Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2023-04-10
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Unified Protocol 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.
Unified Protocol
The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety.
Control group
The control group will not receive any intervention and will complete the same baseline and follow-up assessments.
No interventions assigned to this group
Interventions
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Unified Protocol
The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Kessler Foundation
OTHER
Responsible Party
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Lauren Strober
Principle Investigator
Locations
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Kessler Foundation
East Hanover, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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E-1205-23
Identifier Type: -
Identifier Source: org_study_id
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