Clinical Research Directory

Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy

The aim of the present study is to examine the effects of keeping a therapy journal (journaling) on the effectiveness of cognitive behavioral therapy (CBT). Homework assignments are a fundamental component of behavioral therapies. In line with the learning theory foundation of behavioral therapies, various types of homework are used to facilitate learning processes between therapy sessions and to enable patients to make progress. One way to enhance individual goal setting and reflection in patients is through the use of "therapy journals." The goal of the planned project is to evaluate the effectiveness of goal-oriented journal writing as an additional element in cognitive behavioral therapy (CBT). To do this, psychotherapy patients will be randomly assigned to two treatment groups: CBT vs. CBT + Journaling. Patients will be block-randomized until 40 patients have completed the study in each treatment arm (at least 10 completed sessions).

The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective.

The combination of pharmacotherapy and individual cognitive behavioral therapy in a private practice.

Sensorimotor Psychotherapy for Personality Disorders

SUMMARY Rationale: Personality disorders are treated conform the Dutch GGZ-zorgstandaard mainly with verbal psychotherapies but experts by experience call out to make use of body-oriented approaches as well. In general, the rationale to study the effects of bodily centered therapy for personality disorders is built on the overlap between personality disorders and posttraumatic stress disorder (PTSD). In both classifications, childhood major events and/or traumatic life events play a role in the history of its origins (Karatzias et al., 2023).Traditional psychotherapies for personality disorders address the cognitive and emotional elements of trauma, but lack techniques that work directly with the physiological elements, although trauma profoundly affects the body and many symptoms of traumatized individuals with personality disorders are somatically based. However, studies into the effect of body centered interventions for personality disorders are scarce. This study aims to examine the effects of sensorimotor psychotherapy (SP), a body-oriented intervention, in patients with a personality disorder and PTSD-symptoms. This study studies the effect of sensorimotor psychotherapy (SP) which is a body-oriented intervention which focuses on the combination of a personality disorder and post-traumatic stress disorder. Objective: This multi-center randomized controlled study aims to research the effect of a 12-session sensorimotor psychotherapy (SP) group intervention, in comparison with treatment-as-usual, on emotion regulation in people with a personality disorder. In addition, the effects on body awareness, self-soothing, PTSD-symptoms and personality functioning are assessed. Patients' perception of the intervention will be assessed through qualitative techniques. The study will be carried out in five mental health institutions in the Netherlands. Study design: This is a multi-center randomized controlled trial, in which the intervention group receives a 12-sessions SP-therapy, and the control group receives treatment-as-usual of the assigned institution. Measurements through standardized instruments take place at three moments: pre-intervention (T0), post-intervention (T1), and two months follow-up (T2). Qualitative interviews are conducted after completion of the SP-condition. In combination with the qualitative measurements, a Mixed Methods Design is used. Study population: Patients older than 18 years, who have been diagnosed with a personality disorder and have experienced early childhood trauma. Intervention: patients assigned to the SP-condition receive the 12-session SP group protocol (Fisher \& Ogden, 2016), this protocol introduces diverse successive skills, aiming for the patient to have more somatic resources to regulate arousal of the autonomous nervous system. Every session starts with psychoeducation on a trauma-related theme, followed by one or multiple skills which are practiced in dyads and are later discussed in the group. The subjects which are covered are: autonomous arousal, implicit memory, regulation techniques, survival sources, somatic and internal resources, boundaries, practicing with experiments and repetitions, focus on positive change. Main study parameter: The main parameter of this study is emotion regulation. Emotion regulation is examined with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). Secondary parameters: Second parameters are body awareness, self-soothing, PTSD-symptoms, personality functioning. Body awareness is examined with the Multidimensional Assessment of Interoceptive Awareness (MAIA-2). The Soothing Receptivity Scale (SRS) is used to examine self-soothing abilities. The PTSD-checklist for DSM-5 (PCL-5) is used to assess the PTSD-symptoms. The Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF 2.0) is used to map out personality functioning. The patients' perception of the intervention is explored through qualitative interviews. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients involved in this study are indicated for treatment for a personality disorder. Sensorimotor psychotherapy belongs the treatment options of some mental health institutions. Additionally, patients who are assigned to the control condition are offered the SP-condition after completing the control condition. In this way they can also benefit from the SP-condition. Questionnaires are filled in at three moments during the treatment (T0, T1, T2), filling in the questionnaires will take 60 minutes on average, which is little more than routine outcome measurement takes in Dutch mental healthcare. The qualitative interviews after the SP-condition will take up 60 minutes on average.

Bridging Affect Consciousness, Mentalization and Trauma- Exploring an Integrative Treatment Approach for Personality Disorder (PD).

Study background: Specialized Group Outpatient Clinic within specialist mental health services, tailoring two year group treatment programmes for severe Avoidant PD (AvPD) and Borderline PD (BPD) with Affect Consciousness (AC) targeting specific areas of emotional dysfunction. Aims: Our main hypothesis, adding AC to Mentalization- based treatment (MBT) to expand the breadth and depth of therapeutically productive work on affect, will aim to examine health indicators, processes and mechanisms of change in depth. The study will extracts preliminary data after 5 years and 10 years to investigate clinical change, variation and outcome during MBT for PD employing AC as add on to MBT. The study has a randomized controlled trail design, with MBT with or without AC as add-on. The RCT is grounded on original literature on Affect Theory, as a framework for understanding patient functioning, and MBT, framing the therapy.Implications: AC methodology as add on can lead to more tailored treatment programmes, service planning, allocation of resources, guidelines, ACI certification and method development for PDs.

Evaluation of a Dimensional Adaptation of Good Psychiatric Management (GPM-extended) for the Treatment of Borderline Personality Disorder

The goal of this clinical trial is to evaluate whether a dimensional adaptation of Good Psychiatric Management (called GPM-extended) is more effective than classic Good Psychiatric Management (GPM) in treating adult patients with borderline personality disorder (BPD). Briefly, the GPM-extended model integrates elements from existing adaptations of GPM for narcissistic and obsessive-compulsive personality disorders. It aims to provide a more personalized and dimensional approach to treatment, tailored to each patient's specific personality dysfunction and interpersonal triggers. The main questions it aims to answer are: * Does GPM-extended improve overall BPD symptom severity more than classic GPM after one year of treatment? * Does GPM-extended lead to better outcomes in related clinical domains (e.g., personality functioning, emotional regulation, social functioning...) ? Researchers will compare two groups: * Patients treated in a center using the GPM-extended program. * Patients treated in a center using the classic GPM program. In each group, patients will receive weekly outpatient psychiatric care for one year. In terms of evaluation, patients will be evaluated at baseline, 4 months, 8 months, and 1 year. They will undergo both clinician-administered and self-report assessments to measure BPD symptoms and other relevant psychological dimensions. This study hopes to contribute to the development of dimensional evidence-based treatments for personality disorders.

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

The goal of this clinical trial is to assess if Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) is effective for treating various forms of Eating Disorders (ED) and reducing dropout rates. The trial will also evaluate its feasibility and outcomes in a patient group including also underweight participants. The main questions it aims to answer are: * Does MIT-ED improve eating disorder symptoms and reduce overall maintenance factors, as alexithymia, emotional dysregulation, maladaptive perfectionism, and self-esteem? * Is MIT-ED effective in reducing the severity of personality disorders and associated global psychiatric symptoms? * What are the dropout rates and adherence levels for patients receiving MIT-ED? Participants will: * Undergo an initial screening to confirm eligibility, including a comprehensive clinical interview and assessments based on inclusion and exclusion criteria for the study. * Receive up to 40 individual sessions of MIT-ED, each lasting 50-60 minutes, over a period of approximately 10-12 months. * Attend regular assessment focusing on eating disorder symptoms (Eating Disorder Examination Questionnaire, EDE-Q 6.0, and ED Interview, EDE), emotional dysregulation (Difficulties in Emotion Regulation Scale, DERS), alexithymia (Toronto Alexithymia Scale-20, TAS-20), and self-esteem (Rosenberg Self-Esteem Scale, RSES). Assessment will be conducted at baseline (before starting MIT-ED sessions), after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up. A longer 12-months follow-up is planned. Researchers will evaluate the effectiveness of MIT-ED based on treatment adherence, symptom improvement, and the reduction of maintenance mechanisms associated with Eating Disorders. Positive results could support the design of a larger, controlled Randomized Clinical Trial (RCT).

An Evolutionarily Informed Conceptualization of Personality Pathology

The purpose of this study is to explore the reliability of a new evolutionarily-informed model for conceptualizing personality pathology. In a preliminary phase prior to the present study we investigated reliability by comparing how therapist pairs conceptualized and assessed the same patient and how therapists and patients assessed the acceptability of the model. In this new study we want to confirm that the validity data initially collected are valid across cultures and nations. Therefore, psychology students (n=110) from 5 countries (China, Italy, Poland, Spain, United States) will participate in a specific training on the model and then apply the model on transcripts of the first two sessions and on assessment reports and two supervisors will evaluate the inter-rater reliability and acceptability in using the model on the same patients.

Feasibility, Acceptability, and Preliminary Effects of ISTDP for Personality Disorders in a Specialized Psychiatric Clinic

The primary objective of this study is to evaluate the feasibility and acceptability of a 25-week combined group and individual therapy program using Intensive Short-Term Dynamic Psychotherapy (ISTDP) for patients diagnosed with personality disorders. The secondary objective is to investigate preliminary effects of the treatment in terms of reducing symtoms of depression, anxiety and emotion regulation difficulties.