About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Mental Time Travel Group
Behavioral12 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 Activities
BehavioralParticipants 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.
Treatment groups
Trial 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.
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.
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.
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).
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.
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.
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.
Sponsors and contacts
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