Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment
1 other identifier
interventional
123
1 country
1
Brief Summary
Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality disorders in Poland. There is not enough evidence for its effectiveness in this environment. This study addresses this gap. The aim is to determine the effectiveness of the two kinds of day treatments consisting of intensive, short-term group therapy: psychodynamic and cognitive-behavioral for patients with anxiety disorders and comorbid depressive or personality disorders. Our 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 30, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 30, 2014
April 1, 2014
1.6 years
April 9, 2014
April 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
week 0 (baseline)
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
week 0 (baseline)
Clinical Global Impression - Severity scale
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
week 0 (baseline)
Clinical Global Impression - Improvement scale
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
week 0 (baseline)
Mini-International Neuropsychiatric Interview 5
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
week 0 (screening)
Becks Depression Inventory II
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
week 0 (screening)
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
week 12 (end of treatment)
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
week 12 (end of treatment)
Clinical Global Impression - Severity scale
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
week 12 (end of treatment)
Clinical Global Impression - Improvement scale
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
week 12 (end of treatment)
Mini-International Neuropsychiatric Interview 5
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
week 12 (end of treatment)
Becks Depression Inventory II
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
week 12 (end of treatment)
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
week 24 (follow-up)
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
week 24 (follow-up)
Clinical Global Impression - Severity scale
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
week 24 (follow-up)
Clinical Global Impression - Improvement scale
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
week 24 (follow-up)
Mini-International Neuropsychiatric Interview 5
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
week 24 (follow-up)
Becks Depression Inventory II
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
week 24 (follow-up)
Secondary Outcomes (34)
Structured Clinical Interview for DSM-IV Personality Disorders Questionnaire
week 0 (screening)
Symptoms Checklist
week 0 (baseline)
Self-Esteem Scale
week 0 (baseline)
Defense Style Questionnaire
week 0 (baseline)
Personality Beliefs Questionnaire
week 0 (baseline)
- +29 more secondary outcomes
Study Arms (3)
Intensive Group Analytic Psychotherapy
EXPERIMENTALIntensive Group Analytic Psychotherapy in a day clinic setting
Intensive GCBT
EXPERIMENTALIntensive transdiagnostic cognitive-behavioral group therapy in a day clinic setting
Wait-list control group
NO INTERVENTIONInterventions
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.
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
You may qualify if:
- Current diagnosis of Axis I anxiety disorder (based on M.I.N.I.)
- 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
You may not qualify if:
- Organic disorder
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Warsawlead
- Wola Hospitalcollaborator
- University of Warsawcollaborator
Study Sites (1)
Hospital of Wola
Warsaw, Warsaw, 01-211, Poland
Related Publications (3)
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.
PMID: 32880104DERIVEDStorebo 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.
PMID: 32368793DERIVEDSuszek 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.
PMID: 26220089DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrzej Kokoszka, MD, PhD
Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 30, 2014
Study Start
September 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 30, 2014
Record last verified: 2014-04