Caregiver to a Young Adult With Early Psychosis
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Family Communication | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Illness Appraisals, Emotional Distress About Illness | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Appraisal of Caregiving Experiences** | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Illness Knowledge, Factual Knowledge | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Caregiver Coping, Self-efficacy | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Caregiver Distress | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Caregiver Coping, Activities | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Illness Knowledge, Caregiver Self-rated | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Illness Appraisals, Consequences | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Illness Appraisals, Control | Baseline, 6 weeks, 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Bolster |
|---|---|---|---|
| Age, Continuous | 54.40 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 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 55 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 48 Participants | 30 Participants |
| Sex: Female, Male Female | 19 Participants | 56 Participants | 37 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 20 |
| other Total, other adverse events | 0 / 40 | 0 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 20 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Family Communication | Baseline | 58.94 score on a scale | Standard Deviation 8.36 |
| Bolster | Change in Family Communication | 6 weeks | 53.23 score on a scale | Standard Deviation 8.74 |
| Bolster | Change in Family Communication | 12 weeks | 52.02 score on a scale | Standard Deviation 8.43 |
| Control | Change in Family Communication | 6 weeks | 53.20 score on a scale | Standard Deviation 9.09 |
| Control | Change in Family Communication | Baseline | 56.66 score on a scale | Standard Deviation 6.82 |
| Control | Change in Family Communication | 12 weeks | 53.55 score on a scale | Standard Deviation 8.31 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bolster | Change in Loved One Treatment Engagement, Medication Provider | Baseline | 15 Participants |
| Bolster | Change in Loved One Treatment Engagement, Medication Provider | 12 weeks | 21 Participants |
| Control | Change in Loved One Treatment Engagement, Medication Provider | Baseline | 8 Participants |
| Control | Change in Loved One Treatment Engagement, Medication Provider | 12 weeks | 7 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bolster | Change in Loved One Treatment Engagement, Therapy or Counseling | Baseline | 17 Participants |
| Bolster | Change in Loved One Treatment Engagement, Therapy or Counseling | 12 weeks | 24 Participants |
| Control | Change in Loved One Treatment Engagement, Therapy or Counseling | Baseline | 8 Participants |
| Control | Change in Loved One Treatment Engagement, Therapy or Counseling | 12 weeks | 8 Participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Treatment Facilitation | Baseline | 22.47 score on a scale | Standard Deviation 9.97 |
| Bolster | Change in Treatment Facilitation | 6 weeks | 18.79 score on a scale | Standard Deviation 10.08 |
| Bolster | Change in Treatment Facilitation | 12 weeks | 20.08 score on a scale | Standard Deviation 9.62 |
| Control | Change in Treatment Facilitation | Baseline | 24.29 score on a scale | Standard Deviation 13.89 |
| Control | Change in Treatment Facilitation | 6 weeks | 16.60 score on a scale | Standard Deviation 8.86 |
| Control | Change in Treatment Facilitation | 12 weeks | 19.54 score on a scale | Standard Deviation 11.16 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Appraisal of Caregiving Experiences** | Baseline | 43.04 score on a scale | Standard Deviation 11.08 |
| Bolster | Change in Appraisal of Caregiving Experiences** | 6 weeks | 40.11 score on a scale | Standard Deviation 11.91 |
| Bolster | Change in Appraisal of Caregiving Experiences** | 12 weeks | 37.94 score on a scale | Standard Deviation 10.92 |
| Control | Change in Appraisal of Caregiving Experiences** | Baseline | 45.77 score on a scale | Standard Deviation 11.24 |
| Control | Change in Appraisal of Caregiving Experiences** | 6 weeks | 42.70 score on a scale | Standard Deviation 14.46 |
| Control | Change in Appraisal of Caregiving Experiences** | 12 weeks | 42.76 score on a scale | Standard Deviation 12.26 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Caregiver Coping, Activities | Baseline | 35.32 score on a scale | Standard Deviation 6.06 |
| Bolster | Change in Caregiver Coping, Activities | 6 weeks | 36.07 score on a scale | Standard Deviation 7.3 |
| Bolster | Change in Caregiver Coping, Activities | 12 weeks | 36.81 score on a scale | Standard Deviation 7.8 |
| Control | Change in Caregiver Coping, Activities | Baseline | 37.25 score on a scale | Standard Deviation 6.21 |
| Control | Change in Caregiver Coping, Activities | 6 weeks | 34.72 score on a scale | Standard Deviation 7.3 |
| Control | Change in Caregiver Coping, Activities | 12 weeks | 36.84 score on a scale | Standard Deviation 6.58 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Caregiver Coping, Self-efficacy | Baseline | 135.23 score on a scale | Standard Deviation 42.06 |
| Bolster | Change in Caregiver Coping, Self-efficacy | 6 weeks | 154.86 score on a scale | Standard Deviation 38.9 |
| Bolster | Change in Caregiver Coping, Self-efficacy | 12 weeks | 168.99 score on a scale | Standard Deviation 42.22 |
| Control | Change in Caregiver Coping, Self-efficacy | Baseline | 142.23 score on a scale | Standard Deviation 40.85 |
| Control | Change in Caregiver Coping, Self-efficacy | 6 weeks | 149.25 score on a scale | Standard Deviation 44.57 |
| Control | Change in Caregiver Coping, Self-efficacy | 12 weeks | 160.84 score on a scale | Standard Deviation 44.89 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Caregiver Distress | Baseline | 19.00 score on a scale | Standard Deviation 6.48 |
| Bolster | Change in Caregiver Distress | 6 weeks | 14.14 score on a scale | Standard Deviation 6.18 |
| Bolster | Change in Caregiver Distress | 12 weeks | 11.67 score on a scale | Standard Deviation 6.43 |
| Control | Change in Caregiver Distress | Baseline | 18.45 score on a scale | Standard Deviation 8.68 |
| Control | Change in Caregiver Distress | 6 weeks | 17.75 score on a scale | Standard Deviation 9.03 |
| Control | Change in Caregiver Distress | 12 weeks | 15.68 score on a scale | Standard Deviation 8.85 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Illness Appraisals, Consequences | Baseline | 79.63 score on a scale | Standard Deviation 9.6 |
| Bolster | Change in Illness Appraisals, Consequences | 6 weeks | 76.13 score on a scale | Standard Deviation 9.89 |
| Bolster | Change in Illness Appraisals, Consequences | 12 weeks | 75.93 score on a scale | Standard Deviation 11.93 |
| Control | Change in Illness Appraisals, Consequences | Baseline | 80.90 score on a scale | Standard Deviation 12.46 |
| Control | Change in Illness Appraisals, Consequences | 6 weeks | 79.77 score on a scale | Standard Deviation 12.71 |
| Control | Change in Illness Appraisals, Consequences | 12 weeks | 80.39 score on a scale | Standard Deviation 10.7 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Illness Appraisals, Control | Baseline | 30.06 units on a scale | Standard Deviation 4.18 |
| Bolster | Change in Illness Appraisals, Control | 6 weeks | 30.65 units on a scale | Standard Deviation 4.73 |
| Bolster | Change in Illness Appraisals, Control | 12 weeks | 31.46 units on a scale | Standard Deviation 4.46 |
| Control | Change in Illness Appraisals, Control | Baseline | 31.70 units on a scale | Standard Deviation 4.23 |
| Control | Change in Illness Appraisals, Control | 6 weeks | 31.80 units on a scale | Standard Deviation 4.07 |
| Control | Change in Illness Appraisals, Control | 12 weeks | 31.63 units on a scale | Standard Deviation 4.03 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Illness Appraisals, Emotional Distress About Illness | Baseline | 34.74 score on a scale | Standard Deviation 6.39 |
| Bolster | Change in Illness Appraisals, Emotional Distress About Illness | 6 weeks | 30.63 score on a scale | Standard Deviation 5.3 |
| Bolster | Change in Illness Appraisals, Emotional Distress About Illness | 12 weeks | 29.64 score on a scale | Standard Deviation 6.47 |
| Control | Change in Illness Appraisals, Emotional Distress About Illness | Baseline | 31.85 score on a scale | Standard Deviation 6.28 |
| Control | Change in Illness Appraisals, Emotional Distress About Illness | 6 weeks | 32.55 score on a scale | Standard Deviation 5.63 |
| Control | Change in Illness Appraisals, Emotional Distress About Illness | 12 weeks | 32.11 score on a scale | Standard Deviation 8.15 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Illness Knowledge, Caregiver Self-rated | Baseline | 13.40 score on a scale | Standard Deviation 3.56 |
| Bolster | Change in Illness Knowledge, Caregiver Self-rated | 6 weeks | 10.97 score on a scale | Standard Deviation 3.27 |
| Bolster | Change in Illness Knowledge, Caregiver Self-rated | 12 weeks | 10.92 score on a scale | Standard Deviation 3.21 |
| Control | Change in Illness Knowledge, Caregiver Self-rated | Baseline | 11.35 score on a scale | Standard Deviation 4.18 |
| Control | Change in Illness Knowledge, Caregiver Self-rated | 6 weeks | 10.96 score on a scale | Standard Deviation 4.21 |
| Control | Change in Illness Knowledge, Caregiver Self-rated | 12 weeks | 10.58 score on a scale | Standard Deviation 3.4 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bolster | Change in Illness Knowledge, Factual Knowledge | 6 weeks | 16.16 score on a scale | Standard Deviation 1.54 |
| Bolster | Change in Illness Knowledge, Factual Knowledge | Baseline | 15.90 score on a scale | Standard Deviation 2.25 |
| Bolster | Change in Illness Knowledge, Factual Knowledge | 12 weeks | 16.08 score on a scale | Standard Deviation 1.79 |
| Control | Change in Illness Knowledge, Factual Knowledge | Baseline | 15.65 score on a scale | Standard Deviation 1.53 |
| Control | Change in Illness Knowledge, Factual Knowledge | 6 weeks | 16.15 score on a scale | Standard Deviation 1.53 |
| Control | Change in Illness Knowledge, Factual Knowledge | 12 weeks | 15.63 score on a scale | Standard Deviation 1.95 |