Pilot Study of Motivational Interviewing for Loved Ones

Pilot Study of Motivational Interviewing for Loved Ones

Sponsors

Lead Sponsor: Beth Israel Deaconess Medical Center

Source Beth Israel Deaconess Medical Center
Brief Summary

The proposed trial is entitled "Pilot study of Motivational Interviewing for Loved Ones (MILO)." The study population is 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. I 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.

This study is entitled Motivational Interviewing for Loved Ones (MILO). The study population is parents and concerned significant others (PCSO) of individuals experiencing psychosis (IP) who are not currently engaged with treatment, ambivalently engaged, or at high risk for drop-out. 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 = 30). During phase 2, participants will be randomly assigned to either receive MILO (50%) or TAU (50%). The trial will involve a total of 60 participants. All study activities will take place at the primary site, Beth Israel Deaconess Medical Center.

Overall Status Recruiting
Start Date March 1, 2020
Completion Date August 31, 2023
Primary Completion Date August 31, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mental health service utilization by the individual with psychosis ("IP") Change from Baseline to 12 weeks
Secondary Outcome
Measure Time Frame
PCSO Burden Change from Baseline to 12 weeks
PCSO Distress Change from Baseline to 12 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Motivational Interviewing for Loved Ones (MILO)

Description: 4 sessions of behavioral coaching in motivational interviewing communication techniques

Arm Group Label: Motivational Interviewing for Loved Ones (MILO)

Intervention Type: Behavioral

Intervention Name: Mental Health Services Consultation

Description: 1 session of individualized consultation on relevant mental health services for the IP and participating PCSO, with assistance offered in making a specific referral.

Arm Group Label: Mental Health Services Consultation

Eligibility

Criteria:

Inclusion Criteria:

- Age 18 or older

- 20 or more hours of weekly contact with an individual with an adolescent or young adult (age 15-35) with psychosis who is poorly or not at all engaged with mental health treatment

Exclusion Criteria:

- Not able to provide informed consent

- Not proficient in English

- History of developmental delay

- Current acute mental health problem or distress

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Emily Kline, PhD Principal Investigator Beth Israel Deaconess Medical Center
Overall Contact

Last Name: Emily Kline, PhD

Phone: 617-754-1262

Email: [email protected]

Location
Facility: Status: Contact: Beth Israel Deaconess Medical Center Emily Kline, PhD 617-754-1262 [email protected]
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Beth Israel Deaconess Medical Center

Investigator Full Name: Emily Kline

Investigator Title: Instructor in Psychology in the Department of Psychiatry

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Motivational Interviewing for Loved Ones (MILO)

Type: Experimental

Description: MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.

Label: Mental Health Services Consultation

Type: Active Comparator

Description: This consultation will consist of a 30-45 minute appointment in which participants can meet with a clinician knowledgeable about psychosis treatment resources in their area. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.

Acronym MILO-Pilot
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: The first 30 participants to enroll in this study will automatically receive in a training intervention, called "Motivational Interviewing for Loved Ones" (MILO) ("Phase 1"). After that, participants will be randomly assigned to the intervention (MILO) or to a control condition involving a 30-45 minute mental health services consultation ("Phase 2")

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: Phase 1 will be open label. In Phase 2, the person assessing outcomes will be blinded to study condition.

Source: ClinicalTrials.gov