INFORMED CONSENT FOR PARTICIPATION IN RESEARCH
Study Title:
Changes in Self-Concept and Attachment Narratives During Attachment-Focused EMDR Treatment for Trauma
Principal Investigator:
Ruth Campbell, LCSW, Ph.D.
Connections Counseling Psychotherapy LCSW PLLC
845-255-5022, ruth@connectionscounseling.org
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 audio
● collection of questionnaires connected to your sense of self, your attachments to important people in your life, and measures of trauma
● protection of confidentiality, and
● 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 sign the informed consent and return it to Ruth Campbell through the email at ruth@connectionscounseling.org OR through the postal mail at Ruth Campbell, LCSW, Ph.D.; PO Box 1235; New Paltz, NY 12561 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 EMDR (AF-EMDR). If you are eligible and choose to participate, you will receive AF-EMDR as part of your clinical psychotherapy. The research adds questionnaires, audio recording and transcription of treatment sessions, and analysis of research data; these research portions are not intended to replace or alter clinically appropriate treatment.
The research portion of the study includes collecting questionnaires, audio recordings, and analysis of treatment sessions which will be kept entirely confidential. Identifiable research information will be accessible to the Principal Investigator. Research data shared for 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
- You have experienced one or more adverse childhood experiences (ACE score between 1 and 5, inclusive).
- You currently experience symptoms of posttraumatic stress (PCL-5 score over 30 based on the screening questionnaire).
- You demonstrate anxious or avoidant attachment patterns with at least one parental figure (ECR-RS profile).
- You are able to participate in outpatient 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 are not a resident of New York State
- Your ACE score is 0 or greater than 5.
- You demonstrate secure or disorganized (fearful) attachment with both parental figures.
- 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
- You are undergoing treatment for trauma with another therapist at this time.
These criteria are used to determine whether 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.
Because your therapist is also the researcher, you may feel pressure to participate. You are not required to participate in order 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 one year, although your therapist may recommend additional clinical treatment based on your clinical needs. Your research participation will include assessments during treatment and a follow-up assessment approximately two years after you enter the study. The research participation period therefore extends to the two-year follow-up, even though the planned treatment period is approximately one year.
This study plans to collect the six questionnaires at the beginning of the study, at approximately six months, at approximately one year, and at approximately two years after you enter the study. An open-ended interview about your experience of research participation will also be conducted at the two-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 treatment 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:
- Complete three questionnaires used to determine eligibility:
- Childhood adversity (ACE)
- Posttraumatic stress symptoms (PCL-5)
- Attachment patterns (ECR-RS)
- If you are eligible for the study and you decide to participate, complete three additional questionnaires:
- General Self-efficacy scale (GSE)
- Dissociative Experiences scale (DES-II)
- Self-concept scale (SCCS)
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 same six questionnaires at 6 months, a year, and two years 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 audio recorded and transcribed for research purposes. The recordings/transcripts will be reviewed to identify themes concerning changes in how you describe yourself, important relationships, and trauma-related experiences. Not every statement made during therapy will necessarily be included in the research dataset.
Because therapy sessions may contain sensitive personal information, audio recording creates a confidentiality risk in addition to the ordinary confidentiality risks of psychotherapy. You may ask questions about the recording and 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 845-255-5022. You may also contact North Star IRB using the information below.
There are also risks associated with loss of confidentiality. The researcher 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, 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 audio recorded via Zoom only if you consent to the research procedures, and transcribed by Zoom for research purposes. Only the investigator will have access to identifiable information. De-identified research data may be accessed by authorized individuals who assist with research analysis. Audio recordings, interview transcripts, questionnaires, and clinical notes used for research purposes will be stored securely in password-protected or locked locations.
Audio recordings will be retained for three years after completion of the study, unless the IRB requires a different retention period, and will then be securely destroyed. De-identified research data will be retained for the period approved by the IRB.
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, DES-II, GSE) will be quantitative measures of these themes that can be used to examine these changes.
With your permission, the researcher 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 audio-recorded 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 (Ruth at 845-255-5022). 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:
[Ruth Campbell]
[845-255-5022 (landline)]
[ruth@connectionscounseling.org]
If you have questions about your rights as a research participant, please contact:
[Institutional Review Board Contact Information]
Therapist as Researcher
Your therapist is also the researcher conducting this study. Because of this dual role, you may feel uncomfortable declining participation. The participant needs to understand that the decision about research participation is separate from the decision to seek psychotherapy and that saying no will not negatively affect the clinical relationship. Participation is completely voluntary. Your decision whether or not to participate will not affect your ability to receive psychotherapy services now or in the future. Ruth Campbell, LCSW, Ph.D. has been providing trauma treatment since 1998, first certified in the Shapiro method of EMDR trauma treatment, and later certified in the AF-EMDR style of treatment. Additional information about her professional experience may be found on the Connections Counseling PLLC website.
Questions about research should be directed to Principal Investigator (PI) Ruth Campbell at ruth@connectionscounseling.org or at 845-255-5022 or by US mail at PO Box 1235, New Paltz, NY 12561.
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 my therapist is also the Principal Investigator and that I may choose to receive psychotherapy without participating in the research, subject to the practice’s ordinary clinical policies and availability.
I voluntarily agree to participate in this research study.
Participant Name: ___________________________
Participant Signature: ________________________ Date: __________
Researcher Signature: ________________________ Date: __________