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Generating Evidence for a Support Package to Stabilize Youth Trajectories Out of Homelessness

Generating Evidence for a Comprehensive Support Package to Stabilize Youth Trajectories Out of Homelessness: A Tertiary Prevention Strategy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03277794
Enrollment
65
Registered
2017-09-11
Start date
2017-04-01
Completion date
2018-12-31
Last updated
2021-03-18

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

Conditions

Homelessness, Youth

Brief summary

This project builds upon initial proof of concept work examining the optimal set of supports for youth who have recently exited homelessness - an intervention comprised of mental health and peer supports alongside transitional case management. This collaborative model will be tested as a proof-of-concept in Thunder Bay with Indigenous youth and a trial will be conducted in Toronto to optimize and determine the effectiveness of the existing model of support.

Detailed description

In response to the challenges outlined above, and with the support of a grant from the Ontario Ministry of Child and Youth Services, the investigators developed and tested a tertiary prevention strategy called the Housing Outreach Program Collaborative (HOP-C) which launched in the summer of 2015. In this approach the investigators focused on collaborations and interventions that have the greatest potential to be effective with this population. The investigators brought together partners from a number of sectors in the GTA and have tested a 3-pronged set of supports (intervention described in detail in the methods): * Transitional Case Management * Mental Health Interventions: Group, individual, family * Peer Support This is an intensive, 6-month critical time intervention - one that jointly addresses many points of vulnerability (mental health crises, housing instability, justice involvement) while fostering resilience and connection with resources in employment, education and training domains. It is unique in both content comprehensiveness and integrated process of delivery. Also important was the development of a collaborative and responsive partnering process, to facilitate effective organizational interfaces and seamless service integration so participants can experience a tailored and coherent set of supports. With CAMH, the Centre for Mindfulness Studies, Covenant House, LOFT, and SKETCH at the service level and the Wellesley Institute leading evaluation, the investigators have carefully attended to a collective impact framework. This initiative has proven feasible and is demonstrating good outcomes - with excellent youth engagement, reports of lower social isolation, improved mental health, and engagement with resources, and spin-off benefits of closer collaboration between organizations. The investigators successfully met the target of youth engagement, with a total of 31 youth participating, minimal attrition (n=2), and the investigators observed no indications that HOP-C resulted in risk of any form, both with respect to the intervention itself and the mixed methods research methodology. This promising feasibility work formed the foundation from which the investigators were successful in obtaining a grant from the Local Poverty Reduction Fund to support the study described in this proposal. Current Project Determine through a randomized trial in Toronto if the positive outcomes the investigators are observing are due solely or primarily to transitional case management and if the additional peer and mental health components are necessary. Engaging in intensive, tertiary prevention shows clear promise in disrupting a cycle of poverty and marginalization at a critical time - if proven and scaled a key driver of chronic homelessness would be addressed. Research Questions The objective of this two-part project is to examine the effectiveness and transferability of the Housing Outreach Program-Collaboration (HOP-C) transitional intervention. HOP-C has proven to be feasible with promising outcomes in the Toronto proof-of-concept work currently underway. 1\. Are the benefits of the complex HOP-C intervention with all components in place greater than transitional case management in isolation? • It is hypothesized that the full model will provide benefit in domains of housing stability, mental health, and quality of life that are significantly greater than case management alone. The investigators have data in hand from their recent national work in the area which provides data on 'treatment as usual' or the outcomes that attend typically available supports. The proposed trial will unpack benefit and be essential in economic and viability arguments to be made going forward.

Interventions

BEHAVIORALHOP-C

Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.

BEHAVIORALTransitional Case Management Only

Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 26 Years
Healthy volunteers
No

Inclusion criteria

* between the ages of 16 and 26 * have obtained secure housing in a time period up to 12 months previously

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
HousingChange from Baseline to 6 monthsParticipants coded in a binary manner as having gained or sustained housing (binary positive) or lost (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.
Employment/EducationChange from baseline to 6 monthsParticipants coded in a binary manner as having gained or sustained education or employment (binary positive) or lost (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.
Mental HealthChange from baseline to 6 monthsParticipants coded in a binary manner as having gained or sustained mental health status without crises (binary positive) or experienced a crises that impacted major life domains (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.
Housing Security ScaleChange from Baseline to 6 monthsThe Housing Security Scale contains 12 items on a 5 point likert scale (Frederick et al., 2014). Scores range from strongly disagree (minimum = 1) to strongly agree (maximum = 5). Higher scores indicate better outcomes. Mean item range is 1-5 with pre-post difference reported.
Housing Security Scale (Subjective Housing Stability Subscale)Change from Baseline to 6 monthsThe Housing Security Scale contains a 4 item subscale that measures subjective housing satisfaction and perception of housing stability (Frederick et al., 2014). Scores range from strongly disagree (minimum = 1) to strongly agree (maximum = 5). Higher scores indicate better outcomes with a mean range of 1-5 with pre-post change reported.

Secondary

MeasureTime frameDescription
Adults Hope ScaleChange from baseline to 6 monthsAdult Hope Scale, a cognitive measure of hope, was employed. This self-report questionnaire contains 8 questions that are each scored on an 8 point Likert scale with scores ranging from Definitely False to Definitely True. Higher scores indicate better outcomes. Mean item range is minimum 1 to maximum 8 with pre-post mean differences reported.
GAIN Short Screener (CAMH Modified)Change from baseline to 6 monthsMental health (and addictions) was measured using the Global Assessment of Individual Needs Short Screener, which includes 22 items scored on a 5 point scale ranging from never (0) as the minimum score and past month (4) as the maximum score. Higher scores indicate worse outcomes. Mean item range is 0-4 with pre-post mean change reported.
Resilience ScaleChange from baseline to 6 monthsResilience will be measured using the 10-item Resilience Scale. Each item score ranges from, at minimum, Not true at all (0) to, at maximum, True nearly all the time (4) with higher scores indicating better outcomes. Mean item range is from 0-4 with pre-post change in means reported.
World Health Organization Quality of Life Scale - BREFChange from baseline to 6 monthsThe brief World Health Organization Quality of Life Scale - BREF contains 26 items, each scored from 1 to 5 with various labels for each score (e.g. 1= very poor for item 1 and 1= very dissatisfied for item 2). Higher scores indicate better outcomes with a mean item range of 1-5 with pre-post mean change reported.
Medical Outcomes Study (MOS) Social Support SurveyChange from baseline to 6 monthWe used a modified version of the Medical Outcomes Study Social Support Survey to measure social support. It is a 15-item 5-point Likert-type scale. The maximum score is all of the time (5) and the minimum score is none of the time (1). Higher score indicates better outcome. Item mean range is 1-5 with pre-post mean difference reported.
Mental Health Continuum - Short FormChange from baseline to 6 monthMental Health Continuum - Short Form assess mental health and addictions by measuring emotional, psychological and social well-being. It contains 14 items on a 6 point scale ranging from at minimum never (0) to, at maximum, every day (5). Higher scores indicate better outcomes. Range is 0-5 (means) with pre-post differences reported.
Cognitive and Affective Mindfulness ScaleChange from baseline to 6 monthsCognitive and Affective Mindfulness Scale Revised was used to measure mindfulness and has demonstrated acceptable reliability (Feldman, Hayes, Kumar, Greeson, & Laurenceau, 2007). It contains 10 items. The minimum score is rarely/Not at all (1) and the maximum score is almost always (4). Higher scores indicate better outcomes with a mean item range from 1-4 with pre-post mean change reported.
Community Integration ScaleChange from baseline to 6 monthsBehavioural and psychological aspects of community integration was examined using Community Integration Scale The scale contains 7 dichotomous questions with higher scores indicating greater community integration (better outcomes). Mean item range is 0-1 with mean change reported.
Community Integration MeasureChange from baseline to 6 monthsBehavioural and psychological aspects of community integration were examined using the Community Integration Measure. The measure contains 6 items scored on a 5 point scale ranging from, at minimum, always disagree (1) to, at maximum, always agree (5). Higher scores indicating better outcomes with an item mean range from 1-5 with mean pre-post differences reported.

Countries

Canada

Participant flow

Participants by arm

ArmCount
Transitional Case Management Only
Transitional Case Management Only: Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing.
31
Full HOP-C Service
HOP-C: Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.
34
Total65

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up24
Overall StudyWithdrew due to high acuity10

Baseline characteristics

CharacteristicTransitional Case Management OnlyTotalFull HOP-C Service
Age, Continuous21.74 years
STANDARD_DEVIATION 2.03
21.75 years
STANDARD_DEVIATION 2.07
21.76 years
STANDARD_DEVIATION 2.14
Highest Education
Completed High School
7 Participants18 Participants11 Participants
Highest Education
Other/Not Specified
4 Participants9 Participants5 Participants
Highest Education
Some High School
14 Participants21 Participants7 Participants
Highest Education
Transitional Program
6 Participants17 Participants11 Participants
Homelessness - Lifetime Length
1-2 years
10 Participants16 Participants6 Participants
Homelessness - Lifetime Length
2-3 years
1 Participants11 Participants10 Participants
Homelessness - Lifetime Length
3+ years
13 Participants20 Participants7 Participants
Homelessness - Lifetime Length
6-12 Months
7 Participants18 Participants11 Participants
NEET - Not in Employment, Education or Training14 Participants24 Participants10 Participants
Race/Ethnicity, Customized
Black - African
5 Participants8 Participants3 Participants
Race/Ethnicity, Customized
Black - Caribbean
3 Participants7 Participants4 Participants
Race/Ethnicity, Customized
Mixed Heritage
2 Participants6 Participants4 Participants
Race/Ethnicity, Customized
Other/Not Specified
16 Participants34 Participants18 Participants
Race/Ethnicity, Customized
White - North American
5 Participants10 Participants5 Participants
Sex/Gender, Customized
Female
14 Participants26 Participants12 Participants
Sex/Gender, Customized
Other
17 Participants39 Participants22 Participants
Sexual Orientation
Bi-Sexual
3 Participants7 Participants4 Participants
Sexual Orientation
Heterosexual
21 Participants43 Participants22 Participants
Sexual Orientation
Other/Not Specified
5 Participants11 Participants6 Participants
Sexual Orientation
Prefer not to answer
2 Participants4 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 34
other
Total, other adverse events
0 / 310 / 34
serious
Total, serious adverse events
0 / 310 / 34

Outcome results

Primary

Employment/Education

Participants coded in a binary manner as having gained or sustained education or employment (binary positive) or lost (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

Time frame: Change from baseline to 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transitional Case Management OnlyEmployment/Education18 Participants
Full HOP-C ServiceEmployment/Education24 Participants
Comparison: Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)p-value: 0.159Regression, Logistic
Comparison: Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)p-value: 0.2Regression, Linear
Primary

Housing

Participants coded in a binary manner as having gained or sustained housing (binary positive) or lost (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

Time frame: Change from Baseline to 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transitional Case Management OnlyHousing25 Participants
Full HOP-C ServiceHousing28 Participants
Comparison: Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)p-value: 0.354Regression, Logistic
Comparison: Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)p-value: 0.465Regression, Logistic
Primary

Housing Security Scale

The Housing Security Scale contains 12 items on a 5 point likert scale (Frederick et al., 2014). Scores range from strongly disagree (minimum = 1) to strongly agree (maximum = 5). Higher scores indicate better outcomes. Mean item range is 1-5 with pre-post difference reported.

Time frame: Change from Baseline to 6 months

ArmMeasureValue (MEAN)Dispersion
Transitional Case Management OnlyHousing Security Scale0.017 score on a scaleStandard Error 0.129
Full HOP-C ServiceHousing Security Scale0.153 score on a scaleStandard Error 0.098
p-value: 0.899Regression, Linear
p-value: 0.128Regression, Linear
Primary

Housing Security Scale (Subjective Housing Stability Subscale)

The Housing Security Scale contains a 4 item subscale that measures subjective housing satisfaction and perception of housing stability (Frederick et al., 2014). Scores range from strongly disagree (minimum = 1) to strongly agree (maximum = 5). Higher scores indicate better outcomes with a mean range of 1-5 with pre-post change reported.

Time frame: Change from Baseline to 6 months

ArmMeasureValue (MEAN)Dispersion
Transitional Case Management OnlyHousing Security Scale (Subjective Housing Stability Subscale)-0.259 score on a scaleStandard Error 0.196
Full HOP-C ServiceHousing Security Scale (Subjective Housing Stability Subscale)0.422 score on a scaleStandard Error 0.167
p-value: 0.198Regression, Linear
p-value: 0.017Regression, Linear
Primary

Mental Health

Participants coded in a binary manner as having gained or sustained mental health status without crises (binary positive) or experienced a crises that impacted major life domains (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

Time frame: Change from baseline to 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transitional Case Management OnlyMental Health20 Participants
Full HOP-C ServiceMental Health27 Participants
Comparison: Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)p-value: 0.121Regression, Logistic
Comparison: Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)p-value: 0.134Regression, Logistic
Secondary

Adults Hope Scale

Adult Hope Scale, a cognitive measure of hope, was employed. This self-report questionnaire contains 8 questions that are each scored on an 8 point Likert scale with scores ranging from Definitely False to Definitely True. Higher scores indicate better outcomes. Mean item range is minimum 1 to maximum 8 with pre-post mean differences reported.

Time frame: Change from baseline to 6 months

ArmMeasureValue (MEAN)Dispersion
Transitional Case Management OnlyAdults Hope Scale0.218 score on a scaleStandard Error 0.276
Full HOP-C ServiceAdults Hope Scale-0.038 score on a scaleStandard Error 0.099
p-value: 0.436Regression, Linear
p-value: 0.706Regression, Linear
Secondary

Cognitive and Affective Mindfulness Scale

Cognitive and Affective Mindfulness Scale Revised was used to measure mindfulness and has demonstrated acceptable reliability (Feldman, Hayes, Kumar, Greeson, & Laurenceau, 2007). It contains 10 items. The minimum score is rarely/Not at all (1) and the maximum score is almost always (4). Higher scores indicate better outcomes with a mean item range from 1-4 with pre-post mean change reported.

Time frame: Change from baseline to 6 months

ArmMeasureValue (MEAN)Dispersion
Transitional Case Management OnlyCognitive and Affective Mindfulness Scale0.226 score on a scaleStandard Error 0.099
Full HOP-C ServiceCognitive and Affective Mindfulness Scale0.176 score on a scaleStandard Error 0.058
p-value: 0.03Regression, Linear
p-value: 0.005Regression, Linear
Secondary

Community Integration Measure

Behavioural and psychological aspects of community integration were examined using the Community Integration Measure. The measure contains 6 items scored on a 5 point scale ranging from, at minimum, always disagree (1) to, at maximum, always agree (5). Higher scores indicating better outcomes with an item mean range from 1-5 with mean pre-post differences reported.

Time frame: Change from baseline to 6 months

ArmMeasureValue (MEAN)Dispersion
Transitional Case Management OnlyCommunity Integration Measure-0.006 score on a scaleStandard Error 0.239
Full HOP-C ServiceCommunity Integration Measure-0.051 score on a scaleStandard Error 0.163
p-value: 0.98Regression, Linear
p-value: 0.758Regression, Linear
Secondary

Community Integration Scale

Behavioural and psychological aspects of community integration was examined using Community Integration Scale The scale contains 7 dichotomous questions with higher scores indicating greater community integration (better outcomes). Mean item range is 0-1 with mean change reported.

Time frame: Change from baseline to 6 months

ArmMeasureValue (MEAN)Dispersion
Transitional Case Management OnlyCommunity Integration Scale-0.108 score on a scaleStandard Error 0.075
Full HOP-C ServiceCommunity Integration Scale0.008 score on a scaleStandard Error 0.045
p-value: 0.163Regression, Linear
p-value: 0.865Regression, Linear
Secondary

GAIN Short Screener (CAMH Modified)

Mental health (and addictions) was measured using the Global Assessment of Individual Needs Short Screener, which includes 22 items scored on a 5 point scale ranging from never (0) as the minimum score and past month (4) as the maximum score. Higher scores indicate worse outcomes. Mean item range is 0-4 with pre-post mean change reported.

Time frame: Change from baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Transitional Case Management OnlyGAIN Short Screener (CAMH Modified)Internalizing-0.124 score on a scaleStandard Error 0.236
Transitional Case Management OnlyGAIN Short Screener (CAMH Modified)Externalizing-0.151 score on a scaleStandard Error 0.15
Transitional Case Management OnlyGAIN Short Screener (CAMH Modified)Substance Use-0.308 score on a scaleStandard Error 0.184
Full HOP-C ServiceGAIN Short Screener (CAMH Modified)Internalizing-0.265 score on a scaleStandard Error 0.191
Full HOP-C ServiceGAIN Short Screener (CAMH Modified)Externalizing-0.212 score on a scaleStandard Error 0.171
Full HOP-C ServiceGAIN Short Screener (CAMH Modified)Substance Use-0.291 score on a scaleStandard Error 0.147
Comparison: Internalizingp-value: 0.604Regression, Linear
Comparison: Internalizingp-value: 0.177Regression, Linear
Comparison: Externalizingp-value: 0.325Regression, Linear
Comparison: Externalizingp-value: 0.227Regression, Linear
Comparison: Substance Usep-value: 0.106Regression, Linear
Comparison: Substance Usep-value: 0.058Regression, Linear
Secondary

Medical Outcomes Study (MOS) Social Support Survey

We used a modified version of the Medical Outcomes Study Social Support Survey to measure social support. It is a 15-item 5-point Likert-type scale. The maximum score is all of the time (5) and the minimum score is none of the time (1). Higher score indicates better outcome. Item mean range is 1-5 with pre-post mean difference reported.

Time frame: Change from baseline to 6 month

ArmMeasureGroupValue (MEAN)Dispersion
Transitional Case Management OnlyMedical Outcomes Study (MOS) Social Support SurveyEmotional Supports0.043 score on a scaleStandard Error 0.247
Transitional Case Management OnlyMedical Outcomes Study (MOS) Social Support SurveyTangible Supports0.110 score on a scaleStandard Error 0.264
Transitional Case Management OnlyMedical Outcomes Study (MOS) Social Support SurveyAffectionate Supports-0.115 score on a scaleStandard Error 0.297
Full HOP-C ServiceMedical Outcomes Study (MOS) Social Support SurveyEmotional Supports0.174 score on a scaleStandard Error 0.196
Full HOP-C ServiceMedical Outcomes Study (MOS) Social Support SurveyTangible Supports-0.003 score on a scaleStandard Error 0.194
Full HOP-C ServiceMedical Outcomes Study (MOS) Social Support SurveyAffectionate Supports0.333 score on a scaleStandard Error 0.227
Comparison: Emotional Supportsp-value: 0.862Regression, Linear
Comparison: Emotional Supportsp-value: 0.382Regression, Linear
Comparison: Tangible Supportsp-value: 0.68Regression, Linear
Comparison: Tangible Supportsp-value: 0.988Regression, Linear
Comparison: Affectionatep-value: 0.701Regression, Linear
Comparison: Affectionatep-value: 0.154Regression, Linear
Secondary

Mental Health Continuum - Short Form

Mental Health Continuum - Short Form assess mental health and addictions by measuring emotional, psychological and social well-being. It contains 14 items on a 6 point scale ranging from at minimum never (0) to, at maximum, every day (5). Higher scores indicate better outcomes. Range is 0-5 (means) with pre-post differences reported.

Time frame: Change from baseline to 6 month

ArmMeasureValue (MEAN)Dispersion
Transitional Case Management OnlyMental Health Continuum - Short Form0.276 score on a scaleStandard Error 0.157
Full HOP-C ServiceMental Health Continuum - Short Form0.077 score on a scaleStandard Error 0.141
p-value: 0.091Regression, Linear
p-value: 0.591Regression, Linear
Secondary

Resilience Scale

Resilience will be measured using the 10-item Resilience Scale. Each item score ranges from, at minimum, Not true at all (0) to, at maximum, True nearly all the time (4) with higher scores indicating better outcomes. Mean item range is from 0-4 with pre-post change in means reported.

Time frame: Change from baseline to 6 months

ArmMeasureValue (MEAN)Dispersion
Transitional Case Management OnlyResilience Scale0.252 score on a scaleStandard Error 0.159
Full HOP-C ServiceResilience Scale0.093 score on a scaleStandard Error 0.065
p-value: 0.124Regression, Linear
p-value: 0.168Regression, Linear
Secondary

World Health Organization Quality of Life Scale - BREF

The brief World Health Organization Quality of Life Scale - BREF contains 26 items, each scored from 1 to 5 with various labels for each score (e.g. 1= very poor for item 1 and 1= very dissatisfied for item 2). Higher scores indicate better outcomes with a mean item range of 1-5 with pre-post mean change reported.

Time frame: Change from baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Transitional Case Management OnlyWorld Health Organization Quality of Life Scale - BREFPhysical Health0.201 score on a scaleStandard Error 0.552
Transitional Case Management OnlyWorld Health Organization Quality of Life Scale - BREFPsychological-0.117 score on a scaleStandard Error 0.432
Transitional Case Management OnlyWorld Health Organization Quality of Life Scale - BREFSocial0.308 score on a scaleStandard Error 0.869
Transitional Case Management OnlyWorld Health Organization Quality of Life Scale - BREFEnvironment0.124 score on a scaleStandard Error 0.596
Full HOP-C ServiceWorld Health Organization Quality of Life Scale - BREFEnvironment0.843 score on a scaleStandard Error 0.407
Full HOP-C ServiceWorld Health Organization Quality of Life Scale - BREFPhysical Health0.717 score on a scaleStandard Error 0.484
Full HOP-C ServiceWorld Health Organization Quality of Life Scale - BREFSocial0.099 score on a scaleStandard Error 0.376
Full HOP-C ServiceWorld Health Organization Quality of Life Scale - BREFPsychological0.086 score on a scaleStandard Error 0.355
Comparison: Physical Healthp-value: 0.719Regression, Linear
Comparison: Physical Healthp-value: 0.15Regression, Linear
Comparison: Psychologicalp-value: 0.789Regression, Linear
Comparison: Psychologicalp-value: 0.811Regression, Linear
Comparison: Socialp-value: 0.726Regression, Linear
Comparison: Socialp-value: 0.795Regression, Linear
Comparison: Environmentp-value: 0.837Regression, Linear
Comparison: Environmentp-value: 0.048Regression, Linear

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