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Efficacy of "Attachment-Based Compassion Therapy" in the Treatment of Fibromyalgia: A Randomized Controlled Trial.

ABSTRACT: Objective:There is a growing interest in evaluating the effectiveness of compassion interventions for treating psychological disorders. The present study evaluated the effectiveness of "attachment-based compassion therapy" (ABCT) in the treatment of fibromyalgia (FM), and the role of psychological flexibility as a mediator of improvements. Methods:A total of 42 patients with FM were randomly assigned to ABCT or relaxation (active control group). Both the intervention and control condition were combined with treatment as usual (TAU). The primary outcome was functional status (FIQ), and the secondary outcomes were clinical severity (CGI-S), pain catastrophizing (PCS), anxiety (HADS-A), depression (HADS-D), quality of life (EQ-5D), and psychological flexibility (AAQ-II). Differences between the groups were estimated using mixed-effects models, and mediation assessments were conducted using path analyses. Results:The ABCT group demonstrated superior outcomes compared to the relaxation group, including better FIQ values after treatment (B?=?-3.01; p?=?0.003). Differences in FIQ were maintained at 3-month follow-up (B?=?-3.33; p?=?0.001). The absolute risk reduction in ABCT compared to relaxation increased by 40.0%, with an NNT?=?3 based on criteria of ?50% FIQ reduction after treatment. Psychological flexibility had a significant mediating effect on improvements. Conclusion:These results suggest that ABCT combined with TAU appears to be effective in the treatment of FM symptoms. Clinical Trial Registration:http://ClinicalTrials.gov, identifier NCT02454244.

SUBMITTER: Montero-Marin J

PROVIDER: S-EPMC5775966 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Efficacy of "Attachment-Based Compassion Therapy" in the Treatment of Fibromyalgia: A Randomized Controlled Trial.

Montero-Marín Jesús J Navarro-Gil Mayte M Puebla-Guedea Marta M Luciano Juan V JV Van Gordon William W Shonin Edo E García-Campayo Javier J

Frontiers in psychiatry 20180116

<h4>Objective</h4>There is a growing interest in evaluating the effectiveness of compassion interventions for treating psychological disorders. The present study evaluated the effectiveness of "attachment-based compassion therapy" (ABCT) in the treatment of fibromyalgia (FM), and the role of psychological flexibility as a mediator of improvements.<h4>Methods</h4>A total of 42 patients with FM were randomly assigned to ABCT or relaxation (active control group). Both the intervention and control c ...[more]

PMID: 29387020

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Project description:IntroductionHigher education, particularly university, is a challenge for many students that can lead to their mental health being seriously affected. The stress to which they are subject throughout their time at university can lead to anxiety and depression. "Third wave" psychotherapies, including compassion-based therapy, have been used to improve psychological outcomes, such as stress, anxiety, emotional distress and well-being. There are some signs that third wave psychotherapies reduce psychological distress in university students, but more and higher-quality studies are needed. In this randomised controlled trial (RCT), we hypothesise that the provision of attachment-based compassion therapy (ABCT) will be more effective than an active control group based on relaxation therapy for improving psychological distress in university students.Methods and analysisA two-arm RCT will be conducted involving 140 university undergraduate and postgraduate students from the University of Zaragoza and the National University of Distance Education (UNED) who reside in the autonomous community of Aragon, Spain. Interventions with either ABCT or relaxation therapy will be implemented, with an allocation ratio of 1:1 between groups. Both interventions will last six weeks and consist of six weekly group sessions lasting 1.5 h each. Data will be collected before and after the intervention, and there will be a follow-up at six months. The primary outcome will be psychological distress at post-intervention. Secondary outcomes will be depression, anxiety, stress and burnout symptoms, affectivity and emotional regulation. Attachment style, experiential avoidance, compassion (for others/oneself) and mindfulness skills will be measured as potential mechanistic variables. Intention-to-treat analysis will be performed using linear mixed regression models. The clinical significance of improvements will be calculated. Potential side effects will be monitored by an independent clinical psychologist.Ethics and disseminationThis study was approved by the Clinical Research Ethics Committee of Aragón. Participant data will remain anonymous, and results will be submitted to peer-reviewed open-access journals and disseminated via conferences.Clinical trial registrationClinicalTrials.gov, identifier NCT05197595.

Project description:BACKGROUND:Mindfulness-based interventions, self-compassion training, and cognitive behavioral therapy have garnered much evidence in its salutary effects on mental health. With increasing application of smartphone and mobile technology on health promotion, this study investigated the efficacy and possible moderators of mindfulness, self-compassion, and cognitive behavioral psychoeducation training mobile apps in the improvement of mental health. OBJECTIVE:The aim of this study was to examine the efficacy of 3 mobile app-based programs: mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation program in improving mental well-being and reducing psychological distress. Changes in mindful awareness and self-compassion were also assessed. To further delineate the suitability of each program for different types of individuals, individual difference variables (ie, discomfort with emotions and tolerance for ambiguity) were explored for potential moderation. METHODS:This study was a 3-arm, randomized, controlled, noninferiority trial examining the efficacy of mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation. Participants were randomized into either 1 of the 3 conditions. Throughout the 4-week, 28-session program, participants spent 10-15 min daily reviewing the course content and practicing various related exercises. At preprogram, postprogram, and 3-month follow-up, participants also completed Web-based measures of mental well-being, psychological distress, mindful-awareness, and self-compassion as well as the proposed moderators. RESULTS:Among the 2161 study participants, 508 and 349 completed the post- and 3-month follow-up assessment, respectively. All 3 conditions (mindfulness-based program: N=703; cognitive behavioral psychoeducation: N=753; self-compassion program: N=705) were found to be efficacious in improving mental well-being and reducing psychological distress. All conditions enhanced mindful awareness at postprogram. Significant interaction effect was found on self-compassion; cognitive behavioral psychoeducation and self-compassion program, but not mindfulness-based program, significantly enhanced self-compassion at postprogram. No significant differences regarding usage and users' satisfaction were found among the 3 conditions. None of the proposed moderators were found to be significant. CONCLUSIONS:Mindfulness-based, self-compassion, and cognitive behavioral psychoeducation mobile apps were efficacious in improving mental well-being and reducing psychological distress among adults at postprogram and 3-month follow-up. Future app-based psychological training programs should consider gamification and personalization of content or feedback to enhance engagement and mitigate the high attrition rates that are common in app-based health promotion programs. TRIAL REGISTRATION:Chinese Clinical Trial Registry (ChiCTR) ChiCTR-TRC-13003468; http://www.chictr.org.cn/hvshowproject.aspx?id=6220 (Archived by WebCite at http://www.webcitation.org/734PlOz50).

Project description:IntroductionDepressive, anxiety and adjustment disorders are highly prevalent among mental health outpatients. The lack of funding for mental health problems produces inefficient results and a high burden of disease. New cost-effective group interventions aimed at treating these symptoms might be an appropriate solution to reduce the healthcare burden in mental health units. Mindfulness-based interventions (MBIs) have shown significant reductions in anxious, depressive and adjustment symptomatology. Recent research highlights the influence of compassion as a key mechanism of change. However, MBIs only address compassion implicitly, whereas compassion-based protocols consider it a core aspect of psychotherapy. In this randomised controlled trial, we hypothesise that the provision of attachment-based compassion therapy (ABCT), which is a compassion-based protocol, will be more effective than mindfulness-based stress reduction (MBSR), which is a conventional MBI programme, for the treatment of depressive, anxious and adaptive symptoms in patients in mental health settings.Methods and analysisApproximately 90 patients suffering from depressive, anxious or adjustment disorders recruited from Spanish mental health settings will be randomised to receive 8 weekly 2 hours group sessions of ABCT, 8 weekly 2.5 hours group sessions of adapted MBSR (with no full-day silent retreat) or treatment as usual (TAU), with a 1:1:1 allocation rate. Patients in the ABCT and adapted MBSR groups will also receive TAU. The main outcome will be general affective distress measured by means of the 'Depression Anxiety Stress Scales-21' at post-test as primary endpoint. Other outcomes will be quality of life, mindfulness, self-compassion and the use of healthcare services. There will be a 6-month follow-up assessment. Intention-to-treat analysis will be conducted using linear mixed models. Per-protocol and secondary outcome analyses will be performed. A data monitoring committee comprising the trial manager, the ABCT and MBSR teachers and an independent clinical psychologist will monitor for possible negative side effects.Ethics and disseminationApproval was obtained from the Ethics Committee of the General University Hospital of Castellón, Spain. The results will be submitted to peer-reviewed specialised journals, and brief reports will be sent to participants on request.Trial registration numberNCT03425487.

Project description:IntroductionPrevious studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately one year, leaving questions about the longer-term durability of response. The purpose of this study was to demonstrate continuing efficacy of milnacipran by characterizing changes in pain and other fibromyalgia symptoms after discontinuing long-term treatment. The mean length of milnacipran treatment at the time of randomized withdrawal was 36.1 months from initial exposure to milnacipran (range, 17.9 to 54.4 months).MethodsAfter completing a long-term, open-label, lead-in study of milnacipran (which followed varying periods of exposure in previous studies), adult patients with fibromyalgia entered the four-week open-label period of the current study for evaluation of ongoing treatment response. After the four-week period to confirm new baseline status, 151 patients taking milnacipran ≥100 mg/day and reporting ≥50% improvement from pre-milnacipran exposure in Visual Analogue Scale (VAS) pain scores were classified as responders. These responders entered the 12-week, double-blind withdrawal period in which they were randomized 2:1 to continue milnacipran or switched to placebo. The prespecified primary parameter was loss of therapeutic response (LTR), defined as increase in VAS pain score to <30% reduction from pre-milnacipran exposure or worsening of fibromyalgia requiring alternative treatment. Adverse events and vital signs were also monitored.ResultsTime to LTR was shorter in patients randomized to placebo than in patients continuing milnacipran (P < 0.001). Median time to LTR was 56 days with placebo and was not calculable for milnacipran, because less than half of the latter group of patients lost therapeutic response by study end. Additionally, 81% of patients continuing on milnacipran maintained clinically meaningful pain response (≥30% improvement from pre-milnacipran exposure), compared with 58% of patients switched to placebo (sensitivity analysis II; P < 0.001). The incidences of treatment-emergent adverse events were 58% and 47% for placebo and milnacipran, respectively. Mean decreases in blood pressure and heart rate were found in both groups, with greater decreases for patients switched to placebo.ConclusionsContinuing efficacy of milnacipran was demonstrated by the loss of effect following withdrawal of treatment in patients who received an average of three years of milnacipran treatment.Trial registrationClinicalTrials.gov: NCT01014585.

Dataset Information

Efficacy of "Attachment-Based Compassion Therapy" in the Treatment of Fibromyalgia: A Randomized Controlled Trial.

Publications

Efficacy of "Attachment-Based Compassion Therapy" in the Treatment of Fibromyalgia: A Randomized Controlled Trial.

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