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Trial registered on ANZCTR


Registration number
ACTRN12611001257954
Ethics application status
Approved
Date submitted
1/12/2011
Date registered
7/12/2011
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile Therapy: Get Happy Program Trial- A Randomized Control Study
Scientific title
Randomized Control Trial of a Cognitive Behaviour Therapy Program Using a Mobile App for Adults with Depression
Secondary ID [1] 273513 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 279310 0
Condition category
Condition code
Mental Health 279502 279502 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive access to the Get Happy program, a mCBT (mobile Cognitive Behaviour Therapy) program. This mCBT program is based on the iCBT program with demonstrated efficacy at reducing symptoms of depression (Perini, Titov & Andrews, 2008; Perini, Titov & Andrews, 2009). The mCBT Get Happy program consists of six lessons and summaries. The homework assignments are emailed to the participant to enable printing.

The six lessons represent best practice principles used in CBT for depression including behavioural activation, cognitive restructuring, problem solving, and assertiveness skills. Part of the content of each lesson is presented in the form of an illustrated story about a woman with depression who, with the help of a clinical psychologist, learns to gain mastery over her symptoms. As participants progress through each lesson they have access to additional written documents providing supplementary information about techniques such as managing sleep problems, panic, and other common comorbid symptoms. The participants are also provided with access to vignettes written by previous participants about their own experiences in managing depressing during the Get Happy program. Participants are also expected to complete the homework tasks prior to completing the next lesson.

All participants will begin the 8-week treatment program at the same time. Participants will be advised to complete one lesson every 7-10 days and to complete the six lessons within 8 weeks of starting. All participants will be able to receive automatic emails and/or SMS, depending on their preferred mode of contact, congratulating them for lesson completion. Automatic emails and SMS can also be sent to participants informing them when a lesson is to be completed and reminding about homework. Reminder emails and SMS will also be sent if they have not completed the next lesson within 7 days of notification. There will be a minimum of 5 days between when each lesson can become available.

Participants will have one-on-one contact with the Clinician (Clinical Psychologist) by telephone or email in the first 2 weeks, then as required. The clinician will use a script as a guideline, which identifies the topics covered. After the participants have finished the program, all participants will complete a second set of diagnostic questionnaires.
Intervention code [1] 283826 0
Treatment: Other
Intervention code [2] 283828 0
Behaviour
Comparator / control treatment
Both groups will be offered the same treatment at the same time. However, one group will have access via a mobile or tablet, and the second group will have access via a computer.
Control group
Active

Outcomes
Primary outcome [1] 286066 0
Patient Health Questionnaire-9 (PHQ-9) is a 9 item depression scale.
Timepoint [1] 286066 0
PHQ- 9= At baseline, (midpoint) before lesson 4, 1 week after lesson 6 and follow up is conducted 3 months post.
Primary outcome [2] 286069 0
Beck's Depression Inventory (BDI) II assessment of Depression.
Timepoint [2] 286069 0
BDI II = At baseline, 1 week after lesson 6 and follow up is conducted 3 months post.
Secondary outcome [1] 295064 0
Kessler Psychological Distress Scale 10 Item (K-10), a measure of pscyhological distress.
Timepoint [1] 295064 0
K-10= At baseline, (midpoint) before lesson 4, 1 week after lesson 6 and follow up is conducted 3 months post.
Secondary outcome [2] 295066 0
The World Health Organization Short Disability Assessment Scale (WHODASS -II ) is a tool for the assessment of disabilities in selected areas of functioning for people with mental disorders.
Timepoint [2] 295066 0
WHODASS -II = At baseline,1 week after lesson 6 and follow up is conducted 3 months post.

Eligibility
Key inclusion criteria
Self identified as suffering from depression and have questionnaire scores and results of telephone diagnostic interview consistent with this.
Have access to the internet and a computer with a printer
Participants must have unrestricted access to a Smartphone/ Ipad that uses an Android or iOS.

No history of psychosis or current alcohol and drug dependence

Not currently suicidal
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No regular access to a smartphone/Ipad, to a computer, the Internet, and use of a printer.
Using illicit drugs or consuming more than three standard drinks/day.
History or experience of a psychotic mental illness (schizophrenia or bipolar disorder) or current severe symptoms of depressions (defined as a total score >23 or responding >2 to Question 9 (suicidal ideation) on the Patient Health Questionnaire- 9 item (PHQ-9).
Applicant is taking medication, and has been taking the same dose for less than 1 month or is intending to change that dose during the course of the program.

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)
Applicants will be recruited via our website (www.virtualclinic.org.au) providing information about common mental disorders including depression, and a link to apply online to join a research treatment program. Applicants will first apply online, completing questionnaires about severity of symptoms, demographic details, and chronicity of symptoms. Those scoring 5-19 on the PHQ-9 scale will be invited to proceed. Those scoring lower will be advised via email that their symptoms are below the threshold we are interested in and that they should read the self help material on www.crufad.org. Those scoring higher than 19 on the scale will be advised via email that their condition is unlikely to respond to the mobile therapy; and that they should seek the help of a local clinician. Those scoring PHQ9 Q9=2 and who have a history of a prior suicide attempt and those scoring PHQ9 Q9=3 will also be advised to consult a local clinician. Those invited to proceed will be offered a phone call to discuss the trial at a time that is convenient.

Applicants will be telephoned for a diagnostic interview using the Mini International Neuropsychiatric Interview Version 5.0.0 (MINI) to determine whether they meet DSM-IV criteria for a major depressive episode. Applicants that do not meet the criteria for a major depressive episode using the MINI will be excluded from the study and thanked for their application. These applicants will be encouraged to discuss their symptoms with physician.

Applicants that do meet the criteria for a major depressive episode will be informed of the study design and invited to return a completed consent form via email.


Before the diagnostic interview phone call the patient information sheet and informed consent form will be sent so that it can be discussed over the phone. The technician will administer the structured diagnostic interview and if they meet criteria for major depression they will be admitted 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. The technician is then unaware of which group the participant will be allocated and will open up an envelope at the end of the interview and reveal to the participant which group they have been randomly allocated.

The participant will be enrolled in the study after the informed consent process has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants accepted in the program will be randomized via a true randomization process (www.random.org) to either the treatment group or control group. Allocation will follow the diagnostic telephone call, and self report measures will preclude blinding. Equal randomization (1:1) will be conducted.
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
1/02/2012
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
31/05/2012
Date of last data collection
Anticipated
Actual
31/12/2012
Sample size
Target
126
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4752 0
2010

Funding & Sponsors
Funding source category [1] 284302 0
Hospital
Name [1] 284302 0
St Vincent's Hospital
Country [1] 284302 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria Street Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 283248 0
None
Name [1] 283248 0
Address [1] 283248 0
Country [1] 283248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286263 0
St Vincent's Hospital
Ethics committee address [1] 286263 0
Ethics committee country [1] 286263 0
Australia
Date submitted for ethics approval [1] 286263 0
Approval date [1] 286263 0
15/09/2011
Ethics approval number [1] 286263 0
11/SVH/126

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

Contacts
Principal investigator
Name 33473 0
Prof Professor Gavin Andrews
Address 33473 0
Clinical Research Unit for Anxiety and Depression (CRUfAD) Level 4, The O'Brien Centre St Vincent's Hospital 394-404 Victoria Street Darlinghurst NSW 2010 Sydney
Country 33473 0
Australia
Phone 33473 0
+612 8382 1408
Fax 33473 0
Email 33473 0
gavina@unsw.edu.au
Contact person for public queries
Name 16720 0
Professor Gavin Andrews
Address 16720 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Sydney
Country 16720 0
Australia
Phone 16720 0
+612 8382 1408
Fax 16720 0
+612 8382 1401
Email 16720 0
gavina@unsw.edu.au
Contact person for scientific queries
Name 7648 0
Professor Gavin Andrews
Address 7648 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Sydney
Country 7648 0
Australia
Phone 7648 0
+612 8382 1408
Fax 7648 0
+612 8382 1401
Email 7648 0
gavina@unsw.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseCBT for depression: A pilot RCT comparing mobile phone vs. computer.2013https://dx.doi.org/10.1186/1471-244X-13-49
N.B. These documents automatically identified may not have been verified by the study sponsor.