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"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia (SMART-FM)

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ClinicalTrials.gov Identifier: NCT05005351
Recruitment Status : Completed
First Posted : August 13, 2021
Results First Posted : August 1, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
Swing Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Device: Digital ACT
Device: Digital Symptom Tracker
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Digital Acceptance and Commitment Therapy (ACT) Arm Digital Symptom Tracker Arm
Hide Arm/Group Description Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. 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.
Period Title: Overall Study
Started 39 28
Completed 37 27
Not Completed 2 1
Arm/Group Title Digital Acceptance and Commitment Therapy (ACT) Digital Symptom Tracker Arm Total
Hide Arm/Group Description Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. 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. Total of all reporting groups
Overall Number of Baseline Participants 39 28 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 28 participants 67 participants
52.2  (10.5) 53.6  (10.1) 52.8  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 28 participants 67 participants
Female
38
  97.4%
28
 100.0%
66
  98.5%
Male
1
   2.6%
0
   0.0%
1
   1.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 28 participants 67 participants
Hispanic or Latino
7
  17.9%
4
  14.3%
11
  16.4%
Not Hispanic or Latino
32
  82.1%
24
  85.7%
56
  83.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score
Hide Description FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Digital Acceptance and Commitment Therapy (ACT) Arm Digital Symptom Tracker Arm
Hide Arm/Group Description:
Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
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.
Overall Number of Participants Analyzed 39 28
Mean (Standard Error)
Unit of Measure: score on a scale
-8.7  (2.0) -3.0  (2.4)
2.Secondary Outcome
Title Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement
Hide Description PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Digital Acceptance and Commitment Therapy (ACT) Arm Digital Symptom Tracker Arm
Hide Arm/Group Description:
Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
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.
Overall Number of Participants Analyzed 37 27
Measure Type: Count of Participants
Unit of Measure: Participants
27
  73.0%
6
  22.2%
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Digital Acceptance and Commitment Therapy (ACT) Arm Digital Symptom Tracker Arm
Hide Arm/Group Description Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. 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.
All-Cause Mortality
Digital Acceptance and Commitment Therapy (ACT) Arm Digital Symptom Tracker Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/28 (0.00%) 
Hide Serious Adverse Events
Digital Acceptance and Commitment Therapy (ACT) Arm Digital Symptom Tracker Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Digital Acceptance and Commitment Therapy (ACT) Arm Digital Symptom Tracker Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   7/39 (17.95%)   3/28 (10.71%) 
Blood and lymphatic system disorders     
Worsening Anemia †  1/39 (2.56%)  0/28 (0.00%) 
Ear and labyrinth disorders     
Vertigo †  1/39 (2.56%)  0/28 (0.00%) 
Gastrointestinal disorders     
Exacerbation of Gastroparesis †  1/39 (2.56%)  0/28 (0.00%) 
General disorders     
Fever †  1/39 (2.56%)  0/28 (0.00%) 
Infections and infestations     
COVID-19 †  0/39 (0.00%)  2/28 (7.14%) 
Sinus infection †  0/39 (0.00%)  1/28 (3.57%) 
Urinary Tract Infection †  0/39 (0.00%)  1/28 (3.57%) 
Cellulitis in Face †  0/39 (0.00%)  1/28 (3.57%) 
Post COVID-19 Vaccination Syndrome †  1/39 (2.56%)  0/28 (0.00%) 
Injury, poisoning and procedural complications     
Broken Foot †  1/39 (2.56%)  0/28 (0.00%) 
Left Side Rib Contusions †  1/39 (2.56%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders     
Exacerbation of Fibromyalgia Pain †  1/39 (2.56%)  0/28 (0.00%) 
Nervous system disorders     
Headache †  1/39 (2.56%)  0/28 (0.00%) 
Psychiatric disorders     
Anxiety †  1/39 (2.56%)  0/28 (0.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Project Manager
Organization: Swing Therapeutics, Inc.
Phone: 1 (415) 662-0415
EMail: research@swingtherapeutics.com
Publications of Results:
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.
Layout table for additonal information
Responsible Party: Swing Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05005351    
Other Study ID Numbers: Swing-004
First Submitted: August 10, 2021
First Posted: August 13, 2021
Results First Submitted: July 12, 2023
Results First Posted: August 1, 2023
Last Update Posted: August 1, 2023