Studies
| Study First Submitted Date | 2023-04-12 |
| Study First Posted Date | 2023-07-20 |
| Last Update Posted Date | 2023-07-20 |
| Start Month Year | April 10, 2023 |
| Primary Completion Month Year | April 30, 2025 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-07-20 |
Detailed Descriptions
| Sequence: | 20691301 |
| 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. |
Facilities
| Sequence: | 199714875 |
| Status | Recruiting |
| Name | Kessler Foundation |
| City | East Hanover |
| State | New Jersey |
| Zip | 07936 |
| Country | United States |
Facility Contacts
| Sequence: | 28068790 | Sequence: | 28068791 |
| Facility Id | 199714875 | Facility Id | 199714875 |
| Contact Type | primary | Contact Type | backup |
| Name | Belinda Washington, B.A. | Name | Lauren B Strober, PhD |
| [email protected] | [email protected] | ||
| Phone | 973-324-8446 | Phone | 973-324-8459 |
Facility Investigators
| Sequence: | 18307742 |
| Facility Id | 199714875 |
| Role | Principal Investigator |
| Name | Lauren Strober, PhD |
Conditions
| Sequence: | 52089935 |
| Name | Multiple Sclerosis |
| Downcase Name | multiple sclerosis |
Id Information
| Sequence: | 40094055 |
| Id Source | org_study_id |
| Id Value | E-1205-23 |
Countries
| Sequence: | 42494114 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55504354 | Sequence: | 55504355 |
| Group Type | Experimental | Group Type | No Intervention |
| Title | Unified Protocol intervention | Title | Control group |
| Description | 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. | Description | The control group will not receive any intervention and will complete the same baseline and follow-up assessments. |
Interventions
| Sequence: | 52403146 |
| Intervention Type | Behavioral |
| Name | Unified Protocol |
| Description | The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety. |
Design Outcomes
| Sequence: | 177098831 | Sequence: | 177098832 | Sequence: | 177098833 | Sequence: | 177098834 | Sequence: | 177098835 | Sequence: | 177098836 | Sequence: | 177098837 | Sequence: | 177098838 | Sequence: | 177098839 | Sequence: | 177098840 | Sequence: | 177098841 | Sequence: | 177098842 | Sequence: | 177098843 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Hospital Anxiety and Depression Scale (HADS) – Change in Depression | Measure | Hospital Anxiety and Depression Scale (HADS) – Change in Anxiety | Measure | Modified Fatigue Impact Scale (MFIS) – Change in Fatigue | Measure | Pittsburgh Sleep Quality Index (PQSI) – Change in Sleep | Measure | MOS Pain Effects Scale (PES) – Change in Pain | Measure | General Self-Efficacy Scale (GSES) – Change in Self-efficacy | Measure | University of Washington Self-Efficacy Scale – Change in MS specific self-efficacy | Measure | University of Washington Resilience Scale – Change in Resilience | Measure | COPE inventory – Change in Coping | Measure | Benefit Finding in Multiple Sclerosis (BFIMS) – Change in Benefit-finding | Measure | Satisfaction with Life Scale (SWLS) – Changes in Quality of Life | Measure | Flourishing Scale (FS) – Change in Quality of Life | Measure | Ryff Psychological Well-being Scales (RYFFPWB) – Changes in well-being |
| Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks | Time Frame | Baseline, 12 weeks, 24 weeks |
| Description | Self-report measure of depression. Scores range from 0-21 with higher scores indicating greater depression. | Description | Self-report measure of anxiety. Scores range from 0-21 with higher scores indicating greater anxiety. | Description | Self-report measure of fatigue. Scores range from 0-84 with higher scores indicating greater fatigue. | Description | Self-report measure of sleep. Scores range from 0-21 with higher scores indicating greater sleep problems. | Description | Self-report measure of pain. Scores range from 0-30 with higher scores indicating greater pain. | Description | Self-report measure of self-efficacy. Scores range from 10-40 with higher scores indicating greater self-efficacy. | Description | Self-report measure of disease self-efficacy. Scores range from 0-100 (T-scores) with higher scores indicating greater self-efficacy. | Description | Self-report measure of resilience. Scores range from 8-40 with higher scores indicating greater resilience. | Description | Self-report measure of coping. Scores range from 4-16 for each coping scale with higher scores indicating greater coping. | Description | Self-report measure of positive coping. Scores range from 43-129 for the total scale with higher scores indicating greater benefit-finding. | Description | Self-report measure of quality of life and satisfaction. Scores range from 5-35 with higher scores indicating greater life satisfaction. | Description | Self-report measure of quality of life. Scores range from 8-56 with higher scores indicating greater quality of life. | Description | Self-report measure of psychological well-being. Scores range from 14-84 for each subscale with higher scores indicating greater psychological well-being. |
Browse Conditions
| Sequence: | 193164412 | Sequence: | 193164413 | Sequence: | 193164414 | Sequence: | 193164415 | Sequence: | 193164416 | Sequence: | 193164417 | Sequence: | 193164418 | Sequence: | 193164419 | Sequence: | 193164420 |
| Mesh Term | Multiple Sclerosis | Mesh Term | Sclerosis | Mesh Term | Pathologic Processes | Mesh Term | Demyelinating Autoimmune Diseases, CNS | Mesh Term | Autoimmune Diseases of the Nervous System | Mesh Term | Nervous System Diseases | Mesh Term | Demyelinating Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases |
| Downcase Mesh Term | multiple sclerosis | Downcase Mesh Term | sclerosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | demyelinating autoimmune diseases, cns | Downcase Mesh Term | autoimmune diseases of the nervous system | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | demyelinating diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48244373 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Kessler Foundation |
Central Contacts
| Sequence: | 11991588 | Sequence: | 11991589 |
| Contact Type | primary | Contact Type | backup |
| Name | Belinda L Washington, BA | Name | Lauren B Strober, PhD |
| Phone | 973-324-8446 | Phone | 973-324-8459 |
| [email protected] | [email protected] | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68040567 |
| Design Group Id | 55504354 |
| Intervention Id | 52403146 |
Eligibilities
| Sequence: | 30718404 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253955865 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2023 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Secondary Outcomes To Measure | 11 |
Designs
| Sequence: | 30464922 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Single |
| Masking Description | The assessor is blinded to the group assignment |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 28831375 |
| Responsible Party Type | Principal Investigator |
| Name | Lauren Strober |
| Title | Principle Investigator |
| Affiliation | Kessler Foundation |