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Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial.

ABSTRACT: Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month.This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations.The trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].

SUBMITTER: Lopez-Garcia-Franco A

PROVIDER: S-EPMC3515424 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature

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Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial.

López-García-Franco Alberto A del-Cura-González Ma Isabel MI Caballero-Martinez Luis L Sanz-Cuesta Teresa T Díaz-García Marta Isabel MI Rodriguez-Monje Ma Teresa MT Chahua Marcela M Muñoz-Sanchez Inmaculada I Serrano-González Dolores D Rollán-Llanderas Teresa T Nieto-Blanco Esther E Losada-Cucco Liliana L Caballero-Martínez Fernando F Sanz-García Nuria N Pose-García Belén B Jurado-Sueiro Montserrat M Rey Manuela Luque ML de Blas González Francisca García FG Abanto Ma Angeles Miguel MA Bayona Teresa Sanz TS Ayllón-Camargo Rafaela R Lopez Inmaculada Santamaría IS Hernando María Luisa Santiago ML Beltran-Alvarez Rosario R Aguilar-Gutierrez Ana Isabel AI Mota-Rodriguez Jose Luis JL Cosculluela-Pueyo Rafaél R López-Martín-Aragón Teresa T Bonilla-Sanchez Rosa R Aritieda-González-Granda Ma Carmen MC Razola-Rincón Raquel R Sanchez-de-la-Ventana Ma Angeles MA Martinez-Guinea Concepción C Huerta-Galindo Luis L Barrio-Ovalle Ana Belén AB Miguel-Martín Susana S Portero-Fraile Paz P Pensado-Freire Higinio H Herrera-Garcia Ma Luisa ML Azcoaga-Lorenzo Amaya A Gómez-García Inés I Llamas-Sandino Nuria N López-Borja Isabel I Maldonado-Castro Hortensia H Lumbreras-Villarán Patricia P Ascanio-Durán Carlos C

BMC family practice 20120502

<h4>Background</h4>Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective th ...[more]

PMID: 22551252

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Project description:BackgroundIn primary and secondary care medically unexplained symptoms (MUS) or functional somatic syndromes (FSS) constitute a major burden for patients and society with high healthcare costs and societal costs. Objectives were to provide an overview of the evidence regarding the cost-effectiveness of interventions for MUS or FSS, and to assess the quality of these studies.MethodsWe searched the databases PubMed, PsycINFO, the National Health Service Economic Evaluation Database (NHS-EED) and the CEA registry to conduct a systematic review. Articles with full economic evaluations on interventions focusing on adult patients with undifferentiated MUS or fibromyalgia (FM), irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS), with no restrictions on comparators, published until 15 June 2018, were included. We excluded preventive interventions. Two reviewers independently extracted study characteristics and cost-effectiveness data and used the Consensus on Health Economic Criteria Checklist to appraise the methodological quality.ResultsA total of 39 studies out of 1,613 articles met the inclusion criteria. Twenty-two studies reported costs per quality-adjusted life year (QALY) gained and cost-utility analyses (CUAs). In 13 CUAs the intervention conditions dominated the control conditions or had an incremental cost-effectiveness ratio below the willingness-to-pay threshold of € 50,000 per QALY, meaning that the interventions were (on average) cost-effective in comparison with the control condition. Group interventions focusing on MUS (n = 3) or FM (n = 4) might be more cost-effective than individual interventions. The included studies were heterogeneous with regard to the included patients, interventions, study design, and outcomes.ConclusionThis review provides an overview of 39 included studies of interventions for patients with MUS and FSS and the methodological quality of these studies. Considering the limited comparability due to the heterogeneity of the studies, group interventions might be more cost-effective than individual interventions.RegistrationStudy methods were documented in an international prospective register of systematic reviews (PROSPERO) protocol, registration number: CRD42017060424.

Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.

Project description:To conduct a pilot trial of a primary care Symptoms Clinic for patients with medically unexplained symptoms and evaluate recruitment and retention, and acceptability of the intervention and to estimate potential treatment effects for a full trial.Randomised parallel group pilot trial.Primary care in one locality.Primary care database and postal questionnaire were used to identify patients with multiple specialist referrals and multiple physical symptoms unlikely to be explained by disease.General practitioner (GP) with special interest 'Symptoms Clinic' + usual care versus usual care alone. The Symptoms Clinic comprised one long (1 h) and three short (20 min) appointments.Number of patients identified and recruited; acceptability of the intervention (items from Client Satisfaction Questionnaire and interview); Medical Outcomes Survey Short Form 12 (SF-12) physical component summary.Automated blocked randomisation accessed by telephone.None. NUMBERS RANDOMIZED: 16 to intervention and 16 to usual care alone.72 patients, from seven GP practices, had repeated specialist referrals and a Patient Health Questionnaire (PHQ)-15 score of ?10 indicating a high probability of medically unexplained symptoms. 15 were ineligible and 25 declined to participate. NUMBERS ANALYSED: 26 patients; two patients randomised to the intervention group were incorrectly included, three patients in the intervention group and one control did not complete outcome measures.Most patients randomised to the Symptoms Clinic found the intervention acceptable: eight out of 11 reported the intervention helped them to deal with their problems. The mean difference between groups in SF-12 physical component summary, adjusted for baseline, was 3.8 points (SD 6).No observed harms.Patients with multiple medically unexplained symptoms can be systematically identified in primary care; a randomised trial comparing the Symptoms Clinic with usual care is feasible and has the potential to show clinically meaningful benefit.ISRCTN63083469.

Project description:BackgroundPatients with medically unexplained physical symptoms (MUPS) are prevalent 25-50% in general and specialist care. Medical specialists and residents often find patients without underlying pathology difficult to deal with, whereas patients sometimes don't feel understood. We developed an evidence-based communication training, aimed to improve specialists' interviewing, information-giving and planning skills in MUPS consultations, and tested its effectiveness.MethodsThe intervention group in this multi-center randomized controlled trial received a 14-hour training program to which experiential learning and feedback were essential. Using techniques from Cognitive Behavioral Therapy, they were stimulated to seek interrelating factors (symptoms, cognitions, emotions, behavior, and social environment) that reinforced a patient's symptoms. They were taught to explain MUPS understandably, reassure patients effectively and avoid unnecessary diagnostic testing. Before and after the intervention training, specialists videotaped a total of six consultations with different MUPS patients. These were evaluated to assess doctors' MUPS-focused communicating skills using an adapted version of the Four Habit Coding Scheme on five-point Likert scales. Participants evaluated the training by self-report on three-point Likert scales. Doctors in the control group received training after completion of the study.Results123 doctors (40% specialists, 60% residents) and 478 MUPS patients from 11 specialties were included; 98 doctors completed the study (80%) and 449 videotaped consultations were assessed. Trained doctors interviewed patients more effectively than untrained ones (p < 0.001), summarized information in a more patient-centered way (p = 0.001), and better explained MUPS and the role of perpetuating factors (p < 0.05). No effects on planning skills were found. On a 3-point scale the training was evaluated with 2.79.ConclusionMUPS-focused communication training increases the interviewing and information-giving skills of medical specialists. We recommend that the training is incorporated in postgraduate education for medical specialists and residents who frequently encounter patients with MUPS.Trial registrationDutch Trial Registration NTR2612.

Project description:ImportanceBehavioral addictions were introduced as novel mental disorders in the International Classification of Diseases, 11th Revision, based on evidence that human behavior itself can become addictive, similar to addiction to substances. However, previous studies on prevention of gaming disorder and unspecified internet use disorder lacked randomization, follow-up measurements, and diagnostic interviews that assessed incidence rates; this trial was intended to fill this gap.ObjectivesTo investigate whether the PROTECT (Professioneller Umgang mit technischen Medien [Professional Use of Technical Media]) intervention can reduce the symptom severity and prevent full syndrome and subthreshold onset of gaming disorder and unspecified internet use disorder in at-risk adolescents.Design, setting, and participantsA multicenter cluster randomized clinical trial conducted recruitment, screening, intervention delivery, and data collection among at-risk adolescents aged 12 to 18 years in 33 high schools in Germany. Inclusion criteria for the study and symptom severity analyses were elevated symptoms of gaming disorder and unspecified internet use disorder. A subsample that met the inclusion criteria for incidence analyses (no full syndrome of gaming disorder or unspecified internet use disorder, depression, or anxiety at baseline) was analyzed for illness onset. Participants were randomized to either the PROTECT intervention group or the assessment-only control group. Participants were assessed at baseline, 1-month follow-up, 4-month follow-up, and 12-month follow-up between October 1, 2015, and September 30, 2018. Based on intent-to-treat principle, data analyses were conducted from February 8, 2019, to May 7, 2021.InterventionsPROTECT, a theory-driven, manualized, cognitive behavioral therapy-based indicated preventive group intervention that is delivered in 4 sessions by trained psychologists. It targets changes in addictive reward processing and pathological cognitive mechanisms.Main outcomes and measuresThe primary outcome was symptom severity (measured by CSAS [Computerspielabhängigkeitsskala], a modified German video game dependency scale with a score range of 0-56 [higher scores indicating greater pathology]) along with incidence rates (assessed by a structured clinical interview) after 12 months. Secondary outcomes were comorbid psychopathology and problem behaviors.ResultsA total of 422 at-risk adolescents (mean [SD] age, 15.11 [2.01] years; 229 female participants [54.3%]) were randomized to either the PROTECT intervention group (n = 167; mean [SD] risk score, 29.05 [6.98]) or the assessment-only control group (n = 255; mean [SD] risk score, 26.21 [5.01]) and were included in the symptom severity analyses. Compared with the control group, the PROTECT group showed a significantly greater reduction in symptom severity of gaming disorder or unspecified internet use disorder (γ11 = -0.128; 95% CI, -0.246 to -0.011; P = .03), reflecting a 39.8% vs 27.7% reduction of symptoms with an effect size of Cohen d = 0.67 (baseline vs 12-month follow-up) for the PROTECT group. Differences in incidence rates did not reach statistical significance. The PROTECT group showed a significantly greater decrease in procrastination (γ11 = -0.458; 95% CI, -0.735 to -0.180; P < .001) over 12 months, but no significant differences were found for other secondary outcomes.Conclusions and relevanceResults of this trial showed that the PROTECT intervention effectively reduced symptoms of gaming disorder and unspecified internet use disorder over 12 months. The intervention did not change incidence rates of gaming disorder or unspecified internet use disorder.Trial registrationClinicalTrials.gov Identifier: NCT02907658.

Project description:BackgroundA previous randomized controlled trial in older adults with anxiety symptoms found no differences between a brief blended Acceptance and Commitment Therapy (ACT) intervention and brief face-to-face Cognitive Behavior Therapy (CBT) regarding anxiety symptom severity at posttreatment and 12-month follow-up. A health-economic evaluation comparing these interventions has not yet been conducted.ObjectiveThis study examined the one-year cost-effectiveness and cost-utility of blended ACT compared to face-to-face CBT for older adults with anxiety symptoms.MethodsThe economic evaluation was embedded in a randomized controlled trial comparing blended ACT to CBT in 314 older adults with mild to moderately severe anxiety symptoms. Data were collected at baseline and 3, 6 and 12 months post baseline. For the cost-effectiveness analysis, treatment response was defined as a reliable improvement in anxiety symptom severity (measured with the Generalized Anxiety Disorder-7) between baseline and 12-month follow-up. To assess cost-utility, quality-adjusted life years (QALYs) were computed using EuroQol-5 Dimensions-5 Levels-5 utility scores. Analyses took the societal perspective, including both healthcare costs and productivity costs. Incremental cost-effectiveness ratios were calculated using 2500 bootstraps of seemingly unrelated regression equations of costs and effects. Sensitivity analyses were performed to assess the robustness of the findings.ResultsDifferences between the blended ACT group and CBT group in treatment response and QALYs were statistically insignificant and clinically irrelevant. The ACT intervention was associated with an average per-participant cost reduction of €466 ($593) compared to CBT, which resulted from lower productivity costs in the blended ACT group. From a healthcare perspective, the ACT intervention was associated with higher costs (by €71 ($90)) than CBT.ConclusionsThe results do not indicate that from a health-economic perspective blended ACT should be preferred over CBT in the treatment of older adults with anxiety symptoms. The findings support a model of shared decision making, where clinicians and patients collaboratively decide on the preferred intervention, based on ethical-medical, practical and personal considerations.Trial registrationNetherlands Trial Register: TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131.

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Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial.

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Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial.

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