UnknownPhase 3

Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment

Spain246 participantsStarted 2012-08

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Life Quality

Timeframe: The change from basal point to 2, 6 and 12 months

Trial details

NCT IDNCT01907035

SponsorBasque Health Service

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2013-09

Contact for this trial

María Cruz Gómez

0034946006637 mariacruz.gomezfernandez@osakidetza.net

View on ClinicalTrials.gov More Anxiety-depressive Patients Mild to Moderate trials