Unified Protocol for Multiple Sclerosis

Overseen By Lauren Strober, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Neurological illness, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program designed to help people with multiple sclerosis (MS) manage depression and anxiety. Participants will join virtual group sessions over 12 weeks, focusing on understanding emotions, challenging negative thoughts, and learning new coping strategies. Known as the Unified Protocol, this program is specifically tailored for individuals with MS. People with MS experiencing significant depression or anxiety may be a good fit if they have internet access and can attend group sessions. The trial compares participants in the program to those who do not participate, assessing the program's effectiveness. As an unphased trial, this study offers an opportunity to contribute to valuable research that could enhance mental health support for those with MS.

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 prior data suggests that the Unified Protocol is safe for individuals with MS?

Research has shown that the Unified Protocol (UP) is generally safe for people. Studies have found it effective in treating emotional issues like anxiety and depression. Notably, fewer participants discontinue this program compared to other treatments, suggesting that most find it manageable.

The program increases awareness of emotions and helps change responses to them. It also encourages facing emotions rather than avoiding them. These approaches are usually well-tolerated, with few experiencing serious side effects. Overall, evidence suggests that the UP is a safe choice for managing emotional symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Unified Protocol for Multiple Sclerosis because it offers a fresh, holistic approach to addressing mental health challenges like depression and anxiety, which are common in MS patients. Unlike traditional treatments that often focus on medication, this protocol emphasizes virtual group therapy sessions that enhance emotional awareness and cognitive restructuring, helping patients tackle dysfunctional beliefs. Additionally, it encourages changing action tendencies linked to emotional disorders and fosters a supportive environment for mutual help, making it a potentially transformative tool for improving emotional well-being in MS patients.

What evidence suggests that the Unified Protocol is effective for reducing depression and anxiety in individuals with MS?

Research has shown that the Unified Protocol, which participants in this trial may receive, helps reduce anxiety and depression in people with multiple sclerosis (MS). Studies have found that this method outperforms usual treatments and control groups in enhancing emotional well-being. The protocol includes techniques such as increasing awareness of emotions and challenging negative thoughts, which help individuals manage their feelings better. It is as effective as treatments designed for specific disorders, making it a suitable option for those with emotional challenges related to MS. Overall, it offers a promising way to improve mental health for people living with this condition. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Unified Protocol

Trial Overview

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.

How Is the Trial Designed?

Group I: Unified Protocol intervention Experimental Treatment 1 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 group Active Control 1 Intervention

The control group will not receive any intervention and will complete the same baseline and follow-up assessments.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

The study analyzed daily fluctuations in symptoms, mood, and physical activity in four individuals with multiple sclerosis (MS) over 28 days, revealing significant time-dependent relationships among these factors.

Understanding these individual variability patterns can help tailor interventions for MS patients, addressing the diverse experiences and health outcomes related to their symptoms and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom variability, affect and physical activity in ambulatory persons with multiple sclerosis: Understanding patterns and time-bound relationships. Kasser, SL., Goldstein, A., Wood, PK., et al.[2017]

The unified protocol (UP) significantly reduced depressive symptoms in patients with depressive and/or anxiety disorders over a 20-week period, showing a mean change difference of -3.99 on the GRID-Hamilton depression rating scale compared to the wait-list group.

Patients receiving UP also experienced significant improvements in anxiety symptoms and overall clinical impressions, with these benefits maintained even at 43 weeks, and no serious adverse events were reported, indicating a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the unified protocol for transdiagnostic cognitive-behavioral treatment for depressive and anxiety disorders: a randomized controlled trial. Ito, M., Horikoshi, M., Kato, N., et al.[2023]

In a study involving 69 patients with multiple sclerosis and their spouses, both groups reported significant perceptions of personality change in patients, which were linked to patient distress and cognitive impairment.

Spouses' perceptions of personality change were found to predict the severity of physical symptoms and social support, suggesting that understanding these perceptions could be important for tailoring treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of spouse and patient personality change judgments following MS onset. Weddell, RA., Fisher-Hicks, S.[2023]

In a study of 81 out-patients with multiple sclerosis, it was found that increasing physical dysfunction correlates with lower psychosocial performance, particularly in women, highlighting the impact of MS on mental health and social functioning.

The research suggests a potential typology of individuals with MS based on personality traits and health status, which could help in understanding the diverse experiences of those living with the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and psychosocial functioning in multiple sclerosis: descriptions, correlations, and a tentative typology. Zeldow, PB., Pavlou, M.[2019]

The Unified Protocol (UP) for treating emotional disorders has shown promising results in a virtual group format, with significant improvements in depression, emotional regulation, and quality of life in a previous pilot study of 7 subjects.

After three months, the positive effects of the UP were maintained, indicating its potential for long-term efficacy in teletherapy settings, although more extensive research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study Celleri, M., Cremades, CF., Rojas, L., et al.[2023]

A brief online version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was tested with 19 young adults, showing that 72% attended at least four out of five sessions, indicating good feasibility for this format.

Participants reported that key concepts from the therapy, like understanding emotions and mindfulness, were useful in their daily lives, and there was a significant reduction in anxiety-related life impairment at the 12-week follow-up compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. Dimitropoulos, G., Lindenbach, D., Rowbotham, M., et al.[2023]

Depression is the most common psychiatric issue in people with multiple sclerosis, affecting both adults and children, yet it is often underdiagnosed and undertreated.

The review highlights the importance of proper diagnosis and assessment, as well as the need for both medical and psychological treatment options to effectively manage depression in multiple sclerosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression in multiple sclerosis: a review of assessment and treatment approaches in adult and pediatric populations. Skokou, M., Soubasi, E., Gourzis, P.[2023]

The Unified Protocol (UP) showed the greatest effectiveness in reducing anxiety and depression symptoms among trauma-exposed veterans, with significant decreases in self-reported measures and a notable reduction in the number of comorbid diagnoses.

In a study involving 37 veterans, the UP outperformed both Presented Centered Therapy (PCT) and Treatment as Usual (TAU), demonstrating large effect sizes for improvements in psychosocial functioning and emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans. Gutner, CA., Song, J., Canale, CA., et al.[2023]

There is a significant prevalence of personality disorders (PD) among multiple sclerosis (MS) patients, highlighting the importance of early diagnosis and treatment to improve patient outcomes and quality of life.

The article discusses various therapeutic strategies, including pharmacotherapy and psychotherapy, and emphasizes the necessity of a multidisciplinary approach to effectively manage personality changes in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personality characteristics and disorders in multiple sclerosis patients: assessment and treatment. Stathopoulou, A., Christopoulos, P., Soubasi, E., et al.[2022]

The Unified Protocol (UP) for treating emotional disorders was found to be as effective as established single disorder protocols (SDPs) in reducing symptoms of co-occurring emotional disorders among 179 adults, with significant improvements observed from baseline to post-treatment and at 12-month follow-up.

Both treatment approaches led to large reductions in symptoms of generalized anxiety, social anxiety, and depression, indicating that the UP is a viable and potentially more cost-effective option for treating multiple emotional disorders simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. Steele, SJ., Farchione, TJ., Cassiello-Robbins, C., et al.[2019]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33129356/

Transdiagnostic treatment of emotional disorders in people ...

This study aimed to examine the efficacy of a group format of the unified protocol for the transdiagnostic treatment of emotional disorders in adult PwMS.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7603744/

Transdiagnostic treatment of emotional disorders in people ...

This study aimed to examine the efficacy of a group format of the unified protocol for the transdiagnostic treatment of emotional disorders in adult PwMS

3.

withpower.com

withpower.com/trial/phase-multiple-sclerosis-3-2023-6b27b

Unified Protocol for Multiple Sclerosis

The Unified Protocol (UP) for treating emotional disorders was found to be as effective as established single disorder protocols (SDPs) in reducing symptoms of ...

4.

mdpi.com

mdpi.com/1660-4601/18/10/5077

Unified Protocol for the Transdiagnostic Treatment of ...

The overall results show that the UP is effective in improving emotional symptomatology in most studies, as well as medical symptomatology in some health ...

5.

unifiedprotocol.com

unifiedprotocol.com/research/

Research

The UP outperformed treatment-as-usual and waitlist control conditions in improving symptoms of anxiety and depression and reducing levels of negative affect ...

6.

teps.cl

teps.cl/index.php/teps/article/download/717/449/4907

A Feasibility pilot Study in Chilean Patients in Eating ...

Although these outcomes showed a decrease at the three-month follow-up, the scores remained higher than the baseline levels. Page 17. The Unified Protocol as a ...