Caregiver to a Young Adult With Early PsychosisNCT04949542
Bolster: Caregiver App to Reduce Duration of Untreated Psychosis
A study testing Bolster in people with Caregiver to a Young Adult With Early Psychosis, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Caregiver to a Young Adult With Early Psychosis
- What is being tested?
- Bolster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2023to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Research in Technology and Engineering Center, Health Sciences, UW Medical Center
Seattle, Washington, 98195
About this study
Official title: Development and Testing of a Caregiver-facing Mobile Health Intervention to Reduce Duration of Untreated Psychosis
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.
- Being tested
- Bolster, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BolsterBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bolster | Experimental | 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. Receives: Behavioral: Bolster |
| Control | Other | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
Secondary outcomes (9)
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
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.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start11 Aug 2023
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Caregiver to a Young Adult With Early PsychosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Buck, University of Washington
- Investigators
- Benjamin Buck, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949542
- Sponsor's protocol ID
- STUDY00013334
- Status last verified
- Oct 2025
- First submitted
- 17 Jun 2021
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Caregiver-facing Mobile Health Intervention to Reduce Duration of Untreated Psychosis
- ClinicalTrials.gov ID
- NCT04949542
- Acronym / sponsor ID
- STUDY00013334
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolster | Experimental | Behavioral: BolsterParticipants 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. |
| Control | Other | Behavioral: ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BolsterBolster 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. | Behavioural | Bolster |
| ControlExemplar 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. | Behavioural | Control |
Primary outcome
Change in Family Communication
Time frame: Baseline, 6 weeks, 12 weeks
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.
Change in Treatment Facilitation
Time frame: Baseline, 6 weeks, 12 weeks
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.
Change in Loved One Treatment Engagement, Medication Provider
Time frame: Baseline, 12 weeks
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.
Change in Loved One Treatment Engagement, Therapy or Counseling
Time frame: Baseline, 12 weeks
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.
9 secondary outcomes
Change in Illness Knowledge, Factual Knowledge
Time frame: Baseline, 6 weeks, 12 weeks
Change in Illness Knowledge, Caregiver Self-rated
Time frame: Baseline, 6 weeks, 12 weeks
Change in Illness Appraisals, Consequences
Time frame: Baseline, 6 weeks, 12 weeks
Change in Illness Appraisals, Control
Time frame: Baseline, 6 weeks, 12 weeks
Change in Illness Appraisals, Emotional Distress About Illness
Time frame: Baseline, 6 weeks, 12 weeks
Change in Appraisal of Caregiving Experiences**
Time frame: Baseline, 6 weeks, 12 weeks
Change in Caregiver Coping, Activities
Time frame: Baseline, 6 weeks, 12 weeks
Change in Caregiver Coping, Self-efficacy
Time frame: Baseline, 6 weeks, 12 weeks
Change in Caregiver Distress
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Caregiver to a Young Adult With Early Psychosis
Recruiting
mHealth for Early Psychosis Caregivers in Statewide Program Outreach
Caregiver, Caregiver Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Buck, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bolster in people with Caregiver to a Young Adult With Early Psychosis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Family Communication (time frame: Baseline, 6 weeks, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.