Psychotherapy trial data collection that keeps the scales, sessions and raters straight

Psychotherapy trials usually compare a structured therapy with a control such as treatment as usual, a waitlist, an active comparator therapy or an attention control. The outcome is a change in symptoms, function or wellbeing over weeks or months, and it is nearly always measured on several occasions: baseline, during treatment, at the end of treatment and at one or more follow-ups. That repeated-measures structure is the first design driver. A data system that makes a participant log in to a portal for every scale will lose people; one that sends a short link to the phone and records the answer with a timestamp will not.

The second driver is who delivers the intervention. A trial may have a handful of therapists each seeing many participants, and therapists commonly differ in outcomes. Statisticians often account for that, which means every participant record should carry a therapist identifier, the site and, where relevant, the supervisor. Capture those as typed fields at enrollment and keep a change history when a participant is reassigned. Capture holds that data and the by-site filtering and exports; the statistical handling of therapist effects belongs in your analysis plan.

The third driver is blinding. A participant cannot be blind to a talking therapy, so trials commonly rely on independent raters, who should not know the allocation, to assess the primary outcome. Role-based access means blinded roles never receive treatment-arm values, enforced by masked database views and row-level security. Build the rater interview as a separate eCRF form completed by the blinded role, and keep the therapist-facing session log on different forms that the rater does not use. Confirm the role set-up in the sandbox before you finalize your blinding plan.

Psychotherapy protocols draw on a familiar set of instruments: depression and anxiety scales completed by the participant, trauma symptom checklists, clinician-rated interviews, suicidality screens and general functioning or wellbeing measures. Capture has template pages that show the structure of several of these, including PHQ-9, GAD-7, PCL-5, the Hamilton depression scale and the C-SSRS. The pages describe structure and scoring only; item wording is not reproduced, and you remain responsible for confirming the licence or permission for any instrument you use.

On the licence point, be precise. For participant questionnaires, a study team can switch on Licence required and record the licence number, holder and expiry; staff see a copyright-approval-pending watermark while those details are missing, and after the recorded expiry no new tasks are generated and submissions are rejected. Nothing else is blocked while a licence is missing, and Capture does not verify licences with rights holders or supply instruments. Clinician-rated forms have no licence controls, so the licence for an interview stays with the study documents.

Store each item response and the total as separate fields so the total can be reproduced. The total can be a calculated field where the scoring is a simple sum, shown read-only at entry; reverse-scored or subscale scoring is defined by the instrument owner and your analysis plan. Set visit windows around each timepoint so a late scale is visible at entry, and use edit checks to flag implausible changes for query rather than silently accepting them.

Mental health trials carry a duty to notice deterioration. Protocols usually say how suicidal ideation is screened, which responses trigger a clinician contact and what is recorded. Build the screen as a form with typed fields for the result, the date, who followed up and the action taken. Edit checks can raise a query when a positive screen has no recorded action, which gives the study team a prompt without pretending the software replaces clinical judgment. The clinical response itself happens outside Capture.

Adverse events follow the usual structure of onset, severity, seriousness, relationship and outcome. The adverse event form and the SAE report form are starting points, and the adverse event reporting software page describes the workflow. Psychotherapy protocols often also define events of particular interest such as self-harm, hospitalization or study-related distress, and these can be flags on the AE form so they can be listed without a manual search.

Every change to a record carries a field-level audit trail with timestamp, user, old value, new value and reason, and the trail cannot be edited. That matters when a score is corrected after a participant clarifies an answer, or when a rater changes a rating after a consensus meeting. For the wider picture on behavioral health studies, see EDC for behavioral health studies; for a drug-comparator design in depression, see EDC for major depressive disorder trials.