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临床试验/NCT02126787
NCT02126787Unknown不适用

Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment of Anxiety Disorders and Comorbid Depressive or Personality Disorders

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
123
试验地点
2
主要终点
State-Trait Anxiety Inventory

研究概览

简要总结

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.

详细描述

Anxiety disorders are among the most prevalent mental disorders, with lifetime prevalence of 30% in US (Kessler et al., 2005) and only 9,9% in Poland (Moskalewicz, Wciórka, Kiejna, Wojtyniak, 2012), the study of the similar methodology, like in the U.S. Many studies suggest their strong comorbidity with personality disorders in some countries. Recent meta-analysis of 125 studies conducted by Friborg, Martinussen, Kaiser, Overgård and Rosenvinge (2013) has shown that a risk of comorbid anxiety disorders and personality disorders varies from 35% to 52%. Alongside anxiety disorders, the most frequently co-occurring are cluster C personality disorders. Epidemiologic studies also show high comorbidity rates for anxiety and depressive disorders, ranging from 40%-80% (Jacobi et al., 2004; Lamers et al., 2011). The data on relationships between comorbid mental disorders and treatment outcome is inconsistent. Reviews by Reich and Green (1991) and Reich and Vasile (1993) including 38 studies have shown that comorbid anxiety disorders and personality disorders are negatively related to treatment outcome. However, Dressen and Arntz (1997) after analyzing 15 studies do not share these conclusions.

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

State-Trait Anxiety Inventory

时间窗: week 24 (follow-up)

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.

Hamilton Anxiety Rating Scale

时间窗: week 24 (follow-up)

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).

Clinical Global Impression - Severity scale

时间窗: week 24 (follow-up)

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.

Clinical Global Impression - Improvement scale

时间窗: week 24 (follow-up)

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.

Mini-International Neuropsychiatric Interview 5

时间窗: week 24 (follow-up)

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.

Becks Depression Inventory II

时间窗: week 24 (follow-up)

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.

次要结局

  • Structured Clinical Interview for DSM-IV Personality Disorders Questionnaire(week 0 (screening))
  • Symptoms Checklist(week 12 (end of treatment))
  • Self-Esteem Scale(week 24 (follow-up))
  • Dysfunctional Working Models Scale(week 24 (follow-up))
  • Defense Style Questionnaire(week 24 (follow-up))
  • Personality Beliefs Questionnaire(week 24 (follow-up))
  • Inventory of Interpersonal Problems(week 24 (follow-up))
  • Experiences in Close Relationships(week 24 (follow-up))
  • Bell Object Relations and Reality Testing Inventory(week 24 (follow-up))
  • Meta-cognitions Questionnaire(week 24 (follow-up))
  • Five Facet Mindfulness Questionnaire(week 24 (follow-up))
  • Satisfaction With Life Scale(week 24 (follow-up))
  • Credibility/Expectancy Questionnaire(week 0 (baseline))

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrzej Kokoszka

Professor, MD, PhD

Medical University of Warsaw

研究点 (2)

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