Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Acceptance and Commitment Therapy (ACT) | Active Comparator |
| |
| Digital Symptom Tracker | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital ACT | Device | Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score | FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement | PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse | Week 12 |
Not provided
Key Inclusion Criteria:
Subject is 22 to 75 years of age, inclusive
Subject has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM, which requires satisfaction of the following criteria:
Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
Subject is capable of reading and understanding English and has provided written informed consent to participate.
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Gendreau, MD | Consulting Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excell Research, Inc. | Oceanside | California | 92056 | United States | ||
| Superior Research LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37382794 | Result | Catella S, Gendreau RM, Kraus AC, Vega N, Rosenbluth MJ, Soefje S, Malhotra S, Luciano JV, McCracken LM, Williams DA, Arnold LM. Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial. J Behav Med. 2024 Feb;47(1):27-42. doi: 10.1007/s10865-023-00429-3. Epub 2023 Jun 29. |
| Label | URL |
|---|---|
| Swing Therapeutics Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Digital Acceptance and Commitment Therapy (ACT) Arm | Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. |
| FG001 | Digital Symptom Tracker Arm | Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Digital Acceptance and Commitment Therapy (ACT) | Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. |
| BG001 | Digital Symptom Tracker Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score | FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity. | Posted | Mean | Standard Error | score on a scale | Baseline to Week 12 |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital Acceptance and Commitment Therapy (ACT) Arm | Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Swing Therapeutics, Inc. | 1 (415) 662-0415 | research@swingtherapeutics.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2021 | Jul 12, 2023 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Digital Symptom Tracker | Device | Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual. |
|
| Sacramento |
| California |
| 95831 |
| United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Upstate Clinical Research Associates LLC | Williamsville | New York | 14221 | United States |
| University of Cincinnati Physicians Company, LLC | Cincinnati | Ohio | 45219 | United States |
| Neuro-Behavioral Clinical Research, Inc. | North Canton | Ohio | 44720 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement | PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 7 |
| 39 |
| EG001 | Digital Symptom Tracker Arm | Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual. | 0 | 28 | 0 | 28 | 3 | 28 |
| Sinus infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Cellulitis in Face | Infections and infestations | Systematic Assessment |
|
| Post COVID-19 Vaccination Syndrome | Infections and infestations | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Broken Foot | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Worsening Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Exacerbation of Gastroparesis | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Exacerbation of Fibromyalgia Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Left Side Rib Contusions | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| D009422 |
| Nervous System Diseases |