Evaluation of a mindfulness-based intervention with and without virtual reality dialectical behavior therapy® mindfulness skills training for the treatment of generalized anxiety disorder in primary care: A pilot study

Generalized Anxiety Disorder (GAD) is a very prevalent disorder in primary care (PC). Most patients with GAD never seek treatment, and those who do seek treatment often drop out before completing treatment. Although it is an understudied treatment, Mindfulness-Based Interventions (MBIs) indicate preliminary efficacy for the treatment of GAD symptoms, but many patients with GAD present other associated symptoms (e.g., attention deficits) that complicate the treatment. Virtual Reality DBT® Mindfulness Skills learning has recently been developed to make learning mindfulness easier for patients with emotion dysregulation who have trouble concentrating. Virtual Reality (VR) might serve as a visual guide for practicing mindfulness as it gives patients the illusion of "being there" in the 3D computer generated world. The main goal of this study was to evaluate the effect of two MBIs (a MBI in a group setting alone and the same MBI plus 10 min VR DBT® Mindfulness skills training) to reduce GAD symptoms. A secondary aim was to explore the effect in depression, emotion regulation, mindfulness, and interoceptive awareness. Other exploratory aims regarding the use of VR DBT® Mindfulness skills were also carried out. The sample was composed of 42 patients (roughly half in each group) with GAD attending PC visits. After treatment, both groups of patients showed significant improvements in General Anxiety Disorder measured by the GAD-7 using mixed regression models [MBI alone (B = -5.70; p < 0.001; d = -1.36), MBI+VR DBT® Mindfulness skills (B = -4.38; p < 0.001; d = -1.33)]. Both groups also showed significant improvements in anxiety, depression, difficulties of emotion regulation and several aspects of mindfulness and interoceptive awareness. Patients in the group that received additional 10 min VR DBT Mindfulness Skills training were significantly more adherent to the treatment than those receiving only standard MBI (100% completion rate in MBI + VR vs. 70% completion rate in MBI alone; Fisher = 0.020). Although randomized controlled studies with larger samples are needed, this pilot study shows preliminary effectiveness of MBI to treat GAD, and preliminary evidence that adjunctive VR DBT® Mindfulness Skills may reduce dropouts

Relationship between behavioural coping strategies and acceptance in patients with fibromyalgia syndrome: Elucidating targets of interventions

BACKGROUND: Previous research has found that acceptance of pain is more successful than cognitive coping variables for predicting adjustment to pain. This research has a limitation because measures of cognitive coping rely on observations and reports of thoughts or attempts to change thoughts rather than on overt behaviours. The purpose of the present study, therefore, is to compare the influence of acceptance measures and the influence of different behavioural coping strategies on the adjustment to chronic pain. METHODS: A sample of 167 individuals diagnosed with fibromyalgia syndrome completed the Chronic Pain Coping Inventory (CPCI) and the Chronic Pain Acceptance Questionnaire (CPAQ). RESULTS: Correlational analyses indicated that the acceptance variables were more related to distress and functioning than were behavioural coping variables. The average magnitudes of the coefficients for activity engagement and pain willingness (both subscales of pain acceptance) across the measures of distress and functioning were r = 0.42 and 0.25, respectively, meanwhile the average magnitude of the correlation between coping and functioning was r = 0.17. Regression analyses examined the independent, relative contributions of coping and acceptance to adjustment indicators and demonstrated that acceptance accounted for more variance than did coping variables. The variance contributed by acceptance scores ranged from 4.0 to 40%. The variance contributed by the coping variables ranged from 0 to 9%. CONCLUSIONS: This study extends the findings of previous work in enhancing the adoption of acceptance-based interventions for maintaining accurate functioning in fibromyalgia patients

Evaluation of a Mindfulness-Based Intervention With and Without Virtual Reality Dialectical Behavior Therapy® Mindfulness Skills Training for the Treatment of Generalized Anxiety Disorder in Primary Care: A Pilot Study

Generalized Anxiety Disorder (GAD) is a very prevalent disorder in primary care (PC). Most patients with GAD never seek treatment, and those who do seek treatment often drop out before completing treatment. Although it is an understudied treatment, Mindfulness-Based Interventions (MBIs) indicate preliminary efficacy for the treatment of GAD symptoms, but many patients with GAD present other associated symptoms (e.g., attention deficits) that complicate the treatment. Virtual Reality DBT® Mindfulness Skills learning has recently been developed to make learning mindfulness easier for patients with emotion dysregulation who have trouble concentrating. Virtual Reality (VR) might serve as a visual guide for practicing mindfulness as it gives patients the illusion of “being there” in the 3D computer generated world. The main goal of this study was to evaluate the effect of two MBIs (a MBI in a group setting alone and the same MBI plus 10 min VR DBT® Mindfulness skills training) to reduce GAD symptoms. A secondary aim was to explore the effect in depression, emotion regulation, mindfulness, and interoceptive awareness. Other exploratory aims regarding the use of VR DBT® Mindfulness skills were also carried out. The sample was composed of 42 patients (roughly half in each group) with GAD attending PC visits. After treatment, both groups of patients showed significant improvements in General Anxiety Disorder measured by the GAD-7 using mixed regression models [MBI alone (B = -5.70; p &lt; 0.001; d = -1.36), MBI+VR DBT® Mindfulness skills (B = -4.38; p &lt; 0.001; d = -1.33)]. Both groups also showed significant improvements in anxiety, depression, difficulties of emotion regulation and several aspects of mindfulness and interoceptive awareness. Patients in the group that received additional 10 min VR DBT Mindfulness Skills training were significantly more adherent to the treatment than those receiving only standard MBI (100% completion rate in MBI + VR vs. 70% completion rate in MBI alone; Fisher = 0.020). Although randomized controlled studies with larger samples are needed, this pilot study shows preliminary effectiveness of MBI to treat GAD, and preliminary evidence that adjunctive VR DBT® Mindfulness Skills may reduce dropouts

Validation of the Spanish version of the Chronic Pain Acceptance Questionnaire (CPAQ) for the assessment of acceptance in fibromyalgia

<p>Abstract</p> <p>Background</p> <p>The aim of this study was to validate a Spanish version of the Chronic Pain Acceptance Questionnaire (CPAQ). Pain acceptance is the process of giving up the struggle with pain and learning to live a worthwhile life despite it. The Chronic Pain Acceptance Questionnaire (CPAQ) is the questionnaire most often used to measure pain acceptance in chronic pain populations.</p> <p>Methods</p> <p>A total of 205 Spanish patients diagnosed with fibromyalgia syndrome who attended our pain clinic were asked to complete a battery of psychometric instruments: the Pain Visual Analogue Scale (PVAS) for pain intensity, the Hospital Anxiety and Depression Scale (HADS), the Medical Outcome Study Short Form 36 (SF-36), the Pain Catastrophising Scale (PCS) and the Fibromyalgia Impact Questionnaire (FIQ).</p> <p>Results</p> <p>Analysis of results showed that the Spanish CPAQ had good test-retest reliability (intraclass correlation coefficient 0.83) and internal consistency reliability (Cronbach's α: 0.83). The Spanish CPAQ score significantly correlated with pain intensity, anxiety, depression, pain catastrophising, health status and physical and psychosocial disability. The Scree plot and a Principal Components Factor analysis confirmed the same two-factor construct as the original English CPAQ.</p> <p>Conclusion</p> <p>The Spanish CPAQ is a reliable clinical assessment tool with valid construct validity for the acceptance measurement among a sample of Spanish fibromyalgia patients. This study will make it easier to assess pain acceptance in Spanish populations with fibromyalgia.</p

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

<p>Abstract</p> <p>Background</p> <p>Fibromyalgia (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.</p> <p>Methods</p> <p>Design</p> <p>Multicentric, naturalistic, one-year follow-up study.</p> <p><it>Setting and study sample</it>. 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.</p> <p>Measurements</p> <p>The 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.</p> <p>Main outcome</p> <p>Pain Visual Analogue Scale.</p> <p>Analysis</p> <p>The 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 <it>t </it>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.</p> <p>Discussion</p> <p>In 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.</p

Cost-utility of cognitive behavioral therapy versus U.S. Food and Drug Administration recommended drugs and usual care in the treatment of patients with fibromyalgia: an economic evaluation alongside a 6-month randomized controlled trial

Introduction:- Cognitive behavioral therapy (CBT) and U.S. Food and Drug Administration (FDA)-recommended pharmacologic treatments (RPTs; pregabalin, duloxetine, and milnacipran) are effective treatment options for fibromyalgia (FM) syndrome and are currently recommended by clinical guidelines. We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT (combination of pregabalin + duloxetine) and usual care (TAU) groups in the treatment of FM. Methods:- The economic evaluation was conducted alongside a 6-month, multicenter, randomized, blinded, parallel group, controlled trial. In total, 168 FM patients from 41 general practices in Zaragoza (Spain) were randomized to CBT (n = 57), RPT (n = 56), or TAU (n = 55). The main outcome measures were Quality-Adjusted Life Years (QALYs, assessed by using the EuroQoL-5D questionnaire) and improvements in health-related quality of life (HRQoL, assessed by using EuroQoL-5D visual analogue scale, EQ-VAS). The costs of healthcare use were estimated from patient self-reports (Client Service Receipt Inventory). Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves (CEACs). Results:- On average, the total costs per patient in the CBT group (1,847€) were significantly lower than those in patients receiving RPT (3,664€) or TAU (3,124€). Patients receiving CBT reported a higher quality of life (QALYs and EQ-VAS scores); the differences between groups were significant only for EQ-VAS. From a complete case-analysis approach (base case), the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed, by using both QALYs and EQ-VAS as outcomes. These findings were confirmed by bootstrap analyses, net-benefit curves, and CEACs. Two additional sensitivity analyses (intention-to-treat analysis and per-protocol analysis) indicated that the results were robust. The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs, although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS. Conclusions:- Because of lower costs, CBT is the most cost-effective treatment for adult FM patients. Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT. Trial registration:- Current Controlled Trials ISRCTN10804772. Registered 29 September 2008

Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Fibromyalgia is a prevalent and disabling disorder characterized by widespread pain and other symptoms such as insomnia, fatigue or depression. Catastrophization is considered a key clinical symptom in fibromyalgia; however, there are no studies on the pharmacological or psychological treatment of catastrophizing. The general aim of this study is to assess the effectiveness of cognitive-behaviour therapy and recommended pharmacological treatment for fibromyalgia (pregabalin, with duloxetine added where there is a comorbid depression), compared with usual treatment at primary care level.</p> <p>Method/design</p> <p><it>Design</it>: A multi-centre, randomized controlled trial involving three groups: the control group, consisting of usual treatment at primary care level, and two intervention groups, one consisting of cognitive-behaviour therapy, and the other consisting of the recommended pharmacological treatment for fibromyalgia.</p> <p><it>Setting</it>: 29 primary care health centres in the city of Zaragoza, Spain.</p> <p><it>Sample</it>: 180 patients, aged 18–65 years, able to understand and read Spanish, who fulfil criteria for primary fibromyalgia, with no previous psychological treatment, and no pharmacological treatment or their acceptance to discontinue it two weeks before the onset of the study.</p> <p><it>Intervention</it>: Psychological treatment is based on the manualized protocol developed by Prof. Escobar et al, from the University of New Jersey, for the treatment of somatoform disorders, which has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy. Pharmacological therapy consists of the recommended pharmacological treatment for fibromyalgia: pregabalin (300–600 mg/day), with duloxetine (60–120 mg/day) added where there is a comorbid depression).</p> <p><it>Measurements</it>: The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class. The diagnosis of psychiatric disorders will be made with the Structured Polyvalent Psychiatric Interview. Other instruments to be administered are the Pain Catastrophizing Scale, the Hamilton tests for Anxiety and for Depression, the Fibromyalgia Impact Questionnaire (FIQ), the EuroQuol-5 domains (EQ-5D), and the use of health and social services (CSRI). Assessments will be carried out at baseline, 1, 3, and 6 months.</p> <p><it>Main variable</it>: Pain catastrophizing.</p> <p><it>Analysis</it>: The analysis will be per intent to treat. We will use the general linear models of the SPSS version 15 statistical package, to analyse the effect of the treatment on the result variable (pain catastrophizing).</p> <p>Discussion</p> <p>It is necessary to assess the effectiveness of pharmacological and psychological treatments for pain catastrophizing in fibromyalgia. This randomized clinical trial will determine whether both treatments are effective for this important prognostic variable in patients with fibromyalgia.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN10804772</p

Cost-Utility of Attachment-Based Compassion Therapy (ABCT) and Mindfulness-Based Stress Reduction (MBSR) in the Management of Depressive, Anxious, and Adjustment Disorders in Mental Health Settings: Economic Evaluation Alongside a Randomized Controlled Trial

ObjectivesThe main objective of this paper was to examine the cost-utility of attachment-based compassion therapy (ABCT) compared to Mindfulness-Based Stress Reduction (MBSR) and treatment-as-usual (TAU) on patients with depressive and/or anxious disorder, or adjustment disorder with depressive and/or anxious symptomatology in terms of effects on quality-adjusted life years (QALYs) as well as healthcare costs from a public healthcare system perspective.MethodA 6-month randomized controlled trial was conducted. Ninety Spanish patients with mental disorders (depressive, anxious, or adjustment disorders) received 8 weekly group sessions of TAU + ABCT, TAU + MBSR, or TAU alone. Data collection took place at pre- and 6-month follow-up. Cost-utility of the two treatment groups (ABCT vs MBSR vs TAU) was compared by examining treatment outcomes in terms of QALYs (obtained with the EQ-5D-3L) and healthcare costs (data about service use obtained with the Client Service Receipt Inventory).ResultsBoth MBSR and ABCT were more efficient than TAU alone, although the results did not reach statistical significance. Compared to ABCT, MBSR produced an increase both in terms of costs (euro53.69, 95% CI [- 571.27 to 513.14]) and effects (0.004 QALYs, 95% CI [- 0.031 to 0.049]); ICUR = euro13,422.50/QALY). Both interventions significantly reduced the number of visits to general practice compared to TAU.ConclusionsThis study has contributed to the evidence base of mindfulness- and compassion-based programs and provided promising information about the cost-utility of MBSR for patients with emotional disorders. However, the small sample size and short follow-up period limit the generalizability of the findings.PreregistrationClinicaltrials.gov; NCT03425487

Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study)

Background Clinical practice guidelines for the treatment of major depressive disorder (MDD) recommend antidepressants for patients with moderate-severe depression and active monitoring for patients with mild-moderate symptoms. The feasibility and efficiency of active monitoring has not been proven conclusively. The aim of this study is to evaluate the cost-effectiveness of active monitoring in comparison to antidepressants for primary care patients with mild-moderate MDD. Methods/Design This is a 12-month follow-up multicenter observational prospective controlled trial. Patients are enrolled in 12 primary care centers in Barcelona (Spain). Eligible patients are adults (≥18 years-old) with a new episode of MDD that sign a written consent to participate. This is a naturalistic study in which general practitioners (GPs) use their professional judgment to allocate patients into active monitoring or antidepressants groups. GPs treat the patients following their clinical criteria. At baseline, GPs complete a questionnaire (sociodemographic/job characteristics, training, attitude towards depression, interest on mental health and participation in communication groups). Patients’ measurements take place at baseline and after six and 12 months. Main outcome measures include severity of depression (PHQ-9), health-related quality of life (EuroQol-5D) and use of healthcare and social care services (Client Service Receipt Inventory). Secondary outcomes include diagnosis of MDD according to DSM-IV diagnostic criteria (SCID-I), disability (WHO-DAS), anxiety (BAI), comorbidities, medication side-effects and beliefs about medicines (BMQ). The analysis will be done according to the intention to treat analysis. Missing data will be imputed using multiple imputation by chained equations. To minimize the bias resulting from the lack of randomization, a propensity score will be used. Incremental effects and costs between groups will be modelled in each of the imputed databases using multivariate generalized linear models and then combined as per Rubin’s rules. Propensity scores will be used to adjust the models. Incremental cost-effectiveness ratios will be calculated by dividing the difference in costs between groups by the difference in effects. To deal with the uncertainty, resampling techniques with bootstrapping will be used and cost-effectiveness planes and cost-effectiveness acceptability curves will be constructed. A series of sensitivity analyses will be performed. Discussion Given the high burden and costs generated by depressive disorder, it is important that general practitioners treat major depression efficiently. Recent evidence has suggested that antidepressants have low benefits for patients with mild to moderate major depression. For such cases of depression, active monitoring exists as a treatment option, but it is not without difficulties for implementation and its effectiveness and efficiency have not been demonstrated conclusively. The results of the study will provide information on which is the most efficient approach to treat patients with mild to moderate major depression in primary care