Meeting an Unmet Need in Multiple Sclerosis

Kessler Foundation

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Behavioral: Unified Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05953519

E-1205-23

Details and patient eligibility

About

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.

Full description

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.

To achieve this, the investigation has the following specific aims:

Specific Aim 1: Conduct a pilot Randomized Controlled Trial (RCT) of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in reducing depression and anxiety.

Hypothesis 1: Individuals who participate in the Unified Protocol intervention will report a decrease in their depression and anxiety compared to individuals in the control group.

Specific Aim 2: Conduct a pilot RCT of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in improving secondary outcomes of psychological well-being, QOL, coping, and MS symptomatology over time.

Hypothesis 2: Individuals who participate in the Unified Protocol intervention will report an increase in psychological well-being, QOL, coping, and MS symptomatology over time compared to participants in the control group.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of multiple sclerosis
• 18 years of age or older
• Experiencing significant depression and/or anxiety
• English-speaking
• Able to provide informed consent
• Access to the internet

Exclusion criteria

• History of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia)
• Current participation in another randomized controlled trial
• Cognitive impairment that would affect my ability to fully participate in the group
• Unable to attend group sessions
• Active participation in another formal clinical group or psychological therapy
• Any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Unified Protocol intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Unified Protocol

Control group

No Intervention group

Description:

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