Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001052426
Ethics application status
Approved
Date submitted
20/08/2025
Date registered
24/09/2025
Date last updated
24/09/2025
Date data sharing statement initially provided
24/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effectiveness of Enhancing Autobiographical Thinking on Cognitive Vulnerabilities Associated with Relapse Prevention in Remitted Depression: A Proof-of-Concept Pilot Trial
Scientific title
The Effectiveness of Enhancing Autobiographical Thinking on Cognitive Vulnerabilities Associated with Relapse Prevention in Remitted Depression: A Proof-of-Concept Pilot Trial
Secondary ID [1] 315180 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Remitted depression 338623 0
Mental Health 338624 0
Condition category
Condition code
Mental Health 334918 334918 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the current study is to conduct a proof-of-concept pilot trial to test an Autobiographical Thinking Training Program in people with Remitted Major Depressive Disorder (MDD), and to examine whether this program has an effect on autobiographical thinking (memory and future thinking) by the 3 month endpoint (primary outcome); as well as secondary outcomes of depressive symptoms, anticipatory pleasure, anxiety symptoms, psychosocial functioning, self-efficacy, self-esteem, behavioural activation, perceived control, optimism and meaning in life.

The four-session autobiographical thinking training is conducted in a group-based, online format on the Zoom platform (90 minutes each). This program had been developed for this study and was adapted from memory training programs (e.g., cognitive-reminiscence therapy Hallford & Mellor, 2016; Watt & Cappeliez, 2000; Westerhof & Slatman, 2019) and future thinking training programs (e.g., Future Event Specificity Training; Hallford et al., 2020; Hallford, Rusanov, et al., 2022). Participant groups of 4 led by 1-2 facilitators. The facilitators are a Masters of Applied Science (Psychology) student with experience in running autobiographical thinking training and counselling skills in a clinical trial that had ethics approval, a Masters in Clinical Psychology student with experience in counselling skills, and Psychology Honours graduate with experience in mental health support work, and supervised by a registered clinical psychologist with experience in this training intervention and in assessment and treatment of clinical depression (Dr David Hallford). This program is delivered over the course of four weeks. Additionally, a session attendance was recorded and session adherence checklist was used to assess adherence to the intervention.

Prior to the first session, a homework task is given in which participants will be asked to write down two people that they have a positive relationship with, and for each person listed provide a time in which they shared a positive memory with the person, followed by another instance where they felt supported/cared for by this person. The first session involves a guided imagery exercise recalling times where someone that participants have a positive relationship with shared a positive memory or felt supported/cared for by this person. Facilitators provide individual feedback and a homework task to be completed before the next session consisting of a section in which participants are to provide five memories of a specific experience of someone showing care/support or specific positive memory with that person, and to provide two challenges in the past that they successfully coped with.

The second session (one week later) involves a guided imagery exercise exploring instances where participants successfully coped with challenges in the past. Facilitators provide individual feedback and a homework task to be completed before the next session consisting of a section in which participants are to provide five memories of challenges they overcame, followed by a task to provide four future goals.

The third session (one week later) involves psycho-education about episodic future thinking and its functions. Participants then practice generating future events and goals. This is done with guided mental imagery to elicit meaningful future goals and imagine positive outcomes of achieving the goal (e.g., feelings, significance, meaning, consequences). Facilitators provide individual feedback and a homework task to be completed before the next session consisting of a section in which participants are to provide four future goals, steps to attain them and outcomes of achieving the goal, and also to provide a daily future thought of something that would or could happen the following day.

The fourth session (one week later) involves guided mental imagery to elicit meaningful future goals, steps to attain goals, and positive outcomes of achieving the goal. Facilitators provide individual feedback and a homework task to be completed after the last session consisting of a section in which participants are to provide four future goals, steps to attain them and imagined outcomes of achieving the goal, and to record if any written goal was achieved in the months following the last session and describe the actual outcome of achieving the goal (e.g., thoughts, feelings, meaning, etc.). Participants are also be asked to provide a daily future thought of something that would or could happen the following day for a week following the last session. The four homework tasks were estimated to require 20 to 30 minutes each.

Throughout the guided imagery tasks within all four sessions there is a focus on generating detail (e.g., sensorial and scene details, actions, people, thoughts, feelings, etc.), using mental imagery, imagining future thoughts or recalling past events from a first-person perspective. Facilitators monitor adherence using an attendance and adherence checklist for each session.
Intervention code [1] 331797 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342540 0
Autobiographical Memory Specificity
Timepoint [1] 342540 0
Baseline, then 1-month, and 3-month follow-up time-points post-enrolment
Primary outcome [2] 342541 0
Autobiographical Memory Detail
Timepoint [2] 342541 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Primary outcome [3] 342666 0
Autobiographical Memory Imagery
Timepoint [3] 342666 0
Baseline, then 1-month, and 3-month follow-up time-points post-enrolment
Secondary outcome [1] 451243 0
Depressive symptoms
Timepoint [1] 451243 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [2] 451244 0
Psychosocial functioning
Timepoint [2] 451244 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [3] 451245 0
Anxiety symptoms
Timepoint [3] 451245 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [4] 451246 0
Behavioural activation
Timepoint [4] 451246 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [5] 451247 0
Fluency in future thinking
Timepoint [5] 451247 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [6] 451248 0
Frequency of self-reported functions of future thinking
Timepoint [6] 451248 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [7] 451249 0
Anticipatory pleasure
Timepoint [7] 451249 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [8] 451250 0
Self-efficacy
Timepoint [8] 451250 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [9] 451251 0
Perceived Control
Timepoint [9] 451251 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [10] 451252 0
Meaning in Life
Timepoint [10] 451252 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [11] 451253 0
Optimism
Timepoint [11] 451253 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [12] 451254 0
Self-esteem
Timepoint [12] 451254 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [13] 451736 0
Future thinking Specificity (PRIMARY OUTCOME)
Timepoint [13] 451736 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [14] 451737 0
Future thinking Detail (PRIMARY OUTCOME)
Timepoint [14] 451737 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment
Secondary outcome [15] 451738 0
Future thinking Imagery (PRIMARY OUTCOME)
Timepoint [15] 451738 0
Baseline, then 1-month and 3-month follow-up time-points post-enrolment

Eligibility
Key inclusion criteria
1) Adults (18 and over)
2) English-speaking
3) A history of an MDD diagnosis, with 2 or more depressive episodes experienced within 5 years
4) Not currently meeting threshold for a MDD diagnosis
5) Access to the internet on laptop or home computer
6) an Australian resident.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Alcohol abuse disorder (using a 3-item AUDIT: The Alcohol Use Disorder Identification Test; Babor et al., 1989), bipolar disorder, personality disorder, psychotic, neurodevelopmental disorder diagnosis, or significant acquired brain injury through self-report. These exclusion criteria were chosen as these groups are known to have impairments in autobiographical thinking due to underlying cognitive impairments, and it is currently unclear how this may moderate the effects of the training. Future research could examine this. To increase the generalisability of the findings, exclusion criterion will not include comorbid mental health disorders, with the exception of the ones listed in the exclusion criteria. At the screening phase, participants will be assessed for high risk, by being asked the question “Do you currently have a strong intent to end your life?” If they confirm that this is the case, then they will be excluded from participating in the study and provided with information regarding helplines/support they might wish to contact. It is made clear to participants in the PLS that this research does not include risk management, nor is it an established preventative treatment for relapse prevention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/04/2023
Date of last participant enrolment
Anticipated
Actual
8/10/2024
Date of last data collection
Anticipated
Actual
2/03/2025
Sample size
Target
34
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319751 0
University
Name [1] 319751 0
Higher Degree Research Scholarship, Deakin University
Country [1] 319751 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 322257 0
None
Name [1] 322257 0
Address [1] 322257 0
Country [1] 322257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318303 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 318303 0
Ethics committee country [1] 318303 0
Australia
Date submitted for ethics approval [1] 318303 0
13/11/2022
Approval date [1] 318303 0
10/02/2023
Ethics approval number [1] 318303 0
2022-332

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

Contacts
Principal investigator
Name 143762 0
Dr David John Hallford
Address 143762 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 143762 0
Australia
Phone 143762 0
+61 410 843 679
Fax 143762 0
Email 143762 0
[email protected]
Contact person for public queries
Name 143763 0
David John Hallford
Address 143763 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 143763 0
Australia
Phone 143763 0
+61 410 843 679
Fax 143763 0
Email 143763 0
[email protected]
Contact person for scientific queries
Name 143764 0
David John Hallford
Address 143764 0
School of Psychology, Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 143764 0
Australia
Phone 143764 0
+61 410 843 679
Fax 143764 0
Email 143764 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.