Coping and Adjusting to Living With Multiple Sclerosis

NCT04300816 | Completed

• 1 other identifier: STUDY00007984
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Demographic: MS Progression Type. Measured by self-reported type of MS.

  Baseline

• Demographic: Biological Sex. Measured by self-report.

  Baseline

Study Arms (3)

CBT-UT

EXPERIMENTAL

Seven telephone-based sessions of cognitive behavioral therapy for uncertainty tolerance (CBT-UT) delivered over seven weeks.

Behavioral: CBT for Uncertainty Tolerance

tCBT

ACTIVE COMPARATOR

Seven telephone-based sessions of traditional cognitive behavioral therapy (tCBT) delivered over seven weeks.

Behavioral: Traditional CBT

TAU

NO INTERVENTION

Participant continues with their lives as they normally would.

Interventions

CBT for Uncertainty Tolerance BEHAVIORAL

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.

Also known as: CBT-UT

CBT-UT

Traditional CBT BEHAVIORAL

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.

Also known as: tCBT

tCBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ivan Molton, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research manager will be blinded for this trial. Research coordinator and investigator will not.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine: Psychology

Model Details: 3- arm randomized clinical trial. Arms: (1) CBT for uncertainty tolerance, (2) traditional CBT, (3) treatment as usual

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 9, 2020
• Study Start: October 30, 2019
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after the main study results are published.
• Access Criteria: Although any shared data will be stripped of identifiers prior to release, given the very specific nature of the study sample (individuals who have had a recent diagnosis of MS) it is possible that those who access this data could potentially identify subjects with unusual characteristics or combinations of unusual characteristics. Therefore, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)