Bolster: Caregiver App to Reduce Duration of Untreated Psychosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Caregiver to a Young Adult With Early Psychosis

Intervention / Treatment
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* Behavioral: Bolster
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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 18 and 30, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolster<br>Participants in the experimental arm will be provided access to the Bolster smartphone application designed to support caregivers of young adults with early psychosis. They will also have access to the research team by phone for technical troubleshooting and support as necessary. | Behavioral: Bolster<br>* 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.<br>|
| Other: Control<br>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. | Behavioral: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 6 weeks, 12 weeks | 
| Change in treatment engagement, general | 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 in a variety of categories (i.e. psychiatry, counseling/psychotherapy, vocational support, primary care, other). This will allow the study team to quantify the number of caregivers whose loved ones engaged in mental health treatment during the study period. | Baseline, 6 weeks, 12 weeks | 
| Change in treatment engagement, specialty | 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 in a variety of categories (i.e. psychiatry, counseling/psychotherapy, vocational support, primary care, other). This will allow the study team to quantify the number of caregivers whose loved ones engaged in specialty treatment for psychosis during the study period. | Baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 6 weeks, 12 weeks | 
| Change in illness knowledge, caregiver self-rated | Caregiver perception of illness knowledge will be assessed using the Illness Perception Questionnaire for Schizophrenia Relatives (IPQ), a self-report scale of caregivers' beliefs about the severity, prognosis, and responsiveness to treatment of mental illness. We will examine the illness coherence scale as a measure of self-perceived knowledge/understanding of psychosis, a 5-item score (ranging from 5 to 25) denoting the extent to which one feels that one has a coherent understanding of the mental health problem. | Baseline, 6 weeks, 12 weeks | 
| Change in illness appraisals, consequences | Illness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQ), 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 agree; 5 = strongly disagree). The IPQ is scored by summing individual items with higher scores indicating strong negative feelings and thoughts. 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. | Baseline, 6 weeks, 12 weeks | 
| Change in illness appraisals, control | Illness appraisals will be assessed with the Illness Perception Questionnaire for Schizophrenia Relatives (IPQ), 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 agree; 5 = strongly disagree). The IPQ is scored by summing individual items with higher scores indicating strong negative feelings and thoughts. For the control total, we are totaling the 13 items related to caregiver, affected person, and treatment control over illness course. Scores range from 13 to 65 with higher scores indicating greater perceptions of possibilities for actions that affect the course of illness. | 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 (IPQ), 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 agree; 5 = strongly disagree). The IPQ is scored by summing individual items with higher scores indicating strong negative feelings and thoughts. 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. | Baseline, 6 weeks, 12 weeks | 
| Change in caregiving experiences | Valence of caregiving appraisals 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 (e.g. difficult behaviors, problems with services, stigma) and positive ways (e.g. positive personal experiences). 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. | 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 0 to 3 Likert scale, with higher values representing a greater frequency of engaging in each coping strategy. For this outcome, we will examine total frequency scores of items assessing adaptive coping. | 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. | 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. | Baseline, 6 weeks, 12 weeks |