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Trial registered on ANZCTR


Registration number
ACTRN12617001156370
Ethics application status
Approved
Date submitted
2/08/2017
Date registered
8/08/2017
Date last updated
7/08/2019
Date data sharing statement initially provided
7/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to evaluate online memory specificity training for the treatment of depression
Scientific title
A randomised controlled trial to evaluate online memory specificity training for the treatment of depression
Secondary ID [1] 292567 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 304236 0
Condition category
Condition code
Mental Health 303588 303588 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online Memory Specificity Training program (e-MeST) comprises 11 modules based on content from validated methods of improving the retrieval of specific autobiographical memories (memories of events that occurred within a specific day and place in someone's life) and reducing depressive symptoms.

Initially, the aims, rationale, structure, and process of the intervention are presented to participants. In each module participants are provided with examples of specific memories. They are then provided with a series of cue words and sentences and asked to retrieve memories from their past relating to these cues. These include positive, neutral, and negatively-themed cue words (e.g., proud, sorrow, table), as well as prompt questions to elicit memories. Participants’ responses are fed into an algorithm which has been tuned to identify whether the participants response is a specific memory or not. Feedback is then given to help participants learn how to correctly retrieve specific memories. There is no limit to how long participants can take to complete the modules, although previous pilot research has shown they take approx. between 10 and 45 minutes each.
To assess adherence to the training program protocol, the researchers will have information about how many modules were completed and how much time they took to complete .

Once baseline assessment is complete the participants will have a total of two weeks to access and complete the modules at their leisure. Following this they will no longer be able to access the training program. The training program is fully online and automated and does not require therapist guidance, although the participants will be able to contact the researchers if they encounter any issues while using the training program. Participants can complete the training program anywhere that they can access the internet.
Intervention code [1] 298782 0
Treatment: Other
Comparator / control treatment
The control group will not receive at any intervention. At the cessation of the study follow-up period, three months following the end of the two-week active treatment period, they will have access to the e-MeST training program.
Control group
Active

Outcomes
Primary outcome [1] 302950 0
Incidence of Major Depression as assessed by the e-PASS system, an online, automated, self-report diagnostic tool for mental health disorders
Timepoint [1] 302950 0
Post-Training Intervention, one month, and three-month follow-up
Primary outcome [2] 302951 0
Mean change in the Patient Health Questionnaire (PHQ-9)
Timepoint [2] 302951 0
Post-Training Intervention, one month, and three-month follow-up
Secondary outcome [1] 337541 0
Mean change on the Ruminative Responses Scale
Timepoint [1] 337541 0
Post-Training Intervention, one month, and three-month follow-up
Secondary outcome [2] 337542 0
Mean change in Problem-Solving as assessed by the Means-End Problem-Solving Task
Timepoint [2] 337542 0
Post-Training Intervention, one month, and three-month follow-up
Secondary outcome [3] 337543 0
Mean change in Self-Efficacy as assessed by the New General Self-Efficacy Scale
Timepoint [3] 337543 0
Post-Training Intervention, one month, and three-month follow-up
Secondary outcome [4] 337544 0
Mean change on the Generalised Anxiety Disorder 7 scale
Timepoint [4] 337544 0
Post-Training Intervention, one month, and three-month follow-up
Secondary outcome [5] 346664 0
Mean change in scores on suicidal ideation, as measured by the Suicidal Ideation Ideation Attributes Scale
Timepoint [5] 346664 0
Post-Training Intervention, one month, and three-month follow-up
Secondary outcome [6] 346665 0
Cognitive avoidance, as assessed with mean change on the White Bear Suppression Inventory
Timepoint [6] 346665 0
Post-Training Intervention, one month, and three-month follow-up
Secondary outcome [7] 346666 0
Verbal Fluency, as assessed by mean change on the Controlled Word Association Test
Timepoint [7] 346666 0
Post-Training Intervention, one month, and three-month follow-up
Secondary outcome [8] 346667 0
Changes in autobiographical memory specificity, as assessed with scores on the Autobiographical Memory Test
Timepoint [8] 346667 0
Post-intervention, 1 and 3 month follow-up
Secondary outcome [9] 346668 0
Changes in episodic future thinking specificity, as assessed with scores on the Episodic Future Thinking Test
Timepoint [9] 346668 0
Post-intervention

Eligibility
Key inclusion criteria
(i) greater than or equal to 18 years
(ii) residing in Australia
(iii) fluent in English
(iv) a current diagnosis of a Major Depressive Episode as assessed using the automated electronic Psychological Assessment (e-PASS)
(v) a score on the Patient Health Questionnaire (PHQ) of at least 10
(vi) internet access in the home.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) currently receiving any treatment for depression, with the exception of antidepressant medication that has been stable in type and dosage for at least four weeks,
(ii) Patient Health Questionnaire scores of over 21, indicative of severe depressive symptoms

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)
The allocation will involve central randomisation by a computer, and will occur once participants complete the baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple 1:1 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using G*Power 3.1, it was calculated that a total sample of 125 participants will be needed; 105 for the main analyses and 20 for the pilot sample. This will account for an attrition rate of 35% between baseline and follow-up. This sample will provide 80% power to detect a moderate group by time interaction effect (d = .60) with 5% Type I error (two-sided tail). This effect is conservative relative to previous findings of the MeST training delivered in a face-to-face format (Cohen's d = .97).
Analyses will be on an intention-to-treat basis, with supplementary per protocol analyses. Linear mixed models will assess differences between conditions at each time-point, and allow inclusion of participants with missing data. Condition, time-point, and their interaction will be modelled as fixed effects. Participants will be modelled as random effects at time-points.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/06/2018
Actual
25/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
110
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297148 0
University
Name [1] 297148 0
Deakin University
Country [1] 297148 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 296161 0
None
Name [1] 296161 0
N/A
Address [1] 296161 0
N/A
Country [1] 296161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298316 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 298316 0
Ethics committee country [1] 298316 0
Australia
Date submitted for ethics approval [1] 298316 0
05/06/2017
Approval date [1] 298316 0
10/10/2017
Ethics approval number [1] 298316 0
2017_168

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

Contacts
Principal investigator
Name 76690 0
Dr David John Hallford
Address 76690 0
School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway, Burwood, VIC 3121
Country 76690 0
Australia
Phone 76690 0
+61 421 763 436
Fax 76690 0
Email 76690 0
[email protected]
Contact person for public queries
Name 76691 0
David John Hallford
Address 76691 0
School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway, Burwood, VIC 3121
Country 76691 0
Australia
Phone 76691 0
+61 421 763 436
Fax 76691 0
Email 76691 0
[email protected]
Contact person for scientific queries
Name 76692 0
David John Hallford
Address 76692 0
School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway, Burwood, VIC 3121
Country 76692 0
Australia
Phone 76692 0
+61 421 763 436
Fax 76692 0
Email 76692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.