Decision-making and Decision Support Among Emerging Adults With First Episode Psychosis
- Conditions
- Early Psychosis
- Interventions
- Behavioral: Decision aid
- Registration Number
- NCT04373590
- Lead Sponsor
- Temple University
- Brief Summary
The purpose of this study is to evaluate the impact of an antipsychotic medication decision aid and interpersonal and cognitive factors, such as attachment style and motivation, on emerging adults' ability to engage in shared decision making regarding their medications.
- Detailed Description
The long-term occupational, social, and economic outcomes associated with psychosis make it an urgent public health problem. Coordinated specialty care (CSC) is now the gold standard for early psychosis, demonstrating positive clinical and functional effects in the short-term, and longer-term reduced hospitalization rates. These services include an array of treatment options, including psychotropic medications, individual psychotherapy, family education, and support, and occupational therapy and supported employment/education.
While a shorter period between psychosis onset and receipt of appropriate care is associated with better outcomes, emerging adults often experience significant delays before receiving treatment, and a large percentage disengage from services once they are commenced. Decisional conflict about treatment options (i.e., feeling conflicted about which option to choose) and interpersonal factors such as attachment style and trust in health providers can contribute to decision delay and discontinuance of chosen options. Decision support tools (e.g., decision aids), have been shown to reduce decisional conflict as well as improve service engagement. A requisite step in expanding the array of decision support tools available to emerging adults experiencing early psychosis is to better understand their decision-making ability, capacity, and motivation to engage in decision making and how these relate to their engagement in CSC.
It is well recognized that individuals who are being prescribed antipsychotic medications often face decisional conflict about their treatment options. An especially controversial decision is whether individuals should continue taking medication at the same dose or adjust the dose whilst monitoring their symptoms. This dilemma is the result of some uncertainty about the appropriate treatment strategy for long-term management of psychosis. The present project focuses on evaluating the feasibility and effectiveness of the use of a decision aid for making decisions about antipsychotic medication.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Aged 18 to 25 years
- Experiencing early psychosis, defined as psychosis lasting 18 months or less between the time when threshold symptom criteria were reached (as determined by the admitting CSC program assessor) and the date of CSC program enrollment
- Planning to attend a medication appointment with a participating CSC psychiatrist
- Ability to speak and understand English
- Ability to provide informed consent as assessed by research staff using procedures discussed by Carpenter et al. (2000) including a demonstrated understanding and recall of study procedures, rather than passive consent, and allowance of repetition of study procedures until there is understanding and recall.
- Have a legal guardian
- Have identified co-occurring dementia, delirium, or intellectual disability that will likely affect their ability to provide informed consent or participate in the data collection procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decision aid (DA) Decision aid a one-page DA for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics.
- Primary Outcome Measures
Name Time Method Change in service use Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up . Service Use and Resource Form for Monthly Items (SURF-M) scale to assess change in service use over time (66 items)
Decision-making self-efficacy Post appointment interview (1 day of the appointment ) Decision Self-Efficacy (DSE) scale to assess decision self-efficacy (11 items)
Change in medication adherence Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up . Brief Adherence Rating Scale (BARS) to assess change in medication adherence over time (8 items)
Service engagement Baseline (Pre-appointment interview ) Service Engagement Scale (SES) to assess level of service engagement (14 items)
Decisional Conflict Post appointment interview (1 day of the appointment ) Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)
Shared decision making Post appointment interview (1 day of the appointment ) collaboRATE scale to assess level of shared decision making after an appointment (3 items)
Change in antipsychotics knowledge Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ) Scale to assess change in knowledge about antipsychotic medications over time (9 items)
Decision-making attitudes Post appointment interview (1 day of the appointment ) Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)
- Secondary Outcome Measures
Name Time Method Attachment style Baseline (Pre-appointment interview ) Experiences in Close Relationships-Revised (ECR-R) Questionnaire to assess attachment style (36 items)
Apathy Baseline (Pre-appointment interview ) Marin Apathy Evaluation Scale to assess apathy (18 items)
Insight Baseline (Pre-appointment interview ) Birchwood Insight Scale to assess insight to the illness (8 items)
Working alliance Baseline (Pre-appointment interview ) Working Alliance Inventory (WAI) to assess alliance (36)
Cognitive functioning Baseline (Pre-appointment interview ) Brief Assessment of Cognition in Schizophrenia (BACS) - a battery to assess aspects of cognition such as verbal memory and attention.
Self-stigma Baseline (Pre-appointment interview ) Internalized Stigma of Mental Illness (ISMI) Scale - Brief Version, to assess mental health self-stigma (10 items)
Trust Baseline (Pre-appointment interview ) Trust in the Medical Profession Scale to assess level of trust in the clinician (11 items)
Trial Locations
- Locations (1)
Psychosis Education, Assessment, Care and Empowerment (PEACE)
🇺🇸Philadelphia, Pennsylvania, United States