Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001093572
Ethics application status
Approved
Date submitted
4/09/2015
Date registered
19/10/2015
Date last updated
22/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Timely intervention: Efficacy of a depression symptom monitoring smartphone app to deliver psychological intervention at time of greatest need
Scientific title
In patients with depression, does a guided app-based intervention, compared to self-guided app, reduce depressive symptom severity?
Secondary ID [1] 287416 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 296121 0
Condition category
Condition code
Mental Health 296384 296384 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: self-guided use of a smartphone app-based intervention for depression.
This group is given access to the intervention materials (via app), with the instructions to complete each of the 12 x 30 minute modules in sequence. It is emphasized that the modules are designed to be paced at one per week.
The treatment material consists of six modules based on 3rd Wave Cognitive and Behavioural approaches to treat negative moods and build personal resilience: (1) Acceptance and Commitment Therapy (ACT) to identify personal values (2) Cognitive Behaviour Therapy (CBT) to uncover and dispute unhelpful thinking styles and their underlying assumptions, (3) Mindfulness Based Cognitive Behavioural Therapy (MCBT) to learn to accept negative thoughts without judgment, (4) resilience building to learn to maintain healthy levels of self-esteem, optimism, and to savour acts of kindness and gratitude, (5) Behavioural Activation to increase exposure to positive situations that provide meaning and/or pleasure and, (6) Troubleshooting/Relapse prevention.

Arm 2: app-enhanced use of a smartphone app-based intervention for depression.
This group is also given access to the intervention materials, with the same instructions for self-guided use (i.e., complete one module per week for 12 weeks). However, they are also informed that, based on their scores on the brief app surveys (given up to four times per day, measuring current mood state), they will be invited to undertake brief, additional content (top-up activities) at times of greatest need (i.e., when their depressive mood state scores are elevated they may be recommended to complete a brief relaxation task). These top-up activities are similar to the activities they receive in the online training, but are prompted by scores deemed at risk by the app surveys. Please note, these top-up activities are additional to, rather than substitutes for, the 12 weeks of module content, and participants are encouraged to continue to progress through the 12 modules at the same pace as recommended for Arm 1 participants (regardless of how many times they may engage in top-up activities).

Both groups will have access to the intervention content for 12 weeks. Adherence and usage is monitored by the app for both groups.
Intervention code [1] 292767 0
Treatment: Other
Comparator / control treatment
Control condition (Arm 3):
This group downloads an app that monitors depressive symptoms throughout the duration (12 weeks) of the intervention phase, but does not link to intervention content. This is a more suitable control condition than simply taking baseline and post-intervention measures of depression because the act of filling out ratings of depressed mood throughout the intervention phase (for Arms 1 and 2) may, in itself, be a low-level form of intervention, by enhancing awareness of depressive symptoms.
To mirror the number of assessments given to the intervention conditions, this control group will complete assessments of mood via the app up to 4 times per day for the duration of the intervention phase (12 weeks).
Control group
Active

Outcomes
Primary outcome [1] 296029 0
Depressive symptoms as assessed by the Patient Health Questionnaire 9 (PHQ9)
Timepoint [1] 296029 0
PHQ9 scores will be obtained at baseline, 13 weeks (post-intervention point), and 6 month follow-up (6 months after post-intervention point)
Secondary outcome [1] 317283 0
Retention rates as assessed by those who provide PHQ9 data at all time points (T1-T3) versus those who don’t.
Timepoint [1] 317283 0
At post-intervention and 6 month follow-up

Eligibility
Key inclusion criteria
(1) Aged 18-25 years
(2) Scores of greater than or equal to 10 on the PHQ9, which indicates at least moderate depression
(3) Access to a smartphone for the duration of testing to access and use our app
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Not fluent in English
(2) Currently seeking psychological treatment for depressive symptoms
(3) Initiation of antidepressant medication within 1 month of starting this study
(4) Severe psychiatric condition (such as psychosis, suicidality, or bipolar disorder) that would necessitate intensive therapy
(5) Doesn't have access to a smartphone with internet access for duration of study

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)
After completing the baseline survey, participants click on a link which randomly allocates them to the control or intervention arms of the study. As such, the randomization process is unbiased by researchers selecting participants to one or other of the conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multilevel modelling, with depression scores at the three time points nested within participants, and the effect of time on depression scores allowed to randomly vary across individuals and be predicted by group (Arms 1-3):
Level 1: Yij (depressive symptoms) = b0j + b1j*(time)
Level 2: b0j = b00 + b01*(group)
Level 2: b1j = b11 + b12*(group)

Required sample size of 140 per group for the proposed study was based on a minimum meaningful difference in efficacy of d = .3 between the intervention groups and control condition, with power of .80 and alpha of .05. To allow for a conservative sample attrition estimate of 30%, sample size target of n = 200 per group was set.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/10/2015
Actual
Date of last participant enrolment
Anticipated
28/10/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291984 0
Charities/Societies/Foundations
Name [1] 291984 0
Rotary Mental Health Grant
Country [1] 291984 0
Australia
Primary sponsor type
Individual
Name
Dr Matthew Fuller-Tyszkiewicz
Address
Australian Rotary Health
PO Box 3455 Parramatta NSW 2124
Country
Australia
Secondary sponsor category [1] 290648 0
None
Name [1] 290648 0
-
Address [1] 290648 0
-
Country [1] 290648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293474 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 293474 0
Human Research Ethics Office, Deakin Research Integrity, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Ethics committee country [1] 293474 0
Australia
Date submitted for ethics approval [1] 293474 0
Approval date [1] 293474 0
19/02/2015
Ethics approval number [1] 293474 0
EC00213

Summary
Brief summary
The purpose of this project is to conduct a randomised controlled trial (RCT) to compare self-guided use of an online intervention resource against BlueWatch-enhanced use of the same content. BlueWatch monitors depressive symptoms throughout the duration of intervention, and uses this information to obtain a risk profile for each participant, which can be used to predict periods of greater risk of depressed mood. In instances where greater risk is identified, participants are recommended to use the intervention resources immediately. It is hypothesized that this guided use will lead to stronger and quicker improvement in depressive symptoms, and due to the tailored nature of the intervention, will have lower dropout rates than self-guided use of the same intervention resources.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60070 0
Dr Matthew Fuller-Tyszkiewicz
Address 60070 0
BC4.112, BC Building,
School of Psychology,
Deakin University,
221 Burwood Highway, Burwood,
Victoria, Australia 3125
Country 60070 0
Australia
Phone 60070 0
+61 3 9251 7344
Fax 60070 0
+61 3 9244 6858
Email 60070 0
[email protected]
Contact person for public queries
Name 60071 0
Dr Matthew Fuller-Tyszkiewicz
Address 60071 0
BC4.112, BC Building,
School of Psychology,
Deakin University,
221 Burwood Highway, Burwood,
Victoria, Australia 3125
Country 60071 0
Australia
Phone 60071 0
+61 3 9251 7344
Fax 60071 0
+61 3 9244 6858
Email 60071 0
[email protected]
Contact person for scientific queries
Name 60072 0
Dr Matthew Fuller-Tyszkiewicz
Address 60072 0
BC4.112, BC Building,
School of Psychology,
Deakin University,
221 Burwood Highway, Burwood,
Victoria, Australia 3125
Country 60072 0
Australia
Phone 60072 0
+61 3 9251 7344
Fax 60072 0
+61 3 9244 6858
Email 60072 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

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