Mental DisordersNCT07017543
Dynamics of Psychotherapy and Treatment Outcomes
A study testing Psychotherapy Process-Outcome Study in Group Therapy in people with Mental Disorders and Neurotic Disorders, run by University Hospital in Krakow at 1 site in Poland.
Trial summary
The study is a 3-month controlled trial that aims to measure changes in patient's capacity (mindfulness, resilience, insight, working alliance) and intensity of neurotic symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders, Neurotic Disorders, Personality Disorders
- What is being tested?
- Psychotherapy Process-Outcome Study in Group Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2023to Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnostic criteria for neurotic disorders (ICD-10: F40-F48.9) or personality disorders of mild to moderate severity (ICD-10: F60-F61)
- obtaining informed consent for participation in the study
- being over the age of 18
Who cannot join
- diagnosis of psychotic and/or organic disorders as well as active addictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Capacity and Dynamic Aspects of the Psychotherapeutic Process Impacting the Course and Outcomes of Treatment
The study is a 3-month controlled trial that aims to measure changes in patient's capacity (mindfulness, resilience, insight, working alliance) and intensity of neurotic symptoms. The following tools are used: the Freiburg Mindfulness Inventory, the Psychological Insight Questionnaire, the Connor-Davidson Resilience Scale - Short Version, the Working Alliance Inventory - Short Version and the "O" Symptom Questionnaire. During 12-week group intervention patients are asked to fill in the appropriate set of questionnaires four times (at the beginning, two times between and at the end of treatment). The study is conducted in the Psychotherapy Unit of University Hospital in Krakow.
- Conditions
- Mental Disorders, Neurotic Disorders, Personality Disorders
- Being tested
- Psychotherapy Process-Outcome Study in Group Therapy
- Keywords
- therapeutic alliance, insight, resilience, group therapy, neurotic symptoms, treatment oucome, changes in treatment, mindfulness, process-outcome research
- Medical subject headings
- Mental Disorders, Neurotic Disorders, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy Process-Outcome Study in Group TherapyOther
Also called Group Psychotherapy Focused on Therapeutic Alliance and Insight, Alliance-Focused Group Therapy, Insight-Oriented Group Therapy, Psychodynamic Group Therapy Monitoring Alliance and Insight Development
A manualized group dynamic psychotherapy conducted at the University Hospital in Kraków, focused on monitoring and enhancing therapeutic alliance and insight development. The intervention targeted patients diagnosed with neurotic and personality disorders. Psychological assessments were conducted at weeks 1, 4, 8, and 12 to track changes in symptoms, resilience, alliance, and insight. The psychotherapy emphasized the interplay between trait-like and state-like components of alliance and insight and their relationship to therapeutic outcomes (symptom reduction and resilience enhancement).
| Study group | Role | What they receive |
|---|---|---|
| Trait-like and state-like components of therapeutic alliance and insight influencing psychotherapy o | Other | Patients diagnosed with neurotic and personality disorders were assessed at the 1st, 4th, 8th, and 12th week of treatment using the psychological assessment measures. Receives: Other: Psychotherapy Process-Outcome Study in Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience Level Assessed by the Connor-Davidson Resilience Scale Short Version (CD-RISC-10)
Connor-Davidson Resilience Scale Short Version (CD-RISC-10) is a 10-item scale used to assess resilience, defined as the ability to cope with stress in response to challenging experiences. The full CD-RISC consists of 25 items and has a five-factor structure, both versions displaying sound psychometric properties. Observations made during the development of the original scale indicate that resilience can be modified and improved through appropriate interventions, and greater improvement in resilience scores corresponds to more significant overall treatment outcomes. CD-RISC is one of the most frequently used tools to measure resilience. This study employed the short version, CD-RISC-10, which includes two factors labeled as Endurance and Perseverance. The CD-RISC-10 uses a 5-point Likert scale to assess resilience.
Measured: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
Neurotic Symptoms Questionnaire "O" (SQ-O)
The Symptoms Questionnaire "O" (SQ-O), a validated 187-item self-report tool used to measure the severity of neurotic symptoms across affective, somatic, and behavioral domains. The checklist includes 14 subscales covering different areas of neurotic psychopathology. The SQ-O can be used both diagnostically, to assess the overall severity of symptoms (cut-off scores are sex-adjusted; scores above 165 for men and 200 for women indicate symptoms exceeding the norm), as well as a measure of treatment-related change. This study focused on the overall scale scores measured at specified time points, without analyzing changes in individual subscales. Each item is scored dichotomously (0 = no, 1 = yes).
Measured: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
Psychological Insight Assessed by the Psychological Insight Questionnaire (PIQ)
Psychological Insight Questionnaire (PIQ) is a tool used to assess insight, defined as a series of realizations and discoveries related to personality, relationships, behavioral patterns, and emotions. The questionnaire consists of 23 items rated on a 6-point Likert scale (from 0 - none/not at all to 5 - extreme) to indicate the intensity of each experienced state over the last 7 days. The scale includes two subscales: (1) Avoidance and Maladaptive Patterns Insights and (2) Goals and Adaptive Patterns Insights, both of which demonstrate satisfactory internal consistency (Cronbach's α = 0.93 and 0.85, respectively). Although initially developed to explore the acute and lasting effects of psychedelic use, the content, sound psychometric properties, and simplicity of the PIQ encourage its use in other areas where psychological insight may be critical in predicting psychotherapy outcomes.
Measured: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
Therapeutic Alliance Level Assessed by the Working Alliance Inventory - Short Revised (WAI-SR)
Working Alliance Inventory - Short Revised (WAI-SR) is a 12-item revised measure assessing the quality of the therapeutic alliance as perceived by the patient. Extensive research has confirmed its effectiveness in predicting treatment outcomes. Most researchers recommend using the overall score, as the two identified subscales - Goal/Task and Bond - strongly correlate, which could interfere with accurate interpretation. The WAI-SR uses a 5-point Likert scale to assess the strength of the therapeutic alliance.
Measured: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
Freiburg Mindfulness Inventory - Short Form (FIU-14)
The Freiburg Mindfulness Inventory - Short Form (FIU-14) is a 14-item self-report scale designed to measure mindfulness as a general psychological trait. Mindfulness is described as a personal trait of being mindful of the moment-by-moment experience. Some of the features of mindfulness include openness, receptiveness, curiosity, and a nonjudgmental attitude. It assumes that an open and attentive individual is more in touch with feelings and experiences. Fourteen items of the questionnaire define mindfulness as a process of regulating attention. The items are rated on a 4-point Likert scale, from 1 = "rarely" to 4 = "almost always". The reliability measure of this short version is acceptable (Cronbach's alpha between 0.79 and 0.86).
Measured: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Feb 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital in Krakow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benita Wielgus, University Hospital in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017543
- Sponsor's protocol ID
- 1072.6120.189.2022
- Status last verified
- Jun 2025
- First submitted
- 28 Apr 2025
- Last updated
- 12 Jun 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Capacity and Dynamic Aspects of the Psychotherapeutic Process Impacting the Course and Outcomes of Treatment
- ClinicalTrials.gov ID
- NCT07017543
- Acronym / sponsor ID
- 1072.6120.189.2022
- Conditions
- Mental Disorders, Neurotic Disorders, Personality Disorders
- Keywords
- therapeutic alliance, insight, resilience, group therapy, neurotic symptoms, treatment oucome, changes in treatment, mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital in KrakowUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Jun 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.
The study is a 3-month controlled trial that aims to measure changes in patient's capacity (mindfulness, resilience, insight, working alliance) and intensity of neurotic symptoms. The following tools are used: the Freiburg Mindfulness Inventory, the Psychological Insight Questionnaire, the Connor-Davidson Resilience Scale - Short Version, the Working Alliance Inventory - Short Version and the "O" Symptom Questionnaire. During 12-week group intervention patients are asked to fill in the appropriate set of questionnaires four times (at the beginning, two times between and at the end of treatment). The study is conducted in the Psychotherapy Unit of University Hospital in Krakow.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trait-like and state-like components of therapeutic alliance and insight influencing psychotherapy o | Other | Other: Psychotherapy Process-Outcome Study in Group TherapyPatients diagnosed with neurotic and personality disorders were assessed at the 1st, 4th, 8th, and 12th week of treatment using the psychological assessment measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnostic criteria for neurotic disorders (ICD-10: F40-F48.9) or personality disorders of mild to moderate severity (ICD-10: F60-F61)
- obtaining informed consent for participation in the study
- being over the age of 18
Key exclusion criteria (1 listed)
- diagnosis of psychotic and/or organic disorders as well as active addictions
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 |
|---|---|---|
| Psychotherapy Process-Outcome Study in Group TherapyAlso: Group Psychotherapy Focused on Therapeutic Alliance and Insight, Alliance-Focused Group Therapy, Insight-Oriented Group Therapy, Psychodynamic Group Therapy Monitoring Alliance and Insight DevelopmentA manualized group dynamic psychotherapy conducted at the University Hospital in Kraków, focused on monitoring and enhancing therapeutic alliance and insight development. The intervention targeted patients diagnosed with neurotic and personality disorders. Psychological assessments were conducted at weeks 1, 4, 8, and 12 to track changes in symptoms, resilience, alliance, and insight. The psychotherapy emphasized the interplay between trait-like and state-like components of alliance and insight and their relationship to therapeutic outcomes (symptom reduction and resilience enhancement). | Other | Trait-like and state-like components of therapeutic alliance and insight influencing psychotherapy o |
Primary outcome
Resilience Level Assessed by the Connor-Davidson Resilience Scale Short Version (CD-RISC-10)
Time frame: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
Connor-Davidson Resilience Scale Short Version (CD-RISC-10) is a 10-item scale used to assess resilience, defined as the ability to cope with stress in response to challenging experiences. The full CD-RISC consists of 25 items and has a five-factor structure, both versions displaying sound psychometric properties. Observations made during the development of the original scale indicate that resilience can be modified and improved through appropriate interventions, and greater improvement in resilience scores corresponds to more significant overall treatment outcomes. CD-RISC is one of the most frequently used tools to measure resilience. This study employed the short version, CD-RISC-10, which includes two factors labeled as Endurance and Perseverance. The CD-RISC-10 uses a 5-point Likert scale to assess resilience.
Neurotic Symptoms Questionnaire "O" (SQ-O)
Time frame: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
The Symptoms Questionnaire "O" (SQ-O), a validated 187-item self-report tool used to measure the severity of neurotic symptoms across affective, somatic, and behavioral domains. The checklist includes 14 subscales covering different areas of neurotic psychopathology. The SQ-O can be used both diagnostically, to assess the overall severity of symptoms (cut-off scores are sex-adjusted; scores above 165 for men and 200 for women indicate symptoms exceeding the norm), as well as a measure of treatment-related change. This study focused on the overall scale scores measured at specified time points, without analyzing changes in individual subscales. Each item is scored dichotomously (0 = no, 1 = yes).
Psychological Insight Assessed by the Psychological Insight Questionnaire (PIQ)
Time frame: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
Psychological Insight Questionnaire (PIQ) is a tool used to assess insight, defined as a series of realizations and discoveries related to personality, relationships, behavioral patterns, and emotions. The questionnaire consists of 23 items rated on a 6-point Likert scale (from 0 - none/not at all to 5 - extreme) to indicate the intensity of each experienced state over the last 7 days. The scale includes two subscales: (1) Avoidance and Maladaptive Patterns Insights and (2) Goals and Adaptive Patterns Insights, both of which demonstrate satisfactory internal consistency (Cronbach's α = 0.93 and 0.85, respectively). Although initially developed to explore the acute and lasting effects of psychedelic use, the content, sound psychometric properties, and simplicity of the PIQ encourage its use in other areas where psychological insight may be critical in predicting psychotherapy outcomes.
Therapeutic Alliance Level Assessed by the Working Alliance Inventory - Short Revised (WAI-SR)
Time frame: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
Working Alliance Inventory - Short Revised (WAI-SR) is a 12-item revised measure assessing the quality of the therapeutic alliance as perceived by the patient. Extensive research has confirmed its effectiveness in predicting treatment outcomes. Most researchers recommend using the overall score, as the two identified subscales - Goal/Task and Bond - strongly correlate, which could interfere with accurate interpretation. The WAI-SR uses a 5-point Likert scale to assess the strength of the therapeutic alliance.
Freiburg Mindfulness Inventory - Short Form (FIU-14)
Time frame: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)
The Freiburg Mindfulness Inventory - Short Form (FIU-14) is a 14-item self-report scale designed to measure mindfulness as a general psychological trait. Mindfulness is described as a personal trait of being mindful of the moment-by-moment experience. Some of the features of mindfulness include openness, receptiveness, curiosity, and a nonjudgmental attitude. It assumes that an open and attentive individual is more in touch with feelings and experiences. Fourteen items of the questionnaire define mindfulness as a process of regulating attention. The items are rated on a 4-point Likert scale, from 1 = "rarely" to 4 = "almost always". The reliability measure of this short version is acceptable (Cronbach's alpha between 0.79 and 0.86).
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 12 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy Process-Outcome Study in Group Therapy in people with Mental Disorders and Neurotic Disorders, run by University Hospital in Krakow at 1 site in Poland.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 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 Poland. 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?
Resilience Level Assessed by the Connor-Davidson Resilience Scale Short Version (CD-RISC-10) (time frame: Week 1 (pre-treatment); Week 4 (1 month of treatment); Week 8 (2 months of treatment); Week 12 (post-treatment; end of 3-month therapy cycle)). The study lists 5 primary outcomes in all. 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 12 Jun 2025.