Two Sessions of Coach-Delivered Core Transformation for Distress and Well-Being

Background: Core Transformation (CT) is a structured, manualized process. A trained coach guides the person, step by step, from an issue they choose to work on to a strong, positive state of being, called a "Core State" in CT. The coach then guides them to bring that state to the original issue. CT makes no diagnosis and prescribes nothing. In this study it is offered as coaching, not as psychotherapy or medical treatment.

Three studies of CT have been published: a pilot study in India without a control group; a randomized waitlist-controlled trial of a single CT session (129 participants); and an evaluation of two Zoom sessions given by 25 trainee coaches (219 participants). Participants improved across the studies. Controlled effects on distress were modest. This study addresses limits of earlier research by using individual randomization, pre-specified co-primary outcomes, validated non-spiritual measures, longer follow-up, and standardized assessment of intervention fidelity.

This is a Stage II preliminary estimation study, following the National Institutes of Health (NIH) Stage Model for behavioral intervention development. It estimates the size of the effect of CT, given by a group of coaches in a set two-session format, on psychological distress compared with a waitlist. The results will be used to plan a larger confirmatory trial.

Participants: Adults aged 18 or over from the general community, anywhere in the world, who can take part in English. There is no minimum symptom score. People in the severe range are not enrolled, for safety. The study is run from a single site (Andreas NLP) and takes place entirely online. Each participant takes part for about 14 months.

Study design: Two-arm, randomized waitlist-controlled trial, 1:1. Allocation uses minimization on location (United States vs. rest of world) and gender, and is done by the data capture system. Each cohort has its own randomization. The Study Coordinator randomizes each group of participants who have finished the baseline survey when coach places are available. Day 0 is the first day of the enrollment week. Week 1: consent, screening and baseline survey. Immediate arm: booking in week 2, then two CT sessions in weeks 3-4, then the primary survey (time point 2, T2) the day after the second session. Delayed (waitlist) arm: the primary survey (time point 2, T2) at about 4 weeks, before any session; a coach is then assigned, and the same two sessions take place in weeks 5-6. Both arms complete a survey at about 6 weeks (time point 3, T3), then at about 3, 6 and 12 months after their second session, on fixed target dates.

Sessions and coaches: Sessions are one-to-one over Zoom, about 90 minutes each, about one week apart. Coaches follow a written manual and use only processes taught in the Core Transformation Coach Certification. Each participant works on one moderate issue. Issues that are not suitable are listed in the consent form. Cohort 1 coaches are CT coaches in training, completing their certification. Cohort 2 coaches are certified CT coaches, in a later cycle. For each coach in training, a CT trainer rates one recorded session to check that the manual was followed. Certified coaches' sessions are not reviewed. Coaches send a session report after each session. Coaches are not clinicians and do not give clinical advice. Sessions are video-recorded.

Safety: If a coach is worried about a participant during a session, the coach tells the Study Coordinator the same day. If the Patient Health Questionnaire-8 (PHQ-8) total is 20 or more, or the Generalized Anxiety Disorder-7 (GAD-7) total is 15 or more, at the screen or any later survey, a support message with crisis resources shows on screen straight away. No one reviews survey answers or contacts participants about their scores. Possible adverse events are recorded, and the Principal Investigator decides whether an event is an adverse event.

Data and analysis: Surveys are completed online in a secure data capture system (Capture.Study), with data held on servers in the United States. For each co-primary outcome, the two arms are compared at about 4 weeks with a linear mixed model of the baseline and 4-week scores, adjusted for location, gender and cohort. With complete data this gives the same result as analysis of covariance (ANCOVA) adjusted for baseline adjusted for baseline. The analysis is by intention to treat and assumes data are missing at random. Each co-primary outcome is reported as an adjusted mean difference with a 97.5% confidence interval and Cohen's d. No significance test is used. Sensitivity analyses include complete-case ANCOVA, a model with a coach effect, a multivariate analysis of covariance (MANCOVA) of both co-primary outcomes together, multiple imputation and a tipping-point analysis. The analysis is run with the arms coded until the primary results are final. A statistical analysis plan is finalized before the first database lock and before any outcome data are looked at. Two database locks are planned: once the last participant's 6-week (time point 3, T3) window has closed, and after the last 12-month survey window closes.

Other planned analyses: All outcomes at about 6 weeks (time point 3, T3) are described by arm, because both arms have received CT by then. Benchmarking: CT's effect sizes are compared descriptively with published Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) trials that used the same measures. Moderators: whether baseline severity, or coach experience (trainee vs. certified), affects how much participants benefit (exploratory). Feasibility: recruitment, retention, the spread of baseline severity, fidelity, and sessions received.

Limits: A waitlist does not control for expectancy or coach attention. All outcomes are self-reported. The randomized comparison covers only about 4 weeks; later results are single-group. Coach experience overlaps with cohort and calendar time.

Conflict of interest: The study is run by the organization that develops, teaches and sells Core Transformation training. Members of the study team, including the Principal Investigator, have a professional and financial interest in CT. Results will be reported whatever they show.

Funding: This study has no outside funding.