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NCT Number: NCT07195266

Psychological Outcomes of Strategic Therapy in Adult Outpatients (POST Trial)

This observational study investigates the outcomes of Strategic Psychotherapy, a form of brief psychological treatment focused on specific goals for change. The aim is to evaluate whether patients who receive this therapy in private practice settings experience improvements in their psychological well-being, psychological symptoms, and daily functioning.

The study population includes all adult patients (≥16 years) who spontaneously seek treatment from two strategic therapists between January 2021 and December 2025. Eligible participants must present with psychological problems that meet the criteria for a clinical diagnosis.

Participants will complete two psychological questionnaires (SCL-90R and CORE-OM) before starting therapy and again at the end of their treatment. Changes in scores on these outcome measures will be statistically compared with data from a non-clinical population to assess whether the observed changes are greater than would be expected by chance.

Additional information will be collected, including medication use, the patient's own evaluation of the therapy, the number of sessions attended, the initial diagnosis, family involvement, and the types of therapeutic prescriptions used.

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Key information

Conditions

Mental Disorder Mental Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Studio di psicoterapia Dr. Tinacci, Empoli, Italy

About this study

Strategic Psychotherapy is a brief, goal-oriented form of psychological treatment that emphasizes the collaborative formulation of specific therapeutic goals and the implementation of targeted interventions to facilitate change. Despite its widespread clinical application, systematic evidence regarding patient outcomes in naturalistic private practice settings remains limited.

This observational study aims to contribute to the evidence base by examining the effectiveness of Strategic Psychotherapy in improving psychological well-being, reducing psychological symptom distress, and enhancing everyday functioning. The study includes all patients aged 16 years or older who independently seek treatment from two certified strategic therapists between January 2021 and December 2025. Eligibility is based on the presence of clinically significant psychological problems consistent with a formal clinical diagnosis.

Treatment outcomes will be compared with those of a non-clinical control group whose participants are assessed using the same outcome measures over a follow-up period of equivalent duration, in order to determine whether the observed changes in the clinical sample exceed those expected in the absence of psychological treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 16 years or older.
Individuals voluntarily seeking psychological treatment in private practice with one of the participating strategic therapists.
Presence of clinically relevant psychological problems consistent with a formal diagnosis (e.g., anxiety disorders, depressive disorders, stress-related conditions, relational difficulties).
Ability to provide informed consent.

Exclusion criteria

Individuals younger than 16 years.
Patients with severe psychiatric conditions requiring immediate specialized care (e.g., acute psychosis, severe suicidal risk, substance dependence requiring detoxification).
Patients currently enrolled in another clinical trial.
Inability or unwillingness to complete the required questionnaires (SCL-90-R and CORE-OM).

Treatment and study plan

Strategic Psychoterapy

Behavioral

Strategic psychotherapy as described in scientific literature

Primary outcomes

1. Symptom Checklist-90-Revised (SCL-90-R) 2. Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)

Time frame: Baseline (prior to first psychotherapy session) and at end of treatment (average of 12-16 weeks, depending on number of sessions).
- Symptom Checklist-90-Revised (SCL-90-R) Description: A 90-item self-report scale assessing psychological symptoms across multiple domains. Each item is rated on a 5-point Likert scale (0 = "not at all" to 4 = "extremely"). Higher scores indicate greater symptom severity.
- Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Description: A 34-item self-report questionnaire assessing well-being, problems/symptoms, functioning, and risk. Each item is rated on a 5-point scale (0 = "not at all" to 4 = "most or all of the time"). Higher scores indicate greater distress.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Leonardi, Psychologist

CONTACT

[email protected]

0039 3283261083

Francesco Tinacci, Psychologist

CONTACT

[email protected]

0039 3385014333

Sponsors and collaborators

Lead sponsor

Società Scientifica di Psicoterapia Strategica

Other

Registry information

Official study title

A Naturalistic Study of Psychological Outcomes in Adult Outpatients Receiving Strategic Psychotherapy in Private Practice (POST)

Acronym: POST

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Sep 26, 2025
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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