Mental DisorderPOSTNCT07195266
Psychological Outcomes of Strategic Therapy in Adult Outpatients (POST Trial)
An observational study of Mental Disorder, run by Società Scientifica di Psicoterapia Strategica at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Strategic Psychoterapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Studio di psicoterapia Dr. Tinacci
Empoli, Italy, 50053
Francesco Tinacci, Psychotherapist, + 39 3385014333, tinaccifrancesco@gmail.com
Fabio Leonardi, Psychotherapist, + 39 3283261083, dott.leonardifabio@gmail.com
- Recruiting
Studio di Psicoterapia Dr. Fabio Leonardi
Livorno, Li, 57100
Fabio Leonardi, Psychotherapist, 00393283261083, dott.leonardifabio@gmail.com
Francesco Tinacci, Psychotherapist, + 39 3385014333, tinaccifrancesco@gmail.com
About this study
Official title: A Naturalistic Study of Psychological Outcomes in Adult Outpatients Receiving Strategic Psychotherapy in Private Practice (POST)
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.
Read more
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.
Read the 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.
- Conditions
- Mental Disorder
- Being tested
- Strategic Psychoterapy
- Keywords
- Strategic Therapy, Psychotherapy, Mental disorders
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategic PsychoterapyBehavioural
Strategic psychotherapy as described in scientific literature
| Study group | Role | What they receive |
|---|---|---|
| Strategic Psychotherapy | patients receiving strategic psychotherapy in private practice settings Receives: Behavioral: Strategic Psychoterapy | |
| Control group | non-clinical population |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Symptom Checklist-90-Revised (SCL-90-R) 2. Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
- 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.
Measured: Baseline (prior to first psychotherapy session) and at end of treatment (average of 12-16 weeks, depending on number of sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Società Scientifica di Psicoterapia Strategica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Leonardi, Società Scientifica di Psicoterapia Strategica
- Investigators
- Fabio Leonardi, Psychologist, Principal investigator, Private Practice, Livorno (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195266
- Sponsor's protocol ID
- POST 01
- Acronym
- POST
- Status last verified
- May 2026
- First submitted
- 9 Sep 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
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.
PubMed 16783905Weiner 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.
PubMed 21827260Kazi 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.
PubMed 10369053Jacobson, 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.
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.
PubMed 8561380Lambert, M. J. (2004). Ed. Handbook of Psychotherapy and Behavior Change. 5th ed. New York, NY: John Wiley & Sons Inc.
Weakland, J. H., Fisch, R., Watzlawick, P., & Bodin, A. (1974). Brief therapy: Focused problem resolution. Family Process, 13, 141-168.
Haley, J. (1987). Problem- Solving therapy: New strate- gies for effective family therapy (2nd ed.). San Francisco: Jossey-Bass.
Fisch, R., Weakland, J. H., & Segal, L. (1982). The tactics of change: Doing therapy briefly. San Francisco: Jossey-Bass.
Rohrbaugh, M. (1986). Q-sort comparisons of the structural, strategic, and systemic family therapies. American Journal of Family Therapy, 14, 40-48.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic Study of Psychological Outcomes in Adult Outpatients Receiving Strategic Psychotherapy in Private Practice (POST)
- ClinicalTrials.gov ID
- NCT07195266
- Acronym / sponsor ID
- POST / POST 01
- Conditions
- Mental Disorder
- Keywords
- Strategic Therapy, Psychotherapy, Mental disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Società Scientifica di Psicoterapia StrategicaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategic Psychotherapy | – | Behavioral: Strategic Psychoterapypatients receiving strategic psychotherapy in private practice settings |
| Control group | – | –non-clinical population |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strategic PsychoterapyStrategic psychotherapy as described in scientific literature | Behavioural | Strategic Psychotherapy |
Primary outcome
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- BackgroundStrupp, 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: PubMed 16783905Lyne 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.
- Background: PubMed 21827260Weiner 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.
- BackgroundKazi M. (2003). Realist evaluation for practice, British Journal of Social Work, 33, 6, 803-818.
- Background: PubMed 10369053Kazdin 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.
- BackgroundJacobson, N.S., Follette W.C., Revenstorf D. (1984). Psychotherapy outcome research: methods for reporting variability and evaluating clinical significance, Behaviour Therapy, 15, 336-52.
- BackgroundEvans, 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.
- BackgroundEvans, 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: PubMed 8561380Seligman 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.
- BackgroundLambert, M. J. (2004). Ed. Handbook of Psychotherapy and Behavior Change. 5th ed. New York, NY: John Wiley & Sons Inc.
- BackgroundWeakland, J. H., Fisch, R., Watzlawick, P., & Bodin, A. (1974). Brief therapy: Focused problem resolution. Family Process, 13, 141-168.
- BackgroundHaley, J. (1987). Problem- Solving therapy: New strate- gies for effective family therapy (2nd ed.). San Francisco: Jossey-Bass.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Leonardi, Psychologist principal investigator
Private Practice, Livorno (Italy)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder, run by Società Scientifica di Psicoterapia Strategica at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Leonardi, Psychologist (0039 3283261083, dott.leonardifabio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07195266, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.