Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000754943
Ethics application status
Approved
Date submitted
25/05/2020
Date registered
21/07/2020
Date last updated
1/12/2021
Date data sharing statement initially provided
21/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the Impact of Episodic Future Thinking Training for Adults with Clinical Depression.
Scientific title
The Impact of Episodic Future Thinking Training on Future Thinking, Anticipatory Pleasure and Mental Wellbeing in Adults with Clinical Depression.
Secondary ID [1] 301369 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 317613 0
Mental Health 318012 0
Condition category
Condition code
Mental Health 315690 315690 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the current study is to evaluate a future thinking training program in a sample of clinically-depressed individuals, and examine its effects on future thinking and related cognitive, emotional and behavioural variables.
The two-session future thinking training will be conducted in group-based, online format on the skype platform (60-90 minutes each). Participant groups of 3-6 will be led by 1-2 facilitators. The facilitators will be fourth-year graduate psychology students with experience in running episodic thinking training and counselling skills, supervised by a registered clinical psychologist with experience in this training intervention and in assessment and treatment of clinical depression (Dr David Hallford). It will be delivered over the course of two weeks.

The first session involves psycho-education about episodic future thinking and its functions, and distinguishing between general and specific episodic future thinking. Participants will then practice generating episodic future thoughts in response to cue words, with demonstrations from the facilitator. Cue words will be positively and neutrally valenced cue (e.g., bicycle, car, happy, knowledge) with a focus on generating detail (e.g., sensorial and scene details, actions, people, thoughts, feelings etc.), using mental imagery, and imagining events from a first-person perspective. Facilitators will provide individual feedback and a homework task to be completed before the next session consisting of practice cue words and providing a daily future thought of something that would or could happen the following day.
The second session (1 week later), will follow the same format with additional education on general and specific episodic future thinking, and a focus on anticipation of positive emotions. Participants will be asked to complete the same homework task as Session 1 but generate two specific episodic future thoughts (i.e., one neutral and one positive) per word and include anticipated emotions when generating positive future thoughts. Facilitators will monitor adherence using an attendance and adherence checklist for each session.
Intervention code [1] 317668 0
Treatment: Other
Intervention code [2] 317924 0
Behaviour
Comparator / control treatment
Participants in the wait-list control group will complete the outcomes measures at the same time-points as the intervention group, and will then be offered the training program after completion of the 3 month survey, and separate training sessions will be run for these participants. Therefore, all participants will have the opportunity to receive the future thinking training. Participants in the wait-list control group will not complete outcome measures following their delayed participation in the training sessions. During the 3 month wait-list period prior to joining the training intervention sessions the wait-list control participants will be free to continue or obtain any usual care.
Control group
Active

Outcomes
Primary outcome [1] 323912 0
Future thinking specificity; Episodic Future Thinking-Test (validated questionnaire; Hallford et al., 2019)
Timepoint [1] 323912 0
Baseline, 1 month and 3 months (primary endpoint) follow-up timepoints post-enrolment.
Primary outcome [2] 324251 0
Detail; Episodic Future Thinking-Test (validated questionnaire; Hallford et al., 2019)
Timepoint [2] 324251 0
Baseline, 1 month and 3 months (primary endpoint) follow-up timepoints post-enrolment.
Primary outcome [3] 324252 0
Imagery; Episodic Future Thinking-Test (validated questionnaire; Hallford et al., 2019)
Timepoint [3] 324252 0
Baseline, 1 month and 3 months (primary endpoint) follow-up timepoints post-enrolment.
Secondary outcome [1] 383308 0
Autobiographical Memory; Autobiographical Memory Test (Williams & Broadbent, 1986)
Timepoint [1] 383308 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment
Secondary outcome [2] 383312 0
Cognitive reappraisal; Emotion Regulation Questionnaire (Gross & John, 2003)
Timepoint [2] 383312 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment
Secondary outcome [3] 383313 0
Behavioural activation; Behavioural Activation for Depression Scale (Manos et al. 2011)
Timepoint [3] 383313 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment
Secondary outcome [4] 383314 0
Suicidal Ideation; Suicidal Attributes Ideation Scale (Spijker et al., 2014)
Timepoint [4] 383314 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment
Secondary outcome [5] 383317 0
Psychosocial functioning: Global Assessment of Functioning Scale (Bodlund et al., 1994)
Timepoint [5] 383317 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment
Secondary outcome [6] 383318 0
Depressive symptoms; Patient Health Questionnaire-9 (Kroenke et al., 2001)
Timepoint [6] 383318 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment
Secondary outcome [7] 383319 0
Major Depressive Episode diagnosis; The Electronic Psychological Assessment System (ePASS; Nguyen et al., 2015)
Timepoint [7] 383319 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment
Secondary outcome [8] 384174 0
Primary Outcome [4]: Fluency in future thinking; Number of Positive Future Events on the Future Thinking Task (MacLeod & Byrne, 1996)
Timepoint [8] 384174 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment
Secondary outcome [9] 384175 0
Primary Outcome [5]: Anticipatory pleasure; State-type assessed by self-report items on the Episodic Future Thinking-Test (Hallford et al., 2019), and trait-type measured using the self-report Temporal Experience of Pleasure Scale (Gard et al., 2006)
Timepoint [9] 384175 0
Baseline, 1 month and 3 months follow-up time-points post-enrolment

Eligibility
Key inclusion criteria
1) 18-65 years of age
2) Current diagnosis of Major Depressive Episode assessed using the Electronic Psychological Assessment System (ePASS), an online self-report diagnostic tool validated against face-to-face, structured interviews. This must include endorsement of “more days than not” or “every day” for the anhedonia criterion: “Over the last TWO WEEKS or more, please indicate how often you felt much less interested in or much less able to enjoy most activities".
3) English-speaking
4) An Australian resident.
5) Access to the internet on laptop or home computer
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurodevelopmental disorder diagnosis by health professional through self-report. To increase the generalisability of the findings, comorbid mental health disorders will not be an exclusion criterion, with the exception of neurodevelopmental disorders given that the training is not adapted to the special needs of these populations.

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)
Simple 1:1 randomisation, using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Feedback/evaluation interviews will be conducted by a researcher not directly involved in the intervention, and blinded to participant outcomes.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will estimate a between-group effect of d = 0.70 (.80 power, alpha level: 0.05, 2-tailed). Computations using G*Power indicate that at least 35 participants will be needed in each arm to detect this effect. We will aim to recruit 42 to account for the typical attrition rate of 20% in depression trials. This totals to 84 participants.
Linear mixed models, with group as a fixed effect and time modelled as a random effect grouped by subjects. This will allow for the retention of cases with missing data-points. All analyses will be conducted on an intention-to-treat basis using a full information maximum likelihood model. Mediation effects will be assessed using a bias-corrected bootstrap test. Power calculations with correlations from the literature indicate that the sample size will provide power (ß=0.80, a=0.05, two-tailed test) to detect associations of a moderate effect size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/07/2020
Date of last participant enrolment
Anticipated
1/07/2021
Actual
1/12/2020
Date of last data collection
Anticipated
1/10/2021
Actual
15/03/2021
Sample size
Target
84
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305810 0
University
Name [1] 305810 0
Alfred Deakin Postdoctoral Research Fellowship, Deakin University
Country [1] 305810 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 306252 0
None
Name [1] 306252 0
N/A
Address [1] 306252 0
N/A
Country [1] 306252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306080 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 306080 0
Ethics committee country [1] 306080 0
Australia
Date submitted for ethics approval [1] 306080 0
01/03/2020
Approval date [1] 306080 0
23/06/2020
Ethics approval number [1] 306080 0

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

Contacts
Principal investigator
Name 102630 0
Dr David John Hallford
Address 102630 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 102630 0
Australia
Phone 102630 0
+61 410 843 679
Fax 102630 0
Email 102630 0
[email protected]
Contact person for public queries
Name 102631 0
David John Hallford
Address 102631 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 102631 0
Australia
Phone 102631 0
+61 410 843 679
Fax 102631 0
Email 102631 0
[email protected]
Contact person for scientific queries
Name 102632 0
David John Hallford
Address 102632 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 102632 0
Australia
Phone 102632 0
+61 410 843 679
Fax 102632 0
Email 102632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics not attained to share participant-level data.


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
EmbaseReducing Anhedonia in Major Depressive Disorder with Future Event Specificity Training (FEST): A Randomized Controlled Trial.2023https://dx.doi.org/10.1007/s10608-022-10330-z
N.B. These documents automatically identified may not have been verified by the study sponsor.