Psychosis Clinical Trial
Official title:
Pilot Study of Motivational Interviewing for Loved Ones
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04929938 -
Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients
|
N/A | |
Recruiting |
NCT05863572 -
Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
|
N/A | |
Completed |
NCT04277585 -
Improving Access to Early Psychosis Coordinated Specialty Care
|
N/A | |
Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Terminated |
NCT04404712 -
FAAH Availability in Psychiatric Disorders: A PET Study
|
Early Phase 1 | |
Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Not yet recruiting |
NCT05558332 -
Youth Nominated Support Team
|
N/A | |
Not yet recruiting |
NCT05358457 -
Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)
|
N/A | |
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Completed |
NCT02895269 -
COllaborative Shared Care to IMprove Psychosis Outcome
|
N/A | |
Recruiting |
NCT02622048 -
Understanding and Helping Families: Parents With Psychosis
|
N/A | |
Completed |
NCT02531243 -
Computer-Aided Learning for Managing Stress
|
N/A | |
Completed |
NCT02733575 -
Compassion Focused Therapy for Distressing Experiences
|
N/A | |
Completed |
NCT02653729 -
Cbt for Psychosis and Affect on Psychosis Symptoms
|
Phase 2 | |
Not yet recruiting |
NCT02244970 -
Mindfulness RCT for Early Psychosis
|
N/A | |
Enrolling by invitation |
NCT01364818 -
Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
|
N/A | |
Withdrawn |
NCT00786318 -
Ziprasidone vs Standard Therapy for Agitated Patients in the ED
|
Phase 4 | |
Recruiting |
NCT00722163 -
A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
|
Phase 0 |