The CONNECT Program: Testing a Telephone-Based Mental Health Intervention for Older Adults

NCT05120765 | Withdrawn

• 1 other identifier: HE2021-0124
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test a telephone-based group intervention called "The CONNECT Program" which is designed for adults aged 65+ who are currently experiencing social isolation or loneliness, and symptoms of anxiety or depression. A pilot randomized controlled trial (RCT) will be conducted to evaluate The CONNECT Program using a clinical sample of adults 65+. The goals of this research include, (a) testing the feasibility of conducting a large-scale RCT using a clinical sample of adults 65+; (b) understanding the experiences of this clinical sample of adults 65+ in The CONNECT Program; and (c) investigating the preliminary effectiveness of this program with this sample. Participants (N=16) will be randomly assigned to either the waitlist or intervention group. Both groups will receive the intervention and share their experiences in The CONNECT Program. The waitlist group will receive the intervention after the waiting period. All participants will complete questionnaires before receiving the intervention, after receiving the intervention, and each week during the intervention. This study will provide us with insight regarding what this clinical sample of participants think of The CONNECT Program, how we can improve the program in the future in order to meet the needs of this group, what changes to the study design are needed in order to execute a large-scale randomized controlled trial in the future, and if this program shows preliminary effectiveness in this sample.

Conditions

Social Isolation; Loneliness; Depression; Anxiety

Keywords

Mental health problems; Adults 65+; Loneliness; Social Isolation; Intervention; Telephone therapy; Group therapy; Aging; Older adults; Clinical; Acceptance and Commitment Therapy; Self-compassion; Mindfulness

Outcome Measures

Primary Outcomes (4)

• Treatment Satisfaction and Feedback

  Measured using Group Session Rating Scale (Duncan \& Miller, 2007), and open-ended questions in the post-CONNECT questionnaire. Reference: Duncan, B., \& Miller, S. (2007). The Group Session Rating Scale. Jensen Beach, FL: Author.

  Immediately after session 1, immediately after session 2, immediately after session 3, immediately after session 4, immediately after session 5, immediately after session 6, immediately after the intervention ends

• Acceptance and Action Questionnaire II (AAQ-II) (Bond et al., 2011).

  Measures psychological flexibility

  1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)

• PROMIS (Patient-Reported Outcomes Measurement Information System) Depression Short Form 4a (Cella et al., 2010; Cella et al., 2019)

  Measures symptoms of depression

  1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)

• The PROMIS Anxiety Short Form 4a (Cella et al., 2010; Cella et al., 2019)

  Measures symptoms of anxiety

  1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)

Secondary Outcomes (5)

• Three Item Loneliness Scale (Hughes et al., 2004)

  1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)

• PROMIS Social Isolation 8a (Cella et al., 2010)

  1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)

• PROMIS Emotional Support 8a (Cella et al., 2010)

  1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)

• The Brief Measure of Mental Health Literacy Scale (Mackenzie & Reynolds, in preparation)

  1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)

• Demographic Information

  1 week before the intervention begins

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention to be administered is "The CONNECT Program". This is a 6-week, group-based, telephone-based, mental health intervention for socially isolated older adults. This group-therapy intervention is based on principles of Acceptance and Commitment Therapy (ACT).

Behavioral: The CONNECT Program

Waitlist

NO INTERVENTION

Waitlist intervention requires participants to wait 6 weeks. This waitlist group will receive the intervention after this 6 week waiting period, due to the exploratory nature of this Pilot Randomized Controlled Trial (RCT).

Interventions

The CONNECT Program BEHAVIORAL

The CONNECT Program is a 6-week, group-based, telephone-based, mental health intervention for socially isolated older adults. This group-therapy intervention is based on principles of Acceptance and Commitment Therapy (ACT). The group sessions take place once a week and they last 90 minutes each.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older, currently living in Manitoba, self-reporting symptoms of social isolation and/or loneliness, and self-reporting symptoms of depression and/or anxiety.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

The University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (4)

• Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

  PMID: 22035996 BACKGROUND

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 BACKGROUND

• Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB. PROMIS(R) Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains. Value Health. 2019 May;22(5):537-544. doi: 10.1016/j.jval.2019.02.004.

  PMID: 31104731 BACKGROUND

• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

  PMID: 18504506 BACKGROUND

Related Links

• Statistics Canada. (2019). Population Projections: Canada, provinces, and territories, 2018 to 2068. Statistics Canada.

MeSH Terms

Conditions

Social Isolation; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Inga A Christianson, BA

  The University of Manitoba

  PRINCIPAL INVESTIGATOR

• Kristin Reynolds, Ph.D.

  The University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: November 15, 2021
• Study Start: January 25, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)