Clinical trial NCT05953519: 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
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) - Change in Depression
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Modified Fatigue Impact Scale (MFIS) - Change in Fatigue
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Pittsburgh Sleep Quality Index (PQSI) - Change in Sleep
timeFrame: Baseline, 12 weeks, 24 weeks
measure: MOS Pain Effects Scale (PES) - Change in Pain
timeFrame: Baseline, 12 weeks, 24 weeks
measure: General Self-Efficacy Scale (GSES) - Change in Self-efficacy
timeFrame: Baseline, 12 weeks, 24 weeks
measure: University of Washington Self-Efficacy Scale - Change in MS specific self-efficacy
timeFrame: Baseline, 12 weeks, 24 weeks
measure: University of Washington Resilience Scale - Change in Resilience
timeFrame: Baseline, 12 weeks, 24 weeks
measure: COPE inventory - Change in Coping
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Benefit Finding in Multiple Sclerosis (BFIMS) - Change in Benefit-finding
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Satisfaction with Life Scale (SWLS) - Changes in Quality of Life
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Flourishing Scale (FS) - Change in Quality of Life
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Ryff Psychological Well-being Scales (RYFFPWB) - Changes in well-being
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: