跳至主要内容
临床试验/NCT02112708
NCT02112708已完成不适用

Evaluation of the Effectiveness of Rational Emotive Behavioral Therapy (REBT/CBT) as an Intervention Tool in Clinical Social Work Consultation to Primary Care.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2009年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
129
试验地点
1
主要终点
Change From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.

研究概览

简要总结

Introduction: Minor psychiatric disorders are important in primary care, because of its high prevalence and consumption of healthcare resources generated.

Objective: Evaluate the effectiveness of rational emotive behavioral therapy (REBT), as an instrument of social work intervention to enhance changes in the parameters of quality of life, medical consultations and drug use in patients with dysthymia.

Design: Multicenter, prospective, not randomized clinical trial, with intervention and control group simultaneously in urban primary care settings and 1 year of follow up.

Participants: Out-patients seen in two Primary Care centers diagnosed with dysthymia according to DSM-IV classification of American Psychiatric Association.

Intervention: Subjects receive up to 8 biweekly individual sessions of thirty minutes of REBT administered by the Social Worker.

Variables: Demographic data, educational level, coexistence, comorbidity, quality of life assessment, severity of depression, number of visits to the General Practitioner (GP) and drug consumption: sedatives / antidepressants.

Expected Results: The expected results of the intervention, estimated from previous data, are:

  • A decrease in attendance at medical visits per year
  • An improvement in perceived quality of life, measured as values of the Quality of Life (QOL) questionnaire (Baker & Intagliata)
  • An improvement in severity of depression, measured according to the Beck Depression Inventory.
  • A reduction of treatment with psychotropic drugs (sedatives and antidepressants).

Potential impact expected: The investigators hope that rational emotive theory is an effective intervention method for handling minor psychiatric disorders in clinical social work.

详细描述

The calculation of the size of the population sample was performed for the worst case comparison of different outcome variables, so for a final ratio of 8% people taking hypnotics in Intervention Group (IG) versus 37% in the Control Group (CG), with significance level of 5% and a statistical power of 80%, previewing a 20% loss to follow-up and a ratio of 1 control per case, we need 50 individuals in the CG and 50 individuals in the IG.

Regarding to the attendance to primary care centers, was categorized as "improved" and "not improved or remains the same." "Improvement" is when the number of visits decrease over the previous year, comparing baseline data with respect 12 months. Also, improvement in the use of psychotropic medication is when intakes fall in the previous year by comparing baseline data with respect 12 months. When no data were available at 12 months, the comparison was made with data collected at 4 months.

Patients in IG were recruited from primary care center Sant Andreu, while the CG were enrolled in the primary care center in Martorell. The selection of the two groups in separate centers was determined to avoid the possible effects of contamination bias of the CBT-REBT. In the IG, each physician systematically derived patients with inclusion criteria to the social worker. In the CG, the physician made ordinary care task. In both groups, the number of visits to primary care centers and consumption of psychotropic drugs were extracted from the medical record and other information was obtained through interviews at baseline, 4 and 12 months.

All patients signed informed consent at baseline. In order to recruit homogeneous cases, clearly diagnosed and ensure comparability training for all recruiters was conducted. Collection forms and the database did not include confidential information to ensure confidentiality and anonymity, keeping a separately single list with relation to the number of each case.

Access data base was used to systematize the registration data collection and handling errors by different professionals. Previous comparison of baseline data between completers and dropouts, as well as between the IG and CG was performed by Chi-square and mean comparison. A descriptive analysis of baseline variables as frequencies, means, and dispersion measures was carried out. For the analysis of post-intervention improvement in outcome parameters in one group compared with another, only data from the baseline and 12 months were taken into account. Bivariate and multivariate analysis was performed using logistic regression to control for confounding factors. Values less than 0.05 were considered significant. The Statistical Package for the Social Sciences (SPSS) v.18 software was used.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis fo dysthymia
  • •Aged 14 or older

排除标准

  • •Impaired cognitive ability
  • •Illiteracy
  • •Refuses treatment
  • •Severe psychiatric disorders
  • •Participation in psychoeducational groups or other similar therapies.

研究组 & 干预措施

Rational-Emotive-Behavioral Therapy

Experimental

A social worker held eight 30 minutes sessions fortnightly of Rational-Emotive-Behavioral Therapy. First session is informative about the type of treatment to be performed. The next sessions work events, thoughts and feelings with the goal of changing the dysfunctional thoughts by other more rational ones, measured by scales.

干预措施: Rational-Emotive-Behavioral Therapy (Other)

Control Group

Active Comparator

The control group (GC) will take the usual medical care for dysthymia, according with up-dated guidelines.

干预措施: Control Group usual care (Other)

结局指标

主要结局

Change From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.

时间窗: Baseline, month 4, month 12.

The Beck Depression Inventory (BDI) consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows: * 0-9: indicates minimal depression * 10-18: indicates mild depression * 19-29: indicates moderate depression * 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.

次要结局

  • Change From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 Months(Baseline, month 4, month 12.)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

招募中
不适用
Patients Suffering From Emotional DysregulationEmotional Dysregulation
NCT06616337University Hospital, Strasbourg, France100
已完成
不适用
Evaluating mental health decision units in acute care pathways (DECISION): a quasi-experimental and health economic evaluatioPsychiatric crisis / Mental health crisisMental and Behavioural Disorders
ISRCTN53431343St George's, University of London148
进行中(未招募)
不适用
Effectiveness of Enhanced Mental Health Support for Young PeopleDepressionEmotional StressAnxiety
NCT05356949Turku University Hospital124
已完成
不适用
Effect of mental health literacy education for adolescentsMental health literacy
JPRN-UMIN000044820The University of Tokyo Department of Physical and Health Education, Graduate School of Education2,671
进行中(未招募)
1 期
A pilot study to treat anxiety, depression and somatizations in Spanish Primary Care Services with psychological techniques in seven group sessions: Comparison of results using psychological treatment versus usual Primary Care treatment, with follow-up assessments after 3, 6 and 12 months.Emotional disorders specified as anxiety disorders (e.g., panic disorder, generalized anxiety disorder, social phobia, specific phobia), mood disorders (e.g., major depressive disorder, dysthymia), somatizations (e.g., somatization disorder, pain disorder)
EUCTR2013-001955-11-ESPsicofundación. Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicología1,126