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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02112708
Enrollment
129
Registered
2014-04-14
Start date
2009-10-31
Completion date
2013-06-30
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Health Services, Depression, Dysthymia

Keywords

Psychotherapy, Rational-Emotive, Depression, Social Work, Primary Health 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. * 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.

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 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.

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.

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

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

MeasureTime frameDescription
Change From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 MonthsBaseline, 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

MeasureTime frameDescription
Average Number of Visits of Attendance at Medical Visits in Previous Year and 1 Year of Follow up Date.Baseline, 1 yearAttendance 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.
Percentage of People in the Group Who Stop Taking or Reduce the Dose of Psychotropic Drugs at 12 MonthsBaseline, months 12Percentage 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.

Countries

Spain

Participant flow

Recruitment details

Non randomized assignment: patients from Barcelona were assigned to Intervention Group and Patients from Martorell , assigned to Control Group.

Participants by arm

ArmCount
Intervention Group
The intervention group received REBT by the purposely trained Social Worker at Barcelona
51
Control Group
the control group received the standard medical care by their General Practitioner (GP) at Martorell
39
Total90

Withdrawals & dropouts

PeriodReasonFG000FG001
4 MonthDeath01
4 MonthWithdrawal by Subject120
BaselineLost to Follow-up120
BaselinePhysician Decision1611

Baseline characteristics

CharacteristicIntervention GroupControl GroupTotal
Age, Customized
Age, continuous (years)
60.8 years
STANDARD_DEVIATION 11.5
65.5 years
STANDARD_DEVIATION 13.2
62.86 years
STANDARD_DEVIATION 12.44
Antidepressants agents
no
8 Participants7 Participants15 Participants
Antidepressants agents
yes
43 Participants32 Participants75 Participants
Anxiolytic agents
no
28 Participants17 Participants45 Participants
Anxiolytic agents
yes
23 Participants22 Participants45 Participants
Beck depression inventory score at baseline24.5 scores on a scale
STANDARD_DEVIATION 9.9
22.2 scores on a scale
STANDARD_DEVIATION 11.7
23.50 scores on a scale
STANDARD_DEVIATION 10.7
Educational level
Primary schooling
27 Participants32 Participants59 Participants
Educational level
Secondary schooling and University
24 Participants7 Participants31 Participants
Living arrangements
Lives on his/her own
14 Participants5 Participants19 Participants
Living arrangements
Lives with other people
37 Participants32 Participants69 Participants
Number of comorbidities2.9 comorbidities
STANDARD_DEVIATION 1.2
4.3 comorbidities
STANDARD_DEVIATION 2.1
3.47 comorbidities
STANDARD_DEVIATION 1.78
Number of psycopharmacological agents1.4 agents
STANDARD_DEVIATION 0.8
1.7 agents
STANDARD_DEVIATION 0.9
1.53 agents
STANDARD_DEVIATION 0.82
Number of visits4 visits
STANDARD_DEVIATION 2.9
2.2 visits
STANDARD_DEVIATION 2.7
3.2 visits
STANDARD_DEVIATION 2.95
psychopharmacological agents
No treatment
6 Participants4 Participants10 Participants
psychopharmacological agents
treatment
45 Participants35 Participants80 Participants
Sedative-hypnotics agents
no
44 Participants28 Participants72 Participants
Sedative-hypnotics agents
yes
7 Participants11 Participants18 Participants
Sex: Female, Male
Female
49 Participants34 Participants83 Participants
Sex: Female, Male
Male
2 Participants5 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 511 / 39
other
Total, other adverse events
0 / 510 / 39
serious
Total, serious adverse events
0 / 510 / 39

Outcome results

Primary

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.

Time frame: Baseline, month 4, month 12.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.12 months analysis16.18 score on a scaleStandard Deviation 11.5
Intervention GroupChange From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.4 months analysis16.29 score on a scaleStandard Deviation 10.5
Intervention GroupChange From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.Baseline analysis24.5 score on a scaleStandard Deviation 9.9
Control GroupChange From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.12 months analysis19.90 score on a scaleStandard Deviation 14.43
Control GroupChange From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.4 months analysis20.90 score on a scaleStandard Deviation 13.7
Control GroupChange From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.Baseline analysis22.2 score on a scaleStandard Deviation 11.7
Secondary

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

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

Time frame: Baseline, month 4, month 12.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupChange From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 Months12 months analysis5.02 score on a scaleStandard Deviation 1.48
Intervention GroupChange From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 Months4 months analysis5.00 score on a scaleStandard Deviation 1.01
Intervention GroupChange From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 MonthsBaseline analysis4.43 score on a scaleStandard Deviation 1.01
Control GroupChange From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 Months12 months analysis4.59 score on a scaleStandard Deviation 1.39
Control GroupChange From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 Months4 months analysis4.60 score on a scaleStandard Deviation 1.5
Control GroupChange From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 MonthsBaseline analysis4.60 score on a scaleStandard Deviation 1.24
Other Pre-specified

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

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.

Time frame: Baseline, 1 year

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupAverage Number of Visits of Attendance at Medical Visits in Previous Year and 1 Year of Follow up Date.Baseline4.0 medical visits attendedStandard Deviation 2.9
Intervention GroupAverage Number of Visits of Attendance at Medical Visits in Previous Year and 1 Year of Follow up Date.1 year of follow up date1.4 medical visits attendedStandard Deviation 1.7
Control GroupAverage Number of Visits of Attendance at Medical Visits in Previous Year and 1 Year of Follow up Date.Baseline2.2 medical visits attendedStandard Deviation 2.7
Control GroupAverage Number of Visits of Attendance at Medical Visits in Previous Year and 1 Year of Follow up Date.1 year of follow up date1.7 medical visits attendedStandard Deviation 2.3
Other Pre-specified

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

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.

Time frame: Baseline, months 12

ArmMeasureValue (NUMBER)
Intervention GroupPercentage of People in the Group Who Stop Taking or Reduce the Dose of Psychotropic Drugs at 12 Months47.8 Percentatge of people with any improveme
Control GroupPercentage of People in the Group Who Stop Taking or Reduce the Dose of Psychotropic Drugs at 12 Months11.4 Percentatge of people with any improveme

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026