Unified Protocol for Multiple Sclerosis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kessler Foundation
Disqualifiers: Neurological illness, Cognitive impairment, others
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.
What data supports the effectiveness of the Unified Protocol treatment for Multiple Sclerosis?
The Unified Protocol has been shown to help reduce symptoms like depression and improve emotional regulation in people with emotional disorders, according to a pilot study in Argentina. It has also been effective in treating anxiety and mood disorders, suggesting it might help with emotional challenges in Multiple Sclerosis.12345
How is the Unified Protocol treatment different from other treatments for multiple sclerosis?
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.Inclusion Criteria
English-speaking
I am experiencing severe depression or anxiety.
Able to provide informed consent
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Exclusion Criteria
I do not have any cognitive issues that would prevent me from participating.
I have a history of a neurological condition like epilepsy or dementia.
Current participation in another randomized controlled trial
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Unified Protocol intervention through 12 weeks of virtual group sessions focused on reducing depression and anxiety.
12 weeks
12 virtual group sessions
Follow-up
Participants are monitored for changes in depression, anxiety, and secondary outcomes such as well-being and quality of life.
12 weeks
Assessments at 12 and 24 weeks
Treatment Details
Interventions
- Unified Protocol (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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
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.
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).
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.
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.
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.
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).
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.
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.
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.