mHealth for Early Psychosis Caregivers in Statewide Program Outreach

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

The purpose of this study is to pilot the delivery of an mHealth intervention for caregivers to young people with early psychosis within a network of early psychosis intervention programs in the state of North Carolina. The investigators will examine the feasibility of recruitment through program outreach, develop North Carolina specific outreach resources to be used with the mHealth intervention and evaluate the effectiveness of this intervention for reducing caregiver psychological morbidity and improving family communication. The investigators will also collect pilot data to inform recruitment and development of implementation strategies for delivering Bolster within a statewide early psychosis network.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

North Carolina resident

Caregiver to a young adult with early psychosis, wherein early psychosis is defined as: (1) Being between the ages of 15 and 30, and (2) Within the past five years, the young adult first experienced hallmark symptoms: (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)

Disqualifiers

Participant failed to demonstrate understanding of study details in comprehension screening process.

Previous enrollment in a study involving Bolster.

Activity on screening questionnaires that indicates suspicious or dishonest participation such that the participant is likely to be a "malicious actor" or "gamer" (i.e. an individual that attempts to enroll in online research studies solely for compensation with dishonest or illegitimate responses to study questionnaires)

Trial design

Design model

Single group

Treatments tested in this trial

  • Bolster

    Behavioral

    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. Participants will also have access to a member of the study team for technical troubleshooting and support as necessary.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: BolsterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in family communication / expressed emotion

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, the investigators 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, 12 weeks
2

Change in caregiver psychological morbidity

Caregiver psychological morbidity 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, 12 Weeks

Secondary outcomes

1

Change in illness knowledge

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. The investigators 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. Higher scores suggest higher self-perceived knowledge/understanding of psychosis.

Time frame
Baseline, 12 weeks
2

Change in 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, the investigators 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, 12 weeks
3

Change in 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, 12 weeks
4

Change in appraisals 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.

Time frame
Baseline, 12 weeks

Other outcomes

Sponsors and contacts

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University of North Carolina, Chapel Hill

Lead sponsor

North Carolina Department of Health and Human Services

Collaborator