Unified Protocol for Multiple Sclerosis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Kessler Foundation
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.
Is the Unified Protocol a promising treatment for multiple sclerosis?The Unified Protocol is a promising treatment for multiple sclerosis because it focuses on improving emotional health, which is important for people with MS. It can help manage psychological issues like depression and personality changes, which are common in MS patients. By addressing these emotional challenges, the treatment can improve the overall quality of life for those with MS.135611
What safety data exists for the Unified Protocol for Multiple Sclerosis treatment?The provided research does not directly mention safety data for the Unified Protocol for Multiple Sclerosis or the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. The studies focus on the safety profiles of various disease-modifying therapies (DMTs) for multiple sclerosis, including newer DMTs, mitoxantrone, and other immunomodulatory options. These studies emphasize the importance of understanding treatment-related adverse events and the need for comprehensive risk-benefit assessments in MS treatments. However, none of the studies specifically address the safety data for the Unified Protocol.247910
What data supports the idea that Unified Protocol for Multiple Sclerosis is an effective treatment?The available research shows that the Unified Protocol (UP) is effective for treating emotional disorders, which can be related to conditions like multiple sclerosis. In a pilot study in Argentina, people who received UP in a virtual and group format showed significant improvements in mood and quality of life. Another study found that UP was effective for treating multiple emotional disorders at once, compared to treatments that focus on just one disorder. These findings suggest that UP could be a helpful treatment for emotional challenges associated with multiple sclerosis.812131415
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults over 18 with multiple sclerosis who are dealing with significant depression or anxiety. Participants must speak English, be able to consent, and have internet access. It's not for those with cognitive impairments that affect group participation, other major neurological illnesses, or those already in a different clinical group therapy or trial.Treatment Details
The study is testing the Unified Protocol to see if it can reduce depression and anxiety in people with MS. It also looks at whether this treatment improves overall well-being, quality of life (QOL), and coping strategies.
2Treatment groups
Experimental Treatment
Active Control
Group I: Unified Protocol interventionExperimental Treatment1 Intervention
The Unified Protocol consists of 12-weeks, virtual, group sessions focused on reducing depression and anxiety through: (1) Increasing emotional awareness; (2) Cognitive restructuring against dysfunctional beliefs; (3) Changing action tendencies associated with disordered emotions; (4) Preventing emotional avoidance and utilizing emotion exposure techniques; (5) Providing mutual help among group members; and (6) Providing opportunities for corrective experiences.
Group II: Control groupActive Control1 Intervention
The control group will not receive any intervention and will complete the same baseline and follow-up assessments.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Kessler FoundationEast Hanover, NJ
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Who is running the clinical trial?
Kessler FoundationLead Sponsor
References
Physical and psychosocial functioning in multiple sclerosis: descriptions, correlations, and a tentative typology. [2019]Multiple sclerosis (MS) is a disease of great variety and ambiguity. It outcome is both multidimensional and uncertain. As part of an ongoing effort to describe and differentiate the various courses that MS can follow, 81 out-patients diagnosed with MS completed the California Psychological Inventory (CPI) and the Sickness Impact Profile (SIP) administered as a structured interview. Descriptive statistics for the SIP and the CPI are provided and examined as a function of age and sex. Correlations between health status and personality scales are reported. Increasing physical dysfunction is associated with lowered performance on a broad array of psychosocial dimensions but only among women. A cluster analysis of CPI factor scores is described and a very tentative typology of persons with MS is offered for further investigation.
[EDMUS--a new European databank for multiple sclerosis. A brief introduction of ongoing and planned multicenter studies within the scope of the "European Concentrated Action for Multiple Sclerosis"]. [2013]EDMUS, the European Database for Multiple Sclerosis (MS), was established on the occasion of the first European Concerted Action for MS under the auspices of the European Community. The system is user-friendly and makes it possible to record and retrieve data relevant to MS. Within the framework of another European Concerted Action, several international multicenter trials are currently in progress. EVALUED, a validation of the EDMUS system, assesses the interrater variability; PRIMS examines the influence of pregnancy and the post-partum period on the course of MS; and PRESTIMUS investigates predictive factors in suspected MS. Further, planned studies include ERAZMUS (early azathioprine and interferon-beta treatment in MS) and AZASTOP, which is designed to evaluate the effect of stopping azathioprine treatment.
Personality characteristics and disorders in multiple sclerosis patients: assessment and treatment. [2022]Multiple sclerosis (MS) is a major inflammatory and demyelinating disease of the central nervous system. Although a significant incidence and prevalence of psychological disorders in MS has been reported there is limited data on the prevalence of personality disorders (PD) in these patients. Recent findings indicate the need for early diagnosis and treatment of PD in MS patients in the interests of prognosis, conformity to treatment and patient's quality of life improvement. This article summarizes existing evidence on prevalence, types and diagnostic criteria of PD in MS, clinical manifestations of personality pathology or changes in MS patients, and instruments currently used for diagnosis and assessment of PD in this group of patients. Underlying mechanisms suggested as causes of personality changes in MS patients are also discussed. The article reviews therapeutic strategies, including pharmacotherapy and psychotherapy interventions and emphasizes the need for a multidisciplinary approach to patient's treatment.
Long-term treatment risks in multiple sclerosis: risk knowledge and risk perception in a large cohort of mitoxantrone-treated patients. [2015]Balancing treatment benefits and risks is part of a shared decision-making process before initiating any treatment in multiple sclerosis (MS). Patients understand, appreciate and profit from evidence-based patient information (EBPI). While these processes are well known, long-term risk awareness and risk processing of patients has not been studied. Mitoxantrone treatment in MS is associated with long-term major potential harms - leukaemia (LK) and cardiotoxicity (CT). The risk knowledge and perception among patients currently or previously treated with mitoxantrone is unknown.
Depression in multiple sclerosis: a review of assessment and treatment approaches in adult and pediatric populations. [2023]Multiple sclerosis is a chronic demyelinating disease affecting one million people worldwide, with a significant burden of psychiatric comorbidity. Depression is the commonest psychiatric manifestation but still remains largely underdiagnosed and undertreated. The present work reviews current knowledge on diagnosis, assessment, and somatic and psychotherapeutic treatment interventions for depression in adult and pediatric populations of patients with multiple sclerosis.
Symptom variability, affect and physical activity in ambulatory persons with multiple sclerosis: Understanding patterns and time-bound relationships. [2017]Individuals with multiple sclerosis (MS) experience a clinical course that is highly variable with daily fluctuations in symptoms significantly affecting functional ability and quality of life. Yet, understanding how MS symptoms co-vary and associate with physical and psychological health is unclear.
ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis. [2022]Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process.
Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. [2019]This study aimed to examine whether the Unified Protocol (UP), a transdiagnostic cognitive-behavioral therapy for emotional disorders (i.e., anxiety, mood, and related disorders), is efficacious in the treatment of co-occurring emotional disorders compared to established single disorder protocols (SDPs) that target specific disorders (e.g., panic disorder).
Assessing the risk of multiple sclerosis disease-modifying therapies. [2020]Introduction: The number of immunomodulatory options approved for multiple sclerosis has increased over the past years, resulting in a better control of the disease. Depending on disease activity, neurologists can now propose treatments with different levels of efficacy, from injectable and oral treatments with modest efficacy, to highly active immunosuppressants. Nevertheless, this gain in efficacy has come with an increase in the global burden of treatment-related adverse events. Areas covered: The authors have reviewed extensively the existing literature to gain insight into the adverse events associated with disease modifying therapies, so as to help neurologists choose the right treatment for their patients. The authors classified and summarized the adverse events based on frequency, severity and relevance. Expert opinion: As the number and diversity of adverse events is expected to increase, careful surveillance of patients under treatment will be even more important. The characteristics of the MS population, i.e. mainly young women of childbearing age, who will remain treated for decades, and the need for serial administration of distinct treatments with different mechanisms of action highlights the importance of a comprehensive risk-benefit assessment.
Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. [2022]Optimise:MS is an observational pharmacovigilance study aimed at characterizing the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in a real world population. The study will categorize and quantify the occurrence of serious adverse events (SAEs) in a cohort of MS patients recruited from clinical sites around the UK. The study was motivated particularly by a need to establish the safety profile of newer DMTs, but will also gather data on outcomes among treatment-eligible but untreated patients and those receiving established DMTs (interferons and glatiramer acetate). It will also explore the impact of treatment switching.
Comparison of spouse and patient personality change judgments following MS onset. [2023]This is the first study to estimate the prevalence and predictors of spouse and patient perceptions of global/overall personality change (PC) in patients with multiple sclerosis (MS).
A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans. [2023]The unified protocol (UP) is a promising transdisgnostic treatment for emotional disorders; limited data exists with trauma-exposed populations. This study compared effectiveness of the UP, presented centered therapy (PCT), and treatment as usual (TAU) in trauma-exposed veterans presenting to routine care.
Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. [2023]The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders is a flexible form of cognitive behavioural therapy targeting diverse mental health disorders in children and adults.
Efficacy of the unified protocol for transdiagnostic cognitive-behavioral treatment for depressive and anxiety disorders: a randomized controlled trial. [2023]The efficacy of the unified protocol of the transdiagnostic treatment for emotional disorders (UP) has been poorly studied in patients with depressive disorders. This study aimed to examine the efficacy of UP for improving depressive symptoms in patients with depressive and/or anxiety-related disorders.
Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study [2023]The Unified Protocol (UP) is a psychotherapeutic intervention that has proven to be effective for the transdiagnostic treatment of emotional disorders, both in individual and group format. Recently, its virtual application through teletherapy has begun to be studied. In a previous pilot study carried out in Argentina in a sample of 7 subjects, significant decreases were observed in levels of depression, difficulties in emotional regulation, hopelessness and negative affect and a significant increase in quality of life after having applied the PU in virtual and group format to people with emotional disorders.