Autobiographical Time Travel to Alleviate Loneliness in Older Adults

N/ANot Yet RecruitingNCT07792356

Baycrest144 enrolled

Overview

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.

Older adults (≥65 years) from the Kimel Family Centre registry will be recruited based on a pre-specified score of loneliness. Recruitment will occur on a rolling basis through email and telephone contact, in-person booths, and information sessions. Kimel members who express interest in participating will then be emailed to schedule a time to be screened for eligibility via telephone. Prior to the telephone screening, consent forms will be sent via email for participants to review. The details of the study will be explained at the beginning of a telephone screening process. Participants will be given the opportunity to ask questions and to indicate whether they wish to continue, whereupon the screening questions will be administered to those who agree. Those who meet the eligibility criteria and provide informed consent will be scheduled for randomization into one of the two groups. Randomization will be computer-generated, stratified by baseline loneliness severity, number of other social groups taken at Kimel Family Centre, sex and gender. Participants will be randomly assigned to either: (1) Experimental condition: mental time travel protocol (reminiscence induction + imagery rescripting + positive prospection) or (2) a time-matched control condition: Kimel Centre group activities (see Arms and Interventions). Both groups will be encouraged to continue engaging with existing Kimel Centre programming throughout the study period. Both groups will complete the scheduled outcome assessments at baseline, 1-month post-baseline, 3-month follow-up, and 6-month follow-up. The experimental group will complete additional assessments throughout the experimental sessions (see Outcome measures). After completion of the main study, participants assigned to the time-matched control may be offered an opportunity to receive the structured experimental protocol, provided that the study remains active and the investigators determine that offering the protocol is appropriate.

Study Type

Interventions

Mental Time Travel GroupBEHAVIORAL

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.

Social Engagement Group ActivitiesBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

Patient Health Questionnaire-9 (PHQ-9)

Items rated on 4-point Likert scale (0 = Not at all; 3 = Nearly every day). Total scores range from 0-27, with higher scores indicating greater depressive symptom severity. Severity categories: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).

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

Overall Anxiety Severity and Impairment Scale (OASIS)

Each item is rated on a 5-point scale (0-4). Total scores range from 0-20, with higher scores indicating greater anxiety severity and impairment. A score of 8 or higher is recommended as a cut-off for clinically significant anxiety.

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

Difficulties in Emotion Regulation Scale (DERS)

Items rated on 5-point Likert scale (1 = Almost never; 5 = Almost always). Six subscales measure: (1) non-acceptance of emotional responses, (2) difficulties engaging in goal-directed behavior, (3) impulse control difficulties, (4) lack of emotional awareness, (5) limited access to emotion regulation strategies, and (6) lack of emotional clarity. Higher scores indicate greater emotion regulation difficulties.

Time frame: Baseline, post-intervention, 3-month follow-up, 6-month follow-up

Social Connectedness Scale (SCS)

Items rated on 6-point Likert scale (1 = Strongly disagree; 6 = Strongly agree). Total scores range from 20-120, with higher scores indicating greater social connectedness and sense of belonging.