Consent for Participation in Research
EMDR vs. PC for Trauma Resolution of a Motor Vehicle Accident Memory. Principal Investigator: Ricky Greenwald, PsyD
PURPOSE OF THE STUDY: Eye movement desensitization and reprocessing (EMDR) is the most efficient of the well-established trauma treatments. Progressive counting (PC) is a newer trauma treatment that has been found to be effective and efficient. The purpose of this larger study is to directly compare EMDR to PC, so that those affected by trauma and/or loss can, in the future, be provided the best possible treatment.
DESCRIPTION OF THE RESEARCH: You will be evaluated by a trained interviewer who will not know which treatment you will be receiving. The evaluation will take 15 minutes or less, and include questions about your current symptoms. The evaluation will occur by telephone prior to treatment, two weeks after treatment is finished, and three months later.
You will be assigned to a therapist and randomly assigned to receive either EMDR or PC. Your assigned therapist will contact you to arrange your appointment. You will be responsible for transporting yourself to the therapist’s office for appointments, for being on time, and for notifying the therapist of any necessary cancellations.
You will receive up to three hours of EMDR or PC, focused on the upsetting memory you have identified. Once the memory-related distress is gone (or after three treatment hours regardless), you will receive one follow-up session.
If you wish to continue treatment following completion of the study, you will be provided with referrals, or you may choose to continue with the same therapist if the therapist agrees. However, such treatment would not be provided by the study; you would be responsible for payment.
Some participants (who agree to this) may have their sessions recorded. The recordings will be reviewed to ensure that the treatment was conducted properly; then they’ll be destroyed.
COSTS/REIMBURSEMENTS: There will be no charges or payments for any research activity. You will be volunteering to participate in the study for no compensation, other than the free treatment.
POTENTIAL RISKS AND DISCOMFORTS: Sometimes talking about sensitive issues in the evaluation can make people feel a bit upset. Facing the trauma memory in treatment can also be difficult for a brief period. Trauma-focused therapy also entails a small risk of destabilization if a memory is opened up and activated but not resolved; or if other untreated memories become activated. In similar studies, nearly all participants have reported that the evaluations were not distressing, and even those who reported experiencing some distress said that participation was still worthwhile. The treatment is likely to be distressing at times, and there is no guarantee of successful outcome (although such outcome is likely). If you are uncomfortable after the evaluation or treatment, you will be able to talk to your interviewer at that time. If you are uncomfortable during the therapy, you will be able to talk to your therapist about this. You may also contact the investigator for further help.
POTENTIAL BENEFITS: The primary potential benefit is resolution of the trauma or loss memory, making recall less painful and perhaps reducing or eliminating related symptoms. Depending on the nature and severity of the symptoms, this benefit can be substantial. The secondary potential benefit is the satisfaction of knowing that you have contributed to the development of knowledge, so that others can be better helped. Finally, those who complete the study will have the option to be entered into a drawing to win a $100 gift certificate (to the store, restaurant, or charity of your choice) when the study is finished (anticipated end of 2017).
ALTERNATIVE TO PARTICIPATION: The alternative is not to participate. Then you can decide whether to seek treatment elsewhere, or not.
TERMINATION OF PARTICIPATION: You may discontinue participation in the study at any time without penalty (except that you will not continue to receive free treatment).
CONFIDENTIALITY: Your identity as a participant in this research study will not be given to other people outside of the research team, and will be kept confidential in any publication or presentation of the results of this study. Identifying electronic data will be coded and deleted; identifying written materials will be kept in a locked file until destroyed (within 1 year after completion of the study). If your case is described in detail in a publication or presentation, identifying information will be altered to protect confidentiality, and you will be given the option of reviewing and approving your case description (with veto power) before it is published.
An exception to confidentiality is a previously unreported incident of child/elder abuse or neglect, or evidence that someone is in imminent danger, that may be inadvertently obtained during the evaluation or treatment process. This information would be reported to the appropriate local or state agency in accordance with state law.
COMPENSATION/TREATMENT: If you believe that you may have suffered harm due to participation in this study, you should contact Dr. Greenwald at (413) 774-2340.
VOLUNTARY PARTICIPATION: Participation in this study is voluntary. If you decide not to participate, or decide to stop participating, there will be no adverse consequences (other than absence of potential benefits of participation). You may print out a copy of this consent form for your records.
CONTACT PERSON: If you have any questions, at any time, about this research, please contact Dr. Greenwald at the Trauma Institute, (413) 774-2340.
1. I hereby volunteer to participate in a research program under the supervision of Dr. Greenwald at the Trauma Institute.
2. I acknowledge that I have read, or had explained to me in a language I understand, the attached consent document and that the interviewer has explained to me the nature and purpose of this study. This explanation included a description of the parts of the study that are experimental, the possible discomforts, symptoms, side effects and risks, if any, that I might reasonably expect, and the possible complications, if any, that I might reasonably expect from both known and unknown causes as a result of my participation in these studies. I have had the opportunity to ask questions I had about the study, and all the questions I asked were answered to my satisfaction.
3. I understand that the therapist may determine that I am not suitable for the study, and discontinue my treatment.
4. If the memory to be treated is or might become the focus of a legal case, I have been advised to consult with an attorney regarding the possible legal implications of receiving treatment.
5. I understand that I am free to withdraw this authorization and to discontinue my participation in this study at any time. The consequences and risks, if any, of withdrawing from the study while it is ongoing have been explained to me.