Quality of LifeNCT01484223
Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care
A study testing Cognitive Behavioral Therapy in people with Quality of Life, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal intervention (BCI) in patients with somatization symptoms which has an effect on the perceived quality of life front conventional intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2009to Aug 2012
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending patients with 2 or more medically unexplained somatic symptoms during the last 6 months.
- Having came to medical examination on primary care at least 10 times during the last year.
- be able to follow the trial´s demands, not have plans for moving another place and understand the Spanish language.
- Patients who consent to take part.
Who cannot join
- Diagnostics on serious mental disorder.
- Suicidal intentions at the moment of getting involved in the study.
- Diagnostics on addiction to toxic substances.
- Diagnostics on well-known body illness responsible for the symptoms.
- Previous psychotherapy during the previous year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efectiveness of a Cognitive Behavioral Intervention in Patients With Symptoms Somatization, as Measure Quality of Life, Front the Clinical Practice Usual Action in Primary Health Care. A Controlled Clinical Trial With Parallel Groups
The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal intervention (BCI) in patients with somatization symptoms which has an effect on the perceived quality of life front conventional intervention.
Read the detailed description
Aim: to determine whether a cognitive-behavioral group intervention in patients with unexplicated somatic symptoms, that have come to the primary care medical in Madrid, is more effective than normal practice in terms of improving life quality at one year.
Method:
Design:cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. unit of randomization are centres.Analysis unit: patients between 18 and 65 years old.
Intervention: The cognitive behavioral grupal Terapy in the internention group and the usual intervention in the control group.
Sample size adjusted for design effect=242 (121 in each arm). Main response variable: preceived quality of life (SF-12).
Data Analysis:comparison of the proportion of patients that improve in 4 or more points in the area of Mental Healthcare from the SF-12 in both groups,at 6 months and 1 year after patient inclusion.
- Conditions
- Quality of Life
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Primary Health Care, Somatization symptoms, Cognitive Behavioral Therapy, Nursing intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called Primary Health Care, Somatization symptoms, Nursing intervention, Quality of life
Four Cognitive behavioral group sessions. Each session will last two hours a week
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Intervention group: Structured nursing intervention Receives: Behavioral: Cognitive Behavioral Therapy |
| No intervention | No intervention | Control group: conventional intervention or non_support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived quality of life
Perceived quality of life: Quality of life measured by SF-12 questionnare on Mental Healthcare Change from baseline in quality of life at 3, 6 and 12 months after the intervention.
Measured: Change from baseline in quality of life at 12 months after the intervention
Secondary outcomes (4)
Questionnarie on Global Clinical Impression
It is used to assess the patient´s(PGI questionnarie) and the doctor´s(CGI questionnarie)perception on the former´s improvement after the interventions have been carried out. It will be undertaken 6 and 12 moths later, so as to assess the effectiveness of the group intervention.
Measured: Change from baseline in patient and doctor´s perception at 12 months afer the intervention
Number of examinations
Number of requested and programmed doctor´s examinations during the period of study (itemized between infirmary and medicine)
Measured: Number of examinations from baseline until 12 months after the intervention
Prescribed medicine
Prescribed medicine during the period of study, with doubtful therapeutic value for their processing, related to the unexplained somatic symptoms. The included medicines are those related to the functional symptomatology
Measured: Prescribed medicine from baseline until 12 months after the intervention
Temporary labor disability (TLD)
Measured: Days on TLD from baseline until 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startOct 2009
- Primary completionApr 2012
- Study completionAug 2012
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 Quality of LifeStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria
- Responsible party
- Principal investigator, Esperanza Escortell, Gerencia de Atención Primaria, Madrid
- Investigators
- Alberto López García-Franco, MD, Principal investigator, Gerencia Atención Primaria. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484223
- Sponsor's protocol ID
- FIS PI08/90707
- Status last verified
- Oct 2012
- First submitted
- 30 Nov 2011
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lopez-Garcia-Franco A, del-Cura-Gonzalez MI, Caballero-Martinez L, Sanz-Cuesta T, Diaz-Garcia MI, Rodriguez-Monje MT, Chahua M, Munoz-Sanchez I, Serrano-Gonzalez D, Rollan-Llanderas T, Nieto-Blanco E, Losada-Cucco L, Caballero-Martinez F, Sanz-Garcia N, Pose-Garcia B, Jurado-Sueiro M, Rey ML, de Blas Gonzalez FG, Abanto MA, Bayona TS, Ayllon-Camargo R, Lopez IS, Hernando ML, Beltran-Alvarez R, Aguilar-Gutierrez AI, Mota-Rodriguez JL, Cosculluela-Pueyo R, Lopez-Martin-Aragon T, Bonilla-Sanchez R, Aritieda-Gonzalez-Granda MC, Razola-Rincon R, Sanchez-de-la-Ventana MA, Martinez-Guinea C, Huerta-Galindo L, Barrio-Ovalle AB, Miguel-Martin S, Portero-Fraile P, Pensado-Freire H, Herrera-Garcia ML, Azcoaga-Lorenzo A, Gomez-Garcia I, Llamas-Sandino N, Lopez-Borja I, Maldonado-Castro H, Lumbreras-Villaran P, Ascanio-Duran C. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial. BMC Fam Pract. 2012 May 2;13:35. doi: 10.1186/1471-2296-13-35.
PubMed 22551252
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efectiveness of a Cognitive Behavioral Intervention in Patients With Symptoms Somatization, as Measure Quality of Life, Front the Clinical Practice Usual Action in Primary Health Care. A Controlled Clinical Trial With Parallel Groups
- ClinicalTrials.gov ID
- NCT01484223
- Acronym / sponsor ID
- FIS PI08/90707
- Conditions
- Quality of Life
- Keywords
- Primary Health Care, Somatization symptoms, Cognitive Behavioral Therapy, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria
- Study start
- Oct 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Dec 2011 (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.
The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal intervention (BCI) in patients with somatization symptoms which has an effect on the perceived quality of life front conventional intervention.
Detailed description
Aim: to determine whether a cognitive-behavioral group intervention in patients with unexplicated somatic symptoms, that have come to the primary care medical in Madrid, is more effective than normal practice in terms of improving life quality at one year.
Method:
Design:cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. unit of randomization are centres.Analysis unit: patients between 18 and 65 years old.
Intervention: The cognitive behavioral grupal Terapy in the internention group and the usual intervention in the control group.
Sample size adjusted for design effect=242 (121 in each arm). Main response variable: preceived quality of life (SF-12).
Data Analysis:comparison of the proportion of patients that improve in 4 or more points in the area of Mental Healthcare from the SF-12 in both groups,at 6 months and 1 year after patient inclusion.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Cognitive Behavioral TherapyIntervention group: Structured nursing intervention |
| No intervention | No intervention | –Control group: conventional intervention or non_support |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Attending patients with 2 or more medically unexplained somatic symptoms during the last 6 months.
- Having came to medical examination on primary care at least 10 times during the last year.
- be able to follow the trial´s demands, not have plans for moving another place and understand the Spanish language.
- Patients who consent to take part.
Key exclusion criteria (5 listed)
- Diagnostics on serious mental disorder.
- Suicidal intentions at the moment of getting involved in the study.
- Diagnostics on addiction to toxic substances.
- Diagnostics on well-known body illness responsible for the symptoms.
- Previous psychotherapy during the previous year.
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: Primary Health Care, Somatization symptoms, Nursing intervention, Quality of lifeFour Cognitive behavioral group sessions. Each session will last two hours a week | Behavioural | Experimental Group |
Primary outcome
Perceived quality of life
Time frame: Change from baseline in quality of life at 12 months after the intervention
Perceived quality of life: Quality of life measured by SF-12 questionnare on Mental Healthcare Change from baseline in quality of life at 3, 6 and 12 months after the intervention.
4 secondary outcomes
Questionnarie on Global Clinical Impression
Time frame: Change from baseline in patient and doctor´s perception at 12 months afer the intervention
Number of examinations
Time frame: Number of examinations from baseline until 12 months after the intervention
Prescribed medicine
Time frame: Prescribed medicine from baseline until 12 months after the intervention
Temporary labor disability (TLD)
Time frame: Days on TLD from baseline until 12 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
- Derived from this study: PubMed 22551252Lopez-Garcia-Franco A, del-Cura-Gonzalez MI, Caballero-Martinez L, Sanz-Cuesta T, Diaz-Garcia MI, Rodriguez-Monje MT, Chahua M, Munoz-Sanchez I, Serrano-Gonzalez D, Rollan-Llanderas T, Nieto-Blanco E, Losada-Cucco L, Caballero-Martinez F, Sanz-Garcia N, Pose-Garcia B, Jurado-Sueiro M, Rey ML, de Blas Gonzalez FG, Abanto MA, Bayona TS, Ayllon-Camargo R, Lopez IS, Hernando ML, Beltran-Alvarez R, Aguilar-Gutierrez AI, Mota-Rodriguez JL, Cosculluela-Pueyo R, Lopez-Martin-Aragon T, Bonilla-Sanchez R, Aritieda-Gonzalez-Granda MC, Razola-Rincon R, Sanchez-de-la-Ventana MA, Martinez-Guinea C, Huerta-Galindo L, Barrio-Ovalle AB, Miguel-Martin S, Portero-Fraile P, Pensado-Freire H, Herrera-Garcia ML, Azcoaga-Lorenzo A, Gomez-Garcia I, Llamas-Sandino N, Lopez-Borja I, Maldonado-Castro H, Lumbreras-Villaran P, Ascanio-Duran C. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial. BMC Fam Pract. 2012 May 2;13:35. doi: 10.1186/1471-2296-13-35.
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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.
Alberto López García-Franco, MD principal investigator
Gerencia Atención Primaria. Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Quality of Life, run by Gerencia de Atención Primaria, Madrid at 1 site 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 5 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: finished, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived quality of life (time frame: Change from baseline in quality of life at 12 months after the intervention). 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 NCT01484223, 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 11 Oct 2012.