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Meeting an Unmet Need in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Unified Protocol intervention

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Modified Fatigue Impact Scale (MFIS) - Change in Fatigue
Self-report measure of fatigue. Scores range from 0-84 with higher scores indicating greater fatigue.
Pittsburgh Sleep Quality Index (PQSI) - Change in Sleep
Self-report measure of sleep. Scores range from 0-21 with higher scores indicating greater sleep problems.
MOS Pain Effects Scale (PES) - Change in Pain
Self-report measure of pain. Scores range from 0-30 with higher scores indicating greater pain.
General Self-Efficacy Scale (GSES) - Change in Self-efficacy
Self-report measure of self-efficacy. Scores range from 10-40 with higher scores indicating greater self-efficacy.
University of Washington Self-Efficacy Scale - Change in MS specific self-efficacy
Self-report measure of disease self-efficacy. Scores range from 0-100 (T-scores) with higher scores indicating greater self-efficacy.
University of Washington Resilience Scale - Change in Resilience
Self-report measure of resilience. Scores range from 8-40 with higher scores indicating greater resilience.
COPE inventory - Change in Coping
Self-report measure of coping. Scores range from 4-16 for each coping scale with higher scores indicating greater coping.
Benefit Finding in Multiple Sclerosis (BFIMS) - Change in Benefit-finding
Self-report measure of positive coping. Scores range from 43-129 for the total scale with higher scores indicating greater benefit-finding.
Satisfaction with Life Scale (SWLS) - Changes in Quality of Life
Self-report measure of quality of life and satisfaction. Scores range from 5-35 with higher scores indicating greater life satisfaction.
Flourishing Scale (FS) - Change in Quality of Life
Self-report measure of quality of life. Scores range from 8-56 with higher scores indicating greater quality of life.
Ryff Psychological Well-being Scales (RYFFPWB) - Changes in well-being
Self-report measure of psychological well-being. Scores range from 14-84 for each subscale with higher scores indicating greater psychological well-being.

Full Information

First Posted
April 12, 2023
Last Updated
July 12, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05953519
Brief Title
Meeting an Unmet Need in Multiple Sclerosis
Official Title
Meeting an Unmet Need in Multiple Sclerosis (MS): An Evaluation of the Effectiveness of a Transdiagnostic Psychological Treatment and Its Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor is blinded to the group assignment
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unified Protocol intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not receive any intervention and will complete the same baseline and follow-up assessments.
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol
Intervention Description
The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS) - Change in Depression
Description
Self-report measure of depression. Scores range from 0-21 with higher scores indicating greater depression.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety
Description
Self-report measure of anxiety. Scores range from 0-21 with higher scores indicating greater anxiety.
Time Frame
Baseline, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Modified Fatigue Impact Scale (MFIS) - Change in Fatigue
Description
Self-report measure of fatigue. Scores range from 0-84 with higher scores indicating greater fatigue.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Pittsburgh Sleep Quality Index (PQSI) - Change in Sleep
Description
Self-report measure of sleep. Scores range from 0-21 with higher scores indicating greater sleep problems.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
MOS Pain Effects Scale (PES) - Change in Pain
Description
Self-report measure of pain. Scores range from 0-30 with higher scores indicating greater pain.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
General Self-Efficacy Scale (GSES) - Change in Self-efficacy
Description
Self-report measure of self-efficacy. Scores range from 10-40 with higher scores indicating greater self-efficacy.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
University of Washington Self-Efficacy Scale - Change in MS specific self-efficacy
Description
Self-report measure of disease self-efficacy. Scores range from 0-100 (T-scores) with higher scores indicating greater self-efficacy.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
University of Washington Resilience Scale - Change in Resilience
Description
Self-report measure of resilience. Scores range from 8-40 with higher scores indicating greater resilience.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
COPE inventory - Change in Coping
Description
Self-report measure of coping. Scores range from 4-16 for each coping scale with higher scores indicating greater coping.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Benefit Finding in Multiple Sclerosis (BFIMS) - Change in Benefit-finding
Description
Self-report measure of positive coping. Scores range from 43-129 for the total scale with higher scores indicating greater benefit-finding.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Satisfaction with Life Scale (SWLS) - Changes in Quality of Life
Description
Self-report measure of quality of life and satisfaction. Scores range from 5-35 with higher scores indicating greater life satisfaction.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Flourishing Scale (FS) - Change in Quality of Life
Description
Self-report measure of quality of life. Scores range from 8-56 with higher scores indicating greater quality of life.
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Ryff Psychological Well-being Scales (RYFFPWB) - Changes in well-being
Description
Self-report measure of psychological well-being. Scores range from 14-84 for each subscale with higher scores indicating greater psychological well-being.
Time Frame
Baseline, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Belinda L Washington, BA
Phone
973-324-8446
Email
bwashington@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren B Strober, PhD
Phone
973-324-8459
Email
lstrober@kesslerfoundation.org
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belinda Washington, B.A.
Phone
973-324-8446
Email
bwashington@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Lauren B Strober, PhD
Phone
973-324-8459
Email
lstrober@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Lauren Strober, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Meeting an Unmet Need in Multiple Sclerosis

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