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

NCT07195266 | Recruiting

• 1 other identifier: POST 01
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mental Disorder

Keywords

Strategic Therapy; Psychotherapy; Mental disorders

Outcome Measures

Primary Outcomes (1)

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

  1. 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. 2. 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.

  Baseline (prior to first psychotherapy session) and at end of treatment (average of 12-16 weeks, depending on number of sessions).

Study Arms (2)

Strategic Psychotherapy

patients receiving strategic psychotherapy in private practice settings

Behavioral: Strategic Psychoterapy

Control group

non-clinical population

Interventions

Strategic Psychoterapy BEHAVIORAL

Strategic psychotherapy as described in scientific literature

Strategic Psychotherapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of two groups. The treatment group will include all patients aged 16 years or older who voluntarily seek psychological treatment in private practice with two licensed strategic therapists in Livorno and Empoli, Italy. Participants are individuals presenting with clinically significant psychological problems consistent with a formal clinical diagnosis (e.g., anxiety, depression, stress-related, or relational disorders). Patients are not recruited through advertising or referral; they are self-referred clients seeking therapy between January 2021 and December 2025. The control group will consist of a non-clinical population with socio-demographic characteristics comparable to those of the treatment group. Control participants will be assessed using the same outcome measures over a follow-up period of equivalent duration but will not receive psychological treatment during the observation period.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Società Scientifica di Psicoterapia Strategica: lead

Study Sites (2)

Studio di psicoterapia Dr. Tinacci

Empoli, Italy, 50053, Italy

RECRUITING

Studio di Psicoterapia Dr. Fabio Leonardi

Livorno, Li, 57100, Italy

RECRUITING

Related Publications (14)

• Strupp, H. H., Horowitz, L. M., & Lambert, M. J. (Eds.). (1997). Measuring patient changes in mood, anxiety, and personality disorders: Toward a core battery. Washington, DC: American Psychological Association.

  BACKGROUND

• Lyne KJ, Barrett P, Evans C, Barkham M. Dimensions of variation on the CORE-OM. Br J Clin Psychol. 2006 Jun;45(Pt 2):185-203. doi: 10.1348/014466505x39106.

  PMID: 16783905 BACKGROUND

• Weiner IB. Psychotherapy relationships that work: therapist contributions and responsiveness to patients. Psychother Res. 2003 Jan 1;13(4):529-32. doi: 10.1093/ptr/kpg044. No abstract available.

  PMID: 21827260 BACKGROUND

• Kazi M. (2003). Realist evaluation for practice, British Journal of Social Work, 33, 6, 803-818.

  BACKGROUND

• Kazdin AE. The meanings and measurement of clinical significance. J Consult Clin Psychol. 1999 Jun;67(3):332-9. doi: 10.1037//0022-006x.67.3.332.

  PMID: 10369053 BACKGROUND

• Jacobson, N.S., Follette W.C., Revenstorf D. (1984). Psychotherapy outcome research: methods for reporting variability and evaluating clinical significance, Behaviour Therapy, 15, 336-52.

  BACKGROUND

• Evans, C., Mellor-Clark, J., Margison, F., Barkham, M., McGrath, G., Connell, J., Audin, K. (2000). Clinical outcomes in routine evaluation : the CORE-OM. Journal of Mental Health, 9, 247-55.

  BACKGROUND

• Evans, C., Connell, J., Barkham, M., Marshall, C., & Mellor-Clark, J. (2003). Practice-based evidence: Benchmarking NHS primary care counselling services at national and local levels. Clinical Psychology & Psychotherapy, 1, 374-388.

  BACKGROUND

• Seligman ME. The effectiveness of psychotherapy. The Consumer Reports study. Am Psychol. 1995 Dec;50(12):965-74. doi: 10.1037//0003-066x.50.12.965.

  PMID: 8561380 BACKGROUND

• Lambert, M. J. (2004). Ed. Handbook of Psychotherapy and Behavior Change. 5th ed. New York, NY: John Wiley & Sons Inc.

  BACKGROUND

• Weakland, J. H., Fisch, R., Watzlawick, P., & Bodin, A. (1974). Brief therapy: Focused problem resolution. Family Process, 13, 141-168.

  BACKGROUND

• Haley, J. (1987). Problem- Solving therapy: New strate- gies for effective family therapy (2nd ed.). San Francisco: Jossey-Bass.

  BACKGROUND

• Fisch, R., Weakland, J. H., & Segal, L. (1982). The tactics of change: Doing therapy briefly. San Francisco: Jossey-Bass.

  BACKGROUND

• Rohrbaugh, M. (1986). Q-sort comparisons of the structural, strategic, and systemic family therapies. American Journal of Family Therapy, 14, 40-48.

  BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Fabio Leonardi, Psychologist

  Private Practice, Livorno (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Leonardi, Psychologist

CONTACT

0039 3283261083; dott.leonardifabio@gmail.com

Francesco Tinacci, Psychologist

CONTACT

0039 3385014333; tinacci.francesco@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 26, 2025
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for five years from the date of the first publication.
• Access Criteria: Any researcher can access the data by sending an email to the study coordinator at dott.leonardifabio@gmail.com.

Locations

IT (2)