An interventional study of Core Transformation Process in Psychological Distress and Psychological Well-being, sponsored by Andreas NLP (Legal Entity - Real People Press). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Andreas NLP (Legal Entity - Real People Press) · Not applicable, Interventional, and Other
The goal of this study is to learn if Core Transformation, a guided coaching process, lowers psychological distress in adults. It will also look at well-being, daily functioning, and whether any changes last over time. The main questions it aims to answer are:
Researchers will compare a group that has the sessions earlier with a group that has the same sessions about 2 weeks later (a waitlist group).
Participants will:
Everyone in the study is offered the sessions.
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.
1,045 studies on the registry are indexed under Psychological Well-Being; 509 are open to participants now.
This study's planned enrollment of 480 is above the median of 113 across 888 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →This is the only study on the registry with Andreas NLP (Legal Entity - Real People Press) as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants have a booking week (week 2), then two one-to-one CT sessions over Zoom in weeks 3-4, counted from day 0 (the first day of the enrollment week). Each participant works on one moderate issue they choose. Sessions follow a written manual and are video-recorded. Online surveys at baseline, the day after the second CT session (about 4 weeks), about 6 weeks, and about 3, 6 and 12 months after the second CT session.
Behavioral: Core Transformation Process
Online survey at baseline. No sessions until after the 2nd survey at about 4 weeks, which is a second, untreated baseline. Within 1 day of that survey, a coach is assigned and both sessions are booked. The participant then has the same two CT sessions in weeks 5-6. Surveys follow after the sessions (about 6 weeks) and at about 3, 6 and 12 months after the second session, on target dates 2 weeks later than those for the immediate treatment arm.
Behavioral: Core Transformation Process
Core Transformation (CT) is a structured, manualized process. A trained coach guides the person, step by step, from an issue they choose (a feeling, behavior or thought they want to change) to a strong, positive state of being, called a "Core State" in CT. The coach then guides them to bring that state back to the original issue. Each participant has two one-to-one sessions of about 90 minutes over Zoom, about one week apart. Coaches follow a manualized protocol. Sessions are given by CT coaches in training (Cohort 1) or certified CT coaches (Cohort 2), and are video-recorded.
Psychological distress: Patient Health Questionnaire-8 (PHQ-8) total score
PHQ-8, self-reported online. Total score 0-24; higher scores mean more depressive symptoms. Co-primary outcome. The two arms are compared at about 4 weeks with a linear mixed model adjusted for baseline score, location, gender and cohort, by intention to treat. Reported as an adjusted mean difference with a 97.5% confidence interval and Cohen's d. No significance test is used.
Time frame: 4 week
Psychological distress: Generalized Anxiety Disorder-7 (GAD-7) total score
GAD-7, self-reported online. Total score 0-21; higher scores mean more anxiety symptoms. Co-primary outcome. The two arms are compared at about 4 weeks with a linear mixed model adjusted for baseline score, location, gender and cohort, by intention to treat. Reported as an adjusted mean difference with a 97.5% confidence interval and Cohen's d. No significance test is used.
Time frame: 4 week
Well-being: World Health Organization-Five (WHO-5) Well-Being Index
WHO-5, self-reported online. Score 0-100; higher scores mean better well-being. Compared between arms at about 4 weeks with the same model as the primary outcomes; 95% confidence interval.
Time frame: 4 week
Functioning: Work and Social Adjustment Scale (WSAS)
WSAS, self-reported online. Score 0-40; higher scores mean more impairment. Compared between arms at about 4 weeks with the same model as the primary outcomes; 95% confidence interval.
Time frame: 4 week
Depression: Depression Anxiety Stress Scales-21 (DASS-21) Depression subscale
Depression Anxiety Stress Scales (21-item), Depression subscale, self-reported online. Score 0-42; higher scores mean more symptoms. Compared between arms at about 4 weeks with the same model as the primary outcomes; 95% confidence interval.
Time frame: 4 week
Anxiety: Depression Anxiety Stress Scales-21 (DASS-21) Anxiety subscale
Depression Anxiety Stress Scales (21-item), Anxiety subscale, self-reported online. Score 0-42; higher scores mean more symptoms. Compared between arms at about 4 weeks with the same model as the primary outcomes; 95% confidence interval.
Time frame: 4 week
Stress: Depression Anxiety Stress Scales-21 (DASS-21) Stress subscale
Depression Anxiety Stress Scales (21-item), Stress subscale, self-reported online. Score 0-42; higher scores mean more symptoms. Compared between arms at about 4 weeks with the same model as the primary outcomes; 95% confidence interval.
Time frame: 4 week
Clinical significance: reliable improvement, reliable recovery and reliable deterioration (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7)
Number and percentage of participants in each arm. Caseness: PHQ-8 of 10 or more, or GAD-7 of 8 or more. Reliable improvement: a drop of 6 or more on the PHQ-8, or 4 or more on the GAD-7, with no reliable deterioration on the other. Reliable deterioration: a rise of 6 or more on the PHQ-8, or 4 or more on the GAD-7. Reliable recovery: a case at baseline, below caseness on both measures at 4 weeks, with reliable improvement. Descriptive, with 95% confidence intervals.
Time frame: 4 week
Self-chosen issue ratings
Study-developed ratings, each from 0 to 10, of the issue each participant chooses: how bothered (0 = not at all, 10 = extremely), emotional charge (0 = none, 10 = very strong), and, after Core Transformation, how resolved (0 = not at all, 10 = completely). Higher scores mean more bother, more charge and more resolution. Within-person change, descriptive.
Time frame: From the start of the first CT session to about 12 months after the second CT session
Trait change: Big Five Emotional Stability (International Personality Item Pool, IPIP)
10-item International Personality Item Pool Emotional Stability scale, with the adapted wording used in earlier CT studies, self-reported online. Score 10-50; higher scores mean more emotional stability. Change over time described for all participants together.
Time frame: Baseline, about 4 weeks, about 6 weeks, and about 6 and 12 months
Durability: Patient Health Questionnaire-8 (PHQ-8) total score
Whether changes in depressive symptoms, measured by the Patient Health Questionnaire-8 (PHQ-8) total score, last to 12 months after the second CT session. The PHQ-8 has 8 items, each scored 0 to 3, giving a total from 0 to 24. Higher scores mean a worse outcome (more severe depressive symptoms). Described for all participants together, because both arms have received CT by then. Not a randomized comparison.
Time frame: Baseline, and about 3, 6 and 12 months after the second CT session
Durability: Generalized Anxiety Disorder-7 (GAD-7) total score
Whether changes in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 (GAD-7) total score, last to 12 months after the second CT session. The GAD-7 has 7 items, each scored 0 to 3, giving a total from 0 to 21. Higher scores mean a worse outcome (more severe anxiety symptoms). Described for all participants together, because both arms have received CT by then. Not a randomized comparison.
Time frame: Baseline, and about 3, 6 and 12 months after the second CT session
Target engagement: Positive affect (Positive and Negative Affect Schedule, PANAS, positive affect scale)
Positive and Negative Affect Schedule, positive affect scale, self-reported online. Score 10-50; higher scores mean more positive affect. Compared between arms at about 4 weeks with the same model as the primary outcomes; 95% confidence interval. Exploratory.
Time frame: 4 weeks
Target engagement: Negative affect (Positive and Negative Affect Schedule, PANAS, negative affect scale)
Positive and Negative Affect Schedule, negative affect scale, self-reported online. Score 10-50; higher scores mean more negative affect. Compared between arms at about 4 weeks with the same model as the primary outcomes; 95% confidence interval. Exploratory.
Time frame: 4 weeks
Plan to share: Yes — De-identified individual participant survey data from participants who agreed to data sharing in Part B of the consent form.
Time frame: On request to the Principal Investigator.
Access criteria: De-identified data from participants who said Yes in Part B of the consent form may be shared with other researchers on request. Requests go to the Principal Investigator.
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