Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 49 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND usual | ( Map: Spain )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112708
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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.
  • 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.


Condition or disease Intervention/treatment Phase
Depression Dysthymia Ambulatory Health Services Other: Rational-Emotive-Behavioral Therapy Other: Control Group usual care Not Applicable

Detailed Description:

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 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 SPSS 18 software was used.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rational-Emotive-Behavioral Therapy
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.
Other: Rational-Emotive-Behavioral Therapy
A social worker held eight 30 minutes sessions fortnightly. 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.
Other Names:
  • Cognitive-Emotive-Behavioral Therapy
  • REBT
  • CBT
  • REBT-CBT

Active Comparator: Control Group
The control group (GC) will take the usual medical care for dysthimia, according with up-dated guidelines.
Other: Control Group usual care
In the control group the depression is treated as usual with the conventional treatment.
Other Names:
  • conventional treatment
  • usual care




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Other Outcome Measures:
  1. Change from baseline in number of attendance at medical visits in previous year, at 12 months [ Time Frame: Baseline, 1 year ]
    Number of attendance at medical visits were obtained from computerized medical records for a period of one year previous to the baseline date and 1 year of follow up date.

  2. A reduction from the baseline of type of treatment with psychotropic drugs (sedatives and antidepressants), at [ Time Frame: Baseline, month 4, month 12 ]
    Number of types and doses of treatment with psychotropic drugs were obtained from computerized medical records for a period of one year previous to the baseline date, at month 4 and 1 year of follow up date.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis fo dysthymia
  • 14 years older

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112708


Locations
Layout table for location information
Spain
Catalan Health Institute. ABS Sant Andreu 9D
Barcelona, Spain, 08030
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Layout table for investigator information
Principal Investigator: Carme Rovira Aler, LCSW Catalan Institute of Health

Layout table for additonal information
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02112708     History of Changes
Other Study ID Numbers: P13/035
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: March 2014
Keywords provided by Jordi Gol i Gurina Foundation:
Psychotherapy, Rational-Emotive
Depression
Social Work
Primary Health Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Dysthymic Disorder
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders