Dataset Information

Transdiagnostic treatment of emotional disorders for women with multiple sclerosis: a randomized controlled trial.

ABSTRACT:

Background

Multiple sclerosis (MS) is a chronic, unpredictable, neurodegenerative disease, significantly associated with psychological, behavioral, cognitive, and emotional consequences. MS is more common in females than males and frequently affects women during their reproductive years. Despite the frequent mental disorders, comorbidities, and emotional problems in People with MS (PwMS), these conditions are too often underdiagnosed and undertreated.

Objective

This study aimed to examine the efficacy of a group format of the Unified Protocol (UP) for the Transdiagnostic treatment of depression and anxiety disorders in females with MS.

Methods

In the present study, Sixty-four adult females diagnosed with MS were randomized to either the UP (n?=?32) or treatment-as-usual conditions. The assessment protocol included semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional regulation, and affectivity.

Results

Repeated measure analysis of variance (ANOVA) revealed that the UP significantly improved depression scores [Cohen's d?=?-?2.11, 95% CI (-?2.72, -?1.50)], anxiety scores [Cohen's d?=?-?3.34, 95% CI (-?4.01, -?2.58)], positive and negative affect scale (PANAS)-positive affect scores [Cohen's d?=?1.46, 95% CI (1.46, 2.01)], PANAS-negative affect scores [Coen's d?=?-?2.21, 95% CI (-?2.84, -?1.60)], difficulties emotion regulation scale scores [Cohen's d?=?1.40, 95% CI (-?0.87, -?0.03)], and Worry scale scores [Cohen's d?=?-?0.45, 95% CI (-?0.95, -?0.04)] at the end of treatment relative to compared to the control condition. Also, treatment gains were maintained at the three-month follow-up (p?ConclusionThe findings provide the support that the UP could be an additional efficient psychological treatment for females with MS. ISRCTN Number: ISRCTN95459505.

SUBMITTER: Nazari N

PROVIDER: S-EPMC7603725 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Transdiagnostic treatment of emotional disorders for women with multiple sclerosis: a randomized controlled trial.

Nazari Nabi N Nazari Nabi N Aligholipour Akram A Sadeghi Masoud M

BMC women's health 20201031 1

<h4>Background</h4>Multiple sclerosis (MS) is a chronic, unpredictable, neurodegenerative disease, significantly associated with psychological, behavioral, cognitive, and emotional consequences. MS is more common in females than males and frequently affects women during their reproductive years. Despite the frequent mental disorders, comorbidities, and emotional problems in People with MS (PwMS), these conditions are too often underdiagnosed and undertreated.<h4>Objective</h4>This study aimed to ...[more]

PMID: 33129298

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Project description:Significant evidence does exist on the effectiveness of transdiagnostic interventions to improve emotional problems in clinical populations, and their application as universal and indicated prevention programs. However, no randomized controlled trials (RCT) studying selective transdiagnostic prevention intervention have been published. This is the first known RCT to evaluate the efficacy/effectiveness of an evidence-based selective prevention transdiagnostic program for emotional problems in adolescents. The impact of three different interventions was evaluated: (1) PROCARE (Preventive transdiagnostic intervention for Adolescents at Risk for Emotional disorders), which is a group-based, abbreviated version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A), along with adding a booster session to reduce risk of onset of anxiety and depression, (2) PROCARE + , which includes the PROCARE protocol along with personalized add-on modules tailored to match adolescents' risk factors, and (3) an active control condition (ACC) based on emotional psychoeducation. In total, 208 adolescents (48.5% girls) evidencing high risk and low protective factors were randomized and allocated to PROCARE, PROCARE + or ACC. Data from 153 adolescents who completed all assessments in the different phases of the study were analyzed. Self- and parent-reported measures were taken at baseline, as well as after the intervention, a 6 month follow-up was carried out, together with a 1 month follow-up after the booster session. Differences between conditions were significant on most of the outcome measures, with superior effect sizes for PROCARE + in the short and long term. Interventions were acceptable in terms of acceptability, with good satisfaction rates. Tailored targeted selective transdiagnostic interventions focused on mitigating risk factors and promoting protective factors in vulnerable adolescents are promising.

Project description:BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has been an emotionally challenging time, especially for young adults. It is associated with a substantial increase in the prevalence of mental health problems, negative symptoms, and stressful experiences that compromise well-being. In low-income countries, internet-delivered psychological services could have a remarkable impact on the population's mental health, given the lack of mental health professionals.AimTo investigate the efficacy of internet-delivered cognitive-behavior therapy (CBT)-transdiagnostic intervention for adults with emotional disorders.MethodsIn this internet-delivered randomized controlled trial, 102 students with an emotional disorder (mean age = 28.20 years, standard deviation = 5.07) were randomly allocated to receive unified protocol (UP) (n = 51) or treatment as the usual intervention. Following a semi-structured clinical interview, participants completed an online survey including the Overall Anxiety Severity and Impairment Scale, Overall Depression Severity and Impairment Scale, Difficulties in Emotion Regulation Scale, Positive and Negative Affect Schedule, and Emotional Style Questionnaire.ResultsThe participants showed a high degree of adherence. In total, 78% (n = 40) of the experimental group participants completed the UP treatment. Considering the intention to treat procedure, the results of the analysis of covariance indicated that participants who received UP showed statistically significant changes in depression symptoms [Cohen's d = -1.50 with 95% confidence interval (CI): -1.90 to -1.10], anxiety (Cohen's d = -1.06 with 95%CI: -1.48 to -0.65), difficulties with emotion regulation (Cohen's d = -0.33 with 95%CI: -0.7 to -0.06), positive affect (Cohen's d = 1.27 with 95%CI: 0.85 to 1.68), negative affect (Cohen's d= -1.04 with 95%CI: -1.46 to -0.63), and healthy emotionality (Cohen's d = 0.53 with 95%CI: 0.09 to 0.13) compared with the control group.ConclusionThis study's findings highlight the potential value of transdiagnostic internet-delivered programs for young adults with an emotional disorder during the COVID-19 pandemic, and expand the research examining emotional well-being improvements resulting from CBT-transdiagnostic interventions. The findings suggest that UP, which generally concentrates on reducing negative effects, can increase positive effects.

Project description:BackgroundAnxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments, especially in public health care settings where resources are limited. Recent advances in improving CBT dissemination encompass different perspectives. One is the transdiagnostic approach, which offers treatment protocols that can be used for a range of emotional disorders. Another approach is the use of the internet to reach a larger number of people who could benefit from CBT.ObjectiveThis study aimed to analyze the effectiveness and acceptability of a transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance in patients from public specialized mental health care settings.MethodsA 2-armed randomized controlled trial (RCT) was conducted to compare the effectiveness of EmotionRegulation with treatment as usual (TAU) in specialized mental health care. In all, 214 participants were randomly assigned to receive either EmotionRegulation (n=106) or TAU (n=108). Measurement assessments were conducted at pre- and postintervention and at a 3-month follow-up.ResultsThe results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up. Furthermore, the results for expectations and opinions showed that EmotionRegulation was well accepted by participants.ConclusionsEmotionRegulation was more effective than TAU for the treatment of emotional disorders in the Spanish public mental health system. The implications of this RCT, limitations, and suggestions for future research are discussed.Trial registrationClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668.

Project description:BackgroundEmotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health.ObjectiveThis study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample.MethodsA 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed.ResultsWithin-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol.ConclusionsOverall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component.Trial registrationClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758.International registered report identifier (irrid)RR2-10.1186/s12888-017-1297-z.

Project description:ImportanceTransdiagnostic interventions have been developed to address barriers to the dissemination of evidence-based psychological treatments, but only a few preliminary studies have compared these approaches with existing evidence-based psychological treatments.ObjectiveTo determine whether the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is at least as efficacious as single-disorder protocols (SDPs) in the treatment of anxiety disorders.Design, setting, and participantsFrom June 23, 2011, to March 5, 2015, a total of 223 patients at an outpatient treatment center with a principal diagnosis of panic disorder with or without agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, or social anxiety disorder were randomly assigned by principal diagnosis to the UP, an SDP, or a waitlist control condition. Patients received up to 16 sessions of the UP or an SDP for 16 to 21 weeks. Outcomes were assessed at baseline, after treatment, and at 6-month follow-up. Analysis in this equivalence trial was based on intention to treat.InterventionsThe UP or SDPs.Main outcomes and measuresBlinded evaluations of principal diagnosis clinical severity rating were used to evaluate an a priori hypothesis of equivalence between the UP and SDPs.ResultsAmong the 223 patients (124 women and 99 men; mean [SD] age, 31.1 [11.0] years), 88 were randomized to receive the UP, 91 to receive an SDP, and 44 to the waitlist control condition. Patients were more likely to complete treatment with the UP than with SDPs (odds ratio, 3.11; 95% CI, 1.44-6.74). Both the UP (Cohen d, -0.93; 95% CI, -1.29 to -0.57) and SDPs (Cohen d, -1.08; 95% CI, -1.43 to -0.73) were superior to the waitlist control condition at acute outcome. Reductions in clinical severity rating from baseline to the end of treatment (β, 0.25; 95% CI, -0.26 to 0.75) and from baseline to the 6-month follow-up (β, 0.16; 95% CI, -0.39 to 0.70) indicated statistical equivalence between the UP and SDPs.Conclusions and relevanceThe UP produces symptom reduction equivalent to criterion standard evidence-based psychological treatments for anxiety disorders with less attrition. Thus, it may be possible to use 1 protocol instead of multiple SDPs to more efficiently treat the most commonly occurring anxiety and depressive disorders.Trial registrationclinicaltrials.gov Identifier: NCT01243606.

Project description:BackgroundEmotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied.Methods/designThe study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed.DiscussionAlthough the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low. To our knowledge, this is the first randomized controlled trial studying the effectiveness of a transdiagnostic Internet-based treatment for several emotional disorders in public specialized care. Combining both a transdiagnostic approach with an Internet-based therapy format may help to decrease the burden of mental disorders, reducing the difficulties associated with disorder-specific treatments and facilitating access to people in need of treatment. Strengths and limitations are discussed.Trial registrationClinicalTrials.gov NCT02345668 . Registered 27 July 2015.

Project description:BackgroundEmotional disorders (ED) are among the most prevalent mental disorders. However, less than 50% of people suffering from ED receive the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which tries to address the underlying processes common to ED. Most of these programs focus primarily on down-regulating negative affectivity, rather than increasing strengths and up-regulating positive affectivity. The data suggest the existence of disturbances in positive affectivity in these disorders, and so new interventions focusing on these problems are greatly needed. It is also essential to provide assistance to all the people in need. Information and Communication Technologies can be very useful. This study aims to evaluate the efficacy of a transdiagnostic Internet-based treatment for ED in a community sample. The protocol includes traditional CBT components, as well as a specific component to address positive affect. We intend to test this protocol, including this specific component or not, versus a waiting list control group. Moreover, we aim to test the differential effect of this specific component, and study the effectiveness (in terms of patients' acceptance) of using a self-applied Internet-based program. This paper presents the study protocol.MethodsThe study is a randomized controlled trial. 207 participants will be randomly assigned to: a)Transdiagnostic Internet-based protocol (TIBP), b)Transdiagnostic Internet-based protocol + positive affect component (TIBP + PA), or c)a Waiting List control group (WL). Primary outcomes measures will be the BDI-II, the BAI, and the PANAS. Secondary outcomes will include diagnosis-specific measures of the principal disorder. Participants' treatment acceptance will also be measured. Participants will be assessed at pre-, post-treatment, and 3- and 12- month follow-ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed.DiscussionTo the best of our knowledge, this is the first study of a transdiagnostic Internet-based treatment for ED with a specific component to up-regulate positive affectivity. This intervention could contribute to improve the efficiency and effectiveness of current treatment programs for ED, promote the dissemination of EBTs, and help to decrease the high prevalence of ED.Trial registrationClinicalTrial.gov: NCT02578758 . Registered 15 October 2015.

Project description:BACKGROUND: Spasticity is a common and poorly controlled symptom of multiple sclerosis. Our objective was to determine the short-term effect of smoked cannabis on this symptom. METHODS: We conducted a placebo-controlled, crossover trial involving adult patients with multiple sclerosis and spasticity. We recruited participants from a regional clinic or by referral from specialists. We randomly assigned participants to either the intervention (smoked cannabis, once daily for three days) or control (identical placebo cigarettes, once daily for three days). Each participant was assessed daily before and after treatment. After a washout interval of 11 days, participants crossed over to the opposite group. Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale. Our secondary outcomes included patients' perception of pain (as measured using a visual analogue scale), a timed walk and changes in cognitive function (as measured by patient performance on the Paced Auditory Serial Addition Test), in addition to ratings of fatigue. RESULTS: Thirty-seven participants were randomized at the start of the study, 30 of whom completed the trial. Treatment with smoked cannabis resulted in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo (p < 0.0001). In addition, treatment reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo (p = 0.008). Scores for the timed walk did not differ significantly between treatment and placebo (p = 0.2). Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo (p = 0.003). No serious adverse events occurred during the trial. INTERPRETATION: Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity. Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact.

Project description:BACKGROUND:Demand for primary care (PC) services in Spain exceeds available resources. Part of this strong demand is due to the high prevalence of emotional disorders (EDs)-anxiety, depression, and somatic symptom disorders-and related comorbidities such as pain or chronic illnesses. EDs are often under- or misdiagnosed by general practitioners (GPs) and, consequently, treatment is frequently inadequate. OBJECTIVE:We aim to compare the short- and long-term effectiveness of group-delivered transdiagnostic cognitive behavioral therapy (TD-CBT) versus treatment as usual (TAU) in the treatment of EDs in the PC setting in Spain. We also aim to compare the effect of these treatments on disability, quality of life, cognitive-emotional factors, and treatment satisfaction. METHODS:Here we present the study design of a two-arm, single-blind, randomized controlled trial (N=1126) to compare TAU to TD-CBT for EDs. TAU will consist primarily of pharmacological treatment and practical advice from the GP while TD-CBT will be administered in seven 90-minute group sessions held over a period ranging from 12 to 14 weeks. Psychological assessments are carried out at baseline (ie, pretreatment); posttreatment; and at 3-, 6-, and 12-month follow-up. The study is conducted in approximately 26 PC centers from the National Health System in Spain. RESULTS:This study was initiated in December 2013 and will remain open to new participants until recruitment and follow-up has been completed. We expect all posttreatment evaluations to be completed by December 2017, and follow-up will end in December 2018. CONCLUSIONS:We expect the TD-CBT group to have better results compared to TAU on all posttreatment measures and that this improvement will be maintained during follow-up. This project could serve as a model for use in other areas or services of the National Health System in Spain and even in other countries. CLINICALTRIAL:International Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3).

Dataset Information

Transdiagnostic treatment of emotional disorders for women with multiple sclerosis: a randomized controlled trial.

Background

Objective

Methods

Results

Publications

Transdiagnostic treatment of emotional disorders for women with multiple sclerosis: a randomized controlled trial.

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