Clinical Trial: Cognitive Behavioral Therapy (REBT/CBT) Evaluation for Dysthymia in the Practice of Clinical Social Work at Primary Care

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.
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  Detailed Summary:

  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 IG versus 37% in the 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 con
  Sponsor: Jordi Gol i Gurina Foundation
  

  Current Primary Outcome: Change from baseline in severity of depression, measured according to the Beck Depression Inventory, at 4 and 12 months. [ Time Frame: 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.
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: Change from baseline in perceived quality of life, measured as values of Satisfaction with Life Domains Scale (SLDS) (Baker & Intagliata, 1982) at 4 and 12 months [ Time Frame: Baseline, month 4, month 12. ]

  The Satisfaction with Life Domains Scale (SLDS) is a measure of respondent satisfaction constructed to assess patient's satisfaction regarding 15 life domains.

  The respondent is asked to indicate his/her feelings by choosing one of seven faces ranging from a "delighted" face with a large upturned smile (scored 7) to a "terrible" face with a deep frown (scored 1).

  The patients are asked to pick the face that best represented their degree of satisfaction with the proposed life areas.

  The last of the life areas (The place they live in currently compared with the state hospital) has been discarded for our study, because the patients were treated by primary care.

  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Jordi Gol i Gurina Foundation
  

  Dates:
  Date Received: April 9, 2014
  Date Started: October 2009
  Date Completion:
  Last Updated: April 11, 2014
  Last Verified: March 2014