Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment
NCT ID: NCT02126787
Last Updated: 2014-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
123 participants
INTERVENTIONAL
2014-09-30
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Methods/design: In this randomized controlled trial, a total of 123 patients with anxiety disorders and comorbid depressive or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) waiting list (control group). Therapy will last 12 weeks. Both treatments will be manualized (manuals will address comorbidity). Primary outcome measures are include self-report symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of anxiety disorder. Secondary outcome measures include personality, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, mindfulness and quality of life: symptoms of anxiety, depression, personality, self-esteem and defense mechanisms. Measures are taken at baseline, post-treatment and 3 months following the end of the therapy.
Discussion: The randomized controlled trial format is used to compare effectiveness of intensive group cognitive-behavior therapy and intensive group psychodynamic therapy for anxiety disorders and comorbid depressive or personality disorders. The rationale is to investigate how effectively anxiety disorders and comorbid personality disorders can be treated in a day hospital typical for Polish healthcare system in 3 months treatment.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Day treatment care is directed precisely to the patients who need treatment of a greater intensity and cannot be treated in outpatient care. Group psychotherapy (often used together with pharmacotherapy) is employed in day care since the 1940s (cf. Cameron 1947; Goldman, 1989). This form of therapy is chosen on economic basis. The treatment usually takes place a few days a week and lasts for several months. Different types of psychotherapy or different treatment methods (e.g. therapeutic community, psychodrama, art therapy, psycho-drawing, movie therapy, social skills training) are often applied together. In Poland, group psychotherapy is widely used in day care. Nowadays 300 such wards exist in Poland. Psychotherapy for anxiety disorders and personality disorders lasting for few months (most often three months) is provided for approximately 8000 patients a year (IPIN, 2009).
The effectiveness of day care is investigated to a very small degree, compared to its frequent usage (cf. Marshall et al 2001). However, difficulties in identifying the basic effective components of the treatment and a large diversity of treatment programs make it difficult to generalize the results.
Among a scarce number of published studies, only four were randomized controlled trials (RCT). Three of these studies compared psychotherapy in day care units to outpatient psychotherapy (Tyler et al., 1987; Dick et al., 1991; Arnevik et al., 2009) and one study used a waiting list control group (Piper, Rosie, Azim, \& Joyce, 1993). Tyler et al. (1987) found no significant differences between day care and outpatient care for anxiety disorders. Dick et al. (1991) found a significant difference in the improvement of personality disorder pathology, in favor of day care. In the first study psychotherapy modality was not mentioned, in the second an eclectic psychotherapy was applied. In another study Arnevik et al. (2009), day care (18 week group psychodynamic and cognitive-behavioral psychotherapy) was compared to individual psychotherapy in patients with personality disorders and no significant differences in improvement were observed between the two groups. Piper et al. (1993) found that day care patients suffering from affective disorders and personality disorders experienced a significant improvement that continued in follow-up after 8 months (18 week group psychodynamic psychotherapy), compared to patients in a waiting list control group. Authors of a Cochrane review of day care versus outpatient care notice that because of a small number of existing studies: "there is only limited evidence to justify the provision of day treatment programs and transitional day hospital care, and no evidence to support the provision of day care centers" (Marshall et al. 2001). Existing data is therefore not sufficient to justify the use of group psychotherapy in day care, and more high quality research is needed. The question of which treatment of the two most widely used, psychodynamic or CBT, is more effective also awaits an answer. These questions are relevant in light of the large expenditures incurred by the national health funds financing the treatment. They are also important for the health care in Poland, where this type of treatment is very common.
Objectives
The main objective of the planned research is to evaluate the clinical effectiveness of intensive, short-term, psychodynamic and cognitive-behavioral group psychotherapy for an anxiety disorders with comorbid depressive or personality disorders in day care conditions.
More specific objectives are: 1) Demonstrating effectiveness of each treatment in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and long-term effectiveness of the two active treatments; 3) Preliminary examination of predictors and moderators of treatment response; and 4) Preliminary examination of mediators of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the outcome of used measures.
Study design
This study is a randomized controlled trial (RCT) in which participants will be allocated to one of the three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) or a waiting-list control group (WL). Participants allocated to the waiting list condition start their treatment after 12-week waiting period. The total duration of the study will be three years. Figure 1 shows the trial design. The study protocol, information brochure and informed consent were approved by the Medical Ethics Committee of the Warsaw Medical University.
Study center
The protocol and the design is part of the research grant given to the II Department of Psychiatry Medical University of Warsaw. The study will be carried out at the day unit Wola Center of Mental Health at Hospital of Wola in Warsaw that is used as clinical setting of the II Department of Psychiatry Medical University of Warsaw.
Participants (recruitment, inclusion and exclusion criteria, randomization)
Participants with anxiety disorders and comorbid personality disorders will be recruited in outpatient clinic. Subjects who meet all the inclusion criteria will be randomized to two modalities of treatments and the waiting list. Inclusion and exclusion criteria are listed in Table 1. The number of excluded patients and reasons for exclusion will be recorded. The diagnostic criteria are based on the DSM-V system. Independent researchers not involved in the treatment will make diagnosis of personality with with the Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II; First, Gibbon, Spitzer, Williams, Benjamin, 1997, 2010) and of clinical disorders with International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Masiak \& Przychoda, 1998). Diagnosis and qualification to treatment modality is carried out during ambulatory sessions. Up to 6 individual sessions will be required for the recruitment procedure including 3 sessions with a certified clinical psychologist, 2 sessions with a psychiatrist, and one for outcome measures. Pharmacological consultation take place before randomization. Waiting time before admission is planned to be between 4 and 8 weeks. Participants will be randomized using random numbers tables. Baseline measurement will occur a day before the beginning of therapy. A recruitment flow chart is presented in Figure 1. Patients are planned to be enrolled in the study over a period of three years. Before participating in the study, each patient will be provided with written information about the study and invited to give written consent for inclusion. Participants who will not meet the inclusion criteria will be offered suitable alternative treatment options. The focus of the treatment is on psychotherapy, but a medication is continued or initiated if necessary during the screening procedure at least 4 weeks before the beginning of a group psychotherapy (stable medical treatments with SSRI or SNRI without dose changes during psychotherapy). Due to high comorbidity of anxiety and depressive disorders, depressive disorders patients with mild depression disorders were not excluded, however patients with main depressive pathology were not included.
Assessments
Patients are subjected to 4 assessments: 1) at screening; 2) baseline after randomization; 3) in the end of the 12 weeks treatment; 4) six months after the end of the therapy, in order to evaluate longer-term effects of the treatments. Information from the screening is used to perform stratified randomization and to validate inclusion and exclusion criteria. Patients are assessed by independent and trained clinicians, who are blind to treatment conditions and who will not be involved in the direct clinical care of any of them. Primary outcome measures and secondary outcome measures can be distinguished in this study. Primary outcome measures include self-report symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of anxiety disorder. Secondary outcome measures include personality, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, mindfulness and quality of life. The following socio-demographic data will be collected: sex, age, marital status, education, past treatments, symptom history, medication. We also examine patients' expectancy for change and treatment. Some of the variables (e.g. presence or absence of a personality disorder) will be treated in exploratory analyses as predictors and moderators of treatment response.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intensive Group Analytic Psychotherapy
Intensive Group Analytic Psychotherapy in a day clinic setting
Intensive Group Analytic Psychotherapy
The form of intensive group analytic therapy to be used in the trial has been manualized by the research team for the study. It is rooted in group analysis tradition (Bion 1961; Foulkes \& Anthony, 1965). It is based on two recent group analytic psychotherapy manuals, one developed by Lorentzen (2014), the other by Garland (2010). The manual has been adapted to day treatment setting and also draws on polish psychoanalytical group experiences practiced in a public service. Like in other psychodynamic short-term therapies this approach is more structured and focused on issues relevant to symptoms relief. Thereby additional techniques are used: psychodrama, non-verbal techniques, movie therapy, memoir, summary or relaxation.
Intensive GCBT
Intensive transdiagnostic cognitive-behavioral group therapy in a day clinic setting
Intensive transdiagnostic cognitive-behavioral group therapy
GCBT was designed for treatment in naturalistic settings of diagnostically mixed anxiety disorder patients with comorbid Personality Disorders (PD's) (Holas, Szaniawska, Suszek, Błażejewski, \& Kokoszka, in prep.). It is based on the transdiagnostic approach to emotional and particularly anxiety disorders that has been developed over the past ten years (Barlow, 2000; Barlow, Allen, \& Choate, 2004; Norton, 2006), additionally it includes interventions for personality disorders based of schema therapy and modes of personality disorders. This approach assumes a high overlap between anxiety disorders and is focused on the common aspects of them. Intensive GCBT developed by our group shares the classical assumptions of cognitive-behavioral therapy (Beck, 1976).
Wait-list control group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intensive Group Analytic Psychotherapy
The form of intensive group analytic therapy to be used in the trial has been manualized by the research team for the study. It is rooted in group analysis tradition (Bion 1961; Foulkes \& Anthony, 1965). It is based on two recent group analytic psychotherapy manuals, one developed by Lorentzen (2014), the other by Garland (2010). The manual has been adapted to day treatment setting and also draws on polish psychoanalytical group experiences practiced in a public service. Like in other psychodynamic short-term therapies this approach is more structured and focused on issues relevant to symptoms relief. Thereby additional techniques are used: psychodrama, non-verbal techniques, movie therapy, memoir, summary or relaxation.
Intensive transdiagnostic cognitive-behavioral group therapy
GCBT was designed for treatment in naturalistic settings of diagnostically mixed anxiety disorder patients with comorbid Personality Disorders (PD's) (Holas, Szaniawska, Suszek, Błażejewski, \& Kokoszka, in prep.). It is based on the transdiagnostic approach to emotional and particularly anxiety disorders that has been developed over the past ten years (Barlow, 2000; Barlow, Allen, \& Choate, 2004; Norton, 2006), additionally it includes interventions for personality disorders based of schema therapy and modes of personality disorders. This approach assumes a high overlap between anxiety disorders and is focused on the common aspects of them. Intensive GCBT developed by our group shares the classical assumptions of cognitive-behavioral therapy (Beck, 1976).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of comorbid personality disorder (based on SCID II) or depressive disorder (based on M.I.N.I.)
* Age: 18 to 65 years
* Sufficient knowledge of the Polish language
* Written informed consent of the patient
Exclusion Criteria
* Acute substance related disorders
* Schizophrenia, bipolar affective disorder
* Severe depression \[over 26 points in Beck Questionnaire\] or bipolar disorder.
* Dissocial personality disorder, schizotypal personality disorder
* Current suicidal ideation with a high risk of suicide
* Restriction of intellectual capacity
* Serious unstable medical problems/complications
* Concurrent psychotherapeutic treatment
* Failed treatment of CBT or psychodynamic psychotherapy for anxiety
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wola Hospital
UNKNOWN
University of Warsaw
OTHER
Medical University of Warsaw
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrzej Kokoszka
Professor, MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrzej Kokoszka, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital of Wola
Warsaw, Warsaw, Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Suszek H, Holas P, Wyrzykowski T, Lorentzen S, Kokoszka A. Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial. Trials. 2015 Jul 29;16:319. doi: 10.1186/s13063-015-0827-6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NN402464340
Identifier Type: -
Identifier Source: org_study_id