Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001099819
Ethics application status
Approved
Date submitted
15/10/2012
Date registered
16/10/2012
Date last updated
3/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open trial of a guided internet-delivered cognitive behavioural therapy intervention to determine the benefits of the Mood Mechanic Course for young adults with symptoms of anxiety and depression
Scientific title
An open trial of guided internet-delivered cognitive behavioural therapy intervention to determine the benefits of the Mood Mechanic Course for adults aged 18-24 with symptoms of anxiety and depression
Secondary ID [1] 281393 0
Nil
Universal Trial Number (UTN)
Trial acronym
MMOT1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 287629 0
Depression 287630 0
Condition category
Condition code
Mental Health 287959 287959 0 0
Anxiety
Mental Health 287960 287960 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this open trial participants will receive access to a 5 week internet-delivered education course, the MoodMechanic Course, which teaches participants how to manage symptoms of anxiety, stress 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 MoodMechanic Course comprises 4 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) written or telephone contact from a therapist at the Macquarie University eCentreClinic.

Study questionnaires will be administered at application, pre-intervention, post-intervention, and at 3-months post-intervention. These will take about 20-30 minutes to complete. Additionally, there will be a brief 5 minute questionnaire at the start of each week of the Course.
Intervention code [1] 285871 0
Treatment: Other
Intervention code [2] 285883 0
Behaviour
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288173 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 288173 0
Administered at pre-intervention, at the beginning of each week of the Course, post-intervention, and at 3-months post-intervention
Primary outcome [2] 288184 0
Symptoms of anxiety are measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [2] 288184 0
Administered at pre-intervention, post-intervention, and at 3-months post-intervention
Secondary outcome [1] 299561 0
Severity of psychological is measured by the Kessler 10-item (K-10)
Timepoint [1] 299561 0
Administered at pre-intervention, post-intervention, and at 3-months post-intervention
Secondary outcome [2] 299562 0
Level of disability is measured by the Sheehan Disability Scale (SDS)
Timepoint [2] 299562 0
Administered at pre-intervention, post-intervention, and at 3-months post-intervention
Secondary outcome [3] 299572 0
Frequency of adaptive behaviours measured by the Things You Do Questionnaire (TYDQ)
Timepoint [3] 299572 0
Administered at pre-intervention, at the beginning of each week of the Course, post-intervention, and at 3-months post-intervention

Eligibility
Key inclusion criteria
1. 18+ years of age
2. GAD-7 score > 4, and/or a PHQ9 score > 4 indicating at least mild symptoms
3. Provides informed consent
4. Resident of Australia
Minimum age
18 Years
Maximum age
24 Years
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. Suicidal intention or plan
4. Receiving CBT for target symptoms at same time as the present trial

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)
Potential participants will self-refer to the Course. Potential participants will be assessed for risk by the eCentreClinic staff, and those at elevated risk will be encouraged to access face to face services (GP or primary physician, or emergency services as necessary). 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 provide Informed Consent and will complete an application which will consist of 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 the eCentreClinic 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
Completed
Date of first participant enrolment
Anticipated
22/10/2012
Actual
2/10/2012
Date of last participant enrolment
Anticipated
Actual
2/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286147 0
Charities/Societies/Foundations
Name [1] 286147 0
beyondblue: the national depression initiative
Country [1] 286147 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] 284956 0
None
Name [1] 284956 0
Address [1] 284956 0
Country [1] 284956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288203 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 288203 0
Ethics committee country [1] 288203 0
Australia
Date submitted for ethics approval [1] 288203 0
Approval date [1] 288203 0
07/08/2012
Ethics approval number [1] 288203 0
5201200461

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

Contacts
Principal investigator
Name 34829 0
Prof Nick Titov
Address 34829 0
Department of Psychology
Macquarie University
NSW 2109
Country 34829 0
Australia
Phone 34829 0
61 2 9850 9901
Fax 34829 0
Email 34829 0
[email protected]
Contact person for public queries
Name 18076 0
Associate Professor Nickolai Titov
Address 18076 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 18076 0
Australia
Phone 18076 0
+61298509901
Fax 18076 0
Email 18076 0
[email protected]
Contact person for scientific queries
Name 9004 0
Associate Professor Nickolai Titov
Address 9004 0
C3A 724
Macquarie University
North Ryde
NSW 2109
Country 9004 0
Australia
Phone 9004 0
+61298509901
Fax 9004 0
Email 9004 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.