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

NCT ID: NCT07195266

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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

The study population includes all adult patients (≥18 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.

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

All data will be treated confidentially and used solely for research purposes.

Detailed Description

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

This observational study aims to contribute to the evidence base by examining the effectiveness of Strategic Psychotherapy in improving psychological well-being, reducing symptom distress, and enhancing everyday functioning. The study includes all adult patients (≥18 years) who independently seek treatment from two certified strategic therapists between January 2021 and December 2025. Inclusion is based on the presence of clinically relevant psychological problems consistent with a formal diagnosis.

Participants will be assessed at baseline and post-treatment using two standardized and validated outcome measures: the Symptom Checklist-90 Revised (SCL-90R) and the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM). Additional clinical and process variables will be recorded, including initial diagnosis, medication use, number of sessions attended, involvement of family members, type of prescriptions, and patient's subjective evaluation of therapy.

Therapists will not manipulate or control the number of sessions or content of therapy beyond their usual clinical practice, thereby preserving the ecological validity of the study. The design is naturalistic and observational, without randomization or control groups. All data will be anonymized and handled in accordance with confidentiality and data protection standards. Findings are expected to provide insight into the real-world outcomes of Strategic Psychotherapy and contribute to the development of evidence-based practice guidelines.

Conditions

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Mental Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Strategic Psychotherapy

patients receiving strategic psychotherapy in private practice settings

Strategic Psychoterapy

Intervention Type BEHAVIORAL

Strategic psychotherapy as described in scientific literature

Interventions

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Strategic Psychoterapy

Strategic psychotherapy as described in scientific literature

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 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 18 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Società Scientifica di Psicoterapia Strategica

OTHER

Sponsor Role lead

Responsible Party

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Fabio Leonardi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabio Leonardi, Psychologist

Role: PRINCIPAL_INVESTIGATOR

Private Practice, Livorno (Italy)

Locations

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Studio di psicoterapia Dr. Tinacci

Empoli, Italy, Italy

Site Status RECRUITING

Studio di Psicoterapia Dr. Fabio Leonardi

Livorno, Li, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Fabio Leonardi, Psychologist

Role: CONTACT

0039 3283261083

Francesco Tinacci, Psychologist

Role: CONTACT

0039 3385014333

Facility Contacts

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Francesco Tinacci, Psychotherapist

Role: primary

+ 39 3385014333

Fabio Leonardi, Psychotherapist

Role: backup

+ 39 3283261083

Fabio Leonardi, Psychotherapist

Role: primary

00393283261083

Francesco Tinacci, Psychotherapist

Role: backup

+ 39 3385014333

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 16783905 (View on PubMed)

Lambert, M.J., Barley, D.E. (2002). Research summary on the therapeutic relationship and psychotherapy outcome. In J.C. Norcross (a cura di), Psychotherapy relationships that work: Therapist contributions and responsiveness to patients, 17-32, Oxford University Press.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 10369053 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 8561380 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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POST 01

Identifier Type: -

Identifier Source: org_study_id

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