Skip to content

The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)

Equipping the Aging Network to Address Social Isolation, Loneliness, and Elevated Suicide Risk Among Vulnerable Older Adults: A Partially Nested Randomized Controlled Trial of the BE WITH Innovation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07204444
Acronym
BE_WITH
Enrollment
671
Registered
2025-10-02
Start date
2021-06-01
Completion date
2024-10-25
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Help-Seeking Behavior, Loneliness, Mental Health, Older Adults, Perceived Burdensomeness, Quality of Life, Social Functioning, Social Isolation, Suicide Ideations, Suicide Risk, Thwarted Belongingness

Keywords

mental health clinical trial for older adults

Brief summary

The goal of this clinical trial is to learn if the BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation delivered to older adults improves their mental health. It will also learn about the treatment components that led to improvements. The main questions it aims to answer are: 1. Over the course of the 8 week standardized and manualized warm calling treatment, are mental health outcomes improved for the BE and BE + ASIST (Applied Suicide Intervention Skills Training) treatment conditions relative to a control group? 2. Are there differential outcomes for older adults who start the treatment at low, medium, or high risk? (as defined by a baseline aggregate of measures)? 3. How is this improvement manifested for particular aspects of mental health (i.e. depression, social needs, suicide desire, and overall quality of life)? Participants will: 1. answer questions from a trained data collector to get their baseline, 2. receive 8 weeks of warm calls for 2 months (if assigned to one of the 2 treatment conditions, if assigned to control they will have the option to receive treatment at a later time), and (c) be assessed every 2 weeks.

Detailed description

This study is a partially nested randomized controlled trial research design (PN-RCT) with a two-level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions which receive calls. Given that outcomes for older adults receiving calls from the same treatment provider may be more similar than for those who receive calls from a different provider, the use of multilevel modeling can account for these data dependencies. The investigators will be investigating 1) how our BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation reduces social isolation, loneliness, and elevated suicidality among home delivered meal and former congregate meal clients and improves their social support and well-being. Social isolation, loneliness, and elevated suicidality will be operationalized through a combination of validated psychometric measures taken before, during, and after the structured 8-week intervention. For older adults receiving calls, data from validated measures will be triangulated with behavioral observations of the older adults' emotional states based upon a structured analysis of recorded audio files. The investigators hypothesize that older adults in both treatment conditions will have reduced: social isolation, loneliness, depression, mental health distress, and suicide desire; and they will have increased: social connection, social support, and well-being over time and in comparison to those in the control condition. The investigators will also investigate 2) how BE WITH improves the frequency of empathic and suicide intervention best practice behaviors by trained nutrition service providers. This will be demonstrated in both real-world settings and in situations where a research confederate presents a clinically heightened risk of social isolation, loneliness, and elevated suicidality. Evaluation of counseling skills and suicide intervention skills is challenging, as observations of caregivers working with clients are required. We hypothesize that those trained in both conditions will demonstrate positive global counseling behaviors; however, those trained in BE WITH will more often employ suicide intervention practices when needed.

Interventions

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration

Sponsors

Georgia State University
CollaboratorOTHER
Department of Health and Human Services
CollaboratorFED
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Methodologist

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for older adult participants: 1. Provision of verbal informed consent, 2. Classify as an Older Adult (55+), 3. Stated willingness and ability to comply with all study procedures, 4. Receive nutrition services through the Aging Services Network (i.e. either HDM (home delivered meals services) or CM (congregate meals)), and 5. Be affiliated with one of the 25 senior centers we will contract with through a Memorandum of Understanding. Inclusion Criteria for trained providers: 1. Provision of written informed consent, 2. State willingness to comply with all study procedures, 3. Be a staff or volunteer within the ASN (Aging Services Network), specifically within the 25 senior centers we are working with, 4. Meet criteria identified by Wymann and colleagues (2009) for being a natural helpers (i.e. be warm, empathic, and having ongoing interaction with participants through one's job role), and 5. Be recommended by the senior center leadership as meeting these qualifications.

Exclusion criteria

for older adult participants: 1. Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation, and 2. Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state. The reasons given to exclude participants with dementia/cognitive impairment diagnoses from large-scale clinical research are partially related to the concern of a potential risk of abuse and exploitation. Further, those with cognitive impairment are not able to give informed consent, and there are measurement challenges with behavioral health data.

Design outcomes

Primary

MeasureTime frameDescription
Generalized Anxiety Disorder (GAD-7)Baseline, Week 2, Week 4, Week 6, Week 8The 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).
Social Provisions Scale (SPS-5)Baseline, Week 2, Week 4, Week 6 and Week 8The 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.
University of California, Los Angeles Loneliness ScaleBaseline, Week 2, Week 4, Week 6 and Week 8The 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.
Interpersonal Needs Questionnaire (INQ-15)Baseline, Week 2, Week 4, Week 6 and Week 8The 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.
Patient Health Questionnaire - PHQ-9Baseline, Week 2, Week 4, Week 6 and Week 8The 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).
Short Form Health Survey (SF-12)Baseline, Week 2, Week 4, Week 6 and Week 8The 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.

Secondary

MeasureTime frameDescription
Session Rating ScaleBaseline, Week 2, Week 4, Week 6 and Week 8The 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.

Countries

United States

Participant flow

Recruitment details

Patients were enrolled in the study; Trained Providers/Helpers were not considered enrolled

Participants by arm

ArmCount
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
236
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
227
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.
208
Total671

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath361
Overall StudyMedical/Hospitalization696
Overall StudyProtocol Deviation320
Overall StudyTreatment Provider Issue130
Overall StudyUnable To Reach292617
Overall StudyWithdrawal by Subject1155

Baseline characteristics

CharacteristicBE ConditionBE + ASIST ConditionControlTotal
Age, Continuous73.74 years
STANDARD_DEVIATION 8.6
73.97 years
STANDARD_DEVIATION 8.54
73.75 years
STANDARD_DEVIATION 8.7
73.82 years
STANDARD_DEVIATION 8.6
Age, Customized
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Customized
>=65 years
207 Participants200 Participants185 Participants592 Participants
Age, Customized
Between 18 and 65 years
28 Participants25 Participants23 Participants76 Participants
Age, Customized
Not Reported
1 Participants2 Participants0 Participants3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants3 Participants3 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
230 Participants223 Participants205 Participants658 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants3 Participants6 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
132 Participants129 Participants129 Participants390 Participants
Race (NIH/OMB)
More than one race
7 Participants5 Participants9 Participants21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants8 Participants2 Participants18 Participants
Race (NIH/OMB)
White
88 Participants83 Participants64 Participants235 Participants
Region of Enrollment
United States
236 participants227 participants208 participants671 participants
Sex/Gender, Customized
Female
150 Participants149 Participants126 Participants425 Participants
Sex/Gender, Customized
Male
86 Participants77 Participants82 Participants245 Participants
Sex/Gender, Customized
Transgender, Male to Female
0 Participants1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
3 / 2366 / 2271 / 208
other
Total, other adverse events
0 / 2360 / 2270 / 208
serious
Total, serious adverse events
6 / 2369 / 2276 / 208

Outcome results

Primary

Generalized Anxiety Disorder (GAD-7)

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).

Time frame: Baseline, Week 2, Week 4, Week 6, Week 8

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BE ConditionGeneralized Anxiety Disorder (GAD-7)Baseline4.919 score on a scaleStandard Deviation 5.447
BE ConditionGeneralized Anxiety Disorder (GAD-7)Week 63.628 score on a scaleStandard Deviation 4.318
BE ConditionGeneralized Anxiety Disorder (GAD-7)Week 44.277 score on a scaleStandard Deviation 5.103
BE ConditionGeneralized Anxiety Disorder (GAD-7)Week 83.794 score on a scaleStandard Deviation 4.759
BE ConditionGeneralized Anxiety Disorder (GAD-7)Week 24.005 score on a scaleStandard Deviation 4.713
BE + ASIST ConditionGeneralized Anxiety Disorder (GAD-7)Week 44.083 score on a scaleStandard Deviation 4.893
BE + ASIST ConditionGeneralized Anxiety Disorder (GAD-7)Baseline4.544 score on a scaleStandard Deviation 5.135
BE + ASIST ConditionGeneralized Anxiety Disorder (GAD-7)Week 24.074 score on a scaleStandard Deviation 5.019
BE + ASIST ConditionGeneralized Anxiety Disorder (GAD-7)Week 63.616 score on a scaleStandard Deviation 4.928
BE + ASIST ConditionGeneralized Anxiety Disorder (GAD-7)Week 83.546 score on a scaleStandard Deviation 4.586
ControlGeneralized Anxiety Disorder (GAD-7)Week 83.855 score on a scaleStandard Deviation 4.67
ControlGeneralized Anxiety Disorder (GAD-7)Week 64.295 score on a scaleStandard Deviation 5.025
ControlGeneralized Anxiety Disorder (GAD-7)Baseline4.433 score on a scaleStandard Deviation 4.838
ControlGeneralized Anxiety Disorder (GAD-7)Week 44.489 score on a scaleStandard Deviation 4.542
ControlGeneralized Anxiety Disorder (GAD-7)Week 24.851 score on a scaleStandard Deviation 4.778
Primary

Interpersonal Needs Questionnaire (INQ-15)

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.

Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BE ConditionInterpersonal Needs Questionnaire (INQ-15)Week 418.35 score on a scaleStandard Deviation 5.341
BE ConditionInterpersonal Needs Questionnaire (INQ-15)Week 218.68 score on a scaleStandard Deviation 5.384
BE ConditionInterpersonal Needs Questionnaire (INQ-15)Week 618.77 score on a scaleStandard Deviation 5.163
BE ConditionInterpersonal Needs Questionnaire (INQ-15)Baseline19.06 score on a scaleStandard Deviation 5.396
BE ConditionInterpersonal Needs Questionnaire (INQ-15)Week 818.22 score on a scaleStandard Deviation 5.062
BE + ASIST ConditionInterpersonal Needs Questionnaire (INQ-15)Baseline18.83 score on a scaleStandard Deviation 5.336
BE + ASIST ConditionInterpersonal Needs Questionnaire (INQ-15)Week 218.36 score on a scaleStandard Deviation 5.028
BE + ASIST ConditionInterpersonal Needs Questionnaire (INQ-15)Week 418.05 score on a scaleStandard Deviation 5.113
BE + ASIST ConditionInterpersonal Needs Questionnaire (INQ-15)Week 617.81 score on a scaleStandard Deviation 4.757
BE + ASIST ConditionInterpersonal Needs Questionnaire (INQ-15)Week 817.89 score on a scaleStandard Deviation 5.253
ControlInterpersonal Needs Questionnaire (INQ-15)Week 618.15 score on a scaleStandard Deviation 5.353
ControlInterpersonal Needs Questionnaire (INQ-15)Week 218.24 score on a scaleStandard Deviation 4.497
ControlInterpersonal Needs Questionnaire (INQ-15)Baseline18.59 score on a scaleStandard Deviation 4.742
ControlInterpersonal Needs Questionnaire (INQ-15)Week 418.36 score on a scaleStandard Deviation 5.137
ControlInterpersonal Needs Questionnaire (INQ-15)Week 818.05 score on a scaleStandard Deviation 4.982
Primary

Patient Health Questionnaire - PHQ-9

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).

Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BE ConditionPatient Health Questionnaire - PHQ-9Week 84.661 score on a scaleStandard Deviation 5.275
BE ConditionPatient Health Questionnaire - PHQ-9Week 44.908 score on a scaleStandard Deviation 5.709
BE ConditionPatient Health Questionnaire - PHQ-9Baseline5.768 score on a scaleStandard Deviation 5.655
BE ConditionPatient Health Questionnaire - PHQ-9Week 25.077 score on a scaleStandard Deviation 5.641
BE ConditionPatient Health Questionnaire - PHQ-9Week 64.680 score on a scaleStandard Deviation 5.314
BE + ASIST ConditionPatient Health Questionnaire - PHQ-9Baseline5.404 score on a scaleStandard Deviation 5.419
BE + ASIST ConditionPatient Health Questionnaire - PHQ-9Week 84.229 score on a scaleStandard Deviation 4.901
BE + ASIST ConditionPatient Health Questionnaire - PHQ-9Week 24.759 score on a scaleStandard Deviation 4.742
BE + ASIST ConditionPatient Health Questionnaire - PHQ-9Week 44.692 score on a scaleStandard Deviation 5.287
BE + ASIST ConditionPatient Health Questionnaire - PHQ-9Week 63.797 score on a scaleStandard Deviation 4.263
ControlPatient Health Questionnaire - PHQ-9Week 85.017 score on a scaleStandard Deviation 5.431
ControlPatient Health Questionnaire - PHQ-9Baseline5.433 score on a scaleStandard Deviation 5.318
ControlPatient Health Questionnaire - PHQ-9Week 45.349 score on a scaleStandard Deviation 5.134
ControlPatient Health Questionnaire - PHQ-9Week 65.098 score on a scaleStandard Deviation 5.467
ControlPatient Health Questionnaire - PHQ-9Week 25.342 score on a scaleStandard Deviation 4.86
Primary

Short Form Health Survey (SF-12)

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.

Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BE ConditionShort Form Health Survey (SF-12)Baseline44.02 score on a scaleStandard Deviation 11.61
BE ConditionShort Form Health Survey (SF-12)Week 646.49 score on a scaleStandard Deviation 11.86
BE ConditionShort Form Health Survey (SF-12)Week 446.79 score on a scaleStandard Deviation 12.19
BE ConditionShort Form Health Survey (SF-12)Week 847.19 score on a scaleStandard Deviation 11.89
BE ConditionShort Form Health Survey (SF-12)Week 245.59 score on a scaleStandard Deviation 11.57
BE + ASIST ConditionShort Form Health Survey (SF-12)Week 847.52 score on a scaleStandard Deviation 11.48
BE + ASIST ConditionShort Form Health Survey (SF-12)Week 245.56 score on a scaleStandard Deviation 11.3
BE + ASIST ConditionShort Form Health Survey (SF-12)Week 446.42 score on a scaleStandard Deviation 11.37
BE + ASIST ConditionShort Form Health Survey (SF-12)Week 647.46 score on a scaleStandard Deviation 10.85
BE + ASIST ConditionShort Form Health Survey (SF-12)Baseline44.17 score on a scaleStandard Deviation 11.61
ControlShort Form Health Survey (SF-12)Week 445.32 score on a scaleStandard Deviation 11.07
ControlShort Form Health Survey (SF-12)Week 244.73 score on a scaleStandard Deviation 10.71
ControlShort Form Health Survey (SF-12)Baseline44.24 score on a scaleStandard Deviation 11.78
ControlShort Form Health Survey (SF-12)Week 645.59 score on a scaleStandard Deviation 11.24
ControlShort Form Health Survey (SF-12)Week 846.07 score on a scaleStandard Deviation 10.93
Primary

Social Provisions Scale (SPS-5)

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.

Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BE ConditionSocial Provisions Scale (SPS-5)Week 617.19 score on a scaleStandard Deviation 3.148
BE ConditionSocial Provisions Scale (SPS-5)Week 417.22 score on a scaleStandard Deviation 3.366
BE ConditionSocial Provisions Scale (SPS-5)Baseline16.88 score on a scaleStandard Deviation 3.423
BE ConditionSocial Provisions Scale (SPS-5)Week 217.34 score on a scaleStandard Deviation 3.191
BE ConditionSocial Provisions Scale (SPS-5)Week 817.60 score on a scaleStandard Deviation 3.428
BE + ASIST ConditionSocial Provisions Scale (SPS-5)Week 417.54 score on a scaleStandard Deviation 2.974
BE + ASIST ConditionSocial Provisions Scale (SPS-5)Baseline17 score on a scaleStandard Deviation 3.328
BE + ASIST ConditionSocial Provisions Scale (SPS-5)Week 217.51 score on a scaleStandard Deviation 2.82
BE + ASIST ConditionSocial Provisions Scale (SPS-5)Week 617.35 score on a scaleStandard Deviation 3.037
BE + ASIST ConditionSocial Provisions Scale (SPS-5)Week 817.78 score on a scaleStandard Deviation 2.868
ControlSocial Provisions Scale (SPS-5)Week 817.18 score on a scaleStandard Deviation 3.112
ControlSocial Provisions Scale (SPS-5)Week 617.21 score on a scaleStandard Deviation 3.164
ControlSocial Provisions Scale (SPS-5)Baseline17.16 score on a scaleStandard Deviation 3.047
ControlSocial Provisions Scale (SPS-5)Week 417.03 score on a scaleStandard Deviation 3.1
ControlSocial Provisions Scale (SPS-5)Week 216.98 score on a scaleStandard Deviation 3.095
Primary

University of California, Los Angeles Loneliness Scale

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.

Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BE ConditionUniversity of California, Los Angeles Loneliness ScaleWeek 64.628 score on a scaleStandard Deviation 1.88
BE ConditionUniversity of California, Los Angeles Loneliness ScaleWeek 44.614 score on a scaleStandard Deviation 1.807
BE ConditionUniversity of California, Los Angeles Loneliness ScaleBaseline5.131 score on a scaleStandard Deviation 2.016
BE ConditionUniversity of California, Los Angeles Loneliness ScaleWeek 24.786 score on a scaleStandard Deviation 1.923
BE ConditionUniversity of California, Los Angeles Loneliness ScaleWeek 84.448 score on a scaleStandard Deviation 1.717
BE + ASIST ConditionUniversity of California, Los Angeles Loneliness ScaleWeek 44.670 score on a scaleStandard Deviation 1.854
BE + ASIST ConditionUniversity of California, Los Angeles Loneliness ScaleBaseline5.035 score on a scaleStandard Deviation 1.984
BE + ASIST ConditionUniversity of California, Los Angeles Loneliness ScaleWeek 24.702 score on a scaleStandard Deviation 1.829
BE + ASIST ConditionUniversity of California, Los Angeles Loneliness ScaleWeek 64.372 score on a scaleStandard Deviation 1.761
BE + ASIST ConditionUniversity of California, Los Angeles Loneliness ScaleWeek 84.455 score on a scaleStandard Deviation 1.703
ControlUniversity of California, Los Angeles Loneliness ScaleWeek 84.346 score on a scaleStandard Deviation 1.771
ControlUniversity of California, Los Angeles Loneliness ScaleWeek 64.525 score on a scaleStandard Deviation 1.8
ControlUniversity of California, Los Angeles Loneliness ScaleBaseline4.697 score on a scaleStandard Deviation 1.849
ControlUniversity of California, Los Angeles Loneliness ScaleWeek 44.737 score on a scaleStandard Deviation 1.795
ControlUniversity of California, Los Angeles Loneliness ScaleWeek 24.846 score on a scaleStandard Deviation 1.761
Secondary

Session Rating Scale

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.

Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BE ConditionSession Rating ScaleWeek 238.65 score on a scaleStandard Deviation 3.809
BE ConditionSession Rating ScaleWeek 638.92 score on a scaleStandard Deviation 2.652
BE ConditionSession Rating ScaleWeek 839.28 score on a scaleStandard Deviation 2.198
BE ConditionSession Rating ScaleWeek 438.86 score on a scaleStandard Deviation 3.106
BE + ASIST ConditionSession Rating ScaleWeek 839.24 score on a scaleStandard Deviation 2.688
BE + ASIST ConditionSession Rating ScaleWeek 238.34 score on a scaleStandard Deviation 3.186
BE + ASIST ConditionSession Rating ScaleWeek 438.86 score on a scaleStandard Deviation 3.227
BE + ASIST ConditionSession Rating ScaleWeek 638.89 score on a scaleStandard Deviation 3.01

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026