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Trial registered on ANZCTR


Registration number
ACTRN12619000234112
Ethics application status
Approved
Date submitted
12/02/2019
Date registered
18/02/2019
Date last updated
8/08/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Treatment for Depressed Youth: A Randomised Trial of Adjunct Memory Specificity Training
Scientific title
Enhancing Treatment for Depression: A Randomised Trial of Adjunct Memory Specificity Training
Secondary ID [1] 297368 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 311506 0
Condition category
Condition code
Mental Health 310139 310139 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will examine the effect of c-MeST in addition to usual care, and test whether it enhances treatment effects and reduces risk of depression at follow-up.

The computerised Memory Specificity Training program (c-MeST) comprises seven modules based on content from validated methods of improving autobiographical memory specificity and reducing depressive symptoms. The intervention is accessed online, is individually administered, and completely automated.
Initially, the aims, rationale, structure, and process of the intervention will be presented to participants. In each of the 7 modules (approximately taking 15-30 minutes) participants are provided with examples of specific autobiographical memories (AM). They are then provided with a series of cue words and sentences and asked to retrieve specific 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 AM. Participants’ responses are fed into an algorithm which has been tuned to identify whether the participants response is a specific AM or not. Feedback is then given to help participants learn how to correctly retrieve specific AM. Participants can access the intervention for a period of 1 month, and complete modules at their own pace and convenience.
Intervention code [1] 313623 0
Treatment: Other
Comparator / control treatment
Usual care will consist of care pathway provided by the organisation at which the young person has sought help. This will likely be psychological therapy and/or antidepressant medication.
Control group
Active

Outcomes
Primary outcome [1] 319036 0
Major Depressive Episode as assessed using the electronic Psychological Assessment System (e-PASS; Nguyen...Austin et al., 2015),a diagnostic system for DSM disorders.
Timepoint [1] 319036 0
Baseline, post-intervention (1 months), and follow-up at 3 and 6 months.
Primary outcome [2] 319037 0
Depressive symptoms using the depression subscale of the 21-item version of the Depression, Anxiety, and Stress Scale (Lovibond & Lovibond, 1995)
Timepoint [2] 319037 0
Baseline, post-intervention (1 months), and follow-up at 3 and 6 months.
Primary outcome [3] 319038 0
Autobiographical memory specificity using the Autobiographical Memory Test (Williams & Broadbent, 1986)
Timepoint [3] 319038 0
Baseline, 2 weeks later, post-intervention (1 months), and follow-up at 3 and 6 months.
Secondary outcome [1] 366770 0
Suicidal ideation, using the Suicidal Ideation Attributes Scale (Spijker et al., 2014)
Timepoint [1] 366770 0
Baseline, post-intervention (1 months), and follow-up at 3 and 6 months.
Secondary outcome [2] 366771 0
Rumination, using the Ruminative Response Scale (Nolen-Hoeksema, 2000)
Timepoint [2] 366771 0
Baseline, post-intervention (1 months), and follow-up at 3 and 6 months.
Secondary outcome [3] 366772 0
Cognitive avoidance, using the White Bear Suppression Inventory (Wagner et al., 1994)
Timepoint [3] 366772 0
Baseline, post-intervention (1 months), and follow-up at 3 and 6 months.
Secondary outcome [4] 366773 0
Verbal fluency using the COWAT (Lezak et al., 2004)
Timepoint [4] 366773 0
Baseline, post-intervention (1 months), and follow-up at 3 and 6 months.
Secondary outcome [5] 366774 0
Problem-solving ability, using the Means-End Problem-Solving Procedure (Platt & Spivak, 1972)
Timepoint [5] 366774 0
Baseline, post-intervention (1 months), and follow-up at 3 and 6 months.
Secondary outcome [6] 366775 0
General anxiety symptoms, using the Generalized Anxiety Disorders Scale (Spitzer et al., 2006)
Timepoint [6] 366775 0
Baseline, post-intervention (1 months), and follow-up at 3 and 6 months.

Eligibility
Key inclusion criteria
(i) 15-65 years of age, (ii) residing in Australia, (iii) a current diagnosis of a Major Depressive Episode, and (iv) internet access in the home or phone.
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will be: (i) non-fluency in English, (ii) psychotic, neurodevelopmental, and substance use disorders

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Power calculation and analyses: A total sample of 128 participants will be needed. This will be sufficient to detect a moderate-sized, clinically-meaningful between-groups effect of d = .50, with .80 power and alpha level of 0.05 (two-tailed), while controlling for amount of usual care treatment (type and amount monitored at each time-point). 154 participants will be recruited at baseline to allow for 20% attrition. Analyses will be conducted on an intention-to-treat basis, with supplementary per protocol analyses. Linear mixed models analysis will be used, with group, and interaction modelled as fixed effects, and participants, time-points, and practice location modelled as random effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/08/2019
Actual
Date of last participant enrolment
Anticipated
1/05/2020
Actual
Date of last data collection
Anticipated
1/11/2020
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301936 0
Charities/Societies/Foundations
Name [1] 301936 0
Australian Rotary Health
Country [1] 301936 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood, 3125 VIC Australia
Country
Australia
Secondary sponsor category [1] 301691 0
None
Name [1] 301691 0
Address [1] 301691 0
Country [1] 301691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302618 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 302618 0
Ethics committee country [1] 302618 0
Australia
Date submitted for ethics approval [1] 302618 0
18/02/2019
Approval date [1] 302618 0
15/03/2019
Ethics approval number [1] 302618 0

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

Contacts
Principal investigator
Name 90838 0
Dr David John Hallford
Address 90838 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 90838 0
Australia
Phone 90838 0
+61 421 763 436
Fax 90838 0
Email 90838 0
david.hallford@deakin.edu.au
Contact person for public queries
Name 90839 0
David John Hallford
Address 90839 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 90839 0
Australia
Phone 90839 0
+61 421 763 436
Fax 90839 0
Email 90839 0
david.hallford@deakin.edu.au
Contact person for scientific queries
Name 90840 0
David John Hallford
Address 90840 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 90840 0
Australia
Phone 90840 0
+61 421 763 436
Fax 90840 0
Email 90840 0
david.hallford@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participating organisations have requested that individual data not be shared.


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
EmbaseA study protocol for a randomised trial of adjunct computerised memory specificity training (c-MeST) for major depression in youth: Targeting cognitive mechanisms to enhance usual care outcomes in mental health settings.2020https://dx.doi.org/10.1186/s13063-019-4036-6
N.B. These documents automatically identified may not have been verified by the study sponsor.