Anxiety-depressive Patients Mild to ModeratePhase 3PSICCAPADNCT01907035
Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment
A Phase 3 study testing A cognitive-behavioral intervention in people with Anxiety-depressive Patients Mild to Moderate, run by Basque Health Service at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anxiety-depressive Patients Mild to Moderate
- What is being tested?
- A cognitive-behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 3 sitesSpain
- Study dates
- Aug 2012to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Patients referred to Specialized Care
- Patients who are in private treatment
- Patients with high probability of loss to follow up.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Comarca Ezkerraldea
Barakaldo, Bizkaia
Amale Jauregui, 0034946006637, AMALE.JAUREGUILARRABEITI@osakidetza.net
Maria Cruz Gómez, 0034946006637, mariacruz.gomezfernandez@osakidetza.net
- Recruiting
Comarca Bilbao
Bilbao, Bizkaia
Amale Jauregui, 0034946006637, AMALE.JAUREGUILARRABEITI@osakidetza.net
Maria Cruz Gómez, 0034946006637, mariacruz.gomezfernandez@osakidetza.net
- Recruiting
Comarca Uribe
Leioa, Bizkaia
Amale Jauregui, 0034946006637, AMALE.JAUREGUILARRABEITI@osakidetza.net
Maria Cruz Gómez, 0034946006637, mariacruz.gomezfernandez@osakidetza.net
About this study
Official title: Improving Anxiety-depressive Disorder in Primary Care Applying a Cognitive-behavioral Treatment, Applied by Psychologists.
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.
- Being tested
- A cognitive-behavioral intervention, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A cognitive-behavioral interventionBehavioural
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)
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral intervention | Experimental | 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) Receives: Behavioral: A cognitive-behavioral intervention |
| Usual care | Active comparator | Family practice attention without the psychologist support Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Quality
Change in the scale SF-36
Measured: The change from basal point to 2, 6 and 12 months
Secondary outcomes (1)
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.
Measured: The change from baseline point to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startAug 2012
- Primary completionSep 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety-depressive Patients Mild to ModerateStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amale Jauregui Larrabeiti, Basque Health Service
- Investigators
- Amale Jauregui, Principal investigator, Health Basdque Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907035
- Sponsor's protocol ID
- PSICCAPAD 2012
- Other IDs
- 2011111064
- Acronym
- PSICCAPAD
- Status last verified
- Jul 2013
- First submitted
- 22 Jul 2013
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25879932
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Anxiety-depressive Disorder in Primary Care Applying a Cognitive-behavioral Treatment, Applied by Psychologists.
- ClinicalTrials.gov ID
- NCT01907035
- Acronym / sponsor ID
- PSICCAPAD / PSICCAPAD 2012
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral intervention | Experimental | Behavioral: A cognitive-behavioral interventionCognitive-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) |
| Usual care | Active comparator | Other: Usual careFamily practice attention without the psychologist support |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| A cognitive-behavioral interventionEvaluate 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) | Behavioural | Cognitive-behavioral intervention |
| Usual care | Other | Usual care |
Primary outcome
Life Quality
Time frame: The change from basal point to 2, 6 and 12 months
Change in the scale SF-36
1 secondary outcome
Use of pharmacotherapy and sanitary services
Time frame: The change from baseline point to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
- Derived from this study: PubMed 25879932Jauregui 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.
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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.
Amale Jauregui principal investigator
Health Basdque Service
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A cognitive-behavioral intervention in people with Anxiety-depressive Patients Mild to Moderate, run by Basque Health Service at 3 sites 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Cruz Gómez (0034946006637, mariacruz.gomezfernandez@osakidetza.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Quality (time frame: The change from basal point to 2, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01907035, which also lists 1 linked publication.
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 Jul 2013.