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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
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Scientific title
A randomised controlled trial to evaluate online memory specificity training for the treatment of depression
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Secondary ID [1]
292567
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Condition category
Condition code
Mental Health
303588
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
298782
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Incidence of Major Depression as assessed by the e-PASS system, an online, automated, self-report diagnostic tool for mental health disorders
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Assessment method [1]
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Timepoint [1]
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Post-Training Intervention, one month, and three-month follow-up
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Primary outcome [2]
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Mean change in the Patient Health Questionnaire (PHQ-9)
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Assessment method [2]
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Timepoint [2]
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Post-Training Intervention, one month, and three-month follow-up
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Secondary outcome [1]
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Mean change on the Ruminative Responses Scale
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Assessment method [1]
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Timepoint [1]
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Post-Training Intervention, one month, and three-month follow-up
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Secondary outcome [2]
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Mean change in Problem-Solving as assessed by the Means-End Problem-Solving Task
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Assessment method [2]
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Timepoint [2]
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Post-Training Intervention, one month, and three-month follow-up
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Secondary outcome [3]
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Mean change in Self-Efficacy as assessed by the New General Self-Efficacy Scale
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Assessment method [3]
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Timepoint [3]
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Post-Training Intervention, one month, and three-month follow-up
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Secondary outcome [4]
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Mean change on the Generalised Anxiety Disorder 7 scale
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Assessment method [4]
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Timepoint [4]
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Post-Training Intervention, one month, and three-month follow-up
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Secondary outcome [5]
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Mean change in scores on suicidal ideation, as measured by the Suicidal Ideation Ideation Attributes Scale
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Assessment method [5]
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Timepoint [5]
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Post-Training Intervention, one month, and three-month follow-up
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Secondary outcome [6]
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Cognitive avoidance, as assessed with mean change on the White Bear Suppression Inventory
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Assessment method [6]
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Timepoint [6]
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Post-Training Intervention, one month, and three-month follow-up
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Secondary outcome [7]
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Verbal Fluency, as assessed by mean change on the Controlled Word Association Test
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Assessment method [7]
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Timepoint [7]
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Post-Training Intervention, one month, and three-month follow-up
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Secondary outcome [8]
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Changes in autobiographical memory specificity, as assessed with scores on the Autobiographical Memory Test
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Assessment method [8]
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Timepoint [8]
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Post-intervention, 1 and 3 month follow-up
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Secondary outcome [9]
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Changes in episodic future thinking specificity, as assessed with scores on the Episodic Future Thinking Test
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Assessment method [9]
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Timepoint [9]
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Post-intervention
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
27/06/2018
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Actual
25/08/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
125
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Accrual to date
110
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Deakin University
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Address [1]
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221 Burwood Highway, Burwood, VIC 3125
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
221 Burwood Highway, Burwood, VIC 3125
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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N/A
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Address [1]
296161
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N/A
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Country [1]
296161
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Deakin University Human Research Ethics Committee (DUHREC)
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Ethics committee address [1]
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221 Burwood Highway, Burwood, VIC 3125
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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05/06/2017
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Approval date [1]
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10/10/2017
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Ethics approval number [1]
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2017_168
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Summary
Brief summary
Impairment in the ability to recall detailed autobiographical memories (AM) of in one’s life is a factor in the onset and maintenance of clinical depression. This is due to the critical role that specific AM play in healthy psychological functioning. For example, an impaired ability to retrieve specific AM is associated with poorer problem-solving, imagining, planning, and prediction, inaccurate appraisals of past events, and faulty decision-making. Without the ability to draw on our experiences in a detailed way, our capacity to adapt in the world is clearly impaired.
Interventions designed to improve AM specificity involve training in retrieving memories. Preliminary studies of a face-to-face training program indicate it can produce significant improvement in AM specificity and depressive symptoms. Improving AM specificity appears to be a promising means by which to reduce depressive symptoms. Further, such interventions need not be delivered by a clinician, which provides the opportunity to test its delivery via the internet. Online mental health interventions are clinically- and cost-effective, with good equity of access given the majority of Australians use the internet regularly (83%), and almost all from home (97%). As over 1.1 million Australians meet criteria for a Major Depressive Episode, yet approximately 50% do not access services and 30% do not respond to current first-line treatments, there is clear scope for more accessible and effective interventions.
The objective of this project will be to conduct the first randomised controlled trial of this online memory specificity training intervention to treat clinical depression. The study will also examine the mechanisms of change of this intervention, with implications for its broader use
It is hypothesised that:
- Individuals that receive the intervention, relative to those that don't, will report a lower incidence of depressive disorders at post-intervention and follow-up, and reductions in depressive symptoms;
- the intervention group, relative to the non-intervention group, will report improvements in psychological resources at post-intervention and follow-up.
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Trial website
TBC
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr David John Hallford
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Address
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School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway, Burwood, VIC 3121
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Country
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Australia
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Phone
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+61 421 763 436
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr David John Hallford
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Address
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School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway, Burwood, VIC 3121
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Country
76691
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Australia
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Phone
76691
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+61 421 763 436
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Fax
76691
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr David John Hallford
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Address
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School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway, Burwood, VIC 3121
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Country
76692
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Australia
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Phone
76692
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+61 421 763 436
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Fax
76692
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Email
76692
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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.
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