
Reductions in the Patient Health Questionnaire – 9-Item (PHQ-9)
Timepoint [1] 290766 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Primary outcome [2] 290768 0
Reductions in diabetes distress according to the Problem Areas in Diabetes (PAID) Questionnaire.
Timepoint [2] 290768 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Primary outcome [3] 290769 0
Baseline, 1 week post-treatment (week 11), 3 months after post-treatment (week 24), and 6 months after treatment (week 36).
Timepoint [3] 290769 0
Baseline, 1 week post-treatment (week 11), 3 months after post-treatment (week 24), and 6 months after treatment (week 36).
Secondary outcome [1] 305237 0
Reductions in the Generalized Anxiety Disorder 7-Item (GAD-7)
Timepoint [1] 305237 0
Baseline, 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Secondary outcome [2] 305238 0
Reductions in the SF-12 – a 12 item validated measure of functional health and wellbeing.
Timepoint [2] 305238 0
Baseline, 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Secondary outcome [3] 305239 0
Treatment Credibility/Expectancy Questionnaire (CEQ).
Timepoint [3] 305239 0
Measured at baseline.
Secondary outcome [4] 305240 0
Reductions in psychological distress according to the Kessler-10 (K10).
Timepoint [4] 305240 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Secondary outcome [5] 305241 0
Reductions in symptoms of alcohol abuse, according to the Patient Health Questionnaire alcohol module (PHQ-Alcohol).
Timepoint [5] 305241 0
Baseline, 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Secondary outcome [6] 305242 0
Reductions in symptoms of eating disorders, according to the Patient Health Questionnaire eating disorder module (PHQ-Eating).
Timepoint [6] 305242 0
Baseline, 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Secondary outcome [7] 305243 0
Reduction in somatic (physical) symptoms, according to the Patient Health Questionnaire somatic symptom module (PHQ-15).
Timepoint [7] 305243 0
Baseline, 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Secondary outcome [8] 305244 0
Improvements in Self-Rated Health according to the Self-Rated Health scale.
Timepoint [8] 305244 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24), and 6 months after treatment (week 36).
Secondary outcome [9] 305245 0
The Relationships Questionnaire - a brief validated measure of attachment styles.
Timepoint [9] 305245 0
Measured at baseline
Secondary outcome [10] 305246 0
Improvements in lifestyle factors and active behaviours such as physical exercise, as measured by the Fantastic Checklist.
Timepoint [10] 305246 0
Baseline, 1 week post-treatment (week 11), 3 months after post-treatment (week 24).

Eligibility
Key inclusion criteria
Diagnosis of current Major Depressive Disorder (MDD) based on the Mini International Neuropsychiatric Interview Version 5.0.0.

Diagnosis of Type 1 or Type 2 diabetes according to participant self-report. The recruitment pathway ensures all potential participants (i.e., those who are informed about the study) meet this eligibility criterion.


Age 18+

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If taking medication for anxiety or depression, has been taking the same dose for less than 2 months 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online, followed by a telephone interview to confirm diagnosis via the Mini-International Neuropsychiatric Interview (MINI), a structured clinical interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study. Allocation concealment will occur in the following way: A staff member not involved in the clinical trial will generate the sequence using computer software and place each choice in a sequentially numbered, opaque sealed and stapled envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous results, we anticipate the iCBT group to improve more than the TAU Control group by an ES of 0.8.

Assuming a more conservative ES of .60 for the secondary functional outcome measures we will recruit 50 participants in each group (allowing for at least 20% potential attrition). Sample size is powered to have an 80% chance of detecting differences at p less than or equal to .05.

Analyses will be undertaken using mixed-model repeated measures (MMRM) ANOVA with measurement occasion as a within-groups factor and intervention as a between-groups factor. Relationships between observations at different occasions will be modelled with an unstructured covariance
matrix. For each experimental group, planned contrasts will be used to compare changes from baseline to post-intervention and 3- month follow-up and 6-month follow-up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288172 0
Hospital
Name [1] 288172 0
St Vincent's Hospital, Sydney
Address [1] 288172 0
390 Victoria St
Darlinghurst NSW 2010
Australia
Country [1] 288172 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Australia
Country
Australia
Secondary sponsor category [1] 286895 0
Individual
Name [1] 286895 0
Professor Kay Wilhelm
Address [1] 286895 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country [1] 286895 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290085 0
St Vincent's Hospital HREC
Ethics committee address [1] 290085 0
St Vincent's Hospital
390 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 290085 0
Australia
Date submitted for ethics approval [1] 290085 0
Approval date [1] 290085 0
25/10/2013
Ethics approval number [1] 290085 0
HREC/13/SVH/291

Summary
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 Type 1 or Type 2 diabetes.

This study will recruit 100 people with depression and diabetes and randomly allocate them to 1 of 2 conditions: Diabetes treatment as usual (TAU) + iCBT for depression or Diabetes 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 diabetes-specific outcomes.

We will also measure adherence to the course material and satisfaction with the intervention generally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43890 0
Prof Kay Wilhelm
Address 43890 0
Clinical Research Unit for Anxiety and Depression 390 Victoria St Darlinghurst NSW 2010
Country 43890 0
Australia
Phone 43890 0
+612 8382 1402
Fax 43890 0
Email 43890 0
kwilhelm@stvincents.com.au
Contact person for public queries
Name 43891 0
Dr Jill Newby
Address 43891 0
CRUfAD
Level 4 O'Brien Centre
St Vincent's Hospital
390 Victoria Street Darlinghurst, NSW 2010

Country 43891 0
Australia
Phone 43891 0
+612 8382 1433
Fax 43891 0
Email 43891 0
j.newby@unsw.edu.au
Contact person for scientific queries
Name 43892 0
Dr Jill Newby
Address 43892 0
CRUfAD
Level 4 O'Brien Centre
St Vincent's Hospital
390 Victoria Street Darlinghurst, NSW 2010
Country 43892 0
Australia
Phone 43892 0
+612 8382 1433
Fax 43892 0
Email 43892 0
j.newby@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary