RESEARCH FAQs and INFORMED CONSENT

Study Title:
Changes in Self-Concept and Attachment Narratives During Attachment-Focused EMDR Treatment for Trauma

Principal Investigator:
Andrew Schaeffer, LMHC
acsinnyc@gmail.com
646-586-5597

RESEARCH CONSENT SUMMARY

If you are considering participating in this research study, you are being asked for your informed consent to take part in such a study. Your participation is subject to ethical protections, confidentiality and risks and benefits, as described in the section below. This document provides a concise summary of this research. It describes the key information that we believe most people need to decide whether to take part in this research. This offer involves the following requirements and protections:

● ethical and quality protections for you as a research subject,
● collection of treatment narratives via Zoom My Notes transcription by your therapist
● completion of questionnaires connected to:
>your sense of self
>your attachments to important people in your life
>measures of distress and trauma
● protection of confidentiality
● outline of risks and benefits for you as a research participant

Your participation in the research is separate from your decision to receive psychotherapy. You may receive psychotherapy without participating in the research, subject to the usual clinical policies and availability of the practice. Saying no to research participation will not affect your clinical care. You can find out more by reading through the FAQs below. When you Click on the “Yes” button at the end of the document, your consent to participate in the research will be recorded. You will be given a copy of the signed consent form for your records.

Purpose of the Study

Approximately six participants will be enrolled in this study.

The purpose of this trauma-treatment clinical research study is to develop an understanding of the experience of people who are being treated for trauma with Attachment-Focused Eye Movement Desensitization and Reprocessing (AF-EMDR).  If you are eligible and choose to participate, you will receive EMDR as part of your clinical psychotherapy. Participation in the study requires the completion of  questionnaires, and therapist transcription of sessions. This information will be kept entirely confidential. Identifiable research information will be accessible only to the Principal Investigator and the Therapist.  Research data shared for the analysis will be de-identified whenever possible. The purpose of the research portion of the study is to better understand changes in how you see yourself, describe important relationships, and experience symptoms related to trauma during trauma treatment.

Why You Have Been Asked to Participate

You may be eligible to participate if:

• You are 18 years of age or older.
• You are a resident of New York State or can situate in New York State for therapy sessions
• You currently experience symptoms of posttraumatic stress (score of over 30 based on the PCL-5).
• You demonstrate insecure (anxious, avoidant or fearful) attachment patterns with at least one parental figure (measurement with ECR-RS).
• You are able to participate in outpatient virtual psychotherapy.
• You are not currently using alcohol or illicit substances in a manner that would interfere with treatment
• You are not living in a trauma-inducing situation.

You will not be eligible if:

• You are under age 18.
• You cannot be situated in New York State for therapy
• You demonstrate secure attachment with both parental figures.
• Your score on the PCL5 is 30 or under.
• You are actively using substances that interfere with treatment.
• You are unable to participate safely in outpatient treatment.
• You are currently living in a situation involving ongoing trauma or abuse.
• You are involved in or contemplating litigation related to traumatic events.
• You have current (last 3 months) homicidal or suicidal ideation (per an interview administered by Andrew Schaeffer, Principal Investigator)
• You are undergoing treatment for trauma with another therapist at this time.

These criteria are used to determine whether your participation is appropriate and safe for this study. Meeting the criteria does not guarantee enrollment. The investigator may also determine that participation is not appropriate if circumstances arise that would make outpatient treatment or research participation unsafe.
FAQs:
What should I know about this research?

• Taking part in this research is voluntary. Whether you take part is up to you.
• If you don’t take part, it won’t be held against you.
• You can take part now and later drop out, and it won’t be held against you.
• If you don’t understand, ask questions.
• Ask all the questions you want before you decide.

You are not required to participate in the study to receive psychotherapy. You may decline research participation or withdraw from the research without giving a reason.

How long will I be in this research?

Your clinical treatment is expected to continue for approximately six months. Your research participation will include assessments during treatment and a follow-up assessment approximately one year after you enter the study. The research participation period therefore extends to the one-year follow-up, even though the planned treatment period is approximately six months.

This study plans to collect five questionnaires at the beginning of the study, four questionnaires at approximately three months, the same four questionnaires at approximately six months, and the same four questionnaires at approximately one year after you begin EMDR treatment after you enter the study. An open-ended interview about your experience of research participation will also be conducted at the one-year follow-up.

Why is this research being done?

The purpose of this research is to explore changes in your sense of self and changes in your relationships while you are undergoing EMDR treatment that is meant to reduce your experience of trauma symptoms.

What happens to me if I agree to take part in this research?

If you agree to participate, you will be asked to:

1. Complete two questionnaires used to determine eligibility:
   >Posttraumatic stress symptoms (PCL-5)
   >Attachment patterns (ECR-RS)
2. If you are eligible for the study and you decide to participate, complete three additional questionnaires:
   >General Self-efficacy scale (GSE)
   >Self-concept scale (SCCS)
   >Childhood Adversity scale (ACEs)

These questionnaires are research measures. They may also provide information relevant to your clinical care, but they are being collected and analyzed as part of this research study.

• You will make your first appointment to participate in AF-EMDR therapy. The first appointment is usually a general information-gathering session.
  • You will be asked to complete the four questionnaires (PCL-5, ECR-RS, GSE, SCCS) at 3 months, 6 months, and a year after you begin treatment.

Attachment-focused EMDR treatment is expected to occur once per week or more frequently if you and your therapist determine that this is clinically appropriate. Treatment sessions will be conducted remotely over Zoom.

With your consent to the research, treatment sessions will be transcribed for research purposes. The deidentified transcripts will be reviewed to identify themes concerning changes in how you describe yourself, important relationships, and trauma-related experiences. To help analyze the transcripts of your sessions, the research team will use an artificial intelligence (AI) tool provided by Bastion which runs on Bastion’s secure computer servers. Before any transcript is uploaded, your therapist will remove your name and other information that could identify you, such as names of people and places, dates, and other specific details. Bastion has signed an agreement with Connections Counseling requiring it to protect health information under HIPAA, to not use your information to train or improve its AI, and to delete the data immediately after processing. Data is encrypted while being transmitted and stored.

You may ask questions about the transcription process before deciding whether to participate.

Will it cost me money to take part in this research?

You will not be paid for participating in the study.

If you participate in psychotherapy, you will be responsible for any costs normally associated with treatment, including insurance co-payments or deductibles when applicable. If treatment is provided on a pro bono basis, no fees will be charged.

Could being in this research hurt me?

Your participation is entirely voluntary. You may refuse to participate or withdraw from the research study at any time without penalty or loss of clinical benefits to which you are otherwise entitled. Your decision regarding participation will not affect your access to clinical trauma-informed services.

If you withdraw from the study, you may choose whether information already collected may continue to be used for research purposes.

Participation may involve emotional discomfort or temporary increases in distress. Because this research occurs in the context of trauma-focused psychotherapy, you may experience distress while discussing traumatic experiences, difficult emotions, or significant relationships. Possible reactions include: sadness, anxiety, anger, temporary increases in trauma-related memories, emotional fatigue, or temporary increases in other trauma-related symptoms.

These reactions are common in trauma-focused psychotherapy and are generally temporary, but they can occasionally be more intense or last longer than expected. The research team will monitor distress and will prioritize your clinical safety.  

If you become significantly distressed during a session, your therapist will pause treatment, provide stabilization techniques, assess your safety, and determine whether treatment should continue. If necessary, emergency services or appropriate referrals may be used.

If an event appears to be related to research participation rather than ordinary clinical treatment, it will be evaluated and documented under the practice’s research-related injury/adverse-event procedures and reported to the IRB when required.

Research-related injury in this study may include psychological distress or other harm that is caused or worsened by a research procedure, such as research interviews, questionnaires, recording, or research-related discussion. The study does not provide a separate payment or compensation program for research-related injury. If you believe you have experienced a research-related injury, contact the Principal Investigator at 646-586-5597. You may also contact North Star IRB using the information below.

There are also risks associated with loss of confidentiality. The Investigator will take reasonable steps to protect your information, including use of password-protected and encrypted systems and limiting access to identifiable research information. However, no electronic system can guarantee complete confidentiality.

Will being in this research benefit me?

You may or may not experience a direct benefit from participating in this research. Because you will receive psychotherapy as part of the study, you may experience improvement in trauma-related symptoms or other aspects of your functioning. However, improvement cannot be guaranteed, and these possible benefits may result from the psychotherapy rather than from participation in the research itself.

The information obtained from this study may help improve understanding and treatment of trauma-related difficulties in future clients.

When the studies are completed, the results may be posted on the Connections Counseling website at www.connectionscounseling.org . Any public report will use information presented in a manner intended not to identify individual participants.

What other choices do I have besides taking part in this research?

You may choose not to participate in the research and may receive clinically appropriate trauma-focused treatment through the practice (Connections Counseling PLLC), subject to the practice’s ordinary clinical policies and availability. You may also seek treatment from another provider.

Confidentiality: 

Your records will be kept confidential to the extent permitted by law.

Therapy sessions will be transcribed via Zoom only if you consent to the research procedures. In the research team, only the Investigator will have access to identifiable information. De-identified research data may be accessed by authorized individuals who assist with research analysis. Interview transcripts, questionnaires, and clinical notes used for research purposes will be stored securely in password-protected or locked locations.

Transcripts and de-identified research data will be retained for the period approved by the IRB, and will then be securely destroyed

You will be assigned a participant identification number. Research records will be stored separately from identifying information whenever possible.

The planned research will analyze the de-identified transcripts of sessions for qualitative themes that relate to changes in the ways participants describe themselves, changes in descriptions of important relationships, changes in self-efficacy, and changes in trauma symptoms. The assessments that participants will take (ACE, PCL5, ECR-RS, SCCS, GSE) will be quantitative measures of these themes that can be used to examine these changes.

With your permission, the Investigator may review clinical notes created during your treatment for information relevant to changes in trauma symptoms, self-concept, attachment, or significant life events. Only information relevant to the research will be included in the research dataset.  Identifying information will not be included in publications or presentations.

After analysis, results may be published or presented at professional meetings. No information that could reasonably identify you will be disclosed.

Confidentiality may be broken if required by New York law, including situations involving:

• Risk of serious harm to yourself
• Risk of serious harm to others
• Suspected abuse or neglect of a child, dependent adult, or vulnerable person
• Court orders or other legal requirements

Only those who will allow sessions to be transcribed can participate in the study. Those who decide not to participate in the research or who withdraw from research participation will still have access to clinically appropriate treatment, subject to ordinary clinical policies and availability.
Although Zoom provides security features intended to protect communications, no electronic communication system can guarantee complete confidentiality.

What happens to the information collected for this research?

Your research information will be collected and stored in a secure research dataset. Identifiable research information will be accessible to the Principal Investigator. De-identified Information may be shared with authorized individuals who assist with research activities, if applicable.

The following may have access to research information as appropriate to their roles:

• The Principal Investigator and authorized research personnel;
• The Independent Review Board (North Star IRB) that reviews and oversees this research

Withdrawal from Research

You may withdraw from the research at any time by telling the Principal Investigator. Withdrawal from research will not require you to stop receiving clinical treatment. If you withdraw, you may ask that identifiable research information already collected not be used in future research analysis, to the extent that the information has not already been de-identified and analyzed and incorporated into research results. Information that has already been de-identified or incorporated into complete analyses may not be able to be removed.

Who can answer my questions about this research?

If you have questions, concerns, or complaints, talk to the research team at the phone number listed here (Andrew at 646-586-5597). This research is being overseen by the North Star Independent Review Board (“IRB”). An IRB is a group of people who perform independent review of research studies to assure that the rights and welfare of participants are adequately protected, and that the research is described accurately before you are asked to participate. You may talk to the IRB (by emailing info@northstarreviewboard.org) if:

>You have questions, concerns or complaints that are not being answered by the research team.
>You are not getting answers from the research team.
>You cannot reach the research team.
>You want to talk to someone else about the research.
>For questions about your rights as a research subject in the research study (and not about study visits or procedures), please contact North Star IRB by emailing info@northstarreviewboard.org

Even if you agree to participate after reading this form, if you have questions for the IRB and decide not to participate, you can choose not to fill out the surveys.
If you have questions about the study, please contact:

[Andrew Schaeffer]
[646-586-5597 ]
[acsinnyc@gmail.com]

If you have questions about your rights as a research participant, please contact:

[Institutional Review Board Contact Information]

Questions about research should be directed to Principal Investigator (PI) Andrew Schaeffer at acsinnyc@gmail.com or at 646-586-5597 or by US mail at 325 Clinton Ave 5F, Brooklyn, NY 11205. 

Consent

I have read the information above. I have had the opportunity to ask questions and have received satisfactory answers. I understand that participation in this research is voluntary and that I may withdraw from the research without penalty or loss of clinical benefits to which I am otherwise entitled.

I understand that I may choose to receive psychotherapy without participating in the research, subject to the practice’s ordinary clinical policies and availability.

When you click the “Yes” button below, your name and the date will be recorded for your confidential participation in this trauma study.

 I voluntarily agree to participate in this research study.

YES

NO

No, I do not want to participate in this research study.