NCT05932342

Brief Summary

The I-COACH study will focus on seniors with mental health conditions who are living in senior community housing. This initiative proposes to assess the feasibility and acceptability of a 12-week integrated program of cognitive remediation (CR) in combination with social and physical activity using an open-label design. The program will be provided over three iterative groups of six participants each, with one Personal Support Worker (PSW). The program will be co-designed at a granular level in an iterative process, drawing upon feedback provided by each participant group, PSW, and community housing staff to improve the user experience. We will build the capacity for community personal support workers (PSWs) to deliver this program independently and with fidelity to the intervention model. Our ultimate goal is to help seniors continue to live as long as possible in their homes within the community.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress53%
Jul 2023Dec 2028

First Submitted

Initial submission to the registry

June 27, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

July 4, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.4 years

First QC Date

June 27, 2023

Last Update Submit

April 7, 2026

Conditions

Keywords

cognitive remediationsocial activityexerciseagingcommunity

Outcome Measures

Primary Outcomes (5)

  • Participant's satisfaction

    This is measured using the Satisfaction Survey which assesses participants' agreement on 10 statements each measuring the degree of agreement or disagreement of participants using a 7-point Likert Scale. Minimum score is 10 and maximum score is 70. Higher scores indicate better satisfaction.

    end of week 12 of the intervention

  • Acceptability and Usability of Cognitive Remediation

    This is assessed using the System Usability Scale (SUS). The scale is comprised of 10 statements each measuring the degree of agreement or disagreement of participants using 5 -point Likert Scale. Minimum score is 0 and maximum is 100. Higher scores indicate better usability.

    end of week 12 of the intervention

  • Participants' feedback of the program

    Semi-structured qualitative interview

    end of week 12 of the intervention

  • Staff Feedback of the program

    Semi-structured qualitative interview

    Within one week from the end of week 12 of the intervention

  • Sessions and overall program attendance

    Attendance logs

    end of week 12 of the intervention

Secondary Outcomes (1)

  • Staff Feedback of the delivery of the program

    Within one week from the end of week 12 of the intervention

Study Arms (1)

Integrated program of cognitive remediation, physical exercise and socially- stimulating activity

EXPERIMENTAL

Cognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life. The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement. The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport. The integrated, 12-week, group-based program consists of CR 1h/day, 2 days/week, 30min of physical exercises 1day/week and 1h of socially stimulating activities 1day/week

Behavioral: Integrated program of cognitive remediation, physical exercise and socially stimulating activity

Interventions

Cognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life. The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement. The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport.

Integrated program of cognitive remediation, physical exercise and socially- stimulating activity

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 years and above. The rationale of age cutoff of 50 is that this age is considered a typical geriatric age cutoff especially for people with severe mental illness
  • Any race or ethnicity
  • Any gender identity
  • Meets DSM-V criteria for any disorder
  • Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in psychotropic medication dosage within the 4 weeks prior to assessment, and (3) ascertained to be clinically and medically stable by one the study psychiatrists.
  • Willingness and ability to speak English
  • Willingness to provide informed consent or assent as applicable.
  • Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice. Both vision and hearing ability will be assessed by asking the participant if they can see the text and hear the research personnel during the screening consent and enrolment process.

You may not qualify if:

  • Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine
  • Has profound cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (14)

  • Gilmer T, Ojeda VD, Folsom D, Fuentes D, Criado V, Garcia P, Jeste DV. Costs of community-based public mental health services for older adults: variations related to age and diagnosis. Int J Geriatr Psychiatry. 2006 Dec;21(12):1121-6. doi: 10.1002/gps.1616.

    PMID: 16977681BACKGROUND
  • Bangor A, Kortum PT,Miller JT: An Empirical Evaluation of the System Usability Scale. International Journal of Human Computer Interaction 2008; 24:574-594

    BACKGROUND
  • Arrieta H, Rezola-Pardo C, Echeverria I, Iturburu M, Gil SM, Yanguas JJ, Irazusta J, Rodriguez-Larrad A. Physical activity and fitness are associated with verbal memory, quality of life and depression among nursing home residents: preliminary data of a randomized controlled trial. BMC Geriatr. 2018 Mar 27;18(1):80. doi: 10.1186/s12877-018-0770-y.

    PMID: 29580209BACKGROUND
  • Gremeaux V, Gayda M, Lepers R, Sosner P, Juneau M, Nigam A. Exercise and longevity. Maturitas. 2012 Dec;73(4):312-7. doi: 10.1016/j.maturitas.2012.09.012. Epub 2012 Oct 11.

    PMID: 23063021BACKGROUND
  • Vagetti GC, Barbosa Filho VC, Moreira NB, Oliveira Vd, Mazzardo O, Campos Wd. Association between physical activity and quality of life in the elderly: a systematic review, 2000-2012. Braz J Psychiatry. 2014 Jan-Mar;36(1):76-88. doi: 10.1590/1516-4446-2012-0895. Epub 2014 Jan 17.

    PMID: 24554274BACKGROUND
  • Glass TA, De Leon CF, Bassuk SS, Berkman LF. Social engagement and depressive symptoms in late life: longitudinal findings. J Aging Health. 2006 Aug;18(4):604-28. doi: 10.1177/0898264306291017.

    PMID: 16835392BACKGROUND
  • Cornwell EY, Waite LJ. Social disconnectedness, perceived isolation, and health among older adults. J Health Soc Behav. 2009 Mar;50(1):31-48. doi: 10.1177/002214650905000103.

    PMID: 19413133BACKGROUND
  • McHugh JE, Lawlor BA. Exercise and social support are associated with psychological distress outcomes in a population of community-dwelling older adults. J Health Psychol. 2012 Sep;17(6):833-44. doi: 10.1177/1359105311423861. Epub 2011 Nov 22.

    PMID: 22108290BACKGROUND
  • Krivanek TJ, Gale SA, McFeeley BM, Nicastri CM, Daffner KR. Promoting Successful Cognitive Aging: A Ten-Year Update. J Alzheimers Dis. 2021;81(3):871-920. doi: 10.3233/JAD-201462.

    PMID: 33935078BACKGROUND
  • Reijnders J, van Heugten C, van Boxtel M. Cognitive interventions in healthy older adults and people with mild cognitive impairment: a systematic review. Ageing Res Rev. 2013 Jan;12(1):263-75. doi: 10.1016/j.arr.2012.07.003. Epub 2012 Jul 25.

    PMID: 22841936BACKGROUND
  • Golas AC, Kalache SM, Tsoutsoulas C, Mulsant BH, Bowie CR, Rajji TK. Cognitive remediation for older community-dwelling individuals with schizophrenia: a pilot and feasibility study. Int J Geriatr Psychiatry. 2015 Nov;30(11):1129-34. doi: 10.1002/gps.4329. Epub 2015 Aug 6.

    PMID: 26250542BACKGROUND
  • Harvey PD, Bowie CR. Cognitive enhancement in schizophrenia: pharmacological and cognitive remediation approaches. Psychiatr Clin North Am. 2012 Sep;35(3):683-98. doi: 10.1016/j.psc.2012.06.008. Epub 2012 Jul 15.

    PMID: 22929873BACKGROUND
  • Kurtz MM. Cognitive remediation for schizophrenia: current status, biological correlates and predictors of response. Expert Rev Neurother. 2012 Jul;12(7):813-21. doi: 10.1586/ern.12.71.

    PMID: 22853789BACKGROUND
  • HAPPYneuron I: Scientific Brain Training PRO, Campbell, CA, USA, 2009.

    BACKGROUND

MeSH Terms

Conditions

Mental DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Angela Golas, MD

    Center for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The intervention will be provided over 3 iterative group of 6 participants each
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

July 4, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations