Yolanda López-del-Hoyo

Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

Summary Acceptance and commitment therapy is effective for improving several clinical outcomes in fibromyalgia patients ABSTRACT In the last decade, there has been burgeoning interest in the effectiveness of third‐generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group‐based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health‐related quality of life. The differences between groups were calculated by linear mixed‐effects (intention‐to‐treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6 months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2–2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health‐related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

The efficacy of mindfulness-based interventions in primary care: a meta-analytic review

PURPOSE Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. METHODS We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. RESULTS The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I2 = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I2 = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I2 = 0; P >.05). CONCLUSIONS Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care.

Efficacy of memantine in the treatment of fibromyalgia: A double-blind, randomised, controlled trial with 6-month follow-up

Summary Memantine has shown efficacy in the treatment of pain and other clinical variables (depression, anxiety, quality of life, function, clinical impression) in patients with fibromyalgia. ABSTRACT Fibromyalgia (FM) is a prevalent and disabling chronic disease. Recent studies have found elevated levels of glutamate in several brain regions, leading to hypotheses about the usefulness of glutamate‐blocking drugs such as memantine in the treatment of FM. The aim of this study was to evaluate the efficacy of memantine in the treatment of pain and other clinical variables (global function, clinical impression, depression, anxiety, quality of life) in FM patients. A double‐blind, parallel randomised controlled trial was developed. A total of 63 patients diagnosed with FM were recruited from primary health care centres in Zaragoza, Spain. Memantine was administered at doses of 20 mg/d after 1 month of titration. Assessments were carried out at baseline, posttreatment, and 3‐ and 6‐month follow‐up. Compared with a placebo group, memantine significantly decreased ratings on a pain visual analogue scale (Cohen’s d = 1.43 at 6 months) and pain measured with a sphygmomanometer (d = 1.05). All other secondary outcomes except anxiety also improved, with moderate‐to‐large effect sizes at 6 months. Compared with placebo, the absolute risk reduction obtained with memantine was 16.13% (95% confidence interval = 2.0% to 32.6%), and the number needed to treat was 6.2 (95% confidence interval = 3 to 47). Tolerance was good, with dizziness (8 patients) and headache (4 patients) being the most frequent side effects of memantine. Although additional studies with larger sample sizes and longer follow‐up times are needed, this study provides preliminary evidence of the utility of memantine for the treatment of FM.

Low intensity vs. self-guided internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study.

BackgroundMajor depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.MethodsThe study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed.DiscussionThe comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting.Trial registrationClinical Trials NCT01611818

Expectations, experiences and attitudes of patients and primary care health professionals regarding online psychotherapeutic interventions for depression: Protocol for a qualitative study

BackgroundIn the year 2020, depression will cause the second highest amount of disability worldwide. One quarter of the population will suffer from depression symptoms at some point in their lives. Mental health services in Western countries are overburdened. Therefore, cost-effective interventions that do not involve mental health services, such as online psychotherapy programs, have been proposed. These programs demonstrate satisfactory outcomes, but the completion rate for patients is low. Health professionals’ attitudes towards this type of psychotherapy are more negative than the attitudes of depressed patients themselves. The aim of this study is to describe the profile of depressed patients who would benefit most from online psychotherapy and to identify expectations, experiences, and attitudes about online psychotherapy among both patients and health professionals that can facilitate or hinder its effects.MethodsA parallel qualitative design will be used in a randomised controlled trial on the efficiency of online psychotherapeutic treatment for depression. Through interviews and focus groups, the experiences of treated patients, their reasons for abandoning the program, the expectations of untreated patients, and the attitudes of health professionals will be examined. Questions will be asked about training in new technologies, opinions of online psychotherapy, adjustment to therapy within the daily routine, the virtual and anonymous relationship with the therapist, the process of online communication, information necessary to make progress in therapy, process of working with the program, motivations and attitudes about treatment, expected consequences, normalisation of this type of therapy in primary care, changes in the physician-patient relationship, and resources and risks. A thematic content analysis from the grounded theory for interviews and an analysis of the discursive positions of participants based on the sociological model for focus groups will be performed.DiscussionKnowledge of the expectations, experiences, and attitudes of both patients and medical personnel regarding online interventions for depression can facilitate the implementation of this new psychotherapeutic tool. This qualitative investigation will provide thorough knowledge of the perceptions, beliefs, and values of patients and clinicians, which will be very useful for understanding how to implement this intervention method for depression.

Double-blind single-session neurofeedback training in upper-alpha for cognitive enhancement of healthy subjects

This paper reports on a single-session neurofeedback (NF) training procedure on the user-specific upper alpha band for cognitive enhancement in healthy users. A double-blind study was designed using a NF group and an active control group. Control group performed as the NF group but received sham feedback, minimizing the non-specific factors of training. This design aimed to (i) investigate upper alpha as a NF parameter, (ii) evaluate the NF effects on upper alpha during the execution of a cognitive task, and (iii) evaluate the effects on cognitive performance by means of a cognitive task and a battery of psychological tests. Results of EEG analysis show the key role of the feedback: only the NF group enhanced upper alpha during the training, and it led to a desynchronization increase during the execution of the cognitive task. Regarding the behavioral results, a strong learning effect was observed, with the NF group performing better in almost all measurements but many of them without statistical significance.

Correlational analysis and predictive validity of psychological constructs related with pain in fibromyalgia

AbstractBackgroundFibromyalgia (FM) is a prevalent and disabling disorder characterized by a history of widespread pain for at least three months. Pain is considered a complex experience in which affective and cognitive aspects are crucial for prognosis. The aim of this study is to assess the importance of pain-related psychological constructs on function and pain in patients with FM.MethodsDesignMulticentric, naturalistic, one-year follow-up study. Setting and study sample. Patients will be recruited from primary care health centres in the region of Aragon, Spain. Patients considered for inclusion are those aged 18-65 years, able to understand Spanish, who fulfil criteria for primary FM according to the American College of Rheumatology, with no previous psychological treatment.MeasurementsThe variables measured will be the following: main variables (pain assessed with a visual analogue scale and with sphygmomanometer and general function assessed with Fibromyalgia Impact Questionnaire, and), psychological constructs (pain catastrophizing, pain acceptance, mental defeat, psychological inflexibility, perceived injustice, mindfulness, and positive and negative affect), and secondary variables (sociodemographic variables, anxiety and depression assessed with Hospital Anxiety and Depression Scale, and psychiatric interview assessed with MINI). Assessments will be carried at baseline and at one-year follow-up.Main outcomePain Visual Analogue Scale.AnalysisThe existence of differences in socio-demographic, main outcome and other variables regarding pain-related psychological constructs will be analysed using Chi Square test for qualitative variables, or Student t test or variance analysis, respectively, for variables fulfilling the normality hypothesis. To assess the predictive value of pain-related psychological construct on main outcome variables at one-year follow-up, use will be made of a logistic regression analysis adjusted for socio-demographic and clinical variables. A Spearman Rho non-parametric correlation matrix will be developed to determine possible overlapping between pain-related psychological constructs.DiscussionIn recent years, the relevance of cognitive and affective aspects for the treatment of chronic pain, not only in FM but also in other chronic pain diseases, has been widely acknowledged. However, the relative importance of these psychological constructs, the relationship and possible overlapping between them, or the exact meaning of them in pain are not enough known.

The efficacy and pattern of use of a computer-assisted programme for the treatment of anxiety: a naturalistic study using mixed methods in primary care in Spain.

BACKGROUND Naturalistic studies to assess the efficacy and pattern of use of computer-delivered psychotherapy programmes in real daily clinical conditions are infrequent. Anxiety disorders are the most common mental disorders, and many of them do not receive adequate management, especially in primary care settings. The objective of this study is to assess the efficacy of an internet-delivered programme for anxiety in primary care. METHODS Multicentre, naturalistic study. Patients with generalised anxiety disorder were recruited (N=229). The generalised anxiety disorder 7-item scale (GAD-7) was the only outcome measured. Qualitative methods were used to analyse patient-therapist interactions. RESULTS Only 13.5% of patients completed the programme. Analysis per intent-to-treat using Last Observation Carried Forward showed a significant GAD-7 decrease post-treatment (-2.17: SD=4.77; p=0.001) (Cohen׳s d=0.43) with a correlation between the number of sessions and decrease in anxiety (Rho=-0.34, p=0.001). The analysis per protocol showed significantly decreased GAD-7 (-4.13; SD=6.82; p=0.002) (d=0.80). Withdrawal was related to low programme friendliness, lack of a partner, and higher education. Only 17.47% of the patients consulted their therapists. Facilitators were patient demand for information and sufficient time. Barriers were lack of motivation and lack of connection with the programme. LIMITATIONS The main limitations of this study included the use of an open trial design, the lack of follow-up, and the inclusion of only one outcome (GAD-7). CONCLUSIONS To our knowledge, this is the first study with computer-delivered psychotherapy (CDP) on GAD. CDP for anxiety is efficacious in naturalistic environments. Specific facilitators and barriers should be considered.

Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference

Regular mindfulness practice benefits people both mentally and physically, but many populations who could benefit do not practice mindfulness. Virtual Reality (VR) is a new technology that helps capture participants’ attention and gives users the illusion of “being there” in the 3D computer generated environment, facilitating sense of presence. By limiting distractions from the real world, increasing sense of presence and giving people an interesting place to go to practice mindfulness, Virtual Reality may facilitate mindfulness practice. Traditional Dialectical Behavioral Therapy (DBT®) mindfulness skills training was specifically designed for clinical treatment of people who have trouble focusing attention, however severe patients often show difficulties or lack of motivation to practice mindfulness during the training. The present pilot study explored whether a sample of mindfulness experts would find useful and recommend a new VR Dialectical Behavioral Therapy (DBT®) mindfulness skills training technique and whether they would show any benefit. Forty four participants attending a mindfulness conference put on an Oculus Rift DK2 Virtual Reality helmet and floated down a calm 3D computer generated virtual river while listening to digitized DBT® mindfulness skills training instructions. On subjective questionnaires completed by the participants before and after the VR DBT® mindfulness skills training session, participants reported increases/improvements in state of mindfulness, and reductions in negative emotional states. After VR, participants reported significantly less sadness, anger, and anxiety, and reported being significantly more relaxed. Participants reported a moderate to strong illusion of going inside the 3D computer generated world (i.e., moderate to high “presence” in VR) and showed high acceptance of VR as a technique to practice mindfulness. These results show encouraging preliminary evidence of the feasibility and acceptability of using VR to practice mindfulness based on clinical expert feedback. VR is a technology with potential to increase computerized dissemination of DBT® skills training modules. Future research is warranted.

Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multi-center, three-armed randomized controlled trial conducted in primary care.

Depression is one of the most common mental disorders and will become one of the leading causes of disability in the world. Internet-based CBT programs for depression have been classified as “well established” following the American Psychological Association criteria for empirically supported treatments. The aim of this study is to analyze the cost effectiveness at 12-month follow-up of the Internet-based CBT program “Smiling is fun” with (LITG) and without psychotherapist support (TSG) compared to usual care. The perspective used in our analysis is societal. A sample of 296 depressed patients (mean age of 43.04 years; 76% female; BDI-II mean score = 22.37) from primary care services in four Spanish regions were randomized in the RCT. The complete case and intention-to-treat (ITT) perspectives were used for the analyses. The results demonstrated that both Internet-based CBT interventions exhibited cost utility and cost effectiveness compared with a control group. The complete case analyses revealed an incremental cost-effectiveness ratio (ICER) of €-169.50 and an incremental cost-utility ratio (ICUR) of €-11389.66 for the TSG group and an ICER of €-104.63 and an ICUR of €-6380.86 for the LITG group. The ITT analyses found an ICER of €-98.37 and an ICUR of €-5160.40 for the TSG group and an ICER of €-9.91 and an ICUR of €496.72 for the LITG group. In summary, the results of this study indicate that the two Internet-based CBT interventions are appropriate from both economic and clinical perspectives for depressed patients in the Spanish primary care system. These interventions not only help patients to improve clinically but also generate societal savings. Trial Registration: clinicaltrials.gov NCT01611818