NCT02112708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
10.5 years until next milestone

Results Posted

Study results publicly available

September 24, 2024

Completed
Last Updated

September 24, 2024

Status Verified

March 1, 2014

Enrollment Period

3.5 years

First QC Date

April 9, 2014

Results QC Date

January 26, 2022

Last Update Submit

September 18, 2024

Conditions

Keywords

Psychotherapy, Rational-EmotiveDepressionSocial WorkPrimary Health Care

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline, month 4, month 12.

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

    Baseline, month 4, month 12.

Other Outcomes (2)

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

    Baseline, 1 year

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

    Baseline, months 12

Study Arms (2)

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.

Other: Rational-Emotive-Behavioral Therapy

Control Group

ACTIVE COMPARATOR

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

Other: Control Group usual care

Interventions

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.

Also known as: Cognitive-Emotive-Behavioral Therapy, REBT, CBT, REBT-CBT
Rational-Emotive-Behavioral Therapy

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

Also known as: conventional treatment, usual care
Control Group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis fo dysthymia
  • Aged 14 or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catalan Health Institute. ABS Sant Andreu 9D

Barcelona, 08030, Spain

Location

MeSH Terms

Conditions

DepressionDysthymic Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Principal Investigator: Carme Rovira Aler
Organization
Institut CatalĂ  de la Salut

Study Officials

  • Carme Rovira Aler, LCSW

    Catalan Institute of Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 14, 2014

Study Start

October 1, 2009

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

September 24, 2024

Results First Posted

September 24, 2024

Record last verified: 2014-03

Locations