Process and Outcome Evaluation of Different Psychotherapies

December 30, 2024 updated by: Thomas Probst, University of Salzburg

Process and Outcome Evaluation of Psychotherapeutic Approaches At the Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg

In this study, adult patients and therapists at the Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg will complete questionnaires throughout the course of psychotherapy in order to evaluate the course and outcome of psychotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Paris-Lodron-University Salzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult individuals seeking help for their mental health at Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg.

Description

Inclusion Criteria:

  • Patients: indication for psychotherapy, adult patients capable of giving consent, with sufficient knowledge of German to complete the questionnaires, signed treatment contract and declaration of consent
  • Psychotherapists: officially registered psychotherapists and psychotherapists in training under supervision (in Austria), signed work contract and declaration of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
psychoanalytic-psychodynamic therapy
Other: Psychotherapy
Patients are assigned to a therapist and will receive psychotherapy
humanistic therapy
Other: Psychotherapy
Patients are assigned to a therapist and will receive psychotherapy
systemic therapy
Other: Psychotherapy
Patients are assigned to a therapist and will receive psychotherapy
cognitive-behavioral therapy
Other: Psychotherapy
Patients are assigned to a therapist and will receive psychotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hopkins Symptom Checklist Short Form (HSCL-11)
Time Frame: through study completion, an average of 1 year
11 items, Likert scale: 4-point scale; 1 (not at all) to 4 (very much), Minimum value: 11, Maximum value: 44, Higher scores indicate more mental health problems.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-8 (PHQ-8)
Time Frame: through study completion, an average of 1 year
8 items, Likert scale: 4-point; 0 (not at all) to 3 (nearly every day), Minimun value: 0, Maximum value: 24, Higher scores indicate more depressive symptoms, Score ≥ 10 indicate depression.
through study completion, an average of 1 year
Generalizied Anxiety Disorder Scale-7 (GAD-7)
Time Frame: through study completion, an average of 1 year
7 items, Likert scale: 4-point; 0 (not at all) to 3 (nearly every day), Minimun value: 0, Maximum value: 21, Higher scores indicate more anxiety symptoms, Score ≥ 10 indicate anxiety.
through study completion, an average of 1 year
Patient Health Questionnaire-4 (PHQ-4)
Time Frame: through study completion, an average of 1 year
4 items, Likert scale: 4-point; 0 (not at all) to 3 (nearly every day), Minimun value: 0, Maximum value: 12, Higher scores indicate more depressive and anxiety symptoms, Score ≥3 for first 2 questions indicates depression, Score ≥ 3 for last 2 questions indicates anxiety.
through study completion, an average of 1 year
Positive Mental Health scale (PMH)
Time Frame: through study completion, an average of 1 year
9 items, Likert skala: 4-point; 0 (do not agree) to 3 (agree), Minimun value: 0, Maximum value: 27, Higher scores indicate higher positive mental health.
through study completion, an average of 1 year
Society for Psychotherapy Research Item on Mental Health
Time Frame: through study completion, an average of 1 year
1 item, Likert scale: 5-point; 0 (very bad) to 4 (very good), Minimum value: 0, Maximum value: 4, Higher scores indicate better mental health.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Salzburg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Thomas Probst, Univ.Prof.Dr, Paris-Lodron-University Salzburg
  • Principal Investigator: Franziska Pfannerstill, Dr., Paris-Lodron-University Salzburg
  • Principal Investigator: Hannah van Alebeek, Dr., Paris-Lodron-University Salzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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