Patient Capacity and Dynamic Aspects of the Psychotherapeutic Process Impacting the Course and Outcomes of Treatment
Phase: NA
Conditions: Mental Disorders, Neurotic Disorders, Personality Disorders
Sponsor: University Hospital in Krakow

Patient Capacity and Dynamic Aspects of the Psychotherapeutic 
Process Impacting the Course and Outcomes of Treatment 
 
Short Title: 
Dynamics of Psychotherapy and Treatment Outcomes 
 
NCT Number: 
 
Date: 
June 03, 2025 
Version: 
Version 1.0 
Principal Investigator: 
Benita Wielgus, MSc 
University Hospital in Krakow 
 
 
1. Introduction 
2. Objectives 
3. Study Design 
4. Study Population 
5. Methods 
6. Outcome Measures 
7. Statistical Analysis 
8. Ethical Considerations 
9. Data Management and Confidentiality 
10. References 
11. Appendices 
 
 

1. Introduction 
Psychotherapy outcomes are influenced by dynamic, ongoing factors within the 
therapeutic relationship. Understanding how traits like mindfulness, resilience, and 
insight — as well as therapeutic alliance — affect the process can guide more effective 
treatments. This study aims to track these dynamic factors and their association with 
changes in neurotic symptoms over a 12-week group therapy program. 
2. Objectives 
Primary Objective: 
To investigate the association between dynamic aspects of the psychotherapeutic 
process — such as therapeutic alliance, insight, and mindfulness — and treatment 
outcomes, particularly the reduction of neurotic symptoms and the enhancement of 
resilience. 
Secondary Objectives: 
To conduct multiple analyses based on the collected data, including but not limited to 
the following planned studies: 
 "Trait-like and State-like Components of Therapeutic Alliance and Insight 
Influencing Psychotherapy Outcomes in Group Dynamic Psychotherapy." 
 " Pathways of Change in Psychotherapy: The Role of Insight, Alliance, and 
Mindfulness in Building Resilience” 
 
3. Study Design 
Type: Interventional 
Primary Purpose: Treatment 
Model: Single Group Assignment 
Masking: None (Open Label) 
Allocation: Non-Randomized 
Duration: 12 weeks 
Participants undergo group psychotherapy focused on monitoring and enhancing 
therapeutic alliance, mindfulness and insight development. Assessments occur at four 
points: week 1, week 4, week 8, and week 12. 
4. Study Population 
Inclusion Criteria: 
 Diagnosis of neurotic disorders (ICD-10: F40–F48.9) or mild to moderate 
personality disorders (ICD-10: F60–F61). 
 Age ≥18 years. 
 Ability to provide informed consent. 

Exclusion Criteria: 
 Diagnosis of psychotic and/or organic mental disorders. 
 Active substance addiction. 
Sample Size: 89 participants enrolled. 
5. Methods 
Participants will participate in a manualized group dynamic psychotherapy conducted at 
the Psychotherapy Unit, University Hospital in Krakow. During the 12-week 
intervention, participants will complete a battery of questionnaires at four designated 
time points. 
Assessment Tools: 
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. 
 
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). 
 
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. 
 
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. 
 
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). 
6.  Outcome Measures 
Primary Outcomes: 
 Changes in neurotic symptoms measured by the "O" Symptom Questionnaire. 
 Changes in resilience measured by CD-RISC-SV. 
Secondary Outcomes: 

 Changes in therapeutic alliance (WAI-SR scores). 
 Changes in psychological insight (PIQ scores). 
 Changes in mindfulness (FMI scores). 
 
7. Statistical Analysis 
Descriptive statistics will be calculated for all baseline variables. 
Longitudinal changes will be analyzed using: 
 Correlation analyses between changes in process variables (alliance, insight, 
mindfulness) and clinical outcomes (symptom reduction, resilience) 
 Repeated Measures ANOVA 
 Mixed-Effects Models (Random and Fixed Effects) 
Missing data will be handled using multiple imputation methods. A significance level of α 
= 0.05 will be used for all inferential analyses. 
8. Ethical Considerations 
The study has been reviewed and approved by the Bioethics Committee of the 
Jagiellonian University Medical College (Approval Number: 1072.6120.189.2022). 
Participation is voluntary, and participants can withdraw at any time without affecting 
their ongoing treatment. All participants will provide written informed consent prior to 
enrollment. 
9. Data Management and Confidentiality 
Data will be pseudonymized and stored on secure institutional servers at the University 
Hospital in Krakow. Access to identifiable data will be limited to authorized personnel 
only. Data will be retained for a minimum of five years after study completion. 
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11. Appendices 
    Appendix A: Informed Consent Form for Study Participation (English Version) 

    Appendix A 
INFORMED CONSENT FORM FOR STUDY PARTICIPATION 
I hereby declare that: 
1. I have read the Participant Information Sheet, of which I have received one copy. 
2. I have been informed by the person recruiting participants about the purpose of 
the study entitled " Patient Capacity and Dynamic Aspects of the Psychotherapeutic 
Process Impacting the Course and Outcomes of Treatment”. 
3. The recruiting person has thoroughly explained to me the procedure of the study, 
in accordance with the description provided in the Participant Information Sheet. 
4. I have had the opportunity to ask questions and have received satisfactory 
answers to all my inquiries. 
5. I understand the nature of the study, to which I have been invited, and I 
understand that it involves completing questionnaires. 
6. I understand the risks and benefits associated with my participation in the study. 
7. I understand that my participation in the study is voluntary and that I may refuse 
to participate or withdraw from it at any time without providing any reason. 
8. I am aware that my withdrawal will not affect my further treatment in any way. 
In view of the above, I hereby give my informed and voluntary consent to: 
1. participate in the study entitled "Dynamic Aspects of the Psychotherapeutic 
Process Affecting the Course and Outcomes of Treatment"; 
2. the processing of my data, including data concerning my health, contained in the 
medical documentation of the hospital – the Psychotherapy Department of the 
University Hospital – and collected during the study (questionnaires), to the 
extent necessary for the realization of the study, with the reservation that the 
confidentiality of my personal information will be maintained; 
3. the use of my data in an anonymous form for the preparation of scientific 
publications and presentations. 
I confirm that I have received one copy of this document. 
 
 
………………………………………..……….. 
 
Name and surname  
of the person recruiting participants for the study 
 
 
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Name and surname  
of the study participant 
 
 
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Place and date 
 
 
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Signature of the person recruiting participants for the 
study 
 
 
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Place and date 
 
 
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Signature of the study participant