Clinical trial NCT04373590: Decision-making and Decision Support Among Emerging Adults With First Episode Psychosis
Official title: Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Psychosis
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in antipsychotics knowledge
timeFrame: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment )
measure: Decision-making self-efficacy
timeFrame: Post appointment interview (1 day of the appointment )
measure: Decision-making attitudes
timeFrame: Post appointment interview (1 day of the appointment )
measure: Decisional Conflict
timeFrame: Post appointment interview (1 day of the appointment )
measure: Shared decision making
timeFrame: Post appointment interview (1 day of the appointment )
measure: Change in medication adherence
timeFrame: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .
measure: Change in service use
timeFrame: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .
measure: Service engagement
timeFrame: Baseline (Pre-appointment interview )
Secondary outcomes:
measure: Apathy
timeFrame: Baseline (Pre-appointment interview )
measure: Attachment style
timeFrame: Baseline (Pre-appointment interview )
measure: Working alliance
timeFrame: Baseline (Pre-appointment interview )
measure: Trust
timeFrame: Baseline (Pre-appointment interview )
measure: Cognitive functioning
timeFrame: Baseline (Pre-appointment interview )
measure: Insight
timeFrame: Baseline (Pre-appointment interview )
measure: Self-stigma
timeFrame: Baseline (Pre-appointment interview )
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Psychosis Education, Assessment, Care and Empowerment (PEACE)
state: Pennsylvania
Study officials:
References:
citation: Zisman-Ilani Y, Shern D, Deegan P, Kreyenbuhl J, Dixon L, Drake R, Torrey W, Mishra M, Gorbenko K, Elwyn G. Continue, adjust, or stop antipsychotic medication: developing and user testing an encounter decision aid for people with first-episode and long-term psychosis. BMC Psychiatry. 2018 May 22;18(1):142. doi: 10.1186/s12888-018-1707-x.
citation: Zisman-Ilani Y, Hurford I, Bowen A, Salzer M, Thomas EC. Evaluating the feasibility of a decision aid to promote shared decision making among young adults with first-episode psychosis: protocol for a pilot study. Pilot Feasibility Stud. 2021 Jan 11;7(1):22. doi: 10.1186/s40814-020-00757-0.