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

Primary Purpose

Social Isolation, Loneliness, Depression

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The CONNECT Program
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Social Isolation focused on measuring Mental health problems, Adults 65+, Loneliness, Social Isolation, Intervention, Telephone therapy, Group therapy, Aging, Older adults, Clinical, Acceptance and Commitment Therapy, Self-compassion, Mindfulness

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 65 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.

Exclusion Criteria:

  • Under 65 years of age, living outside of Manitoba, being unable to provide consent independently, deafness not corrected by hearing aids (hearing is needed as this is a telephone program), an absence of self-reported symptoms of anxiety or depression, an absence of symptoms of loneliness or social isolation, self-reporting suicidal ideation or suicidal behaviours that are current, substance use or substance dependence within the past six months, bipolar I or II, psychotic disorders, and major neurocognitive disorders. Another exclusion criteria would be an individual who does not have access to a telephone, or is not comfortable using the telephone for the purpose of The CONNECT Program or The research components (i.e., the questionnaires).

Sites / Locations

  • The University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Waitlist

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
Acceptance and Action Questionnaire II (AAQ-II) (Bond et al., 2011).
Measures psychological flexibility
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression Short Form 4a (Cella et al., 2010; Cella et al., 2019)
Measures symptoms of depression
The PROMIS Anxiety Short Form 4a (Cella et al., 2010; Cella et al., 2019)
Measures symptoms of anxiety

Secondary Outcome Measures

Three Item Loneliness Scale (Hughes et al., 2004)
Measures feelings of loneliness
PROMIS Social Isolation 8a (Cella et al., 2010)
Measures feelings of social isolation
PROMIS Emotional Support 8a (Cella et al., 2010)
Measures emotional support
The Brief Measure of Mental Health Literacy Scale (Mackenzie & Reynolds, in preparation)
Measures mental health literacy (one's knowledge of mental health problems and services available for these mental health problems).
Demographic Information
Gender identification, age, highest level of education completed, occupational status, marital status, living arrangement, location of residence, and racial and ethnic background.

Full Information

First Posted
October 17, 2021
Last Updated
August 24, 2022
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT05120765
Brief Title
The CONNECT Program: Testing a Telephone-Based Mental Health Intervention for Older Adults
Acronym
CONNECT
Official Title
A Pilot Randomized Controlled Trial of The CONNECT Program: Testing a Telephone-Based Mental Health Intervention in a Clinical Sample of Socially Isolated Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Change in study design was implemented and the study design no longer follows a pilot randomized controlled trial.
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The population of adults aged 65+ in Canada is increasing (Statistics Canada, 2019). Some of the most common mental health and psychosocial problems experienced by adults aged 65+ include anxiety, depression, social isolation, and loneliness. The current research will test a telephone-based group intervention called "CONNECT" which is designed for adults aged 65+ who are currently experiencing social isolation or loneliness, and symptoms of anxiety or depression. CONNECT stands for: "Creating Opportunities to build social Networks, learn New skills to manage challenging emotions Enhance mindful awareness and acceptance of emotions, and increase self-Compassion, through Telephone-based group programming". A pilot randomized controlled trial will be conducted to evaluate The CONNECT Program using a clinical sample of adults 65+ recruited from Winnipeg and Brandon. We will use a randomized design to pilot this intervention and assess the feasibility of implementing and testing this intervention with a clinical sample of adults 65+. Participants will be randomized 1:1 to one of two conditions (1 = intervention, 2 = waitlist). The quantitative data we collect will inform us about changes in self-reported symptoms on the primary and secondary outcome measures and it will reveal information about treatment satisfaction and how participants experienced each session. Additionally, the questionnaire that will be administered after each session and the post-CONNECT questionnaire will include open-ended questions where participants can expand on their answers about treatment satisfaction and their experiences in the program. Within one week before the first CONNECT session, all participants will complete the baseline questionnaire and will then be randomized to one of two groups (1 = intervention, 2 = waitlist). One week after the baseline questionnaire is complete, participants in the intervention group will receive six weeks of CONNECT group therapy, and participants in the waitlist group will begin the waiting period. Within one week of the last CONNECT session, all participants will complete the post-CONNECT questionnaire. Participants receiving the intervention will also complete the Group Session Rating Scale (GSRS) after each session in order to monitor the participant progress from session to session and to evaluate the group-therapy alliance. Due to the exploratory nature of this pilot RCT, participants in the waitlist group will complete the baseline questionnaire again, they will receive the intervention and complete the GSRS each week, and they will complete post-CONNECT questionnaire one week after the last session. We plan to collect this data because we want to capture the experiences of the waitlist participants both when they are waiting for the intervention and when they receive the intervention. The purpose of including a waitlist group is to help determine if the current study procedures are acceptable. This will allow us to better understand potential issues such as participant dropout, and it will help us identify changes that should be made for a future RCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
The CONNECT Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Satisfaction and Feedback
Description
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.
Time Frame
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
Title
Acceptance and Action Questionnaire II (AAQ-II) (Bond et al., 2011).
Description
Measures psychological flexibility
Time Frame
1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Title
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression Short Form 4a (Cella et al., 2010; Cella et al., 2019)
Description
Measures symptoms of depression
Time Frame
1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Title
The PROMIS Anxiety Short Form 4a (Cella et al., 2010; Cella et al., 2019)
Description
Measures symptoms of anxiety
Time Frame
1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Secondary Outcome Measure Information:
Title
Three Item Loneliness Scale (Hughes et al., 2004)
Description
Measures feelings of loneliness
Time Frame
1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Title
PROMIS Social Isolation 8a (Cella et al., 2010)
Description
Measures feelings of social isolation
Time Frame
1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Title
PROMIS Emotional Support 8a (Cella et al., 2010)
Description
Measures emotional support
Time Frame
1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Title
The Brief Measure of Mental Health Literacy Scale (Mackenzie & Reynolds, in preparation)
Description
Measures mental health literacy (one's knowledge of mental health problems and services available for these mental health problems).
Time Frame
1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Title
Demographic Information
Description
Gender identification, age, highest level of education completed, occupational status, marital status, living arrangement, location of residence, and racial and ethnic background.
Time Frame
1 week before the intervention begins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 65 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. Exclusion Criteria: Under 65 years of age, living outside of Manitoba, being unable to provide consent independently, deafness not corrected by hearing aids (hearing is needed as this is a telephone program), an absence of self-reported symptoms of anxiety or depression, an absence of symptoms of loneliness or social isolation, self-reporting suicidal ideation or suicidal behaviours that are current, substance use or substance dependence within the past six months, bipolar I or II, psychotic disorders, and major neurocognitive disorders. Another exclusion criteria would be an individual who does not have access to a telephone, or is not comfortable using the telephone for the purpose of The CONNECT Program or The research components (i.e., the questionnaires).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inga A Christianson, BA
Organizational Affiliation
The University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin Reynolds, Ph.D.
Organizational Affiliation
The University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share this data.
Citations:
PubMed Identifier
22035996
Citation
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.
Results Reference
background
PubMed Identifier
20685078
Citation
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.
Results Reference
background
PubMed Identifier
31104731
Citation
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.
Results Reference
background
PubMed Identifier
18504506
Citation
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.
Results Reference
background
Links:
URL
https://www150.statcan.gc.ca/n1/en/daily-quotidien/190917/dq190917b-eng.pdf?st=uXx6TuhX
Description
Statistics Canada. (2019). Population Projections: Canada, provinces, and territories, 2018 to 2068. Statistics Canada.

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

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