Clinical trial NCT04010747: Pilot Study of Motivational Interviewing for Loved Ones
Official title: Pilot Study of Motivational Interviewing for Loved Ones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Psychosis
Psychotic Episode
Keywords: Parents
Family Members
Partner, Domestic
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: National Institute of Mental Health (NIMH)
First posted: 2019-07-08
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The first 30 participants to enroll in this study will receive a training intervention called "Motivational Interviewing for Loved Ones" (MILO).

After that, participants will be randomly assigned to the intervention (MILO) or to a control condition involving a 30-minute mental health services consultation and a 6 week waitlist followed by the opportunity to participate in the MILO intervention ("Phase 2")
Primary purpose: TREATMENT

Brief summary: The study population for this research will include parents and concerned significant others (PCSO) of individuals experiencing recent (past five years) onset of a psychotic disorder (hereafter referred to as individuals with psychosis, "IP") who are not currently engaged with, or at risk for disengagement from, treatment. MILO is a brief and structured intervention that teaches motivational interviewing communication strategies. The initial aim (phase 1) of this pilot study is to evaluate feasibility of the intervention. The secondary aims are to evaluate the effectiveness of MILO for (1) enhancing the engagement of IP with evidence-based treatments and (2) reducing distress among PCSO. The investigators hypothesize that the intervention will be superior to control condition for both enhancing IP engagement with mental health services and reducing PCSO distress.

Detailed description: First Episode Psychosis (FEP) often represents a time of crisis for young people and their families. Since peak onset occurs during late adolescence and early adulthood, the onset of serious mental health challenges can disrupt plans for education, relationships, and other milestones of independence. Although some psychoses are brief and self-limiting, more often these symptoms portend a potentially chronic and disabling psychiatric disorder such as schizophrenia. FEP can also be acutely dangerous: youth with FEP are far more likely to die in the year following their diagnosis relative to the general population of 16-30 year old's in the United States. Approximately 100,000 youth in the United States experience FEP every year. Young people identified by providers as experiencing FEP often slip through the cracks before they reach appropriate treatment. A review of privately insured adolescents and young adults in the US showed that 62% of young people in the US with FEP filled no outpatient prescriptions, and 41% received no outpatient psychotherapy, in the year following their index diagnosis. Among those who do have an initial encounter with specialized FEP outpatient care, high attrition is a common problem, with 30% of individuals initially enrolled in first episode programs dropping out prior to completing treatment.

Many individuals experiencing psychosis are reluctant to seek mental health treatment due to lack of insight and fear of psychiatric interventions. Young adults may be torn between distress and dissatisfaction relating to their symptoms and functioning, and mistrust of mental health providers and irritation with their parents' concern. Motivational Interviewing (MI) techniques are designed to elicit this ambivalence through nonjudgmental listening, so that discrepancies between current behaviors and ideal outcomes can be explored. Clinician-delivered MI has been identified as effective for enhancing adherence once individuals with psychosis are involved in care, and may also be useful for engaging those who are not yet interested in treatment. Several studies have found positive results in training and deploying non-professionals to use MI to influence others' health behaviors. MI training for parents and concerned significant others (PCSO) is a promising venue through which PCSO can specifically influence their loved one's decision to seek care and adhere to treatment plans.

MILO is a structured and goal oriented intervention that seeks to accomplish two aims. The primary aim is to facilitate the engagement of IP with evidence-based treatments. The secondary aim is to reduce the distress and increase the wellbeing of PCSO. The intervention will be trialed for feasibility (phase 1, n = 30) and then tested against a small "treatment as usual" (TAU) control arm (phase 2, n = 40). During phase 2, participants will be randomly assigned to either receive MILO (50%) or TAU (50%). The trial will involve a total of 70 participants.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Primary caregiver or other close contact of an individual within first 5 years of onset of a psychotic disorder who is poorly engaged or unengaged in psychiatric treatment

Exclusion Criteria:

* Not able to provide informed consent
* Not proficient in English
* History of developmental delay
* Current acute mental health problem or distress

Primary outcomes:
measure: Change in the Number of Mental Health Related Appointments Attended by the Individual With Psychosis (IP) in the Past 30 Days
timeFrame: Change from Baseline to 12 weeks
Secondary outcomes:
measure: Change in Parents and Concerned Significant Others (PCSO) Expressed Emotion
timeFrame: Change from Baseline to 12 weeks
measure: Change in Parents and Concerned Significant Others (PCSO) Distress
timeFrame: Change from Baseline to 12 weeks
Other outcomes:
measure: Change in Parents and Concerned Significant Others (PCSO) Acquisition of Motivational Interviewing Skills
timeFrame: Change from Baseline to 6 weeks
measure: Change in PCSO Beliefs and Self Confidence to Parent
timeFrame: Change from Baseline to 6 weeks
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Emily R Kline, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kline ER, Thibeau H, Sanders AS, English K, Davis BJ, Fenley AR, Keshavan MS. Motivational Interviewing for Loved Ones in Early Psychosis: Development and Pilot Feasibility Trial of a Brief Psychoeducational Intervention for Caregivers. Front Psychiatry. 2021 Apr 1;12:659568. doi: 10.3389/fpsyt.2021.659568. eCollection 2021.