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Can brief talk therapy improve mental health? new study aims to find out

NCT ID NCT07195266

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This observational study follows 300 adults receiving strategic psychotherapy—a short-term, goal-focused talk therapy—in private practice. Participants fill out questionnaires about their symptoms and well-being before and after treatment. The goal is to see if this therapy leads to real improvements in mental health and daily life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
strategic psychotherapy
What this could lead to
If successful, this study could provide real-world evidence that strategic psychotherapy helps reduce symptoms and improve daily functioning for adults with mental health conditions.
What could go wrong
This is an observational study without a control group, so improvements may be due to natural recovery or other factors. Results may not apply to all therapy settings or patient types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Studio di Psicoterapia Dr. Fabio Leonardi

    RECRUITING

    Livorno, Li, 57100, Italy

  • Studio di psicoterapia Dr. Tinacci

    RECRUITING

    Empoli, Italy, 50053, Italy

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