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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

Poland1 site
  • University Hospital

    Krakow, Małopolska, 31-138

Other trials in Poland

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.

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 groups in NCT07017543
Study groupRoleWhat they receive
Trait-like and state-like components of therapeutic alliance and insight influencing psychotherapy oOtherPatients 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.

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  1. First posted12 Jun 2025
  2. Study start1 Feb 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

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