Multiple SclerosisNCT05953519
Meeting an Unmet Need in Multiple Sclerosis
A study testing Unified Protocol in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Belinda Washington, B.A., 973-324-8446, bwashington@kesslerfoundation.org
Lauren B Strober, PhD, 973-324-8459, lstrober@kesslerfoundation.org
About this study
Official title: Meeting an Unmet Need in Multiple Sclerosis (MS): An Evaluation of the Effectiveness of a Transdiagnostic Psychological Treatment and Its Outcomes
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Unified Protocol
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol intervention | Experimental | 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. Receives: Behavioral: Unified Protocol |
| Control group | No intervention | The control group will not receive any intervention and will complete the same baseline and follow-up assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (11)
Modified Fatigue Impact Scale (MFIS) - Change in Fatigue
Self-report measure of fatigue. Scores range from 0-84 with higher scores indicating greater fatigue.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
MOS Pain Effects Scale (PES) - Change in Pain
Self-report measure of pain. Scores range from 0-30 with higher scores indicating greater pain.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
University of Washington Resilience Scale - Change in Resilience
Self-report measure of resilience. Scores range from 8-40 with higher scores indicating greater resilience.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start10 Apr 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Strober, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953519
- Sponsor's protocol ID
- E-1205-23
- Status last verified
- Jul 2023
- First submitted
- 12 Apr 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meeting an Unmet Need in Multiple Sclerosis (MS): An Evaluation of the Effectiveness of a Transdiagnostic Psychological Treatment and Its Outcomes
- ClinicalTrials.gov ID
- NCT05953519
- Acronym / sponsor ID
- E-1205-23
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol intervention | Experimental | Behavioral: Unified ProtocolThe 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. |
| Control group | No intervention | –The control group will not receive any intervention and will complete the same baseline and follow-up assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of multiple sclerosis
- 18 years of age or older
- Experiencing significant depression and/or anxiety
- English-speaking
- Able to provide informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified ProtocolThe Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety. | Behavioural | Unified Protocol intervention |
Primary outcome
Hospital Anxiety and Depression Scale (HADS) - Change in Depression
Time frame: Baseline, 12 weeks, 24 weeks
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
Time frame: Baseline, 12 weeks, 24 weeks
Self-report measure of anxiety. Scores range from 0-21 with higher scores indicating greater anxiety.
11 secondary outcomes
Modified Fatigue Impact Scale (MFIS) - Change in Fatigue
Time frame: Baseline, 12 weeks, 24 weeks
Pittsburgh Sleep Quality Index (PQSI) - Change in Sleep
Time frame: Baseline, 12 weeks, 24 weeks
MOS Pain Effects Scale (PES) - Change in Pain
Time frame: Baseline, 12 weeks, 24 weeks
General Self-Efficacy Scale (GSES) - Change in Self-efficacy
Time frame: Baseline, 12 weeks, 24 weeks
University of Washington Self-Efficacy Scale - Change in MS specific self-efficacy
Time frame: Baseline, 12 weeks, 24 weeks
University of Washington Resilience Scale - Change in Resilience
Time frame: Baseline, 12 weeks, 24 weeks
COPE inventory - Change in Coping
Time frame: Baseline, 12 weeks, 24 weeks
Benefit Finding in Multiple Sclerosis (BFIMS) - Change in Benefit-finding
Time frame: Baseline, 12 weeks, 24 weeks
Satisfaction with Life Scale (SWLS) - Changes in Quality of Life
Time frame: Baseline, 12 weeks, 24 weeks
Flourishing Scale (FS) - Change in Quality of Life
Time frame: Baseline, 12 weeks, 24 weeks
Ryff Psychological Well-being Scales (RYFFPWB) - Changes in well-being
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belinda L Washington, BA (973-324-8446, bwashington@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) - Change in Depression (time frame: Baseline, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.