PEC Study Consent Form

INFORMED CONSENT TO PARTICIPATE IN RESEARCH

 Purpose

As many as 20% of women who are in transition into motherhood experience perinatal emotional complications (PEC; i.e. commonly referred to as postpartum depression).  PEC includes experiences of maternal distress, anxiety, and depression during the perinatal and postpartum periods, sometimes lasting through the first year of birth or even longer. For many women, trauma is a primary source of PEC, where the trauma was either caused or exacerbated by the pregnancy or birth. And while trauma is a primary source, outdated maternal ideologies and ways of thinking about motherhood (e.g., viewing the eternally happy, self sacrificing mother as a good mother, and the mother who is struggling, is sad or unhappy, and/or wishes to have a social life and/or career out of the home, as a bad mother), seem to impact (a) the way that events become experienced as traumatic; (b) the way that posttraumatic stress and PEC symptoms are acknowledged or denied by the mother, her spouse or partner, other family or friends, and institutions of care; and (c) the ability to seek and obtain appropriate treatment.

Prolonged poor maternal mental health can wreak havoc on the new mother, resulting in severe consequences for the mother, her child, and family. For example, mothers with PEC are sometimes unable to be as present with their baby as they would like, because of debilitating anxiety and/or depression. This affects the ability of the mother to bond with her baby, and may result in developmental and/or attachment difficulties for the child – difficulties which can have life-long consequences. When the mother is still able to function well enough to care for her child, she may still have difficulty taking care of herself properly. The mother may struggle with eating or sleeping, daily hygiene, isolation/ difficulty socializing, and poor self-image. These adversities often impact the women’s intimate relationship with her spouse or partner and with her older children.

No women should have to struggle with PEC, especially for a prolonged period of time. The potential consequences can be severe, and this must be avoided or mitigated to the extent possible. Unfortunately, there is still no established treatment for PEC, although many different types of treatments such as psychotropic medications, group treatments, and counseling and psychotherapy interventions have been considered.  Trauma-focused treatment, using eye movement desensitization and reprocessing (EMDR) is one such treatment that has been considered. EMDR was found to be effective in reducing symptoms in two separate studies, and has also been highly recommended by Dr. Kathleen Kendell-Tackett – a world renowned health psychologist and internationally board certified clinical lactation consultant – as a beneficial non-drug treatment for mothers with PEC symptoms related to birth trauma. Please visit Dr. Kendell-Tackett’s website at: http://www.kathleenkendall-tackett.com/  for more information about her books and other publications on the subject.

In light of the research indicating the role of trauma in PEC symptomology, and EMDR’s modest success in treating PEC related symptoms, as well as the pathologizing effects of outdated maternal ideologies on the mother, a newer trauma-focused treatment – progressive counting (PC) – is being proposed as a treatment intervention for PEC symptoms. PC is often used within a phase model of trauma-informed treatment, which is how it will be used in this study. This model implicates unresolved trauma and loss memories (broadly defined), and associated mental models, as the primary underlying basis for most clients’ presenting problems. By locating the problem of PEC within unresolved trauma and loss memories and associated life transitions and adversities, instead of within a women’s perceived abnormal biological makeup, this treatment is de-stigmatizing and non-pathologizing.  PC is a research-supported treatment, and has been found to be as effective as EMDR, less difficult for clients, and substantially more efficient. However, PC has not been evaluated or tested as an intervention for PEC.

The purpose of this study is to determine if PC, within a phase model of trauma-informed care, is an appropriate and effective treatment for PEC; and to further develop and/or modify the treatment approach so that it meets the unique needs of women with PEC. This will contribute to the preliminary research data already implicating trauma-focused treatments as effective for eliminating and/or significantly reducing PEC symptoms.

This project is being conducted by Kymberly Lasser, who is a 3rd year doctoral graduate student of Saybrook University, as part of the class RES 1140 requirement. Kymberly is already affiliated with the Trauma Institute & Child Trauma Institute (TI & CTI), which is directed by Dr. Ricky Greenwald – the executive and clinical director of TI & CTI, developer of PC and the phase-model treatment approach, and world-renowned trauma expert – in the use of PC in many challenging and difficult cases with children, teens, and adults.  The administration of pre-treatment and post-treatment assessments will be conducted by a Trauma Institute & Child Trauma Institute associate who has been trained in research ethics.

Procedures

[1] After you have spoken with the interviewer to complete the screening for this research study, and you have been informed you that you meet eligibility criteria to participate, you will be asked for your preference on treatment location – either your home or the TI & CTI office – and then we will schedule a time with you to complete three assessments over the phone.

(a)To measure PEC related symptoms, the Edinburgh Postnatal Depression Scale (EPDS) will be used. The EPDS is a ten-question self-report questionnaire typically used to identify a mother’s experience of postpartum depression, inclusive of anxiety symptoms.

(b)To measure posttraumatic stress symptoms, the Trauma Symptom Inventory (TSI) will be used. The TSI is used in the evaluation of posttraumatic stress symptomology, including the effects of events such as – but not limited to – rape, assault, abuse, combat experience, major accident, natural disasters, and even complex trauma symptoms related to childhood abuse. The TSI consists of 100 items regarding participant symptoms, which are rated in terms of frequency on a four point scale, where 0 is never and 3 is often.

(c)To account for your current presenting problems, a Problem Rating Scale (PRS) will be used. The PRS is a tool used to identify current  presenting problems in your life, including a scale of 0-10 for current levels of distress regarding each problem.

[2] You will complete these three assessments over the phone and this will take around 30 minutes to complete, although it could be more or less depending on your specific situation. After completing these assessments, we will be confirming treatment dates with you, and a confirmation email will be provided to you.

[3] Treatment will be provided to you over the course of 2-4 days either at your home or at the TI & CTI office. Four days will be blocked off, but you may complete treatment earlier. Depending on your preference, we will meet for up to four consecutive days, or up to two (2) day sessions. All sessions will be video recorded so that your accounts/experiences of the treatment can be properly documented.

[4] There will be a morning session (approx. 9:00-12:30) and an afternoon session (approx. 1:30-5:00) each day, with breaks in between as needed. At the end of each session, you will be asked to identify what went well and what didn’t go well during your treatment, and follow-up questions will be used, as appropriate, to clarify responses and/or to obtain more detail about a particular response.       

[5] The first time we meet together, I (KL) will be providing you with an introduction to the treatment, explaining its differences from other treatments and the pros and cons of this type of treatment.

[6] I will then be spending some time to get to know you a little better, asking you questions about your current situation, your goals, your family, and past experiences. This is often considered to be one version of what is known as a ‘psychosocial assessment’.

[7] Once I collect enough information, we will talk about what I think I have learned about you, and you will let me know if this seems accurate or if there was something I didn’t explain about you correctly.

[8] Together, we will formulate a treatment plan, which will indicate your goals for treatment (based on your life goals). I will suggest the types of interventions we can use to help you meet your treatment goals, and you may agree or disagree with some of this, and that is okay either way. I will explain to you why the interventions suggested may be helpful in you reaching your treatment and life goals, and then we can decide on how to proceed. If something doesn’t work for you, I will encourage you to let me know, and that way we can address it so that it doesn’t end up causing you undue distress later on in treatment.       

[9] After the treatment plan has been established, we will be moving into the part of treatment where we get to use PC. This is called the trauma-resolution phase of treatment.  PC involves you thinking about a memory in your head, as if you are watching it like a movie, while I count out loud to 10, 20, 30, and so on until there is no more distress associated with the memory. This part of treatment can be a short part of the treatment or can take up the bulk of treatment. In either case, it is quite normal.   

[10] Once all distressing memories have been processed, we will get to talk about different behaviors that may be getting in the way of you reaching your goals. Once you have identified what these behaviors are, I will guide you through an exercise to guide you in figuring out how to change these behaviors, and then you will complete a guided visualization that incorporates this information. For each behavior identified, you will complete at least one behavior change exercise and guided visualization.

[11] Once you have addressed all the behaviors you want to change, then we will be talking about future events and/or anticipated challenges which you are worried or anxious about. We will work together to help prepare you for these events, by completing an intervention using PC – similar to what we did during the trauma-resolution phase of treatment.     

[12] After you have identified and addressed the anticipated challenges or events in the future that are causing you worry or anxiety, we will be moving into the final part of treatment. I will support you to develop a plan for what you will do to manage future struggles or adversities, and what else you will do after you complete treatment that will help you to get to your goals. 

[13] The last 30 minutes of treatment will be used as our wrap-up session, where you will get a chance to talk about your overall experience, and I will be asking you about what you found most helpful and what you found least helpful in your treatment. I will then talk with you about the post-treatment phone follow up assessments, which will assist you in completing.

[14] Approximately two weeks after completing treatment, I will contact you and you will be asked to complete the EPDS and TSI, and PRS again. You will also be providing an update on your level of distress with the previously processed memories, using a 0-10 scale.

Possible Risks and Safeguards

This study is designed to minimize as much as possible any potential physical, psychological, and social risks to you. Although very unlikely, there are always risks in research, which you are entitled to know in advance of giving your consent, as well as the safeguards to be taken by those who conduct the project to minimize the risks.

You may be disclosing information of a personal and sensitive nature. This information may cause you to feel strong emotions, and some discomfort. If you decide that you would like the treatment at your home, I am ensuring that you have direct access to your primary supports; and this prevents you from having to drive anywhere under emotional distress. If you experience some difficulty or distress during or after completing treatment (by the time we talk during the two week follow-up call), I will help facilitate communication between you and your therapist, primary support, or in the event of a major crisis, emergency services if you feel that you might harm yourself or someone else.

If you feel so inclined, you may decide to disclose information about past traumas or distressing experiences, as applicable. I will be prepared to respond to your experience of discomfort or emotional distress, if it is presented. Also, we will make sure that you will have direct and immediate access (subsequent or during the interview) to individuals identified as your support.

To safeguard your information, all data (assessments and recorded interview) will be stored on a securely locked hard drive, to prevent information being stolen or hacked, and/or viewed by unauthorized personnel, from my laptop computer.

I understand that:

[1]      My participation shall in no way have any bearing on any benefits or services I receive as a result of mental health conditions, or alter or deprive me of any or all services presently received in the institution and setting in which I participate.

 [2]     Although my identity shall be known to the Principal Researcher, and her supervisor, all identifying information shall be removed at the time of transcription of the interview.

[3]      All identifiers, such as names, addresses, employers, and related information that might be used to identify me, will be deleted and/or given a pseudonym.

[4]      This informed consent form will be kept separate from the data I provide, in a locked file for five years, known only to the Principal Researcher, after which it will be destroyed.

[5]      The data collected in their raw and transcribed forms are to be kept anonymous, stored in a locked container accessible only to the Principal Researcher for five years, after which it shall be destroyed.

[6]      Transcribed, anonymous data in the form of video recorded interview will be kept indefinitely for future research.

[7]      All the information I give will be kept confidential to the extent required by law. The information obtained from me will be examined in terms of group findings, and will be reported anonymously.

[8]      There is to be no individual feedback regarding assessment scores or interpretations of these responses. Only general findings will be presented in a Summary Report of which I am entitled a copy, and my individual responses are to remain anonymous.

[9]      None of the personal information I provide associated with my identity will be released to any other party without my explicit written permission.

[10]     If quotes of my responses are used in the research report for the course, as well as any and all future publications of these quotations, my identity shall remain anonymous, and at most make use of a fictitious name.

[11]     I have the right to refuse to answer any question asked of me.

[12]     I have the right to refuse at any time to engage in any procedure requested of me.

[13]     I have the right to withdraw from participation at any time for any reason without stating my reason.

[14]     I have the right to participate without prejudice on the part of the Principal Researcher and other persons assisting the Principal Researcher.

[15]     It is possible that the procedures may bring to my mind thoughts of an emotional nature that may upset me. In the unlikely event that I should experience emotional distress from my participation, the Principal Researcher present shall be available to me. They shall make every effort to minimize such an occurrence. However, should an upset occur and become sufficiently serious to warrant professional attention, the principal researcher will assist me in connecting with my own therapist, primary support, or emergency services if needed. I also understand that a licensed mental health professional that I have already identified will be available to me. If I do not have such a person, the Principal Researcher will refer me and reasonable costs up to the first two visits will be paid by the Principal Researcher.

[16]     By my consent, I understand I am required to notify the Principal Researcher at the time of any serious emotional upset that may cause me to seek therapy and compensation for this upset.

[17]     I will receive a copy of this signed consent form for my records.

[18]     I understand that regardless of treatment format and treatment activities, every person and situation is unique, and treatment results are not guaranteed.

 [19]    I affirm that I am not suicidal or dangerous to myself, to other people, or to property. If I am experiencing dissociative or psychotic behavior, I have already identified this to the principal researcher. I affirm that I will not become drunk, high, or otherwise under the influence of drugs either during the treatment or for the 2 days prior to the treatment start date.

[20]    I affirm that I have access to a designated mental health professional during and beyond the completion of this treatment. 

[21]    I have had the opportunity to resolve any questions about these conditions of participation in this research study. I have received a copy of this form for my own records. I understand that signing my name below will indicate my understanding and agreement with the stated conditions of treatment.   

___________________________________________________________________________________________________

Regarding any concern and serious upset, you may contact me directly at kl@childtrauma.com or (603) 845-9525.

You may also contact the Research Supervisor of the project, David St. John at dstjohn@saybrook.edu . Should you have any concerns regarding the conduct and procedures of this research project that are not addressed to your satisfaction by the Principal Researcher and her Research Supervisor, you may report and discuss them with Dr. M. Willson Williams (SIRB@Saybrook.edu), the Director of the Saybrook Institutional Review Board.

Possible Benefits

I understand that my participation in this study may have possible benefits.

[1] The treatment I receive may help reduce or resolve traumatic or distressing memories, and help me to identify my life goals, and present me with ways to get to those goals, addressing barriers along the way. This may benefit not only me, but also my child (ren) and partner, providing them with a more fully present mother and partner. 

[2] This study will provide some evidence of what works and what doesn’t work re: the delivery and application of the proposed treatment. The information I provide will be valuable in shaping the delivery of treatment for women with PEC.  My contributions to this study will have - over time - an impact on the way women are treated and receiving treatment in transition to motherhood. Thus, I will be, in part, helping future generations of women to have better, more enjoyable motherhood experiences, and fewer experiences of PEC and/or unresolved distressing traumatic or loss memories.

[3] My participation may enable the Principal Researcher and others working in the topic area to contribute to knowledge and theory re: treatment of PEC to be studied.

Consent of Principal Researcher

I have explained the above procedures and conditions of this study, provided an opportunity for the research participant to ask questions, and have attempted to provide satisfactory answers to all questions that have been asked in the course of this explanation.

Kymberly Lasser, MS

2015-06-23


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