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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral Strategic Psychoterapy
  Strategic psychotherapy as described in scientific literature

Primary outcome measures

• 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).]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Italy · 2 centers

• Studio di psicoterapia Dr. Tinacci — Empoli
• Studio di Psicoterapia Dr. Fabio Leonardi — Livorno

Publications

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

Identifiers

NCT: NCT07195266 · POST 01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗