Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000212853
Ethics application status
Approved
Date submitted
20/02/2012
Date registered
20/02/2012
Date last updated
3/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial (RCT) of brief internet-delivered education about managing symptoms of anxiety and depression in tertiary students
Scientific title
A randomised controlled trial (RCT) of brief internet-delivered education comparing immediate education vs. delayed education on symptoms of anxiety and depression in tertiary students
Secondary ID [1] 279968 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 285884 0
anxiety 285885 0
depression 285886 0
Condition category
Condition code
Mental Health 286075 286075 0 0
Anxiety
Mental Health 286076 286076 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this trial Macquarie University students (participants) will receive access to a 6 week internet-delivered education course. Participants will be directed to read 3 online lessons about management of symptoms of stress, anxiety, low mood, and depression. One lesson will be completed every 7 to 14 days. Each lesson will take about 15 minutes to read. Participants will also have access to summaries and homework assignment for each lesson, and will read anonymous stories about students with similar symptoms, taking a further 20 minutes per week. All participants will also receive automatic emails and brief weekly (<10minutes week) supportive telephone calls from an intern Psychologist.

Study questionnaires will be administered at application, pre-education, post-education, and at 3-months post-treatment. These will take about 20-30 minutes to complete. The treatment materials include cognitive behavioural treatment (CBT) skills.
Intervention code [1] 284306 0
Behaviour
Comparator / control treatment
The delayed waitlist control group (beginning the course 6 weeks after the immediate education group beings). This is a wait-list control group.
Control group
Active

Outcomes
Primary outcome [1] 286556 0
Symptoms and severity of low mood/depression are measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 286556 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education
Primary outcome [2] 286557 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [2] 286557 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education
Secondary outcome [1] 296154 0
Health status is measured by the European Quality of Life-5 Dimensions- 5 Level (EQ-5D-5L)
Timepoint [1] 296154 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education
Secondary outcome [2] 296155 0
Psychological distress is measured by the Kessler-10 Item (K-10)
Timepoint [2] 296155 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education
Secondary outcome [3] 296156 0
Disability is measured by the Sheehan Disability Scales (SDS)
Timepoint [3] 296156 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education
Secondary outcome [4] 296157 0
Positive adaptive behaviours are measured by the Things You Do Questionnaire (TYD)
Timepoint [4] 296157 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education
Secondary outcome [5] 296158 0
Working alliance is measured by the Working Alliance Inventory (WAI)
Timepoint [5] 296158 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education
Secondary outcome [6] 296159 0
Self-efficacy is measured by the New General Self Efficacy Scale (NGSE)
Timepoint [6] 296159 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education
Secondary outcome [7] 296160 0
Wellbeing and scholastic engagement are measured by the Macquarie University Student Wellbeing Questionnaire
Timepoint [7] 296160 0
Administered at pre-education, prior to each Lesson in the course, post-education, and at 3-months post-education

Eligibility
Key inclusion criteria
1. Macquarie University student
2. Aged 18+ years
3. Self-identified difficulties managing stress, anxiety, low mood, or depression
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe depression (total score > 22 on the PHQ-9)
2. Suicidal intent or plan
3. Presenting problem not stress, anxiety, low mood, or depression

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online, and those who meet inclusion criteria are administered a telephone interview to identify psychiatric diagnoses using the Mini Neuropsychiatric Interview Schedule (MINI 5.0.0). Participants are then randomly allocated to one of the two groups. Allocation concealment will occur by providing allocation details for each successive participant in a sealed envelope, which recruitment staff are required to open serially.
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 via a software program (www.random.org), at another site, in another country. The list will then be transcribed and details transferred to sealed envelopes.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/02/2012
Actual
20/02/2012
Date of last participant enrolment
Anticipated
Actual
30/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284736 0
University
Name [1] 284736 0
Macquarie University
Country [1] 284736 0
Australia
Primary sponsor type
University
Name
Centre for Emotional Health, Department of Psychology, Macquarie University
Address
Department of Psychology
Building C3A
Balaclava Road, North Ryde
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 283632 0
University
Name [1] 283632 0
Student Counselling Service, Macquarie University
Address [1] 283632 0
Macquarie University
Balaclava Road, North Ryde
NSW 2109
Country [1] 283632 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286745 0
Human Research Ethics Committee
Ethics committee address [1] 286745 0
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Ethics committee country [1] 286745 0
Australia
Date submitted for ethics approval [1] 286745 0
Approval date [1] 286745 0
28/11/2011
Ethics approval number [1] 286745 0
5201100795

Summary
Brief summary
The purpose of this project is to explore the efficacy of a clinician-guided education course for symptoms of anxiety and depression in tertiary students (aged 18+), administered over the internet in a randomised controlled trial. A secondary purpose is to determine the acceptability of the education protocol and materials to tertiary students with symptoms of anxiety and depression. A tertiary purpose of this project is to explore the efficacy of a self-guided version of the course, with participants from the Waitlist Control Group.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske M, McEvoy P. (2011). Transdiagnostic Internet treatment of anxiety and depression: A randomised controlled trial. Behaviour Research and Therapy, 49; 441-452.

Dear, B. F., Titov, N., Schwencke, G., Andrews, G., Johnston, L., Craske, M. G., & McEvoy, P. (2011). An open trial of a brief transdiagnostic treatment for anxiety and depression. Behaviour Research and Therapy, 49, 830-837.

Mullin, A., Dear, B. F., Karin, E., Wootton, B. W., Johnston, L., Staples, L. G., Gandy, M., Fogliati, V., & Titov, N. (2015). The UniWellbeing Course: Examining a transdiagnostic internet-delivered cognitive behavioural therapy (CBT) program for university students with anxiety and depression. Internet Interventions, 2, 128-136.
Public notes

Contacts
Principal investigator
Name 33799 0
A/Prof Nickolai Titov
Address 33799 0
Centre for Emotional Health Department of Psychology, C3A 724 Balaclava Road, North Ryde Macquarie University NSW 2109
Country 33799 0
Australia
Phone 33799 0
+61 2 98509901
Fax 33799 0
Email 33799 0
nick.titov@mq.edu.au
Contact person for public queries
Name 17046 0
A/Prof Associate Professor Nickolai Titov
Address 17046 0
Centre for Emotional Health
Department of Psychology, C3A 724
Balaclava Road, North Ryde
Macquarie University NSW 2109
Country 17046 0
Australia
Phone 17046 0
+61 (2) 9850 9901
Fax 17046 0
+61 (2) 9850 8062
Email 17046 0
nick.titov@mq.edu.au
Contact person for scientific queries
Name 7974 0
A/Prof Associate Professor Nickolai Titov
Address 7974 0
Centre for Emotional Health
Department of Psychology, C3A 724
Balaclava Road, North Ryde
Macquarie University NSW 2109
Country 7974 0
Australia
Phone 7974 0
+61 (2) 9850 9901
Fax 7974 0
+61 (2) 9850 8062
Email 7974 0
nick.titov@mq.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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