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?
Research Team
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
See 3 more
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
See 3 more
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 Foundation
Lead Sponsor
Trials
190
Patients Recruited
11,300+
Findings from Research
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 studyCelleri, M., Cremades, CF., Rojas, L., et al.[2023]
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]
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]
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]
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]
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]
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]
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]
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]
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]
Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. [2019]
Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. [2023]
A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans. [2023]
Efficacy of the unified protocol for transdiagnostic cognitive-behavioral treatment for depressive and anxiety disorders: a randomized controlled trial. [2023]
Comparison of spouse and patient personality change judgments following MS onset. [2023]
Personality characteristics and disorders in multiple sclerosis patients: assessment and treatment. [2022]
Physical and psychosocial functioning in multiple sclerosis: descriptions, correlations, and a tentative typology. [2019]
Depression in multiple sclerosis: a review of assessment and treatment approaches in adult and pediatric populations. [2023]
Symptom variability, affect and physical activity in ambulatory persons with multiple sclerosis: Understanding patterns and time-bound relationships. [2017]