Process Measures. Outputs for Each Strategy As depicted in the logic model, each strategy is expected to produce some key outputs. These outputs serve as process measures, indicating that the strategy is being successfully implemented. Here are some sample/placeholder outputs that would be measured by jurisdictions. Note that not ALL of these would be measured in any given incident. These are samples for illustration only.
Process Measures. All psychotherapy sessions, including experimental sessions, will be recorded to audio and video, with all recordings preserved for research and training purposes. Adherence criteria and competence ratings will be conducted by qualified, trained blinded adherence raters who will analyze video data from selected preparatory, experimental and integrative sessions. The elements included in adherence criteria are specific to each type of session. These ratings will be collected, at minimum, for each therapist team in the study. The goal of these ratings will be to correlate therapist adherence to the treatment manual with outcome as a part of the sponsor’s ongoing efforts to standardize treatment methods of MDMA-assisted psychotherapy for PTSD. Therapeutic alliance will be assessed using the Segmented Working Alliance Inventory- Observer form (S-WAI-O) on video data from selected preparatory, experimental and integrative sessions [114]. The S-WAI-O is an observer-based measure designed to assess changes in working alliance over the course of a session. The scale can provide two scores, one measuring the bond between the subject and therapist and the other measuring their agreement on tasks of therapy. These ratings will be collected, at minimum, for each therapist team in the study. The goal of these ratings will be to correlate overall S-WAI-O scores of therapeutic alliance with outcome, as measured by CAPS scores. Belief of condition assignment and certainty will be collected from each therapist responsible for treating the subject and the subject at the integrative session on the day after each blinded experimental session in Stage 1. At the primary endpoint, the IR for the study will also provide their guess and certainty of condition assignment prior to unblinding. These beliefs are collected as a part of the sponsor’s ongoing initiative to optimize the double-blind as a part of dose response studies.
Process Measures. All sessions after enrollment may be recorded to audio and video, including introductory, integrative and experimental sessions for research and training purposes. These recordings will be used for further development of the manual of standard procedures for performing MDMA-assisted psychotherapy in people with PTSD. Adherence criteria and competence ratings will be conducted by qualified, trained blinded adherence raters who will analyze video data from selected preparatory, experimental and integrative sessions. The elements included in adherence criteria are specific to each type of session. These ratings will be collected, at minimum, for each therapist team in the study. The goal of these ratings will be to correlate therapist adherence to the treatment manual with outcome as a part of the sponsor’s ongoing efforts to standardize treatment methods of MDMA-assisted psychotherapy for PTSD. The SOCQ is a 100-item questionnaire based on the “Peak Experience Profile” designed by Xxxxxx and colleagues [166, 167]. Subjects respond to the SOCQ using a six-point Likert-type scale anchored at 0=none at all and 5=extreme (more than ever before in my life). It has seven subscale scores; internal unity, external unity, transcendence of time and space, ineffability and paradoxicality (claim of difficulty in describing the experience in words), sense of sacredness, noetic quality, and deeply felt positive mood. The measure is a self-report instrument and takes approximately 20 to 30 minutes to complete. Subjects will complete the SOCQ after each experimental session, at any time between the end of an experimental session and prior to leaving the treatment facility the next day. Response to study participation and perceived degree of choice in taking part in the study will be assessed with the Reactions to Research Participation Questionnaire (RRPQ) [168]. Subjects will complete this measure during their final study visit, roughly six weeks after the last experimental session. The RRPQ is intended to assess the subject’s experience as a research subject, perceived reasons for consenting to be a research subject and perceived freedom to take part in the study, and is a process measure. Questions regarding the belief of condition assignment and certainty of the belief will be asked of the therapists and subjects at the integrative session on the day after each blinded experimental session in Stage 1. Each therapist responsible for treating the subject will indicate the...
Process Measures. 7.4.1.1 Increase percentage of enrollees who receive PCP annual visit;
