NCT07792356

Brief Summary

The goal of this clinical trial is to examine whether updating fundamental beliefs about self, others and the world using a mental time-travel group program can reduce loneliness and improve well-being in older adults when combined with multimodal social engagement opportunities. Over the span of eight sessions, participants within the experimental group will be guided to complete autobiographical simulations grounded in therapeutic techniques including reminiscence, imagery rescripting and positive future thinking. Participants within the active control group will be instructed to continue with their usual social group activities.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Aug 2026Aug 2027

Study Start

First participant enrolled

August 15, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2027

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 20, 2026

Last Update Submit

August 26, 2026

Conditions

Keywords

AgingLonelinessSchemasMental Time TravelImagery RescriptingReminiscence therapyFuture Prospection

Outcome Measures

Primary Outcomes (3)

  • UCLA Loneliness Scale (Version 3)

    Items are scored on a 4-point Likert scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Always). Items 1, 5, 6, 9, 10, 15, 16, 19, and 20 are reverse scored. Total scores range from 20-80, with higher scores indicating greater levels of loneliness.

    Baseline, 1-month post baseline, 3-month follow-up, and 6-month follow-up

  • Brief Core Schema Scale (BCSS)

    Four subscales measure: (1) negative self-belief ("I am bad"), (2) negative other-belief ("Others are bad/hostile"), (3) positive self-belief ("I am good"), and (4) positive other-belief ("Others are good/trustworthy"). Items rated on 5-point Likert scale. Higher scores indicate greater endorsement within the subscale.

    Baseline, twice at each of the eight experimental group sessions, 1 month post-baseline, 3-month follow-up, 6-month follow-up

  • Positive and Negative Affect Schedule (PANAS)

    Two 10-item subscales measure positive affect (e.g., interested, excited, proud) and negative affect (e.g., distressed, fearful, guilty). Items rated on 5-point Likert scale (1 = Very slightly or not at all; 5 = Extremely). Subscale scores range from 10-50, with higher scores indicating greater positive or negative affect.

    Baseline, twice at each of the eight experimental group sessions, 1 month post-baseline, 3-month follow-up, 6-month follow-up

Secondary Outcomes (13)

  • Patient Health Questionnaire-9 (PHQ-9)

    Baseline, 1-month post-baseline , 3-month follow-up, and 6-month follow-up

  • Overall Anxiety Severity and Impairment Scale (OASIS)

    Baseline, 1-month post-baseline , 3-month follow-up, and 6-month follow-up

  • Difficulties in Emotion Regulation Scale (DERS)

    Baseline, post-intervention, 3-month follow-up, 6-month follow-up

  • Social Connectedness Scale (SCS)

    Baseline, 1 month post-baseline, 3-month follow-up, 6-month follow-up

  • Mini-Social Phobia Inventory (Mini-SPIN)

    Baseline, 1 month post-baseline, 3-month follow-up, 6-month follow-up

  • +8 more secondary outcomes

Study Arms (2)

Mental Time Travel Group

EXPERIMENTAL

Participants in this arm will participate in the 8-session Mental Time Travel group in addition to their regular social programming at the Kimel Family Centre at Baycrest.

Behavioral: Mental Time Travel GroupBehavioral: Social Engagement Group Activities

Social Engagement Control Group

ACTIVE COMPARATOR

Participants in this arm will participate in their regular social programming at the Kimel Family Centre at Baycrest.

Behavioral: Social Engagement Group Activities

Interventions

12 groups of six participants each. Groups will attend two 90- minute therapeutic sessions per week over a four-week period. A structured protocol session format will be used, including a short check-in, brief-assessment (i.e., PANAS and BCSS), the core session activity, a second brief-assessment (i.e., PANAS and BCSS), and a closing reflection. The primary session activities will consist of reminiscence induction, imagery rescripting, and positive prospection. In all these sessions, participants will be asked to write down their thoughts in response to the session prompts/exercises which they will not be required to share with the rest of the group. In addition to these sessions, participants will continue their usual weekly social group programming at the Kimel Centre.

Mental Time Travel Group

Participants in this condition will continue engaging in their usual weekly social group programming provided at the Kimel Centre. The Kimel Centre offers over 300 group-based programs across multiple categories, including Fitness \& Aquatics, Lectures \& Continued Education, Mind, Body, and Soul Wellness, Performing Arts, Nutrition \& Cooking, and Fine Arts \& Crafts, with offerings varying seasonally.

Mental Time Travel GroupSocial Engagement Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥65
  • Elevated loneliness based on a pre-specified cutoff of 44 on the UCLA version 3 Loneliness Scale (Russell, 1997)
  • Capacity to provide informed consent
  • Ability to participate in group sessions twice a week for four weeks

You may not qualify if:

  • A diagnosis of dementia, mild cognitive impairment, stroke, other neurodegenerative disorders, schizophrenia, bipolar disorder, personality disorders
  • Any condition that would limit participants' capacity to benefit from or safely and comfortably complete the protocol. Given the nature of the protocol, which involves autobiographical memory recall in a group setting, individuals with a history of trauma-related diagnoses (e.g., PTSD or acute stress disorder) and/or those who score in the severe or extremely severe range on any of the depression (≥ 21), anxiety (≥ 15), or stress (≥ 26) subscales of the DASS-21, will be excluded in order to minimize the risk of significant distress during sessions
  • Participants who are unable to complete short questionnaires at each session and online at follow-up will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest Academy for Research and Education

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (22)

  • Bluck S, Alea N. Crafting the TALE: construction of a measure to assess the functions of autobiographical remembering. Memory. 2011 Jul;19(5):470-86. doi: 10.1080/09658211.2011.590500.

    PMID: 21864212BACKGROUND
  • Lind M, R Cowan H, Adler JM, McAdams DP. Development and Validation of the Narrative Identity Self-Evaluation Scale (NISE). J Pers Assess. 2025 May-Jun;107(3):292-305. doi: 10.1080/00223891.2024.2425663. Epub 2024 Nov 15.

    PMID: 39546387BACKGROUND
  • McEvoy PM, Saulsman LM. Imagery-enhanced cognitive behavioural group therapy for social anxiety disorder: a pilot study. Behav Res Ther. 2014 Apr;55:1-6. doi: 10.1016/j.brat.2014.01.006. Epub 2014 Feb 7.

    PMID: 24561919BACKGROUND
  • Hallford DJ, Yeow JJE, Fountas G, Herrick CA, Raes F, D'Argembeau A. Changing the future: An initial test of Future Specificity Training (FeST). Behav Res Ther. 2020 Aug;131:103638. doi: 10.1016/j.brat.2020.103638. Epub 2020 May 7.

    PMID: 32416495BACKGROUND
  • Hallford, D. J., Rusanov, D., Yeow, J. J. E., Austin, D. W., D'Argembeau, A., Fuller-Tyszkiewicz, M., & Raes, F. (2023). Reducing anhedonia in major depressive disorder with future event specificity training (FEST): A randomized controlled trial. Cognitive Therapy and Research, 47(1), 20-37. https://doi.org/10.1007/s10608-022-10330-z

    BACKGROUND
  • Hallford DJ, Mellor D. Autobiographical Memory-Based Intervention for Depressive Symptoms in Young Adults: A Randomized Controlled Trial of Cognitive-Reminiscence Therapy. Psychother Psychosom. 2016;85(4):246-9. doi: 10.1159/000444417. Epub 2016 May 27. No abstract available.

    PMID: 27230870BACKGROUND
  • Hallford DJ, Hardgrove S, Sanam M, Oliveira S, Pilon M, Duran T. Remembering for resilience: Brief cognitive-reminiscence therapy improves psychological resources and mental well-being in young adults. Appl Psychol Health Well Being. 2022 Aug;14(3):1004-1021. doi: 10.1111/aphw.12364. Epub 2022 May 2.

    PMID: 35502002BACKGROUND
  • Zvelc G, Jovanoska K, Zvelc M. Development and Validation of the Relational Needs Satisfaction Scale. Front Psychol. 2020 Jun 10;11:901. doi: 10.3389/fpsyg.2020.00901. eCollection 2020.

    PMID: 32587540BACKGROUND
  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PMID: 3397865BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.

    PMID: 8576833BACKGROUND
  • Marks DF. Visual imagery differences in the recall of pictures. Br J Psychol. 1973 Feb;64(1):17-24. doi: 10.1111/j.2044-8295.1973.tb01322.x. No abstract available.

    PMID: 4742442BACKGROUND
  • Lee, R. M., Draper, M., & Lee, S. (2001). Social connectedness, dysfunctional interpersonal behaviors, and psychological distress: Testing a mediator model. Journal of Counseling Psychology, 48(3), 310-318. https://doi.org/10.1037/0022-0167.48.3.310

    BACKGROUND
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND
  • Greenwald AG, Farnham SD. Using the implicit association test to measure self-esteem and self-concept. J Pers Soc Psychol. 2000 Dec;79(6):1022-38. doi: 10.1037//0022-3514.79.6.1022.

    PMID: 11138752BACKGROUND
  • Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94

    BACKGROUND
  • Gilbert, P., McEwan, K., Mitra, R., Franks, L., Richter, A., & Rockliff, H. (2008). Feeling safe and content: A specific affect regulation system? Relationship to depression, anxiety, stress, and self-criticism. The Journal of Positive Psychology, 3(3), 182-191. https://doi.org/10.1080/17439760801999461

    BACKGROUND
  • Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, Coker S, Hodgekins J, Gracie A, Dunn G, Garety P. The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006 Jun;36(6):749-59. doi: 10.1017/S0033291706007355. Epub 2006 Mar 27.

    PMID: 16563204BACKGROUND
  • Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: A brief screening assessment for generalized social anxiety disorder. Depress Anxiety. 2001;14(2):137-40. doi: 10.1002/da.1055.

    PMID: 11668666BACKGROUND
  • Cenzer I, Torres JM, Yang Y, Romero KRF, Thoma MC, Kotwal AA. Development and Evaluation of a Brief Social Isolation Measure in the Nationally-Representative Health and Retirement Study. J Am Geriatr Soc. 2025 Dec;73(12):3807-3813. doi: 10.1111/jgs.70056. Epub 2025 Aug 29.

    PMID: 40880184BACKGROUND
  • Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009 Jan;112(1-3):92-101. doi: 10.1016/j.jad.2008.03.014. Epub 2008 May 16.

    PMID: 18486238BACKGROUND
  • Blajenkova, O., Kozhevnikov, M., & Motes, M. A. (2006). Object-spatial imagery: A new self-report imagery questionnaire. Applied Cognitive Psychology: The Official Journal of the Society for Applied Research in Memory and Cognition, 20(2), 239-263. https://doi.org/10.1002/acp.1182

    BACKGROUND

Study Officials

  • Brian Levine, Ph.D

    Baycrest Academy for Research and Education

    PRINCIPAL INVESTIGATOR
  • David Moscovitch, Ph.D

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Levine, Ph.D

CONTACT

David Moscovitch, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 28, 2026

Study Start

August 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 20, 2027

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified study data may be shared through the following mechanisms: i) Direct sharing with collaborators: De-identified data may be shared with external collaborators for secondary analysis purposes ii) Posted online in open science data repository such as the Open Science Framework. (b) Personally identifiable information, the participant code linking document and signed consent forms, will not be shared under any circumstances. (c) Given that participants disclose sensitive mental health information and personal autobiographical memories, re-identifiability is a meaningful concern. Prior to any data sharing, the dataset will be reviewed to ensure no combination of variables could reasonably identify.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
De-identified data and supporting documents will be made available on the Open Science Framework (OSF) upon publication of the primary study results, with no end date.
Access Criteria
De-identified quantitative outcome data from self-report questionnaires, along with the study protocol, statistical analysis plan, and blank informed consent form, will be stored in a controlled-access component on the Open Science Framework (OSF). Qualified researchers may request access by contacting the principal investigator with a brief description of the intended use. Requests will be reviewed for scientific merit and consistency with the original participant consent, and access will be granted subject to Research Ethics Board approval where required. Memory narratives will not be shared due to the risk of participant re-identification.

Locations