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The Mindflex Assessment Project
 
Principal Investigator: Ronald. D. Rogge, Ph.D.
Research Coordinator: Brooke A. Dubler, M.A.
 
This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision.  Please read this form carefully.

 
Please know that…
  • Being in this study is voluntary – it is your choice.
  • If you join this study, you can change your mind and stop at any time.
  • There are risks from participating and you should understand what these mean to you
 
OUR GOAL 
We are committed to developing an ongoing and self-sustaining service for the ACT community that provides cutting-edge testing and clinically useful flexibility profiles to aid in treatment. Although the Mindflex service will eventually charge small fees to generate flexibility profiles (to cover operating costs, website development and maintenance), we are currently offering the service for free as we conduct this project to develop this service over the next 1-2 years. Thus, clinicians willing to participate in this project will be provided with unlimited free access to Mindflex profiles for their clients (based on the Multidimensional Psycological Flexibility Inventory; MPFI; Rolffs, Rogge, & Wilson, 2016).
THE PROFILES
Those profiles will be based on the normative data from 2,668 respondents used to develop the MPFI and will provide clinicians with a sense of the strengths and challenges that each client brings into treatment. The profiles will specifically plot standardized scores on the 6 dimensions of flexibility and 6 dimensions of inflexibility suggested by the hexaflex model, showing where each client falls compared to normative levels and tentative clinical thresholds (see samples).

The Mindflex system also assesses depressive symptoms (PHQ-9; Spitzer, Kroenke, & Williams, 1999), anxiety symptoms (GAD-7; Spitzer, Kroenke, & Williams, 2006), and general well-being (SWLS, Diener Emmons Larsen & Griffin, 1985; BPNSFS, Chen et al., 2015) to provide information on global levels of functioning.

For clients completing follow-up assessments, the profiles will also indicate on which dimensions the clients showed significant improvement or deterioration.

STUDY PROCEDURE
Enrollment: : If you decide to take part in this study, we ask that you fill out the following (5-10min) enrollment form, providing some basic information on yourself as a clinician. You will then be given a therapist ID and will be given a link to another online form with which you can enroll clients. Each time you enroll a new client or prompt an existing client to complete a follow-up flexibility assessment, you will be asked to fill out a short (2-5min) survey giving basic information on the case. [To comply with HIPPA regulations, you will need to discuss this process with each client and get them to complete an appropriate release form before enrolling them in this project and sharing details of their case with us.] The Mindflex client-focused online forms will then send emails to your clients encouraging them to participate in the project by completing Mindflex assessments.

Follow-up Assessments: We encourage clinicians to enroll clients near the beginning of treatment to get a baseline assessment of functioning, and then to prompt clients to complete the assessment again in the last few weeks of treatment to get a sense of meaningful change from therapy. To help with this, 2 months after a client completes his or her baseline assessment, we will email the client as well as his or her therapist to encourage them to complete short follow-up forms (2-5min for the therapist) and assessments (10-15min for the client) through the system.

Therapists are also encouraged to prompt clients to complete a Mindflex assessment as often as they find it useful throughout the course of treatment, whenever they would like to get an objective assessment of progress.

NUMBER OF SUBJECTS: We estimate that approximately 9000 participants (1000 therapists and 8000 clients) will take part in this study.

RISKS: If you agree to participate, you may feel uncomfortable or stressed answering some questions, you are free to decline to answer any question or stop participation at any time. Communicating via e-mail with the study team while participating in this study presents additional risks related to privacy and confidentiality that you should consider. These include, but are not limited to, the following:
  • E-mail can be circulated, forwarded, stored electronically and on paper, and broadcast to unintended recipients.
  • E-mail senders can easily misaddress an e-mail.
  • Backup copies of e-mail may exist even after the sender or the recipient has deleted his or her copy.
  • Employers and on-line services have a right to inspect e-mail transmitted through their systems.
  • E-mail can be intercepted, altered, forwarded, or used without authorization or detection.
  • E-mail can be used to introduce viruses into computer systems.
BENEFITS: There are no direct benefits. However, we are hopeful that the flexibility profiles generated by the Mindflex Assessments will be helpful in your work with your clients.

COSTS: There will be no cost to you to participate in this study.

PAYMENTS – The primary recruitment incentive for participating in this study will be the MindFlex profiles you receive when clients complete Mindflex assessments. Roughly the first 100 therapists that sign up will also receive: $20 for enrolling themselves in the Mindflex system by thoroughly completing the Mindflex Therapist Enrollment Form (~10min), $10 for each of the first 3-4 client enrollment forms that they complete (~5min each), $10 for each Therapist Follow-up Forms they complete for each of those clients (~7min each), and $5 for each feedback form they complete after receiving Mindflex profiles (~2-3min each). Thus, each of those first 100 therapists could receive as much as $100 in total payments.

Similarly, roughly the first 300 clients will receive $40 for thoroughly completing the baseline Mindflex assessment and another $40 for thoroughly completing their first follow-up Mindflex assessment.

CONFIDENTIALITY: The University of Rochester makes every effort to keep the information collected from you private. In order to do so, your data will not be shared with third parties and only investigators on the study will have access to that data. Although the data from clients and therapists participating in the survey will be linked via random ID numbers in our final data set, none of your responses would ever be shared with your client. The responses of all participants will be stored numerically and only the investigators on the study will have access to that data. Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators or the study sponsor. If this does happen we will take precautions to protect the information you have provided. Results of the research may be presented at meetings or in publications, but your name will not be used. 

Conditions for the Use of E-mail
The researcher cannot guarantee but will use reasonable means to maintain security and confidentiality of e-mail information sent and received. You and researcher must consent to the following conditions:
  • E-mail is not appropriate for urgent or emergency situations. The researcher cannot guarantee that any particular e-mail will be read and responded to.
  • E-mail must be concise. You should schedule an appointment if the issue is too complex or sensitive to discuss via e-mail.
  • E-mail communications between you and the researcher will be filed in your research record.
  • Your messages may also be delegated to any member of the study team for response.
  • The researcher will not forward subject-identifiable e-mails outside of URMC and Affiliates without your prior written consent, except as authorized or required by law.
  • You should not use e-mail for communication regarding sensitive medical information.
  • It is your responsibility to follow up and/or schedule an appointment if warranted.
E-Mail Instructions:
  • Avoid use of your employer’s computer.
  • Put your name in the body of the e-mail.
  • Put the topic (e.g., study question) in the subject line.
  • Inform the researcher of changes in your e-mail address.
  • Take precautions to preserve the confidentiality of e-mail.
  • Contact the researcher’s office via conventional communication methods (phone, fax, etc.) if you do not receive a reply within a reasonable period of time.
CONTACT PERSONS: For more information concerning this research or if you feel that your participation has resulted in any emotional or physical discomfort please contact: Ronald D. Rogge, University of Rochester, Department of Clinical and Social Psychology, RC Box 270266 or rogge@psych.rochester.edu , (585)-317-1848.

Please contact the University of Rochester Research Subjects Review Board at 265 Crittenden Blvd., CU 420315, Rochester, NY 14642, Telephone (585) 276-0005 or (877) 449-4441 for the following reasons:
  • You wish to talk to someone other than the research staff about your rights as a research subject
  • To voice concerns about the research
  • To provide input concerning the research process
  • In the event the study staff could not be reached
VOLUNTARY PARTICIPATION: Taking part in this study is voluntary. You are free not to take part or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled. In the event that you do withdraw from this study, the information you have already provided will be kept in a confidential manner.

VOLUNTARY PARTICIPATION OF CLIENTS: Although therapists can encourage clients to participate in the project and complete Mindflex assessments, it is the right of each client to choose if they will or will not participate and they are free to discontinue participation at any point. We encourage therapists to have open discussions with clients about the potential risks and benefits to completing Mindflex assessments and any concerns the clients might have about participating in this project. However, if one of your clients ultimately chooses not to participate or to no longer participate at any point in the process, the Mindflex project staff would ask that you respect that client’s decision to help ensure that the client will not feel any undue pressure or coercion.

After reading the information in this consent form you should understand:
  • Why this study is being done
  • What will happen during the study
  • Any possible risks and benefits to you
  • Other options you may have instead of being in the study
  • How your personal information will be protected
  • What to do if you have problems or questions about this study.

Please contact us if you have any questions or concerns. We would also be grateful for any feedback you might have on this site and the profiles generated.

Thank you for your interest in participating in this project. We hope you'll participate and that you will find the flexibility profiles useful in your clinical work.

Sincerely,

Brooke Dubler, M.A.
Clinical Psychology Ph.D. Candidate
University of Rochester
Co-Director MindFlex Assessments
staff@mindflex.org

Ron Rogge, Ph.D.
Associate Professor of Clinical Psychology
University of Rochester
Director MindFlex Assessments
(585) 317-1848


 
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