Protocol Director: / Dr, Kate Hardy
Protocol Title: Family Cognitive Behavioral Therapy for Psychosis (CBTpF): Development of a Family Intervention for Caregivers
PRELIMINARY CONSENT FORM
Research Study: Family Cognitive Behavioral Therapy for Psychosis (CBTpF)
Protocol Director: Dr. Kate Hardy
Please read the Preliminary Consent Form in full if interested in participating in the CBTpF study.
PURPOSE OF RESEARCH
Family Cognitive Behavioral Therapy for Psychosis (CBTpF) is a research study being conducted at Stanford University. Symptoms of a psychotic disorder have a profound impact on individuals and their caregivers. Caregiver health has been especially linked to patient relapse and recovery. CBTpF is a pilot intervention specifically designed to meet caregiver needs and to support caregivers in learning Cognitive Behavioral Therapy for psychosis skills and tools, a widely used and effective psychological therapy in the treatment of schizophrenia and other psychotic disorders.
This study will provide a short-term workshop to caregivers in the use of Cognitive Behavioral Therapy for Psychosis, over the course of two-days and a half-day booster session. In doing so, we hope to learn more about the impact of providing skills and tools to caregivers in the use of an evidence-based psychotherapeutic treatment for schizophrenia and other psychotic disorders.
You self-identified as a caregiver of an individual diagnosed with a schizophrenia spectrum or other psychotic disorder and therefore may meet criteria to participate in our study.
If you enroll and afterwards decide to terminate your participation in this study, you should notify study personnel at .
This research study is looking for 40 participants who are caregivers of a person diagnosed with a schizophrenia or psychotic spectrum disorder. Enrollment for this study will occur within the United States. Stanford University expects to enroll 40 research study participants.
VOLUNTARY PARTICIPATION
Your participation in this study is entirely voluntary. If you are extended an invitation to enroll and decide to participate you are free to withdraw your consent and discontinue participation in the study at any time without any loss of benefits or medical care to which you are entitled. Your decision not to participate will not have any negative effect on you or your medical care.
If you enroll and afterwards decide to terminate your participation in this study, you should notify study personnel at .
DURATION OF STUDY INVOLVEMENT
This research study is expected to take approximately six weeks, with 2.5 days of active participation by each participant and six weeks and one day of collection of medical information. Data will be collected at three time points over the course of six weeks, which are:
· During the first day of active participation
· At the two week mark of enrollment
· At the six week mark of enrollment
PROCEDURES
The purpose of this research study is to learn more about the impact of supporting caregivers to learn the skills and tools of Cognitive Behavioral Therapy for psychosis. If interested in enrolling, you will be asked to complete a brief online questionnaire after you review the preliminary consent form in order to determine whether or not the study is a good fit for you. If it is determined that you meet study criteria and if there is room in the study for more participants, study staff will extend an invitation to you to enroll in the study. You are under no obligation to enroll if extended an invitation.
If you enroll, Dr. Kate Hardy and her research study staff will provide you with a two-day workshop and half-day booster session in Cognitive Behavioral Therapy for psychosis (CBTp), an evidence-based and widely used psychotherapeutic treatment of schizophrenia and other psychotic spectrum disorders (e.g. schizoaffective disorder, schizophreniform disorder, delusional disorder). The CBTp workshop and booster session will be provided free of charge.
Research study staff will also collect data about your behavior, emotional status, experiences as a caregiver and knowledge about CBTp. Data will be collected at three different time points over the course of approximately six weeks.
A detailed outline of procedures is as follows:
1) Active participation phase: All participants will be asked to attend a two-day Cognitive Behavioral Therapy for psychosis (CBTp) workshop and a booster or review session that will take place two weeks after the CBTp workshop. Both the CBTp workshop and booster session will take place at the Stanford University campus and will be led by trained research study staff. Participants are expected to attend the entire two-day CBTp workshop and booster session, however participation is entirely voluntary.
a. The CBTp workshop will be on January 23-24, 2016 from 9:30am – 4:00pm (6.5 hours per day; 13 hours total).
b. The booster session will be on February 7, 2016 from 9:00am – 12:30pm (3.5 hours).
2) Collection of data: Research study staff will collect data about participants’ with the use of questionnaires about participant behavior, emotional status, experiences as a caregiver and knowledge about CBTp. Data will be collected from each participant at three different time points during his/her participation in this study, over the course of six weeks. You have the right to refuse to answer particular questions. Procedures for data collection are as follows:
a. Collection of pre-intervention data from each participant will occur before commencing the CBTp workshop on the first day. Participants will be asked to complete 4 questionnaires before beginning the workshop. Completion of the questionnaires should take approximately 40 minutes.
b. Data will be collected before starting the booster session, two-weeks post CBTp workshop. Participants will be asked to complete 4 questionnaires before beginning the booster session. Completion of the questionnaires should take approximately 40 minutes.
c. Collection of post-intervention data from each participant will occur one-month after the booster session. Participants will be asked to complete 4 questionnaires online. Completion of the questionnaires is expected to take approximately 40 minutes. Instructions and reminders will be provided.
- Participants will be asked to complete a brief, 5-minute demographic form before beginning the CBTp workshop on the first day. Participants will be asked to complete feedback questionnaires at the end of each CBTp workshop day and at the end of the booster session.
EXCLUSION
Individuals who have been diagnosed with a serious medical, psychiatric or neurological condition (e.g. dementia, a disorder, bipolar disorder) or a sensory impairment (vision or hearing loss) may be disqualified from participation if these conditions prevent full participation in the workshop.
All study procedures will be carried out in English. As such, participants will be required to be fluent in English, including be able to read and write in English.
Participants will be required to arrange their own transportation to and from the CBTp workshop and booster session.
Please contact study personnel at if you have any questions or concerns.
PARTICIPANT RESPONSIBILITIES
Participant responsibilities include:
· Following the instructions of the Protocol Director and study staff.
· Keeping your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff as soon as you know you will miss the appointment.
· Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.
· Complete your questionnaires as instructed.
· Ask questions as you think of them.
· Tell the Protocol Director or research staff if you change your mind about staying in the study.
While participating in this research study, you should not take part in any other research project without prior approval from the Protocol Directors of each study.
WITHDRAWAL FROM STUDY
If you enroll and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. Your decision will not affect your ability to receive medical care and you will not lose any benefits to which you would otherwise be entitled.
If you enroll and then decide to terminate your participation in this study, you should immediately notify study personnel at .
Upon your notification, you will immediately be withdrawn from the study and receive confirmation (by email or telephone). At this point, no further duties will be asked of you and no further data will be collected from you as part of the research study. All data gathered from you prior to your withdrawal from the study will be stripped of identifying information (e.g. name, telephone number) and may be privately stored and analyzed for research study purposes.
The Protocol Director may also withdraw you from the study without your consent for one or more of the following reasons:
· Failure to follow the instructions of the Protocol Director and study staff.
· The Protocol Director decides that continuing your participation could be harmful to you.
· You need treatment not allowed in the study.
· The study is cancelled.
· Other administrative reasons.
· Unanticipated circumstances.
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES
There are risks, discomforts, and inconveniences associated with any research study. While there are no known physical health risks associated with this study, study procedures may involve risks to the study participant that are currently unforeseeable. These deserve careful thought.
It is important to note that topics discussed during the CBTp workshop and booster session, and responses elicited by administered questionnaires will be sensitive and may induce strong emotional responses and/or discomfort in participants. Such topics include personal experiences, management of stress, psychological distress and perceived difficulties caring for ill family members or loved ones.
Furthermore, study participants are under no obligation to share personal experiences if they do not wish to do so. However, participants can consider the CBTp workshop and booster session a safe place to participate if they wish to do so. Participants will also be allowed to take breaks as needed, ask questions, express concerns and observe as they choose.
Study personnel will be mindful, sensitive of and respond to all risks, discomfort and inconvenience. Study participants are also invited to speak to any study personnel should significant risk, discomfort and/or inconvenience occur. Participants will be given appropriate resources and psychological referrals if necessary or requested. You should talk with the Protocol Director or research study personnel if you have any questions.
Economic risks include potential financial impact of missing work and transportation costs to and from the Stanford University campus for study visits.
POTENTIAL BENEFITS
Benefits that may be reasonably expected from your participation in this study include:
· Improvement in caregiver emotional, psychological and/or physical symptoms (if applicable) as a result of using skills learned during the study intervention.
· Improvement in patient emotional, psychological and/or physical symptoms (if applicable) as a result of caregiver use of skills learned during the study intervention.
· Improvement in caregiver awareness, knowledge of and use of evidence-based psychological treatment for schizophrenia and psychotic disorders, Cognitive Behavioral Therapy for psychosis.
THE ABOVE ARE POTENTIAL BENEFITS THAT MAY BE REASONABLY EXPECTED AS A RESULT OF THIS STUDY. WE CANNOT AND DO NOT GUARANTEE OR PROMISE THAT YOU WILL RECEIVE ANY BENEFITS FROM THIS STUDY.
All study interventions, including the CBTp workshop and booster session, will be provided to participants free of charge.
The possible general benefit for science resulting from your participation in this study consists of adding to the knowledge regarding the impact of Family Cognitive Behavioral Therapy for psychosis (CBTpF).
PARTICIPANT’S RIGHTS
You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director.
You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.
While participating in this study you should not take part in any other research project without prior approval from all of the investigators. This is to protect you from possible injury arising from such things as interaction of different research interventions and/or treatments or similar hazards.
CONFIDENTIALITY
Your identity will be kept as confidential as possible as required by law. Except as required by law, you will not be identified by name, social security number, address, telephone number or any other direct personal identifier to any one other than the research study personnel. Your research records may be disclosed outside of Stanford, but in this case you will be identified by a unique code number. Information about the code will be kept in a secure location and access to it will be limited to research study personnel.
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified.
Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.
This is a copy of the
Authorization to Use Your Health Information for Research Purposes form, provided to you during enrollment.
Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this authorization form provided to you upon enrollment, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with the authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.
What is the purpose of this research study and how will my health information be utilized in the study?
The purpose of this research study is to gather exploratory information about the impact of Family Cognitive Behavioral Therapy for Psychosis (CBTpF). Your information will only be used in accordance with the provisions of this consent form and applicable law.