UNC Department of Psychiatry
Chapel Hill, North Carolina, 27514, United States
Location status: Recruiting
NCT Number: NCT07225179
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27514, United States
Location status: Recruiting
The team aims to pilot test 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. This will involve (1) examining the feasibility of recruitment through program outreach, (2) developing and optimizing state-specific outreach resources and recruitment approaches to be implemented for this mHealth intervention, and (3) evaluating the effectiveness of this intervention in reducing caregiver psychological morbidity and improving family communication. Participants will be caregivers to young people experiencing early psychosis within the state of North Carolina. Remote recruitment resources will be developed and distributed through the EPI-NC outreach program (i.e. network of UNC-based early psychosis clinicians and stakeholders aiming to raise awareness of early psychosis and specialty programs). Recruited participants will complete baseline measures and be given access to the Bolster mHealth intervention, which provides self-guided psychoeducation and communication coaching for early psychosis caregivers. The investigators will collect baseline and post-test data and evaluate within-subjects changes in proposed targets and outcomes including primary outcomes of caregiver psychological morbidity and family communication.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 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, 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
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
University of North Carolina, Chapel Hill
Other
Bolster-NC: A Pilot Study of the Bolster mHealth Intervention Within Early Psychosis Program Outreach in North Carolina
Acronym: Bolster-NC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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