DepressionNCT02112708
Cognitive Behavioral Therapy (REBT/CBT) Evaluation for Dysthymia in the Practice of Clinical Social Work at Primary Care
A study testing Rational-Emotive-Behavioral Therapy in people with Depression and Dysthymia, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Depression, Dysthymia, Ambulatory Health Services
- What is being tested?
- Rational-Emotive-Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis fo dysthymia
- Aged 14 or older
Who cannot join
- Impaired cognitive ability
- Illiteracy
- Refuses treatment
- Severe psychiatric disorders
- Participation in psychoeducational groups or other similar therapies.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Depression, Dysthymia, Ambulatory Health Services
- Being tested
- Rational-Emotive-Behavioral Therapy, Control Group usual care
- Keywords
- Psychotherapy, Rational-Emotive, Depression, Social Work, Primary Health Care
- Medical subject headings
- Depression, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rational-Emotive-Behavioral TherapyOther
Also called Cognitive-Emotive-Behavioral Therapy, REBT, CBT, REBT-CBT
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.
Control Group usual careOther
Also called conventional treatment, usual care
In the control group the dysthymia is treated as usual with the conventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Baseline, month 4, month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startOct 2009
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carme Rovira Aler, LCSW, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112708
- Sponsor's protocol ID
- P13/035
- Status last verified
- Mar 2014
- First submitted
- 9 Apr 2014
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02112708
- Acronym / sponsor ID
- P13/035
- Conditions
- Depression, Dysthymia, Ambulatory Health Services
- Keywords
- Psychotherapy, Rational-Emotive, Depression, Social Work, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rational-Emotive-Behavioral Therapy | Experimental | Other: Rational-Emotive-Behavioral TherapyA 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. |
| Control Group | Active comparator | Other: Control Group usual careThe control group (GC) will take the usual medical care for dysthymia, according with up-dated guidelines. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis fo dysthymia
- Aged 14 or older
Key exclusion criteria (5 listed)
- Impaired cognitive ability
- Illiteracy
- Refuses treatment
- Severe psychiatric disorders
- Participation in psychoeducational groups or other similar therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rational-Emotive-Behavioral TherapyAlso: Cognitive-Emotive-Behavioral Therapy, REBT, CBT, REBT-CBTA 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 | Rational-Emotive-Behavioral Therapy |
| Control Group usual careAlso: conventional treatment, usual careIn the control group the dysthymia is treated as usual with the conventional treatment. | Other | Control Group |
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carme Rovira Aler, LCSW principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rational-Emotive-Behavioral Therapy in people with Depression and Dysthymia, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.