Trial Outcomes & Findings for The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT) (NCT NCT07204444)
NCT ID: NCT07204444
Last Updated: 2025-11-12
Results Overview
The Social Provisions Scale (SPS-5) is a 5-item measure used to evaluate a participant's level of social support. It is a shortened version of the 10-item SPS and designed for use in research studies to reduce participant burden while maintaining strong psychometric properties. The SPS is based on a theory of social support developed by Irwin Weiss and uses one positive item to assess the social provisions of Attachment, Guidance, Social Integration, Reliable alliance, and Reassurance of worth. Each item is rated on a 4-point Likert scale, from "Strongly Disagree" to "Strongly Agree". Sample items include, "There is someone I could talk to about important decisions in my life", "I feel part of a group of people who share my attitudes and beliefs", and "There are people I can count on in an emergency." A total score is calculated by summing the responses to the 5 questions. The scores can range from 5 to 20, with higher scores indicating higher levels of perceived social support.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
671 participants
Primary outcome timeframe
Baseline, Week 2, Week 4, Week 6 and Week 8
Results posted on
2025-11-12
Participant Flow
Patients were enrolled in the study; Trained Providers/Helpers were not considered enrolled
Participant milestones
| Measure |
BE Condition
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
Overall Study
STARTED
|
236
|
227
|
208
|
|
Overall Study
COMPLETED
|
183
|
176
|
179
|
|
Overall Study
NOT COMPLETED
|
53
|
51
|
29
|
Reasons for withdrawal
| Measure |
BE Condition
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
Overall Study
Medical/Hospitalization
|
6
|
9
|
6
|
|
Overall Study
Treatment Provider Issue
|
1
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
5
|
5
|
|
Overall Study
Death
|
3
|
6
|
1
|
|
Overall Study
Unable To Reach
|
29
|
26
|
17
|
|
Overall Study
Protocol Deviation
|
3
|
2
|
0
|
Baseline Characteristics
Missing record for age for three individuals
Baseline characteristics by cohort
| Measure |
BE Condition
n=236 Participants
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 Participants
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
n=208 Participants
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
Total
n=671 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.74 years
STANDARD_DEVIATION 8.60 • n=235 Participants • Missing record for age for three individuals
|
73.97 years
STANDARD_DEVIATION 8.54 • n=225 Participants • Missing record for age for three individuals
|
73.75 years
STANDARD_DEVIATION 8.70 • n=208 Participants • Missing record for age for three individuals
|
73.82 years
STANDARD_DEVIATION 8.60 • n=668 Participants • Missing record for age for three individuals
|
|
Age, Customized
Not Reported
|
1 Participants
n=236 Participants
|
2 Participants
n=227 Participants
|
0 Participants
n=208 Participants
|
3 Participants
n=671 Participants
|
|
Age, Customized
<=18 years
|
0 Participants
n=236 Participants
|
0 Participants
n=227 Participants
|
0 Participants
n=208 Participants
|
0 Participants
n=671 Participants
|
|
Age, Customized
Between 18 and 65 years
|
28 Participants
n=236 Participants
|
25 Participants
n=227 Participants
|
23 Participants
n=208 Participants
|
76 Participants
n=671 Participants
|
|
Age, Customized
>=65 years
|
207 Participants
n=236 Participants
|
200 Participants
n=227 Participants
|
185 Participants
n=208 Participants
|
592 Participants
n=671 Participants
|
|
Sex/Gender, Customized
Female
|
150 Participants
n=236 Participants
|
149 Participants
n=227 Participants
|
126 Participants
n=208 Participants
|
425 Participants
n=671 Participants
|
|
Sex/Gender, Customized
Male
|
86 Participants
n=236 Participants
|
77 Participants
n=227 Participants
|
82 Participants
n=208 Participants
|
245 Participants
n=671 Participants
|
|
Sex/Gender, Customized
Transgender, Male to Female
|
0 Participants
n=236 Participants
|
1 Participants
n=227 Participants
|
0 Participants
n=208 Participants
|
1 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=236 Participants
|
3 Participants
n=227 Participants
|
3 Participants
n=208 Participants
|
11 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
230 Participants
n=236 Participants
|
223 Participants
n=227 Participants
|
205 Participants
n=208 Participants
|
658 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=236 Participants
|
1 Participants
n=227 Participants
|
0 Participants
n=208 Participants
|
2 Participants
n=671 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=236 Participants
|
2 Participants
n=227 Participants
|
3 Participants
n=208 Participants
|
6 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=236 Participants
|
0 Participants
n=227 Participants
|
0 Participants
n=208 Participants
|
0 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=236 Participants
|
0 Participants
n=227 Participants
|
1 Participants
n=208 Participants
|
1 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Black or African American
|
132 Participants
n=236 Participants
|
129 Participants
n=227 Participants
|
129 Participants
n=208 Participants
|
390 Participants
n=671 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=236 Participants
|
83 Participants
n=227 Participants
|
64 Participants
n=208 Participants
|
235 Participants
n=671 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=236 Participants
|
5 Participants
n=227 Participants
|
9 Participants
n=208 Participants
|
21 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=236 Participants
|
8 Participants
n=227 Participants
|
2 Participants
n=208 Participants
|
18 Participants
n=671 Participants
|
|
Region of Enrollment
United States
|
236 participants
n=236 Participants
|
227 participants
n=227 Participants
|
208 participants
n=208 Participants
|
671 participants
n=671 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: Not all individuals completed every survey question. As a result, the total number of responses for each survey was less than or equal to the arm size.
The Social Provisions Scale (SPS-5) is a 5-item measure used to evaluate a participant's level of social support. It is a shortened version of the 10-item SPS and designed for use in research studies to reduce participant burden while maintaining strong psychometric properties. The SPS is based on a theory of social support developed by Irwin Weiss and uses one positive item to assess the social provisions of Attachment, Guidance, Social Integration, Reliable alliance, and Reassurance of worth. Each item is rated on a 4-point Likert scale, from "Strongly Disagree" to "Strongly Agree". Sample items include, "There is someone I could talk to about important decisions in my life", "I feel part of a group of people who share my attitudes and beliefs", and "There are people I can count on in an emergency." A total score is calculated by summing the responses to the 5 questions. The scores can range from 5 to 20, with higher scores indicating higher levels of perceived social support.
Outcome measures
| Measure |
BE Condition
n=236 Participants
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 Participants
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
n=208 Participants
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
Social Provisions Scale (SPS-5)
Baseline
|
16.88 score on a scale
Standard Deviation 3.423
|
17 score on a scale
Standard Deviation 3.328
|
17.16 score on a scale
Standard Deviation 3.047
|
|
Social Provisions Scale (SPS-5)
Week 2
|
17.34 score on a scale
Standard Deviation 3.191
|
17.51 score on a scale
Standard Deviation 2.820
|
16.98 score on a scale
Standard Deviation 3.095
|
|
Social Provisions Scale (SPS-5)
Week 4
|
17.22 score on a scale
Standard Deviation 3.366
|
17.54 score on a scale
Standard Deviation 2.974
|
17.03 score on a scale
Standard Deviation 3.100
|
|
Social Provisions Scale (SPS-5)
Week 8
|
17.60 score on a scale
Standard Deviation 3.428
|
17.78 score on a scale
Standard Deviation 2.868
|
17.18 score on a scale
Standard Deviation 3.112
|
|
Social Provisions Scale (SPS-5)
Week 6
|
17.19 score on a scale
Standard Deviation 3.148
|
17.35 score on a scale
Standard Deviation 3.037
|
17.21 score on a scale
Standard Deviation 3.164
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: Not all individuals completed every survey question. As a result, the total number of responses for each survey was less than or equal to the arm size.
The three-item UCLA Loneliness Scale (Hughes et al., 2004) is a widely used instrument for measuring subjective feelings of loneliness. The scale assesses three core dimensions of loneliness through corresponding items: relational connectedness ("How often do you feel that you lack companionship?"), social connectedness ("How often do you feel left out?"), and self-perceived isolation ("How often do you feel isolated from others?"). Participants respond using a 3-point scale ranging from "hardly ever" to "often." Total scores range from 3 to 9, with higher scores indicating greater loneliness. The scale demonstrates good psychometric properties in middle-aged and older adult populations.
Outcome measures
| Measure |
BE Condition
n=236 Participants
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 Participants
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
n=208 Participants
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
University of California, Los Angeles Loneliness Scale
Baseline
|
5.131 score on a scale
Standard Deviation 2.016
|
5.035 score on a scale
Standard Deviation 1.984
|
4.697 score on a scale
Standard Deviation 1.849
|
|
University of California, Los Angeles Loneliness Scale
Week 2
|
4.786 score on a scale
Standard Deviation 1.923
|
4.702 score on a scale
Standard Deviation 1.829
|
4.846 score on a scale
Standard Deviation 1.761
|
|
University of California, Los Angeles Loneliness Scale
Week 4
|
4.614 score on a scale
Standard Deviation 1.807
|
4.670 score on a scale
Standard Deviation 1.854
|
4.737 score on a scale
Standard Deviation 1.795
|
|
University of California, Los Angeles Loneliness Scale
Week 6
|
4.628 score on a scale
Standard Deviation 1.880
|
4.372 score on a scale
Standard Deviation 1.761
|
4.525 score on a scale
Standard Deviation 1.800
|
|
University of California, Los Angeles Loneliness Scale
Week 8
|
4.448 score on a scale
Standard Deviation 1.717
|
4.455 score on a scale
Standard Deviation 1.703
|
4.346 score on a scale
Standard Deviation 1.771
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8Population: Not all individuals completed every survey question. As a result, the total number of responses for each survey was less than or equal to the arm size.
The GAD-7 is a 7-item questionnaire designed to assess the symptoms of Generalized Anxiety Disorder (GAD). Each item describes a common GAD symptom and is rated on a four-point scale (0-3) based on how often the individual has experienced that symptom over the past 2 weeks. The 7 questions assess feelings such as nervousness, inability to control worrying, trouble relaxing, restlessness, irritability, and feeling afraid. Sample items include, "how often have you felt nervous, anxious, or on edge", "how often have you worried too much about different things", "how often have you had trouble relaxing", and "fFelt afraid as if something awful might happen." Total scores range from 0 to 21, with higher scores indicating increased anxiety severity. Scores are categorized as: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety).
Outcome measures
| Measure |
BE Condition
n=236 Participants
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 Participants
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
n=208 Participants
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
Generalized Anxiety Disorder (GAD-7)
Baseline
|
4.919 score on a scale
Standard Deviation 5.447
|
4.544 score on a scale
Standard Deviation 5.135
|
4.433 score on a scale
Standard Deviation 4.838
|
|
Generalized Anxiety Disorder (GAD-7)
Week 2
|
4.005 score on a scale
Standard Deviation 4.713
|
4.074 score on a scale
Standard Deviation 5.019
|
4.851 score on a scale
Standard Deviation 4.778
|
|
Generalized Anxiety Disorder (GAD-7)
Week 4
|
4.277 score on a scale
Standard Deviation 5.103
|
4.083 score on a scale
Standard Deviation 4.893
|
4.489 score on a scale
Standard Deviation 4.542
|
|
Generalized Anxiety Disorder (GAD-7)
Week 6
|
3.628 score on a scale
Standard Deviation 4.318
|
3.616 score on a scale
Standard Deviation 4.928
|
4.295 score on a scale
Standard Deviation 5.025
|
|
Generalized Anxiety Disorder (GAD-7)
Week 8
|
3.794 score on a scale
Standard Deviation 4.759
|
3.546 score on a scale
Standard Deviation 4.586
|
3.855 score on a scale
Standard Deviation 4.670
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: Not all individuals completed every survey question. As a result, the total number of responses for each survey was less than or equal to the arm size.
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure to assess depressive symptoms in the past 2 weeks (Kroenke et al., 2001). The scale items correspond to the 9 diagnostic criteria for major depressive disorder. Respondents rate the frequency of each symptom on a 4-point scale ranging from "not at all" to "nearly every day." Sample items include "Little interest or pleasure in doing things" and "Poor appetite or overeating." Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. The PHQ-9 includes an additional functional impairment item that assesses how much the problems have affected the respondents' daily activities. The scale has shown strong psychometric properties across diverse populations. Among U.S. older adults, the PHQ-9 showed high sensitivity (88%) and specificity (80%) for identifying major depression, as well as the combination of major and minor depression (Phelan et al., 2010).
Outcome measures
| Measure |
BE Condition
n=236 Participants
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 Participants
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
n=208 Participants
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
Patient Health Questionnaire - PHQ-9
Baseline
|
5.768 score on a scale
Standard Deviation 5.655
|
5.404 score on a scale
Standard Deviation 5.419
|
5.433 score on a scale
Standard Deviation 5.318
|
|
Patient Health Questionnaire - PHQ-9
Week 2
|
5.077 score on a scale
Standard Deviation 5.641
|
4.759 score on a scale
Standard Deviation 4.742
|
5.342 score on a scale
Standard Deviation 4.860
|
|
Patient Health Questionnaire - PHQ-9
Week 4
|
4.908 score on a scale
Standard Deviation 5.709
|
4.692 score on a scale
Standard Deviation 5.287
|
5.349 score on a scale
Standard Deviation 5.134
|
|
Patient Health Questionnaire - PHQ-9
Week 6
|
4.680 score on a scale
Standard Deviation 5.314
|
3.797 score on a scale
Standard Deviation 4.263
|
5.098 score on a scale
Standard Deviation 5.467
|
|
Patient Health Questionnaire - PHQ-9
Week 8
|
4.661 score on a scale
Standard Deviation 5.275
|
4.229 score on a scale
Standard Deviation 4.901
|
5.017 score on a scale
Standard Deviation 5.431
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: Not all individuals completed every survey question. As a result, the total number of responses for each survey was less than or equal to the arm size.
The Short Form Health Survey (SF-12) is a self-reported outcome measure to assess health-related quality of life. The raw answers from the 12 questions are processed to produce two main, standardized summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). We only used the MCS factor in this study as the treatment is targeting mental health. The MCS computed score has a range from 17 to 64 in the analysis and was based on the linear combination of six computed, generated, iterated weights. A low Mental Component Summary (MCS) score indicates poorer self-perceived mental health and lower health-related quality of life.
Outcome measures
| Measure |
BE Condition
n=236 Participants
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 Participants
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
n=208 Participants
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
Short Form Health Survey (SF-12)
Week 2
|
45.59 score on a scale
Standard Deviation 11.57
|
45.56 score on a scale
Standard Deviation 11.30
|
44.73 score on a scale
Standard Deviation 10.71
|
|
Short Form Health Survey (SF-12)
Baseline
|
44.02 score on a scale
Standard Deviation 11.61
|
44.17 score on a scale
Standard Deviation 11.61
|
44.24 score on a scale
Standard Deviation 11.78
|
|
Short Form Health Survey (SF-12)
Week 4
|
46.79 score on a scale
Standard Deviation 12.19
|
46.42 score on a scale
Standard Deviation 11.37
|
45.32 score on a scale
Standard Deviation 11.07
|
|
Short Form Health Survey (SF-12)
Week 6
|
46.49 score on a scale
Standard Deviation 11.86
|
47.46 score on a scale
Standard Deviation 10.85
|
45.59 score on a scale
Standard Deviation 11.24
|
|
Short Form Health Survey (SF-12)
Week 8
|
47.19 score on a scale
Standard Deviation 11.89
|
47.52 score on a scale
Standard Deviation 11.48
|
46.07 score on a scale
Standard Deviation 10.93
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: Not all individuals completed every survey question. As a result, the total number of responses for each survey was less than or equal to the arm size.
The Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012) was used to evaluate thwarted belongingness and perceived burdensomeness through 15 items. We used an adapted version tailored specifically for older adults which includes 3-point Likert scale ranging from 1 (Not at all true for me) to 3 (Very true for me). The instrument includes 2 sets of characteristics: (1) the 9-item Thwarted Belongingness (e.g., "I feel disconnected from other people."); and (2) the 6-item Perceived Burdensomeness (e.g., "I think my death would be a relief to the people in my life."). Six questions from the Thwarted Belongingness subscale were reverse-coded when the overall score across questions was computed due to the nature of those questions. In particular, the total score on the INQ is calculated by summing the questions responses to all items and reversing the appropriate ones. As a result, greater scores on each subscale reflect higher levels of the respective construct being measured.
Outcome measures
| Measure |
BE Condition
n=236 Participants
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 Participants
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
n=208 Participants
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
Interpersonal Needs Questionnaire (INQ-15)
Baseline
|
19.06 score on a scale
Standard Deviation 5.396
|
18.83 score on a scale
Standard Deviation 5.336
|
18.59 score on a scale
Standard Deviation 4.742
|
|
Interpersonal Needs Questionnaire (INQ-15)
Week 2
|
18.68 score on a scale
Standard Deviation 5.384
|
18.36 score on a scale
Standard Deviation 5.028
|
18.24 score on a scale
Standard Deviation 4.497
|
|
Interpersonal Needs Questionnaire (INQ-15)
Week 4
|
18.35 score on a scale
Standard Deviation 5.341
|
18.05 score on a scale
Standard Deviation 5.113
|
18.36 score on a scale
Standard Deviation 5.137
|
|
Interpersonal Needs Questionnaire (INQ-15)
Week 6
|
18.77 score on a scale
Standard Deviation 5.163
|
17.81 score on a scale
Standard Deviation 4.757
|
18.15 score on a scale
Standard Deviation 5.353
|
|
Interpersonal Needs Questionnaire (INQ-15)
Week 8
|
18.22 score on a scale
Standard Deviation 5.062
|
17.89 score on a scale
Standard Deviation 5.253
|
18.05 score on a scale
Standard Deviation 4.982
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The SRS is designed to provide therapists with immediate feedback on how the client is experiencing the therapeutic relationship and session. The study control group does not applicable for this measurement. Nothing is measured at baseline.
The 4-item Session Rating Scale is a therapeutic practice measure that treatment recipients complete after receiving treatment. This allows trained helpers to make real-time adjustments to improve treatment effectiveness and prevent dropout. Participants marked their responses on a Likert-Scale, ranging from 0 to 10, representing: (a) the quality of the therapeutic relationship, (b) agreement on goals and topics, (c) the relevance and fit of the treatment provider's approach, and (d) the overall effectiveness of the treatment dosage. The scores for each domain were summed to generate a total possible score of 40. A total score below 36 or a score below 9 on any single item is a potential indicator of concern, which should prompt the therapist to discuss the issue openly with the client and make necessary adjustments to the session's direction or approach.
Outcome measures
| Measure |
BE Condition
n=236 Participants
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 Participants
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
Session Rating Scale
Week 2
|
38.65 score on a scale
Standard Deviation 3.809
|
38.34 score on a scale
Standard Deviation 3.186
|
—
|
|
Session Rating Scale
Week 4
|
38.86 score on a scale
Standard Deviation 3.106
|
38.86 score on a scale
Standard Deviation 3.227
|
—
|
|
Session Rating Scale
Week 6
|
38.92 score on a scale
Standard Deviation 2.652
|
38.89 score on a scale
Standard Deviation 3.010
|
—
|
|
Session Rating Scale
Week 8
|
39.28 score on a scale
Standard Deviation 2.198
|
39.24 score on a scale
Standard Deviation 2.688
|
—
|
Adverse Events
BE Condition
Serious events: 6 serious events
Other events: 0 other events
Deaths: 3 deaths
BE + ASIST Condition
Serious events: 9 serious events
Other events: 0 other events
Deaths: 6 deaths
Control
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BE Condition
n=236 participants at risk
The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components:
1. reciprocity: the feeling that both parties are benefiting
2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes)
3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters
4. proximity: feeling more connected to people within your community
5. autonomy: feeling both parties are willingly participating with each connection
standardized and manualized warm calls from providers trained in the BE training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
BE + ASIST Condition
n=227 participants at risk
The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)
standardized and manualized warm calls from providers trained in the BE training + ASIST training: Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration
|
Control
n=208 participants at risk
participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.
|
|---|---|---|---|
|
General disorders
Medical/Hospitalization
|
2.5%
6/236 • Adverse events were collected from subject consent up to 200 days.
|
4.0%
9/227 • Adverse events were collected from subject consent up to 200 days.
|
2.9%
6/208 • Adverse events were collected from subject consent up to 200 days.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place