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Completed

NCT Number: NCT02112708

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

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catalan Health Institute. ABS Sant Andreu 9D

Barcelona, 08030, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis fo dysthymia
  • Aged 14 or older

Exclusion criteria

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

Treatment and study plan

Rational-Emotive-Behavioral Therapy

Other

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

Control Group usual care

Other

In the control group the dysthymia is treated as usual with the conventional treatment.

Other names: conventional treatment, usual care

Primary outcomes

  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 outcomes

  1. Change From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) 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 in each of 15 domains 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.

    The overall scale (summatory of 15 domains) runs from minimum as 0 to maximum as 98

Other outcomes

  1. Average Number of Visits of Attendance at Medical Visits in Previous Year and 1 Year of Follow up Date.

    Time frame: Baseline, 1 year

    Attendance means 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. Percentage of People in the Group Who Stop Taking or Reduce the Dose of Psychotropic Drugs at 12 Months

    Time frame: Baseline, months 12

    Percentage of people with any improvement in the dosage of psychotropic drugs (sedatives and antidepressants) in the group at 12 months compared to the baseline date of the study.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 14, 2014
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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