Mental IllnessNCT06538675
Process and Outcome Evaluation of Different Psychotherapies
An observational study of Mental Illness and Psychiatric Disorder, run by University of Salzburg at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mental Illness, Psychiatric Disorder, Mental Disorder
- What is being tested?
- Psychotherapy
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 30 Sep 2024to Dec 2035
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult individuals seeking help for their mental health at Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Paris-Lodron-University Salzburg
Salzburg, State of Salzburg, 5020
About this study
Official title: 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.
- Conditions
- Mental Illness, Psychiatric Disorder, Mental Disorder
- Being tested
- Psychotherapy
- Keywords
- psychotherapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
Patients are assigned to a therapist and will receive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| psychoanalytic-psychodynamic therapy | Not described Receives: Other: Psychotherapy | |
| humanistic therapy | Not described Receives: Other: Psychotherapy | |
| systemic therapy | Not described Receives: Other: Psychotherapy | |
| cognitive-behavioral therapy | Not described Receives: Other: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Symptom Checklist Short Form (HSCL-11)
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Patient Health Questionnaire-8 (PHQ-8)
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.
Measured: through study completion, an average of 1 year
Generalizied Anxiety Disorder Scale-7 (GAD-7)
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.
Measured: through study completion, an average of 1 year
Patient Health Questionnaire-4 (PHQ-4)
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.
Measured: through study completion, an average of 1 year
Positive Mental Health scale (PMH)
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.
Measured: through study completion, an average of 1 year
Society for Psychotherapy Research Item on Mental Health
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start30 Sep 2024
- Primary completionDec 2030 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salzburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Probst, University of Salzburg
- Investigators
- Thomas Probst, Univ.Prof.Dr, Study director, Paris-Lodron-University SalzburgFranziska Pfannerstill, Dr., Principal investigator, Paris-Lodron-University SalzburgHannah van Alebeek, Dr., Principal investigator, Paris-Lodron-University Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538675
- Sponsor's protocol ID
- 14/2024
- Status last verified
- Aug 2024
- First submitted
- 15 Jul 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process and Outcome Evaluation of Psychotherapeutic Approaches At the Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg
- ClinicalTrials.gov ID
- NCT06538675
- Acronym / sponsor ID
- 14/2024
- Conditions
- Mental Illness, Psychiatric Disorder, Mental Disorder
- Keywords
- psychotherapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of SalzburgUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 6 Aug 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| psychoanalytic-psychodynamic therapy | – | Other: Psychotherapy |
| humanistic therapy | – | Other: Psychotherapy |
| systemic therapy | – | Other: Psychotherapy |
| cognitive-behavioral therapy | – | Other: Psychotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals seeking help for their mental health at Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PsychotherapyPatients are assigned to a therapist and will receive psychotherapy | Other | cognitive-behavioral therapy, humanistic therapy, psychoanalytic-psychodynamic therapy, systemic therapy |
Primary outcome
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.
5 secondary outcomes
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 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
Patient Health Questionnaire-4 (PHQ-4)
Time frame: through study completion, an average of 1 year
Positive Mental Health scale (PMH)
Time frame: 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
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 1 Jan 2025.
- Related InfoLink provided by the sponsor.
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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.
Thomas Probst, Univ.Prof.Dr study director
Paris-Lodron-University Salzburg
Franziska Pfannerstill, Dr. principal investigator
Paris-Lodron-University Salzburg
Hannah van Alebeek, Dr. principal investigator
Paris-Lodron-University Salzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Illness and Psychiatric Disorder, run by University of Salzburg at 1 site in Austria.
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 2 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Symptom Checklist Short Form (HSCL-11) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2025.