Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment (PSICCAPAD)

Basque Health Service

Status and phase: Unknown; Phase 3

Conditions: Anxiety-depressive Patients Mild to Moderate

Treatments: Other: Usual care; Behavioral: A cognitive-behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01907035

PSICCAPAD 2012

2011111064 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 246 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Cognitive-behavioral intervention

Experimental group

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)

Treatment:

Behavioral: A cognitive-behavioral intervention

Usual care

Active Comparator group

Description:

Family practice attention without the psychologist support

Treatment:

Other: Usual care