Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000955819
Ethics application status
Approved
Date submitted
2/09/2012
Date registered
6/09/2012
Date last updated
1/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to determine the benefits of the UniWellbeing Course for consumers of Macquarie University Campus Wellbeing with symptoms of anxiety or low mood
Scientific title
An open trial of guided internet-delivered cognitive behavioural therapy education to determine the benefits of the UniWellbeing Course for consumers of Macquarie University Campus Wellbeing with symptoms of anxiety or low mood
Secondary ID [1] 281133 0
Nil
Universal Trial Number (UTN)
Trial acronym
MUCW Open Trial 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 287302 0
Depression 287303 0
Condition category
Condition code
Mental Health 287633 287633 0 0
Anxiety
Mental Health 287634 287634 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this open trial participants will receive access to an 8 week internet-delivered education course, the UniWellbeing Course, which teaches participants how to manage symptoms of anxiety and low mood. All participants will have at least mild symptoms of anxiety or low mood (GAD-7 total score of >4 or PHQ-9 total score of >4).

The UniWellbeing Course comprises 5 online lessons, which describe evidence-based cognitive behavioural and interpersonal therapy strategies for managing cognitive, behavioural, and physical symptoms of anxiety and low mood. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to read. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with anxiety and low mood, taking a further 20 minutes per week. All participants will also receive 10-20 automatic emails to promote adherence and engagement, and brief weekly (<10minutes week) supportive telephone calls from a therapist at the Macquarie University Campus Wellbeing Service.

Study questionnaires will be administered at application, pre-intervention, post-intervention, and at 2-months post-intervention. These will take about 20-30 minutes to complete.
Intervention code [1] 285590 0
Treatment: Other
Intervention code [2] 285628 0
Behaviour
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287884 0
Symptoms of anxiety are measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7).
Timepoint [1] 287884 0
Administered at pre-intervention, prior to each Lesson in the course, post-intervention, and at 2-months post-intervention
Primary outcome [2] 287885 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [2] 287885 0
Administered at pre-intervention, prior to each Lesson in the course, post-intervention, and at 2-months post-intervention
Secondary outcome [1] 298982 0
Symptoms of psychological distress are measured by the Kessler-10 Item (K-10)
Timepoint [1] 298982 0
Administered at pre-intervention, post-intervention, and at 2-months post-intervention
Secondary outcome [2] 298983 0
Frequency of adaptive behaviours are measured by the Things You Do Questionnaire (TYDQ)
Timepoint [2] 298983 0
Administered at pre-intervention, post-intervention, and at 2-months post-intervention
Secondary outcome [3] 298984 0
Disability is measured by the Sheehan Disability Scale (SDS)
Timepoint [3] 298984 0
Administered at pre-intervention, post-intervention, and at 2-months post-intervention

Eligibility
Key inclusion criteria
1. Macquarie University student
2. 18+ years of age
3. GAD-7 score > 4, and/or a PHQ9 score > 4 indicating at least mild symptoms
4. Provides informed consent
5. MQCW Counselling Team Risk Guidelines clinical indicators rated None, Mild or Moderate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe depression (score of 23 or greater on PHQ-9)
2. Presenting problem not anxiety or depression
3. MQCW Counselling Team Guidelines clinical indicators rated Severe or Extremely Severe

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from students attending the triage service at MQCW over a 2 month period from September 2012. As part of that service, students are interviewed by trained and supervised MQCW staff. Students will be assessed for risk by the MQCW staff, and those at elevated risk will be referred for immediate treatment or referral. Those who do not require urgent intervention and who report symptoms of stress, anxiety, or low mood will be informed about the aims of this study, and invited to apply. Those interested will completed Informed Consent procedures and will be given access to a computer by the MQCW staff to complete a brief, online registration process and will create a user-id for the online UniWellbeing Course. This online registration process involves completing questionnaires of symptoms of depression and anxiety, the Patient Health Questionnaire-9 Item and Generalised Anxiety Disorder-7 item questionnaires, respectively. Applicants with scores too low or too high on these questionnaires will not be eligible but will be referred to other services by MQCW staff, while eligible applicants will be asked to provide demographic details. Participants who meet eligibility criteria will be given access codes to begin the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
8/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285914 0
University
Name [1] 285914 0
eCentreClinic, Centre for Emotional Health, Department of Psychology, Macquarie University
Country [1] 285914 0
Australia
Primary sponsor type
University
Name
eCentreClinic, Centre for Emotional Health, Department of Psychology, Macquarie University
Address
C3A 724
Macquarie University
North Ryde
NSW 2109
Country
Australia
Secondary sponsor category [1] 284735 0
University
Name [1] 284735 0
Macquarie University Campus Wellbeing
Address [1] 284735 0
Macquarie University
North Ryde
NSW 2109
Country [1] 284735 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287943 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 287943 0
Ethics committee country [1] 287943 0
Australia
Date submitted for ethics approval [1] 287943 0
Approval date [1] 287943 0
31/08/2012
Ethics approval number [1] 287943 0
5201200348

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34647 0
A/Prof Nickolai Titov
Address 34647 0
C3A 724 Macquarie University North Ryde NSW 2109
Country 34647 0
Australia
Phone 34647 0
+61 2 98509901
Fax 34647 0
Email 34647 0
[email protected]
Contact person for public queries
Name 17894 0
Nickolai Titov
Address 17894 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 17894 0
Australia
Phone 17894 0
+61298509901
Fax 17894 0
Email 17894 0
[email protected]
Contact person for scientific queries
Name 8822 0
Nickolai Titov
Address 8822 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 8822 0
Australia
Phone 8822 0
+61298509901
Fax 8822 0
Email 8822 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.