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Bolster: Caregiver App to Reduce Duration of Untreated Psychosis

Development and Testing of a Caregiver-facing Mobile Health Intervention to Reduce Duration of Untreated Psychosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04949542
Enrollment
60
Registered
2021-07-02
Start date
2023-08-11
Completion date
2024-10-04
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

Caregiver to a Young Adult With Early Psychosis

Brief summary

The proposed research project aims to develop and test a mobile health intervention designed to improve caregivers' illness knowledge and caregiving skills through interactive cognitive-behavioral modules, and through these improvements, reduce distress, improve coping, improve family communication, increase caregiver treatment facilitation and reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial comparing this new intervention to existing online caregiving support resources. Analyses will determine whether this approach is acceptable and feasible, as well as explore its effectiveness and impact on key components of the cognitive model of caregiving.

Interventions

BEHAVIORALBolster

Bolster is a native mobile app that provides on-demand content to caregivers of young adults with early psychosis to support their caregiving skills and knowledge of psychosis.

BEHAVIORALControl

Exemplar resources provided in the control arm will include a selection from the National Alliance on Mental Illness and Mental Health America designed to support caregivers helping loved ones access care.

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 18 years old or older * Live in the United States * Caregiver to a young adult with early psychosis, wherein early psychosis is defined as: (1) Being between the ages of 15 and 35, and (2) Within the past five years, the young adult first experienced: (2A) Presence of psychotic symptoms represented by one or more of hallucinations, delusions, marked thought disorder, psychomotor disorder or bizarre behavior, as well as (2B) Definite change of personality or behavior manifesting as two or more of the following: serious deterioration of function, marked social withdrawal, persistent self-neglect, episodic marked anxiety. * A positive screen according to the Caregiver Prime Screen - Revised (endorsed two or more responses of five or six (somewhat/definitely agree)) * Own an Apple iPhone * Self-identify as a caregiver of the affected person * The affected person is not enrolled in specialty mental health services (i.e. a program wherein the affected person can access psychiatry and counseling/therapy services), and has not been enrolled in such services for at least three months prior to screening. If an affected person is receiving one of these services, the caregiver reports that this is an inadequate level of care.

Exclusion criteria

* Incarceration or long-term care setting for either the caregiver or identified affected young adult. * Participant failed to demonstrate understanding of study details in comprehension screening process. * The affected person is unengaged in services, but only as a result of having completed or graduated from a specialty treatment program for psychosis.

Design outcomes

Primary

MeasureTime frameDescription
Change in Family CommunicationBaseline, 6 weeks, 12 weeksFamily communication will be assessed with the Family Questionnaire (FQ). The FQ is a 20-item self-report assessment of criticism and emotional expression in interactions with family members toward patients with mental illness. Each item is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The FQ is scored by summing individual items with higher scores indicating greater levels of expressed emotion. As a primary outcome, we will examine the combined total of emotional overinvolvement and critical comments; scores range from 20 to 80 with higher scores indicating greater expressed emotion.
Change in Treatment FacilitationBaseline, 6 weeks, 12 weeksTreatment seeking will be measured using the Measure to Assess Steps to Service-Caregivers (MASS-CG). The MASS-CG is a 23-item self-report assessment of steps taken by the caregiver towards the attainment of mental health treatment for their loved one, including research, social support, encouragement or support of the loved one's help-seeking actions, and engagement with service provider steps. Each item is endorsed on a three-point Likert scale (0 = No, I have not done this, 1 = I have done this once or twice, 2 = I have done this multiple times). The MASS-CG is scored by summing individual items with higher scores indicating greater levels of treatment facilitation activities.
Change in Loved One Treatment Engagement, Medication ProviderBaseline, 12 weeksTreatment facilitation / duration of untreated psychosis will be assessed according to participants' report of appointments attended by their relative in the past during the treatment period. This first category includes meeting with a clinician providing psychiatric medications. At screening, participants report treatment engagement over the previous three months and during the study period, participants are asked to report on this weekly. This count variable represents the number of participants who reported that their loved one attended an appointment with a medication provider in the three months preceding the study period reported at screening (Baseline) as well as for the duration of the study period reported in weekly brief assessments (12 weeks). The 12 week data point includes participants who completed at least half of the weekly brief assessments.
Change in Loved One Treatment Engagement, Therapy or CounselingBaseline, 12 weeksTreatment facilitation / duration of untreated psychosis will be assessed according to participants' report of appointments attended by their relative in the past during the treatment period. This first category includes meeting with a clinician providing mental health therapy or counseling. At screening, participants report treatment engagement over the previous three months and during the study period, participants are asked to report on this weekly. This count variable represents the number of participants who reported that their loved one attended an appointment for psychotherapy or counseling in the three months preceding the study period reported at screening (Baseline) as well as for the duration of the study period reported in weekly brief assessments (12 weeks). The 12 week data point includes participants who completed at least half of the weekly brief assessments.

Secondary

MeasureTime frameDescription
Change in Illness Appraisals, Emotional Distress About IllnessBaseline, 6 weeks, 12 weeksIllness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQSR), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illnesses. Each item is rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree), and totals are scored by summing individual items. For the emotional distress score, we are examining the emotional representation scale, a 9-item scale with scores ranging from 9 to 45, with higher scores indicating greater emotional distress.
Change in Appraisal of Caregiving Experiences**Baseline, 6 weeks, 12 weeksAppraisals of caregiving experiences will be assessed with the Brief Experience of Caregiving Inventory (BECI).\*\* The BECI is a 19-item assessment of the impact of caregiving on the individual's life, both in negative and positive ways. The items are rated on a 5-point Likert scale (never to nearly always), and scores range from 0 to 76, with a higher score denoting more negative appraisals of one's caregiving experience. \*\*NOTE: The version of the BECI that was administered used instructions asking participants to report on their experiences in the month following their loved one's first hospitalization. Due to this, this measure is best interpreted as caregivers' changing appraisals of their early experiences of caregiving. There was also heterogeneity in participants' report of their loved one ever having experienced a hospitalization in our sample that also affects interpretation of this measure.
Change in Illness Knowledge, Factual KnowledgeBaseline, 6 weeks, 12 weeksThis is assessed with the Knowledge About Schizophrenia (KAST), an 18-item multiple-choice assessment examining individuals' knowledge of the etiology, symptoms, and prognosis of schizophrenia. Total scores indicate the number of correct responses, and thus range from 0 to 18.
Change in Caregiver Coping, Self-efficacyBaseline, 6 weeks, 12 weeksCaregiver coping self-efficacy will be assessed with the Coping Self-Efficacy Scale, a 26-item self-report questionnaire measuring the perceived ability of coping with various life challenges. Responses are rated on a 0 to 10 scale, and scores range from 0 to 260, with higher scores denoting a greater sense of self-efficacy in coping.
Change in Caregiver DistressBaseline, 6 weeks, 12 weeksCaregiver distress (secondary mediator) will be assessed with General Health Questionnaire (GHQ), a 12-item questionnaire assessing general psychological morbidity. Respondents indicate agreement on a four-point scale (0 = Not at all; 3 = More than usual) and total scores ranging from 0 to 36 with higher scores indicating more severe psychological morbidity.
Change in Caregiver Coping, ActivitiesBaseline, 6 weeks, 12 weeksCaregiver coping will be assessed with the Brief COPE Inventory, a 28-item self-report scale of coping skills in response to stressors, based on the full COPE inventory; items generate a range of subscale scores related to specific coping areas. The instrument consists of 28 items which will be scored on a 1 to 4 Likert scale (I haven't been doing this at all to I've been doing this a lot), with higher values representing a greater frequency of engaging in each coping strategy. For this outcome, we will examine total frequency sum of items (14) assessing variables a priori selected to represent adaptive coping. Scores on this scale range from 14 to 56.
Change in Illness Knowledge, Caregiver Self-ratedBaseline, 6 weeks, 12 weeksIllness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQSR), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illnesses. Each item is rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree), and totals are scored by summing individual items. For the coherence total, we are totaling the 5 items related to the caregiver's report of how much they understand or know about their loved one's illness. Scores range from 5 to 25 with lower scores indicating better self-rated understanding or coherence.
Change in Illness Appraisals, ConsequencesBaseline, 6 weeks, 12 weeksIllness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQSR), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illnesses. Each item is rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree), and totals are scored by summing individual items. For the consequences total, we are totaling the 20 items related to consequences affecting the caregiver and the affected person. Scores range from 20 to 100 with higher scores indicating greater perceptions of negative consequences.
Change in Illness Appraisals, ControlBaseline, 6 weeks, 12 weeksIllness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQSR), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illnesses. Each item is rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree), and totals are scored by summing individual items. For the control total, we are totaling the 8 items related to caregiver, affected person, and treatment control over illness course. Scores range from 8 to 40 with higher scores indicating greater perceptions of possibilities for actions that affect the course of illness.

Countries

United States

Participant flow

Participants by arm

ArmCount
Bolster
Participants in the experimental arm will be provided access to the Bolster smartphone application designed to support caregivers of young adults with early psychosis as well as the support resources offered in the control condition. They will also have access to the research team by phone for technical troubleshooting and support as necessary. Bolster: Bolster is a native mobile app that provides on-demand content to caregivers of young adults with early psychosis to support their caregiving skills and knowledge of psychosis.
40
Control
Participants in the control condition will be provided support resources from mental health advocacy organizations representing currently available resources for caregivers (including a selection from the National Alliance on Mental Illness and Mental Health America). They will also have access to the research team by phone for technical troubleshooting and support as necessary. Control: Exemplar resources provided in the control arm will include a selection from the National Alliance on Mental Illness and Mental Health America designed to support caregivers helping loved ones access care.
20
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up41

Baseline characteristics

CharacteristicControlTotalBolster
Age, Continuous54.40 years
STANDARD_DEVIATION 8.31
54.62 years
STANDARD_DEVIATION 7.56
54.73 years
STANDARD_DEVIATION 7.26
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants5 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants55 Participants37 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Asian
1 Participants3 Participants2 Participants
Race/Ethnicity, Customized
Black or African American
1 Participants5 Participants4 Participants
Race/Ethnicity, Customized
More than one race
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Other
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
White
18 Participants48 Participants30 Participants
Sex: Female, Male
Female
19 Participants56 Participants37 Participants
Sex: Female, Male
Male
1 Participants4 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 20
other
Total, other adverse events
0 / 400 / 20
serious
Total, serious adverse events
0 / 400 / 20

Outcome results

Primary

Change in Family Communication

Family communication will be assessed with the Family Questionnaire (FQ). The FQ is a 20-item self-report assessment of criticism and emotional expression in interactions with family members toward patients with mental illness. Each item is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The FQ is scored by summing individual items with higher scores indicating greater levels of expressed emotion. As a primary outcome, we will examine the combined total of emotional overinvolvement and critical comments; scores range from 20 to 80 with higher scores indicating greater expressed emotion.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Family CommunicationBaseline58.94 score on a scaleStandard Deviation 8.36
BolsterChange in Family Communication6 weeks53.23 score on a scaleStandard Deviation 8.74
BolsterChange in Family Communication12 weeks52.02 score on a scaleStandard Deviation 8.43
ControlChange in Family Communication6 weeks53.20 score on a scaleStandard Deviation 9.09
ControlChange in Family CommunicationBaseline56.66 score on a scaleStandard Deviation 6.82
ControlChange in Family Communication12 weeks53.55 score on a scaleStandard Deviation 8.31
Primary

Change in Loved One Treatment Engagement, Medication Provider

Treatment facilitation / duration of untreated psychosis will be assessed according to participants' report of appointments attended by their relative in the past during the treatment period. This first category includes meeting with a clinician providing psychiatric medications. At screening, participants report treatment engagement over the previous three months and during the study period, participants are asked to report on this weekly. This count variable represents the number of participants who reported that their loved one attended an appointment with a medication provider in the three months preceding the study period reported at screening (Baseline) as well as for the duration of the study period reported in weekly brief assessments (12 weeks). The 12 week data point includes participants who completed at least half of the weekly brief assessments.

Time frame: Baseline, 12 weeks

Population: Participants are included in the 12 week total if they completed more than half the brief assessments during the study period.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BolsterChange in Loved One Treatment Engagement, Medication ProviderBaseline15 Participants
BolsterChange in Loved One Treatment Engagement, Medication Provider12 weeks21 Participants
ControlChange in Loved One Treatment Engagement, Medication ProviderBaseline8 Participants
ControlChange in Loved One Treatment Engagement, Medication Provider12 weeks7 Participants
Primary

Change in Loved One Treatment Engagement, Therapy or Counseling

Treatment facilitation / duration of untreated psychosis will be assessed according to participants' report of appointments attended by their relative in the past during the treatment period. This first category includes meeting with a clinician providing mental health therapy or counseling. At screening, participants report treatment engagement over the previous three months and during the study period, participants are asked to report on this weekly. This count variable represents the number of participants who reported that their loved one attended an appointment for psychotherapy or counseling in the three months preceding the study period reported at screening (Baseline) as well as for the duration of the study period reported in weekly brief assessments (12 weeks). The 12 week data point includes participants who completed at least half of the weekly brief assessments.

Time frame: Baseline, 12 weeks

Population: Participants are included in the 12 week total if they completed more than half the brief assessments during the study period.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BolsterChange in Loved One Treatment Engagement, Therapy or CounselingBaseline17 Participants
BolsterChange in Loved One Treatment Engagement, Therapy or Counseling12 weeks24 Participants
ControlChange in Loved One Treatment Engagement, Therapy or CounselingBaseline8 Participants
ControlChange in Loved One Treatment Engagement, Therapy or Counseling12 weeks8 Participants
Primary

Change in Treatment Facilitation

Treatment seeking will be measured using the Measure to Assess Steps to Service-Caregivers (MASS-CG). The MASS-CG is a 23-item self-report assessment of steps taken by the caregiver towards the attainment of mental health treatment for their loved one, including research, social support, encouragement or support of the loved one's help-seeking actions, and engagement with service provider steps. Each item is endorsed on a three-point Likert scale (0 = No, I have not done this, 1 = I have done this once or twice, 2 = I have done this multiple times). The MASS-CG is scored by summing individual items with higher scores indicating greater levels of treatment facilitation activities.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Treatment FacilitationBaseline22.47 score on a scaleStandard Deviation 9.97
BolsterChange in Treatment Facilitation6 weeks18.79 score on a scaleStandard Deviation 10.08
BolsterChange in Treatment Facilitation12 weeks20.08 score on a scaleStandard Deviation 9.62
ControlChange in Treatment FacilitationBaseline24.29 score on a scaleStandard Deviation 13.89
ControlChange in Treatment Facilitation6 weeks16.60 score on a scaleStandard Deviation 8.86
ControlChange in Treatment Facilitation12 weeks19.54 score on a scaleStandard Deviation 11.16
Secondary

Change in Appraisal of Caregiving Experiences**

Appraisals of caregiving experiences will be assessed with the Brief Experience of Caregiving Inventory (BECI).\*\* The BECI is a 19-item assessment of the impact of caregiving on the individual's life, both in negative and positive ways. The items are rated on a 5-point Likert scale (never to nearly always), and scores range from 0 to 76, with a higher score denoting more negative appraisals of one's caregiving experience. \*\*NOTE: The version of the BECI that was administered used instructions asking participants to report on their experiences in the month following their loved one's first hospitalization. Due to this, this measure is best interpreted as caregivers' changing appraisals of their early experiences of caregiving. There was also heterogeneity in participants' report of their loved one ever having experienced a hospitalization in our sample that also affects interpretation of this measure.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Appraisal of Caregiving Experiences**Baseline43.04 score on a scaleStandard Deviation 11.08
BolsterChange in Appraisal of Caregiving Experiences**6 weeks40.11 score on a scaleStandard Deviation 11.91
BolsterChange in Appraisal of Caregiving Experiences**12 weeks37.94 score on a scaleStandard Deviation 10.92
ControlChange in Appraisal of Caregiving Experiences**Baseline45.77 score on a scaleStandard Deviation 11.24
ControlChange in Appraisal of Caregiving Experiences**6 weeks42.70 score on a scaleStandard Deviation 14.46
ControlChange in Appraisal of Caregiving Experiences**12 weeks42.76 score on a scaleStandard Deviation 12.26
Secondary

Change in Caregiver Coping, Activities

Caregiver coping will be assessed with the Brief COPE Inventory, a 28-item self-report scale of coping skills in response to stressors, based on the full COPE inventory; items generate a range of subscale scores related to specific coping areas. The instrument consists of 28 items which will be scored on a 1 to 4 Likert scale (I haven't been doing this at all to I've been doing this a lot), with higher values representing a greater frequency of engaging in each coping strategy. For this outcome, we will examine total frequency sum of items (14) assessing variables a priori selected to represent adaptive coping. Scores on this scale range from 14 to 56.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Caregiver Coping, ActivitiesBaseline35.32 score on a scaleStandard Deviation 6.06
BolsterChange in Caregiver Coping, Activities6 weeks36.07 score on a scaleStandard Deviation 7.3
BolsterChange in Caregiver Coping, Activities12 weeks36.81 score on a scaleStandard Deviation 7.8
ControlChange in Caregiver Coping, ActivitiesBaseline37.25 score on a scaleStandard Deviation 6.21
ControlChange in Caregiver Coping, Activities6 weeks34.72 score on a scaleStandard Deviation 7.3
ControlChange in Caregiver Coping, Activities12 weeks36.84 score on a scaleStandard Deviation 6.58
Secondary

Change in Caregiver Coping, Self-efficacy

Caregiver coping self-efficacy will be assessed with the Coping Self-Efficacy Scale, a 26-item self-report questionnaire measuring the perceived ability of coping with various life challenges. Responses are rated on a 0 to 10 scale, and scores range from 0 to 260, with higher scores denoting a greater sense of self-efficacy in coping.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Caregiver Coping, Self-efficacyBaseline135.23 score on a scaleStandard Deviation 42.06
BolsterChange in Caregiver Coping, Self-efficacy6 weeks154.86 score on a scaleStandard Deviation 38.9
BolsterChange in Caregiver Coping, Self-efficacy12 weeks168.99 score on a scaleStandard Deviation 42.22
ControlChange in Caregiver Coping, Self-efficacyBaseline142.23 score on a scaleStandard Deviation 40.85
ControlChange in Caregiver Coping, Self-efficacy6 weeks149.25 score on a scaleStandard Deviation 44.57
ControlChange in Caregiver Coping, Self-efficacy12 weeks160.84 score on a scaleStandard Deviation 44.89
Secondary

Change in Caregiver Distress

Caregiver distress (secondary mediator) will be assessed with General Health Questionnaire (GHQ), a 12-item questionnaire assessing general psychological morbidity. Respondents indicate agreement on a four-point scale (0 = Not at all; 3 = More than usual) and total scores ranging from 0 to 36 with higher scores indicating more severe psychological morbidity.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Caregiver DistressBaseline19.00 score on a scaleStandard Deviation 6.48
BolsterChange in Caregiver Distress6 weeks14.14 score on a scaleStandard Deviation 6.18
BolsterChange in Caregiver Distress12 weeks11.67 score on a scaleStandard Deviation 6.43
ControlChange in Caregiver DistressBaseline18.45 score on a scaleStandard Deviation 8.68
ControlChange in Caregiver Distress6 weeks17.75 score on a scaleStandard Deviation 9.03
ControlChange in Caregiver Distress12 weeks15.68 score on a scaleStandard Deviation 8.85
Secondary

Change in Illness Appraisals, Consequences

Illness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQSR), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illnesses. Each item is rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree), and totals are scored by summing individual items. For the consequences total, we are totaling the 20 items related to consequences affecting the caregiver and the affected person. Scores range from 20 to 100 with higher scores indicating greater perceptions of negative consequences.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Illness Appraisals, ConsequencesBaseline79.63 score on a scaleStandard Deviation 9.6
BolsterChange in Illness Appraisals, Consequences6 weeks76.13 score on a scaleStandard Deviation 9.89
BolsterChange in Illness Appraisals, Consequences12 weeks75.93 score on a scaleStandard Deviation 11.93
ControlChange in Illness Appraisals, ConsequencesBaseline80.90 score on a scaleStandard Deviation 12.46
ControlChange in Illness Appraisals, Consequences6 weeks79.77 score on a scaleStandard Deviation 12.71
ControlChange in Illness Appraisals, Consequences12 weeks80.39 score on a scaleStandard Deviation 10.7
Secondary

Change in Illness Appraisals, Control

Illness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQSR), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illnesses. Each item is rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree), and totals are scored by summing individual items. For the control total, we are totaling the 8 items related to caregiver, affected person, and treatment control over illness course. Scores range from 8 to 40 with higher scores indicating greater perceptions of possibilities for actions that affect the course of illness.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Illness Appraisals, ControlBaseline30.06 units on a scaleStandard Deviation 4.18
BolsterChange in Illness Appraisals, Control6 weeks30.65 units on a scaleStandard Deviation 4.73
BolsterChange in Illness Appraisals, Control12 weeks31.46 units on a scaleStandard Deviation 4.46
ControlChange in Illness Appraisals, ControlBaseline31.70 units on a scaleStandard Deviation 4.23
ControlChange in Illness Appraisals, Control6 weeks31.80 units on a scaleStandard Deviation 4.07
ControlChange in Illness Appraisals, Control12 weeks31.63 units on a scaleStandard Deviation 4.03
Secondary

Change in Illness Appraisals, Emotional Distress About Illness

Illness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQSR), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illnesses. Each item is rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree), and totals are scored by summing individual items. For the emotional distress score, we are examining the emotional representation scale, a 9-item scale with scores ranging from 9 to 45, with higher scores indicating greater emotional distress.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Illness Appraisals, Emotional Distress About IllnessBaseline34.74 score on a scaleStandard Deviation 6.39
BolsterChange in Illness Appraisals, Emotional Distress About Illness6 weeks30.63 score on a scaleStandard Deviation 5.3
BolsterChange in Illness Appraisals, Emotional Distress About Illness12 weeks29.64 score on a scaleStandard Deviation 6.47
ControlChange in Illness Appraisals, Emotional Distress About IllnessBaseline31.85 score on a scaleStandard Deviation 6.28
ControlChange in Illness Appraisals, Emotional Distress About Illness6 weeks32.55 score on a scaleStandard Deviation 5.63
ControlChange in Illness Appraisals, Emotional Distress About Illness12 weeks32.11 score on a scaleStandard Deviation 8.15
Secondary

Change in Illness Knowledge, Caregiver Self-rated

Illness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQSR), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illnesses. Each item is rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree), and totals are scored by summing individual items. For the coherence total, we are totaling the 5 items related to the caregiver's report of how much they understand or know about their loved one's illness. Scores range from 5 to 25 with lower scores indicating better self-rated understanding or coherence.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Illness Knowledge, Caregiver Self-ratedBaseline13.40 score on a scaleStandard Deviation 3.56
BolsterChange in Illness Knowledge, Caregiver Self-rated6 weeks10.97 score on a scaleStandard Deviation 3.27
BolsterChange in Illness Knowledge, Caregiver Self-rated12 weeks10.92 score on a scaleStandard Deviation 3.21
ControlChange in Illness Knowledge, Caregiver Self-ratedBaseline11.35 score on a scaleStandard Deviation 4.18
ControlChange in Illness Knowledge, Caregiver Self-rated6 weeks10.96 score on a scaleStandard Deviation 4.21
ControlChange in Illness Knowledge, Caregiver Self-rated12 weeks10.58 score on a scaleStandard Deviation 3.4
Secondary

Change in Illness Knowledge, Factual Knowledge

This is assessed with the Knowledge About Schizophrenia (KAST), an 18-item multiple-choice assessment examining individuals' knowledge of the etiology, symptoms, and prognosis of schizophrenia. Total scores indicate the number of correct responses, and thus range from 0 to 18.

Time frame: Baseline, 6 weeks, 12 weeks

Population: Participants are only analyzed (and total scores mean imputed) if they completed more than half the items on the scale.

ArmMeasureGroupValue (MEAN)Dispersion
BolsterChange in Illness Knowledge, Factual Knowledge6 weeks16.16 score on a scaleStandard Deviation 1.54
BolsterChange in Illness Knowledge, Factual KnowledgeBaseline15.90 score on a scaleStandard Deviation 2.25
BolsterChange in Illness Knowledge, Factual Knowledge12 weeks16.08 score on a scaleStandard Deviation 1.79
ControlChange in Illness Knowledge, Factual KnowledgeBaseline15.65 score on a scaleStandard Deviation 1.53
ControlChange in Illness Knowledge, Factual Knowledge6 weeks16.15 score on a scaleStandard Deviation 1.53
ControlChange in Illness Knowledge, Factual Knowledge12 weeks15.63 score on a scaleStandard Deviation 1.95

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