Trial Outcomes & Findings for Bolster: Caregiver App to Reduce Duration of Untreated Psychosis (NCT NCT04949542)

NCT ID: NCT04949542

Last Updated: 2025-11-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline, 6 weeks, 12 weeks
• Results posted on: 2025-11-12

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	40	20
Overall Study COMPLETED	36	19
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

Bolster: Caregiver App to Reduce Duration of Untreated Psychosis

Baseline characteristics by cohort

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	54.73 years STANDARD_DEVIATION 7.26 • n=10 Participants	54.40 years STANDARD_DEVIATION 8.31 • n=10 Participants	54.62 years STANDARD_DEVIATION 7.56 • n=20 Participants
Sex: Female, Male Female	37 Participants n=10 Participants	19 Participants n=10 Participants	56 Participants n=20 Participants
Sex: Female, Male Male	3 Participants n=10 Participants	1 Participants n=10 Participants	4 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=10 Participants	18 Participants n=10 Participants	55 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Race/Ethnicity, Customized Asian	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Race/Ethnicity, Customized Other	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Race/Ethnicity, Customized White	30 Participants n=10 Participants	18 Participants n=10 Participants	48 Participants n=20 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Family Communication Baseline	58.94 score on a scale Standard Deviation 8.36	56.66 score on a scale Standard Deviation 6.82
Change in Family Communication 6 weeks	53.23 score on a scale Standard Deviation 8.74	53.20 score on a scale Standard Deviation 9.09
Change in Family Communication 12 weeks	52.02 score on a scale Standard Deviation 8.43	53.55 score on a scale Standard Deviation 8.31

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Treatment Facilitation Baseline	22.47 score on a scale Standard Deviation 9.97	24.29 score on a scale Standard Deviation 13.89
Change in Treatment Facilitation 6 weeks	18.79 score on a scale Standard Deviation 10.08	16.60 score on a scale Standard Deviation 8.86
Change in Treatment Facilitation 12 weeks	20.08 score on a scale Standard Deviation 9.62	19.54 score on a scale Standard Deviation 11.16

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Loved One Treatment Engagement, Medication Provider Baseline	15 Participants	8 Participants
Change in Loved One Treatment Engagement, Medication Provider 12 weeks	21 Participants	7 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Loved One Treatment Engagement, Therapy or Counseling Baseline	17 Participants	8 Participants
Change in Loved One Treatment Engagement, Therapy or Counseling 12 weeks	24 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Illness Knowledge, Factual Knowledge 12 weeks	16.08 score on a scale Standard Deviation 1.79	15.63 score on a scale Standard Deviation 1.95
Change in Illness Knowledge, Factual Knowledge Baseline	15.90 score on a scale Standard Deviation 2.25	15.65 score on a scale Standard Deviation 1.53
Change in Illness Knowledge, Factual Knowledge 6 weeks	16.16 score on a scale Standard Deviation 1.54	16.15 score on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Illness Knowledge, Caregiver Self-rated Baseline	13.40 score on a scale Standard Deviation 3.56	11.35 score on a scale Standard Deviation 4.18
Change in Illness Knowledge, Caregiver Self-rated 6 weeks	10.97 score on a scale Standard Deviation 3.27	10.96 score on a scale Standard Deviation 4.21
Change in Illness Knowledge, Caregiver Self-rated 12 weeks	10.92 score on a scale Standard Deviation 3.21	10.58 score on a scale Standard Deviation 3.40

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Illness Appraisals, Consequences Baseline	79.63 score on a scale Standard Deviation 9.60	80.90 score on a scale Standard Deviation 12.46
Change in Illness Appraisals, Consequences 6 weeks	76.13 score on a scale Standard Deviation 9.89	79.77 score on a scale Standard Deviation 12.71
Change in Illness Appraisals, Consequences 12 weeks	75.93 score on a scale Standard Deviation 11.93	80.39 score on a scale Standard Deviation 10.70

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Illness Appraisals, Control 6 weeks	30.65 units on a scale Standard Deviation 4.73	31.80 units on a scale Standard Deviation 4.07
Change in Illness Appraisals, Control 12 weeks	31.46 units on a scale Standard Deviation 4.46	31.63 units on a scale Standard Deviation 4.03
Change in Illness Appraisals, Control Baseline	30.06 units on a scale Standard Deviation 4.18	31.70 units on a scale Standard Deviation 4.23

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Illness Appraisals, Emotional Distress About Illness Baseline	34.74 score on a scale Standard Deviation 6.39	31.85 score on a scale Standard Deviation 6.28
Change in Illness Appraisals, Emotional Distress About Illness 6 weeks	30.63 score on a scale Standard Deviation 5.30	32.55 score on a scale Standard Deviation 5.63
Change in Illness Appraisals, Emotional Distress About Illness 12 weeks	29.64 score on a scale Standard Deviation 6.47	32.11 score on a scale Standard Deviation 8.15

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Appraisal of Caregiving Experiences** Baseline	43.04 score on a scale Standard Deviation 11.08	45.77 score on a scale Standard Deviation 11.24
Change in Appraisal of Caregiving Experiences** 6 weeks	40.11 score on a scale Standard Deviation 11.91	42.70 score on a scale Standard Deviation 14.46
Change in Appraisal of Caregiving Experiences** 12 weeks	37.94 score on a scale Standard Deviation 10.92	42.76 score on a scale Standard Deviation 12.26

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Caregiver Coping, Activities Baseline	35.32 score on a scale Standard Deviation 6.06	37.25 score on a scale Standard Deviation 6.21
Change in Caregiver Coping, Activities 6 weeks	36.07 score on a scale Standard Deviation 7.30	34.72 score on a scale Standard Deviation 7.30
Change in Caregiver Coping, Activities 12 weeks	36.81 score on a scale Standard Deviation 7.80	36.84 score on a scale Standard Deviation 6.58

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Caregiver Coping, Self-efficacy 12 weeks	168.99 score on a scale Standard Deviation 42.22	160.84 score on a scale Standard Deviation 44.89
Change in Caregiver Coping, Self-efficacy Baseline	135.23 score on a scale Standard Deviation 42.06	142.23 score on a scale Standard Deviation 40.85
Change in Caregiver Coping, Self-efficacy 6 weeks	154.86 score on a scale Standard Deviation 38.90	149.25 score on a scale Standard Deviation 44.57

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Bolster n=40 Participants 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.	Control n=20 Participants 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.
Change in Caregiver Distress Baseline	19.00 score on a scale Standard Deviation 6.48	18.45 score on a scale Standard Deviation 8.68
Change in Caregiver Distress 6 weeks	14.14 score on a scale Standard Deviation 6.18	17.75 score on a scale Standard Deviation 9.03
Change in Caregiver Distress 12 weeks	11.67 score on a scale Standard Deviation 6.43	15.68 score on a scale Standard Deviation 8.85

Adverse Events

Bolster

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benjamin Buck, Associate Professor

University of Washington (affiliate) / University of North Carolina at Chapel Hill

Phone: (919) 445-4330

Email: buckbe@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place