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The following features are not all considered mandatory but can strengthen a clinical study’s chances of favorable review and eventual funding:
- Clearly defined population, use of standardized diagnostic measures (according to DSM-V criteria if possible).
- Objective standardized outcome measures administered by independent staff trained or experienced in their use.
- Outcome assessment by staff blinded to subjects’ treatment condition.
- Specific method of random assignment of subjects to treatment conditions.
- Appropriate control condition. Use of waitlist controls would be considered the weakest experimental design which controls only for the passage of time and expectancy. Conditions that control for nonspecific factors such as therapist time, monitoring of symptoms (supportive counseling, for example) allow stronger conclusions to be drawn about treatment efficacy. Better yet are comparisons to active treatments- those which are expected to have an effect, albeit one which may work by a different mechanism or to a different degree than EMDR (CBT, for example).
- Adequate sample size. If possible, including power analysis (estimate of the number of subjects needed to permit reliable comparisons) as part of their procedure will strengthen the study.
- Adequate treatment time. Though some studies have shown a high rate of remission in single-trauma PTSD subjects with as few as 4 sessions, studies of more complex problems have used longer trials of at least 12 sessions. Midpoint analysis can be conducted if speed of symptom improvement is of interest.
- Treatment fidelity of EMDR (or a clearly identified EMDR variant) and specific control treatments such as CBT. Evidence of treatment fidelity can range from use of trained therapists and treatment manuals to the use of video/audio tapes sampled and independently reviewed with a fidelity checklist. An EMDR Fidelity Scale can be found on the Research Foundation’s website https://emdrresearchfoundation.org/research- grants/emdr-fidelity-rating-scale/. Care should be taken to minimize experimenter effects which could bias results in favor of one of the treatments.
- A plan for providing information about dropouts or negative reactions. This can range from simple follow-up with subjects on their reasons for discontinuing treatment to Intent-to-Treat Analysis in which data from all randomized subjects are analyzed, whether they complete treatment or not. A review of intention-to-treat procedures can be found at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159210/.
- Clearly defined exclusion criteria (psychotic symptoms, suicidality, current substance abuse, etc.). Rigorous exclusion criteria are not always preferable, as some studies are designed to assess a treatment’s use in more naturalistic clinical settings but this should be reflected in the proposal.
- Pre-post-follow-up design. Follow-ups as short as 1 month have been used early in the evaluation of a new treatment. However, as EMDR research has accumulated the interest in assessing long-term effects has increased. Later studies have included follow-up periods as long as 1-5 years. While this answers important questions about the durability of effects, very long follow-up periods are vulnerable to dropout and loss of data.
- Pilot studies. Many researchers find it helpful to conduct a pilot study with a small number of subjects before applying for funding. This allows them to identify and address any problems with procedures before beginning the main study.
- Specific plan for data analysis.
Applications are reviewed for completeness and the narratives sent to multiple reviewers who score them and provide comments to guide decision-making. Each funding cycle is independent of others and some cycles are more competitive than others due to the number or quality of the submissions. Feedback is provided to unfunded applicants which could be helpful should they decide to improve and resubmit their studies for consideration.