Coping and Adjusting to Living With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CALMS  

Official title:

Efficacy of a Psychosocial Intervention to Improve Ability to Cope With Uncertainty in MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300816
• Other study ID #: STUDY00007984
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: November 11, 2022

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to test a brief, telephone-based psychological intervention, CBT-UT, to improve the ability to tolerate uncertainty-and thereby to reduce distress-in people with a recent diagnosis of Multiple Sclerosis (MS). There are three treatment arms for this study. Participants will receive either (1) CBT for Uncertainty Tolerance, (2) Traditional CBT, or (3) treatment as usual.

Description:

Despite substantial improvements in diagnosis and treatment, Multiple Sclerosis (MS) remains an unpredictable disease. Although some physicians can make some predictions about expected progression, the variable course of exacerbations makes it almost impossible to predict how MS will develop or affect function over time. As a result, people with MS must learn to live in a state of chronic uncertainty and the ability to tolerate and cope with this kind of uncertainty is central to quality of life with MS. Individuals who require certainty about the future and are not able to tolerate ambiguity are said to be high in a personality trait known as intolerance of uncertainty (IU). There is a significant gap in MS clinical intervention that necessitates attention. An intervention that specifically targets IU, is developed for people recently diagnosed with MS, and can be provided remotely via telehealth can make a significant impact for this population. Study aims include: (1) to determine the efficacy of CBT-UT relative to traditional cognitive behavioral therapy (tCBT) or treatment as usual (TAU) in people diagnosed with MS in the past 3 years; and (2) To increase our understanding of the mechanisms underlying the intervention effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults over 18 years of age
• MS diagnosis using revised McDonald Criteria
• Able to read, speak, and understand English
• At least mild psychological distress evidenced by (1) a score of 20 or higher on the Kessler Psychological Distress Scale OR (2) a score greater than or equal to 5 on the Perceived Stress Scale.

Exclusion Criteria:

• Severe cognitive impairment defined as one or more error on the Six-Item Screener
• Psychiatric condition or symptoms that would interfere with participation, specifically (1) current, active suicidal ideation with current intent to harm oneself, (2) current psychosis, or (3) current mania.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• CBT for Uncertainty Tolerance
Participants work one-on-one with an interventionist. Treatment sessions focus on understanding the difference between the controllable and uncontrollable aspects of MS, ability to tolerate not knowing exactly what the future will hold, setting personal goals for what "accepting" what MS will look like, and finding ways to live in conjunction with personal values despite the MS diagnosis.
• Traditional CBT
Participants work one-on-one with an interventionist. Treatment sessions focus on goal setting, positive activities, identifying and challenging unhelpful thoughts, and bolstering social support.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire.	This is a self-reported measure of perceived MS Acceptance. Greater scores represent greater MS Acceptance.	6 Months
Primary	Questionnaire: Level of anxiety as measured by the Global Anxiety Disorder-7 scale (GAD-7).	This is a self-reported measure of perceived anxiety. Greater scores represent greater levels of anxiety.	6 Months
Primary	Questionnaire: Level of depression as measured by the Patient Health Questionnaire (PHQ-9).	This is a self-reported measure of perceived depression. Greater scores represent greater levels of depression.	6 Months
Secondary	Demographic: MS Progression Type. Measured by self-reported type of MS.	This is a self-reported demographic question. Options include: Relapsing-Remitting, Primary-Progressive, Secondary-Progressive, Progressive-Relapsing, and Don't Know.	Baseline
Secondary	Demographic: Biological Sex. Measured by self-report.	This is a self-reported demographic question. Options include: Male, Female, Transgender, and If not listed explain.	Baseline