Coping and Adjusting to Living With Multiple Sclerosis (CALMS)
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|ClinicalTrials.gov Identifier: NCT04300816|
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: CBT for Uncertainty Tolerance Behavioral: Traditional CBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||3- arm randomized clinical trial. Arms: (1) CBT for uncertainty tolerance, (2) traditional CBT, (3) treatment as usual|
|Masking:||None (Open Label)|
|Masking Description:||Research manager will be blinded for this trial. Research coordinator and investigator will not.|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of a Psychosocial Intervention to Improve Ability to Cope With Uncertainty in MS|
|Actual Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2023|
Seven telephone-based sessions of cognitive behavioral therapy for uncertainty tolerance (CBT-UT) delivered over seven weeks.
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.
Other Name: CBT-UT
Active Comparator: tCBT
Seven telephone-based sessions of traditional cognitive behavioral therapy (tCBT) delivered over seven weeks.
Behavioral: 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.
Other Name: tCBT
No Intervention: TAU
Participant continues with their lives as they normally would.
- Questionnaire: Level of MS Acceptance as measured by the Acceptance of Chronic Health Conditions, MS Version Questionnaire. [ Time Frame: 6 Months ]This is a self-reported measure of perceived MS Acceptance. Greater scores represent greater MS Acceptance.
- Questionnaire: Level of anxiety as measured by the Global Anxiety Disorder-7 scale (GAD-7). [ Time Frame: 6 Months ]This is a self-reported measure of perceived anxiety. Greater scores represent greater levels of anxiety.
- Questionnaire: Level of depression as measured by the Patient Health Questionnaire (PHQ-9). [ Time Frame: 6 Months ]This is a self-reported measure of perceived depression. Greater scores represent greater levels of depression.
- Demographic: MS Progression Type. Measured by self-reported type of MS. [ Time Frame: Baseline ]This is a self-reported demographic question. Options include: Relapsing-Remitting, Primary-Progressive, Secondary-Progressive, Progressive-Relapsing, and Don't Know.
- Demographic: Biological Sex. Measured by self-report. [ Time Frame: Baseline ]This is a self-reported demographic question. Options include: Male, Female, Transgender, and If not listed explain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300816
|Contact: Katie Singsank, BAfirstname.lastname@example.org|
|Contact: Aaron Flaster, BAemail@example.com|
|Principal Investigator:||Ivan Molton, PhD||University of Washington|