Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment (PSICCAPAD)
Primary Purpose
Anxiety-depressive Patients Mild to Moderate
Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
A cognitive-behavioral intervention
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety-depressive Patients Mild to Moderate
Eligibility Criteria
Inclusion Criteria:
- Primary care patients.
- Adults.
- Of both sexes.
- With disorder mixed anxiety-depressive mild-moderate active diagnosed by their general practitioner and showing more than 4 points in Goldberg-Anxiety, and more than 3 in Goldberg Depression.
Exclusion Criteria:
- Patients under 18 or over 75 years
- Patients with inability to understand, read or speak Spanish
- Patients with cognitive impairment
- Patients with severe disease which in the opinion of your doctor have a presumably fatal end during the 12 month follow-up
- Patients with psychotic disorders or other serious mental disease
- Patients with attempted suicide or suicidal ideation persistent
- Patients referred to Specialized Care
- Patients who are in private treatment
- Patients with high probability of loss to follow up.
Sites / Locations
- Comarca EzkerraldeaRecruiting
- Comarca BilbaoRecruiting
- Comarca UribeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive-behavioral intervention
Usual care
Arm Description
Cognitive-behavioral intervention: Evaluate the effectiveness of a cognitive-behavioral intervention by psychologists in collaboration with practitioner plus routine therapy in the field of primary care in anxiety-depressive patients mild to moderate, with respect to standardized usual care by physicians, improve quality of life of these people, producing at least ten-point increase in the level of overall quality of life (SF-36)
Family practice attention without the psychologist support
Outcomes
Primary Outcome Measures
Life Quality
Change in the scale SF-36
Secondary Outcome Measures
Use of pharmacotherapy and sanitary services
Change from basal point to one year in the use of pharmacotherapy and the use of sanitary services in primary care.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01907035
Brief Title
Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment
Acronym
PSICCAPAD
Official Title
Improving Anxiety-depressive Disorder in Primary Care Applying a Cognitive-behavioral Treatment, Applied by Psychologists.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
OBJECTIVE: Evaluate the effectiveness of quality of life score, a cognitive-behavioral intervention by psychologists in the field of primary care in anxiety-depressive patients, mild to moderate, compared with usual care.
DESIGN: Clinical trial, multicenter, prospective, and randomized into two parallel groups. SCOPE AND SUBJECTS: We included a random sample of 246 patients anxious-depressive, mild / moderate, belonging to the target population of 41 doctors from several health centers. INTERVENTION: In the 246 patients randomly assigned to the intervention group, with a standardized program of cognitive behavioral therapy applied by psychologists, by the usual treatment or control group, which will be standard care. MEASUREMENTS: The main result will be changes in general health scores of the SF-36. It will also measure the change in frequency and intensity of anxiety-depressive symptoms on the scales HARS, HDRS, STAI and BDI at baseline and at 2, 6 and 12 months. In addition, also collected for drug use and health services.
ANALYSIS: Analyses were performed by intention to treat, comparing the change obtained in both groups at the end of the 12 month follow up. Estimates of the effect attributable to the intervention by the difference in those changes, adjusting in addition to the baseline, the possible confounding covariates or effect modifiers of the intervention, using longitudinal mixed-effects models.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety-depressive Patients Mild to Moderate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral intervention
Arm Type
Experimental
Arm Description
Cognitive-behavioral intervention: Evaluate the effectiveness of a cognitive-behavioral intervention by psychologists in collaboration with practitioner plus routine therapy in the field of primary care in anxiety-depressive patients mild to moderate, with respect to standardized usual care by physicians, improve quality of life of these people, producing at least ten-point increase in the level of overall quality of life (SF-36)
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Family practice attention without the psychologist support
Intervention Type
Behavioral
Intervention Name(s)
A cognitive-behavioral intervention
Intervention Description
Evaluate the effectiveness of a cognitive-behavioral intervention by psychologists in collaboration with MF plus routine therapy in the field of APS in anxiety-depressive patients mild to moderate, with respect to standardized usual care by physicians, improve quality of life of these people, producing at least ten-point increase in the level of overall quality of life (SF-36)
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
Life Quality
Description
Change in the scale SF-36
Time Frame
The change from basal point to 2, 6 and 12 months
Secondary Outcome Measure Information:
Title
Use of pharmacotherapy and sanitary services
Description
Change from basal point to one year in the use of pharmacotherapy and the use of sanitary services in primary care.
Time Frame
The change from baseline point to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary care patients.
Adults.
Of both sexes.
With disorder mixed anxiety-depressive mild-moderate active diagnosed by their general practitioner and showing more than 4 points in Goldberg-Anxiety, and more than 3 in Goldberg Depression.
Exclusion Criteria:
Patients under 18 or over 75 years
Patients with inability to understand, read or speak Spanish
Patients with cognitive impairment
Patients with severe disease which in the opinion of your doctor have a presumably fatal end during the 12 month follow-up
Patients with psychotic disorders or other serious mental disease
Patients with attempted suicide or suicidal ideation persistent
Patients referred to Specialized Care
Patients who are in private treatment
Patients with high probability of loss to follow up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Cruz Gómez
Phone
0034946006637
Email
mariacruz.gomezfernandez@osakidetza.net
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Burgos, Dr
Phone
0034946006637
Email
natalia.burgosalonso@osakidetza.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amale Jauregui
Organizational Affiliation
Health Basdque Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comarca Ezkerraldea
City
Barakaldo
State/Province
Bizkaia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amale Jauregui
Phone
0034946006637
Email
AMALE.JAUREGUILARRABEITI@osakidetza.net
First Name & Middle Initial & Last Name & Degree
Maria Cruz Gómez
Phone
0034946006637
Email
mariacruz.gomezfernandez@osakidetza.net
Facility Name
Comarca Bilbao
City
Bilbao
State/Province
Bizkaia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amale Jauregui
Phone
0034946006637
Email
AMALE.JAUREGUILARRABEITI@osakidetza.net
First Name & Middle Initial & Last Name & Degree
Maria Cruz Gómez
Phone
0034946006637
Email
mariacruz.gomezfernandez@osakidetza.net
Facility Name
Comarca Uribe
City
Leioa
State/Province
Bizkaia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amale Jauregui
Phone
0034946006637
Email
AMALE.JAUREGUILARRABEITI@osakidetza.net
First Name & Middle Initial & Last Name & Degree
Maria Cruz Gómez
Phone
0034946006637
Email
mariacruz.gomezfernandez@osakidetza.net
12. IPD Sharing Statement
Citations:
PubMed Identifier
25879932
Citation
Jauregui A, Ponte J, Salgueiro M, Unanue S, Donaire C, Gomez MC, Burgos-Alonso N, Grandes G; Representing the PSICCAPAD Group. Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol. BMC Fam Pract. 2015 Mar 20;16:39. doi: 10.1186/s12875-015-0248-3.
Results Reference
derived
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Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment
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