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

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05120765
• Other study ID #: HE2021-0124
• Status: Withdrawn
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: August 2022

Study information

• Verified date: August 2022
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Loneliness
• Social Isolation

Intervention

Behavioral:
• The CONNECT Program
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.

Locations

Country	Name	City	State
Canada	The University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & 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. — View 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(®) 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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	Three Item Loneliness Scale (Hughes et al., 2004)	Measures feelings of loneliness	1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Secondary	PROMIS Social Isolation 8a (Cella et al., 2010)	Measures feelings of social isolation	1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Secondary	PROMIS Emotional Support 8a (Cella et al., 2010)	Measures emotional support	1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Secondary	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).	1 week before the intervention begins, immediately after intervention ends (approximately 7 weeks)
Secondary	Demographic Information	Gender identification, age, highest level of education completed, occupational status, marital status, living arrangement, location of residence, and racial and ethnic background.	1 week before the intervention begins

External Links

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