Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000257268
Ethics application status
Approved
Date submitted
9/02/2018
Date registered
16/02/2018
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Episodic Future Thinking for Positive Events: Enhancing Anticipated Pleasure in Depression
Scientific title
Episodic Future Thinking for Positive Events: Enhancing Anticipated Pleasure in Depression
Secondary ID [1] 294007 0
Nil
Universal Trial Number (UTN)
U1111-1209-1953
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 306520 0
Condition category
Condition code
Mental Health 305628 305628 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited from inpatient and outpatient settings at the adult mental health service of the National Institute for Mental Health and Neurosciences, Bengaluru, India.
The intervention will consist of a series of brief questions asking participants to provide some detail about the upcoming positive events they anticipate might happen (e.g., what will happen, who will be there, how will you feel, have you enjoyed this before). The intervention is designed to stimulate episodic future thinking about the upcoming event in order to increase anticipated pleasure. This will be implemented as part of monitoring of activity over a 14 day period for depressed individuals recruited from an adult mental health service.

After providing informed consent participants will be randomised to a Phase B start-point, which will be after a minimum of 30 Phase A observations (6 days). Phase B will commence, at the latest, after 55 observations (11 days), and therefore last a minimum of 15 observations (3 days). The actual start-point, and therefore the length of the respective phases, will be randomly determined. Participants will be asked to engage in monitoring of their activity over the 14 days, and over this period, dependent on what start-point they were randomized to, they will switch from Phase A to Phase B.

Participants will receive email links to online surveys 5 times per day (8:30am, 11:30am, 2pm, 4:30pm, and 7pm). Each survey will ask them to indicate what activity they are most looking forward to in the next 2 hours. They will choose from a list of options for each activity (e.g., work/school/study, media/tv/internet, and conversation/socialising, specified other). Participants will then complete a brief series of questions relating to the upcoming positive activity, including how vivid their mental image was, how easy it was to think of the activity, how pleasurable they think it will be, their intention to engage in it, and their current affect. At each prompt they will be also be asked whether or not they engaged in the previously nominated activity, and how enjoyable it was. The surveys are expected to take 3-5 minutes to complete, and the future thinking task approximately 2-4 minutes.

-In Phase A, participants will complete the surveys
-In Phase B, participants will complete these surveys, and also engage in a future thinking task after they nominate the upcoming positive activity. This task will involve mentally simulating the positive activity through a series of online written prompts as part of the survey, and including questions such as 'who will be there', 'what will happen', 'why might you enjoy it', 'what emotion might you feel' etc.

All participants will start in Phase A and then switch to Phase B at some point.

If participants fail to complete several surveys in a row they will be contacted with a phone call to assess for any complicating factors in adherence.

At the cessation of Phase B, the participants will receive evidence-based treatment for depression as per NIMHANS usual care protocols.
Intervention code [1] 300278 0
Treatment: Other
Comparator / control treatment
As described above, the study will involve a within-groups design, with participants completing activity monitoring in Phase A and then switching to activity monitoring + future thinking in Phase B. Therefore all participants will be involved in Phase A and Phase B, with Phase A being the 'reference' Phase.
Control group
Active

Outcomes
Primary outcome [1] 304740 0
Mean anticipatory pleasure as assessed by self-report Likert Scale
Timepoint [1] 304740 0
Standardised mean score in Phase B of the study period, compared to Phase A. Assessments of anticipatory pleasure will be made at each observation (i.e., 'Assessments will be completed daily at 8:30am, 11:30am, 2pm, 4:30pm, and 7pm for the 14 day intervention period.).
Primary outcome [2] 306780 0
Mean anticipated pleasure, as assessed by self-report Likert Scale
Timepoint [2] 306780 0
Standardised mean score in Phase B of the study period, compared to Phase A. Assessments of anticipated pleasure will be made at each observation (i.e., 'Assessments will be completed daily at 8:30am, 11:30am, 2pm, 4:30pm, and 7pm for the 14 day intervention period.).
Secondary outcome [1] 342989 0
Frequency of engagement in nominated activities, as assessed at each observation by endorsement of one dichotomous question (Yes/No) relating to having engaged in the previously nominated activity.
Timepoint [1] 342989 0
Standardised mean score in Phase B of the study period, compared to Phase A. Assessments of engagement in nominated activities will be made at each observation (i.e., Assessments will be completed daily at 8:30am, 11:30am, 2pm, 4:30pm, and 7pm for the 14 day intervention period).
Secondary outcome [2] 342990 0
State Mood, as assessed by visual analogue scales:
• Please rate how depressed you are right (0 = not at all depressed, 100 = extremely).

Timepoint [2] 342990 0
Standardised mean score in Phase B of the study period, compared to Phase A. Assessments of state mood will be made at each observation (i.e., Assessments will be completed daily at 8:30am, 11:30am, 2pm, 4:30pm, and 7pm for the 14 day intervention period)
Secondary outcome [3] 343231 0
State Mood, as assessed by visual analogue scales:
• Please rate how happy you are right now (0 = not at all happy, 100 = extremely).
Timepoint [3] 343231 0
Standardised mean score in Phase B of the study period, compared to Phase A. Assessments of state mood will be made at each observation (i.e., Assessments will be completed daily at 8:30am, 11:30am, 2pm, 4:30pm, and 7pm for the 14 day intervention period)
Secondary outcome [4] 349626 0
Trait anticipated pleasure, as assessed by the mean score of participants on the anticipatory pleasure subscale of the Temporal Experience of Pleasure Scale.
Timepoint [4] 349626 0
Observations will be made at the start of Phase A, between Phase A and Phase B, and at the end of Phase B.
Secondary outcome [5] 349627 0
Depressive symptoms, as assessed by the mean score of participants on the depression subscale of the Depression, Anxiety, and Stress Scale
Timepoint [5] 349627 0
Observations will be made at the start of Phase A, between Phase A and Phase B, and at the end of Phase B.
Secondary outcome [6] 349628 0
Episodic Future Thinking Detail, as assessed by the number of episodic details and specificity score on the Episodic Future Thinking-Test
Timepoint [6] 349628 0
Observations will be made at the start of Phase A, between Phase A and Phase B, and at the end of Phase B.
Secondary outcome [7] 349629 0
Behavioural activation, as assessed by the mean score of participants on the Behavioural Activation for Depression Scale
Timepoint [7] 349629 0
Observations will be made at the start of Phase A, between Phase A and Phase B, and at the end of Phase B.
Secondary outcome [8] 349630 0
Mean vividness of simulated upcoming events as assessed by self-report Likert Scale
Timepoint [8] 349630 0
Standardised mean score in Phase B of the study period, compared to Phase A. Assessments of vividness will be made at each observation (i.e., 'Assessments will be completed daily at 8:30am, 11:30am, 2pm, 4:30pm, and 7pm for the 14 day intervention period.).

Eligibility
Key inclusion criteria
(i) 18 years or over, (ii) residing in Bengaluru, India, (iii) a current diagnosis of a Major Depressive Disorder as their primary presenting complaint, (iv) mobile smartphone with internet access, and (v) fluent in the English language, and (vi) assessed as able to receive outpatient care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) psychotic disorder, bipolar disorder, neurodevelopmental disorder, neurodegenerative disorders, substance use disorders, obsessive-compulsive disorders, borderline personality disorder (ii) already receiving treatment for depression, with the exception of antidepressant medication commenced more than 4 weeks ago, and (iii) requires ongoing inpatient care for risk management that precludes transition to outpatient setting.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A replicated, start-point randomized, single-case series A-B phase design will be used. Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation for start-point allocation and statistical analyses will be conducted using ExPRT Package for Statistical Analyses of Single-Case Intervention Data
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A randomisation test with this design will be powered to indicate whether standardized mean score differences of 0.6 or greater between Phase A and Phase B pleasure represent statistically-significant differences, with an alpha of .05 and power > .80.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/07/2018
Actual
Date of last participant enrolment
Anticipated
3/09/2018
Actual
Date of last data collection
Anticipated
17/09/2018
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 9573 0
India
State/province [1] 9573 0
Karnataka

Funding & Sponsors
Funding source category [1] 298633 0
Charities/Societies/Foundations
Name [1] 298633 0
Australian Academy of Sciences
Country [1] 298633 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gherinhap St, Geelong, Victoria 3220, Australia
Country
Australia
Secondary sponsor category [1] 297798 0
Other
Name [1] 297798 0
National Institute for Mental Health and Neuroscience
Address [1] 297798 0
Hosur Road, Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560029, India
Country [1] 297798 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299592 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 299592 0
Ethics committee country [1] 299592 0
Australia
Date submitted for ethics approval [1] 299592 0
19/02/2018
Approval date [1] 299592 0
Ethics approval number [1] 299592 0
Ethics committee name [2] 299593 0
National Institute of Mental Health and Neurosciences Ethics Committee
Ethics committee address [2] 299593 0
Ethics committee country [2] 299593 0
India
Date submitted for ethics approval [2] 299593 0
02/04/2018
Approval date [2] 299593 0
12/02/2018
Ethics approval number [2] 299593 0

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

Contacts
Principal investigator
Name 80954 0
Dr David Hallford
Address 80954 0
Deakin University, Burwood Campus. 221 Burwood Highway, Burwood, Victoria, 3125, Australia
Country 80954 0
Australia
Phone 80954 0
+61 3 9244 6100
Fax 80954 0
Email 80954 0
[email protected]
Contact person for public queries
Name 80955 0
David Hallford
Address 80955 0
Deakin University, Burwood Campus. 221 Burwood Highway, Burwood, Victoria, 3125, Australia
Country 80955 0
Australia
Phone 80955 0
+61 3 9244 6100
Fax 80955 0
Email 80955 0
[email protected]
Contact person for scientific queries
Name 80956 0
David Hallford
Address 80956 0
Deakin University, Burwood Campus. 221 Burwood Highway, Burwood, Victoria, 3125, Australia
Country 80956 0
Australia
Phone 80956 0
+61 3 9244 6100
Fax 80956 0
Email 80956 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComputerised memory specificity training (c-MeST) for the treatment of major depression: A study protocol for a randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-024508
EmbaseIncreasing Anticipatory Pleasure in Major Depression through Enhancing Episodic Future Thinking: a Randomized Single-Case Series Trial.2020https://dx.doi.org/10.1007/s10862-020-09820-9
N.B. These documents automatically identified may not have been verified by the study sponsor.