NCT05953519

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

April 12, 2023

Last Update Submit

July 12, 2023

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Hospital Anxiety and Depression Scale (HADS) - Change in Depression

    Self-report measure of depression. Scores range from 0-21 with higher scores indicating greater depression.

    Baseline, 12 weeks, 24 weeks

  • Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety

    Self-report measure of anxiety. Scores range from 0-21 with higher scores indicating greater anxiety.

    Baseline, 12 weeks, 24 weeks

Secondary Outcomes (11)

  • Modified Fatigue Impact Scale (MFIS) - Change in Fatigue

    Baseline, 12 weeks, 24 weeks

  • Pittsburgh Sleep Quality Index (PQSI) - Change in Sleep

    Baseline, 12 weeks, 24 weeks

  • MOS Pain Effects Scale (PES) - Change in Pain

    Baseline, 12 weeks, 24 weeks

  • General Self-Efficacy Scale (GSES) - Change in Self-efficacy

    Baseline, 12 weeks, 24 weeks

  • University of Washington Self-Efficacy Scale - Change in MS specific self-efficacy

    Baseline, 12 weeks, 24 weeks

  • +6 more secondary outcomes

Study Arms (2)

Unified Protocol intervention

EXPERIMENTAL

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.

Behavioral: Unified Protocol

Control group

NO INTERVENTION

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

Interventions

Unified ProtocolBEHAVIORAL

The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety.

Unified Protocol intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Belinda L Washington, BA

CONTACT

973-324-8446bwashington@kesslerfoundation.org

Lauren B Strober, PhD

CONTACT

973-324-8459lstrober@kesslerfoundation.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor is blinded to the group assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 12, 2023

First Posted

July 20, 2023

Study Start

April 10, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2026

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

US(1)