Trial Outcomes & Findings for Cognitive Behavioral Therapy (REBT/CBT) Evaluation for Dysthymia in the Practice of Clinical Social Work at Primary Care (NCT NCT02112708)
NCT ID: NCT02112708
Last Updated: 2024-09-24
Results Overview
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.
COMPLETED
NA
129 participants
Baseline, month 4, month 12.
2024-09-24
Participant Flow
Non randomized assignment: patients from Barcelona were assigned to Intervention Group and Patients from Martorell , assigned to Control Group.
Participant milestones
| Measure |
Intervention Group
The intervention group received REBT by the purposely trained Social Worker at Barcelona
|
Control Group
the control group received the standard medical care by their General Practitioner (GP) at Martorell
|
|---|---|---|
|
Baseline
STARTED
|
79
|
50
|
|
Baseline
COMPLETED
|
51
|
39
|
|
Baseline
NOT COMPLETED
|
28
|
11
|
|
4 Month
STARTED
|
51
|
39
|
|
4 Month
COMPLETED
|
39
|
38
|
|
4 Month
NOT COMPLETED
|
12
|
1
|
|
12 Month
STARTED
|
39
|
38
|
|
12 Month
COMPLETED
|
39
|
38
|
|
12 Month
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Intervention Group
The intervention group received REBT by the purposely trained Social Worker at Barcelona
|
Control Group
the control group received the standard medical care by their General Practitioner (GP) at Martorell
|
|---|---|---|
|
Baseline
Physician Decision
|
16
|
11
|
|
Baseline
Lost to Follow-up
|
12
|
0
|
|
4 Month
Death
|
0
|
1
|
|
4 Month
Withdrawal by Subject
|
12
|
0
|
Baseline Characteristics
Cognitive Behavioral Therapy (REBT/CBT) Evaluation for Dysthymia in the Practice of Clinical Social Work at Primary Care
Baseline characteristics by cohort
| Measure |
Intervention Group
n=51 Participants
The intervention group received REBT by the purposely trained Social Worker at Barcelona
|
Control Group
n=39 Participants
the control group received the standard medical care by their General Practitioner (GP) at Martorell
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, continuous (years)
|
60.8 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
65.5 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
62.86 years
STANDARD_DEVIATION 12.44 • n=27 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Educational level
Primary schooling
|
27 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Educational level
Secondary schooling and University
|
24 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Living arrangements
Lives on his/her own
|
14 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Living arrangements
Lives with other people
|
37 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
psychopharmacological agents
No treatment
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
psychopharmacological agents
treatment
|
45 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Sedative-hypnotics agents
no
|
44 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Sedative-hypnotics agents
yes
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Antidepressants agents
no
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Antidepressants agents
yes
|
43 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Anxiolytic agents
no
|
28 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Anxiolytic agents
yes
|
23 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Number of visits
|
4 visits
STANDARD_DEVIATION 2.9 • n=93 Participants
|
2.2 visits
STANDARD_DEVIATION 2.7 • n=4 Participants
|
3.2 visits
STANDARD_DEVIATION 2.95 • n=27 Participants
|
|
Number of psycopharmacological agents
|
1.4 agents
STANDARD_DEVIATION 0.8 • n=93 Participants
|
1.7 agents
STANDARD_DEVIATION 0.9 • n=4 Participants
|
1.53 agents
STANDARD_DEVIATION .82 • n=27 Participants
|
|
Beck depression inventory score at baseline
|
24.5 scores on a scale
STANDARD_DEVIATION 9.9 • n=93 Participants
|
22.2 scores on a scale
STANDARD_DEVIATION 11.7 • n=4 Participants
|
23.50 scores on a scale
STANDARD_DEVIATION 10.70 • n=27 Participants
|
|
Number of comorbidities
|
2.9 comorbidities
STANDARD_DEVIATION 1.2 • n=93 Participants
|
4.3 comorbidities
STANDARD_DEVIATION 2.1 • n=4 Participants
|
3.47 comorbidities
STANDARD_DEVIATION 1.78 • n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
The intervention group received REBT by the purposely trained Social Worker at Barcelona
|
Control Group
n=38 Participants
the control group received the standard medical care by their General Practitioner (GP) at Martorell
|
|---|---|---|
|
Change From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.
12 months analysis
|
16.18 score on a scale
Standard Deviation 11.50
|
19.90 score on a scale
Standard Deviation 14.43
|
|
Change From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.
4 months analysis
|
16.29 score on a scale
Standard Deviation 10.50
|
20.90 score on a scale
Standard Deviation 13.70
|
|
Change From Baseline in Severity of Depression, Measured According to the Beck Depression Inventory, at 4 and 12 Months.
Baseline analysis
|
24.5 score on a scale
Standard Deviation 9.9
|
22.2 score on a scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention Group
n=51 Participants
The intervention group received REBT by the purposely trained Social Worker at Barcelona
|
Control Group
n=38 Participants
the control group received the standard medical care by their General Practitioner (GP) at Martorell
|
|---|---|---|
|
Change From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 Months
12 months analysis
|
5.02 score on a scale
Standard Deviation 1.48
|
4.59 score on a scale
Standard Deviation 1.39
|
|
Change From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 Months
4 months analysis
|
5.00 score on a scale
Standard Deviation 1.01
|
4.60 score on a scale
Standard Deviation 1.50
|
|
Change From Baseline in Perceived Quality of Life, Measured as Values of Satisfaction With Life Domains Scale (SLDS) at 4 and 12 Months
Baseline analysis
|
4.43 score on a scale
Standard Deviation 1.01
|
4.60 score on a scale
Standard Deviation 1.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
The intervention group received REBT by the purposely trained Social Worker at Barcelona
|
Control Group
n=38 Participants
the control group received the standard medical care by their General Practitioner (GP) at Martorell
|
|---|---|---|
|
Average Number of Visits of Attendance at Medical Visits in Previous Year and 1 Year of Follow up Date.
Baseline
|
4.0 medical visits attended
Standard Deviation 2.9
|
2.2 medical visits attended
Standard Deviation 2.7
|
|
Average Number of Visits of Attendance at Medical Visits in Previous Year and 1 Year of Follow up Date.
1 year of follow up date
|
1.4 medical visits attended
Standard Deviation 1.7
|
1.7 medical visits attended
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
The intervention group received REBT by the purposely trained Social Worker at Barcelona
|
Control Group
n=38 Participants
the control group received the standard medical care by their General Practitioner (GP) at Martorell
|
|---|---|---|
|
Percentage of People in the Group Who Stop Taking or Reduce the Dose of Psychotropic Drugs at 12 Months
|
47.8 Percentatge of people with any improveme
Interval 34.8 to 61.2
|
11.4 Percentatge of people with any improveme
Interval 4.7 to 25.2
|
Adverse Events
Rational-Emotive-Behavioral Therapy
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator: Carme Rovira Aler
Institut Català de la Salut
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place