Fibromyalgia (FM)NCT07715877
Social Media Connectedness in Fibromyalgia
An observational study of Fibromyalgia (FM) and Social Connection, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
Patients suffering from fibromyalgia commonly experience depressive symptoms such as loneliness and hopelessness due to the nebulousness of the disease. A primary purpose of social media is to promote connectedness, which is associated with improved well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM), Social Connection, Suicidal Thoughts
- What is being tested?
- Social Media
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,041 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2023to 31 Oct 2023
- Phase
- Observational
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
Study population: Study participants were adults who can regularly access/use social media, who were recruited via online advertisements.
Who may be able to join
- 18 years of age or older
- Can read and write English proficiently
- Live in the USA
- Carry a diagnosis of fibromyalgia
Who cannot join
- Younger than 18-years-old
- Cannot read or write English proficiently
- Does not live in the U.S.
- Does not carry fibromyalgia diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Connectedness Via Social Media in Fibromyalgia Patients
Patients suffering from fibromyalgia commonly experience depressive symptoms such as loneliness and hopelessness due to the nebulousness of the disease. A primary purpose of social media is to promote connectedness, which is associated with improved well-being. Using archival, de-identified data collected by a social media company, this study aims to explore whether connectedness among patients with fibromyalgia facilitated by social media can improve mental and physical health outcomes.
Read the detailed description
Fibromyalgia is a chronically complex disease of unknown etiology defined by extensive vague musculoskeletal pain, modestly effective treatments, and strong association with psychiatric disorders such as depression and anxiety. Due to the nebulousness of fibromyalgia that engenders stigma and invalidation, psychiatrically related symptoms of hopelessness and loneliness are prevalent among patients suffering from it. These symptoms in turn can worsen outcomes and make this population vulnerable to suicidal ideation. Social support has been shown to improve physical and mental well-being in patients with fibromyalgia. Given that the primary purpose of social media is to promote social support, there has been increasing interest in harnessing social media as a therapeutic intervention. However, evidence for the therapeutic benefit of social media, particularly for loneliness mitigation and suicide prevention, is mixed. In the limited literature about fibromyalgia patients specifically, use of existing social media networks, such as Facebook and Instagram, has been shown to improve pain and depressive symptoms. The benefit of social media appears to derive from a sense of connectedness via (1) developing a sense of community among individuals with common experiences and (2) exchanging experiences, information, and support. Given the lack of research around the use of social media in fibromyalgia patients, this study aims to investigate whether social media tailored to fibromyalgia patients can improve physical and mental health. Specifically, participants were randomized to conditions of differing social media engagement (i.e. passively consuming information [TAU] vs. receiving specific user-generated content evaluated to be validating and supportive [e-TAU] vs. receiving this helpful content while participating in a support group [e-TAU+G]) to delineate how different aspects social media use contribute to connectedness and improved outcomes. This study is needed, as fibromyalgia patients are a group that would benefit most from an easily accessible and affordable modality that can bolster social support.
This study constitutes analysis of data collected by themighty.com. Themighty.com is a social media platform dedicated to promoting health and well-being. The platform features stories reflecting lived experience with physical and mental health challenges. In addition, themighty.com offers a peer-to-peer forum for users to solicit and receive support. From January to October 2023, themighty.com collected data to evaluate users' engagement with and benefits of their platform. The study collected data using a randomized control design (three arms) over an 18-week period before crossover. Participants were randomized using simple randomization. Condition assignment was not blinded. However, a cross-over strategy was employed, wherein participants originally assigned to the TAU condition were then allocated to the e-TAU+G condition after the initial 18-week trial.
This study's hypothesis is that the e-TAU+G arm would show greatest improvements in outcomes, followed by the e-TAU arm, with the TAU arm showing the least improvement.
- Conditions
- Fibromyalgia (FM), Social Connection, Suicidal Thoughts
- Being tested
- Social Media
- Keywords
- social media, depression, suicide, fibromyalgia
- Medical subject headings
- Fibromyalgia, Suicidal Ideation, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social MediaBehavioural
Participants were invited to join a closed group to facilitate discussion about their experiences with fibromyalgia and offer social support.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | Participants used the platform as usual (e.g., log in, read stories). Receives: Behavioral: Social Media | |
| Enhanced TAU (e-TAU) | Participants received specialized emails from the platform containing user-generated stories featuring lived experience with fibromyalgia that were identified as helpful for increasing social connectedness/support and hope, in addition to typical platform use. Receives: Behavioral: Social Media | |
| Enhanced TAU + group (e-TAU+G) | In addition to receiving the specialized emails with supportive narratives, participants were invited to join a closed group of other people with fibromyalgia that would facilitate communication amongst members. Receives: Behavioral: Social Media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Shared Experiences
Perceived shared experiences were assessed via online survey by asking participants the question, "In the past week, how much did you feel like you are not the only person living with your struggles?" Participants provided responses using a 7-item Likert scale ranging from 1 ("Definitely not the only one") to 7 ("Completely the only one"), such that lower scores were indicative of an increased sense of shared experiences and higher scores were indicative of a decreased sense of shared experiences. This survey was administered weekly during the trial.
Measured: Weeks 6, 12, and 18
Hopefulness/Hopelessness
Hopefulness and hopelessness were assessed via online survey by asking participants the question, "In the past week, how much do you feel like the problems you are currently facing might get better in the future?" Participants provided responses using a 7-item Likert scale ranging from 1 ("Not at all") to 7 ("Definitely"), such that higher scores were indicative of increased feelings of hopefulness and lower scores were indicative of increased feelings of hopelessness. This survey was administered weekly during the trial.
Measured: Weeks 6, 12, and 18
Validation and Understanding
Validation and feelings of being understood were assessed via online survey by asking participants the question, "In the past week, how understood did you feel by others?" Participants provided responses using a 7-item Likert scale ranging from 1 ("Not at all understood") to 7 ("Definitely understood"), such that higher scores were indicative of increased feelings of validation and understanding and lower scores were indicative of decreased feelings of validation and understanding. This survey was administered weekly during the trial.
Measured: Weeks 6, 12, and 18
Secondary outcomes (4)
Suicidal Ideation
Suicidal ideation was assessed via online survey by asking participants the question, "In the past week, how often did you have thoughts of not wanting to be alive or of hurting yourself in some way?" Participants provided responses using a 7-item Likert scale ranging from 1 ("I didn't have these thoughts at all") to 7 ("Every day"), such that higher scores were indicative of increased thoughts of suicidal ideation and lower scores were indicative of decreased thoughts of suicidal ideation. Milestone surveys were administered at weeks 6, 12, and 18. Scores were summarized by study arm.
Measured: Weeks 6, 12, and 18
Depression
Depression was assessed using the 9-item Patient Health Questionnaire (PHQ-9). The PHQ-9 is a standard measurement tool used for screening, diagnosing, monitoring and measuring the severity of depression. Participants were asked how often they had been bothered by symptoms like depressed mood, trouble sleeping, or low energy over the past two weeks. Each question is scored on a 4-point scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), for an overall possible scoring range of 0-27, such that higher scores were indicative of increased depressive symptoms. Milestone surveys were administered at weeks 6, 12, and 18. Scores were summarized by study arm.
Measured: Weeks 6, 12, and 18
Anxiety
Anxiety was assessed using the 7-item Generalized Anxiety Disorder-7 (GAD-7) scale. The GAD-7 is a self-assessment tool used to screen for and asses the severity of anxiety. Participants were asked how often they had been bothered by common symptoms of anxiety over the prior two week period. Each question is scored on a 4-point scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), for an overall possible scoring range of 0-21, such that higher scores were indicative of increased anxiety symptoms. Milestone surveys were administered at weeks 6, 12, and 18. Scores were summarized by study arm.
Measured: Weeks 6, 12, and 18
Functional Impairment
Functional impairment was assessed via online survey by asking participants the question, "In the past week, how often did your fibromyalgia symptoms get in the way of your goals?" Participants provided responses using a 7-item Likert scale ranging from 1 ("Not at all") to 7 ("Every day"), such that higher scores were indicative of increased functional impairment and lower scores were indicative of decreased functional impairment. Milestone surveys were administered at weeks 6, 12, and 18. Scores were summarized by study arm.
Measured: Weeks 6, 12, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start19 Jan 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Franz, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715877
- Sponsor's protocol ID
- 2024-16294
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kleykamp BA, Ferguson MC, McNicol E, Bixho I, Arnold LM, Edwards RR, Fillingim R, Grol-Prokopczyk H, Turk DC, Dworkin RH. The Prevalence of Psychiatric and Chronic Pain Comorbidities in Fibromyalgia: an ACTTION systematic review. Semin Arthritis Rheum. 2021 Feb;51(1):166-174. doi: 10.1016/j.semarthrit.2020.10.006. Epub 2020 Dec 29.
PubMed 33383293Loge-Hagen JS, Saele A, Juhl C, Bech P, Stenager E, Mellentin AI. Prevalence of depressive disorder among patients with fibromyalgia: Systematic review and meta-analysis. J Affect Disord. 2019 Feb 15;245:1098-1105. doi: 10.1016/j.jad.2018.12.001. Epub 2018 Dec 3.
PubMed 30699852Kool MB, Geenen R. Loneliness in patients with rheumatic diseases: the significance of invalidation and lack of social support. J Psychol. 2012 Jan-Apr;146(1-2):229-41. doi: 10.1080/00223980.2011.606434.
PubMed 22303622Ordonez-Carrasco JL, Sanchez-Castello M, Calandre EP, Cuadrado-Guirado I, Rojas-Tejada AJ. Suicidal Ideation Profiles in Patients with Fibromyalgia Using Transdiagnostic Psychological and Fibromyalgia-Associated Variables. Int J Environ Res Public Health. 2020 Dec 30;18(1):209. doi: 10.3390/ijerph18010209.
PubMed 33396651Jaremka LM, Andridge RR, Fagundes CP, Alfano CM, Povoski SP, Lipari AM, Agnese DM, Arnold MW, Farrar WB, Yee LD, Carson WE 3rd, Bekaii-Saab T, Martin EW Jr, Schmidt CR, Kiecolt-Glaser JK. Pain, depression, and fatigue: loneliness as a longitudinal risk factor. Health Psychol. 2014 Sep;33(9):948-57. doi: 10.1037/a0034012. Epub 2013 Aug 19.
PubMed 23957903Wolf LD, Davis MC. Loneliness, daily pain, and perceptions of interpersonal events in adults with fibromyalgia. Health Psychol. 2014 Sep;33(9):929-37. doi: 10.1037/hea0000059.
PubMed 25180546Reig-Garcia G, Bosch-Farre C, Suner-Soler R, Juvinya-Canal D, Pla-Vila N, Noell-Boix R, Boix-Roqueta E, Mantas-Jimenez S. The Impact of a Peer Social Support Network from the Perspective of Women with Fibromyalgia: A Qualitative Study. Int J Environ Res Public Health. 2021 Dec 4;18(23):12801. doi: 10.3390/ijerph182312801.
PubMed 34886527O'Day, E. B., & Heimberg, R. G. (2021). Social media use, social anxiety, and loneliness: A systematic review. Computers in Human Behavior Reports, 3(100070). https://doi.org/10.1016/j.chbr.2021.100070
Robinson J, Cox G, Bailey E, Hetrick S, Rodrigues M, Fisher S, Herrman H. Social media and suicide prevention: a systematic review. Early Interv Psychiatry. 2016 Apr;10(2):103-21. doi: 10.1111/eip.12229. Epub 2015 Feb 19.
PubMed 25702826Berard AA, Smith AP. Post Your Journey: Instagram as a Support Community for People With Fibromyalgia. Qual Health Res. 2019 Jan;29(2):237-247. doi: 10.1177/1049732318789102. Epub 2018 Aug 1.
PubMed 30066603Pester BD, Tankha H, Cano A, Tong S, Grekin E, Bruinsma J, Gootee J, Lumley MA. Facing Pain Together: A Randomized Controlled Trial of the Effects of Facebook Support Groups on Adults With Chronic Pain. J Pain. 2022 Dec;23(12):2121-2134. doi: 10.1016/j.jpain.2022.07.013. Epub 2022 Sep 9.
PubMed 36096353Cipolletta S, Tomaino SCM, Lo Magno E, Faccio E. Illness Experiences and Attitudes towards Medication in Online Communities for People with Fibromyalgia. Int J Environ Res Public Health. 2020 Nov 23;17(22):8683. doi: 10.3390/ijerph17228683.
PubMed 33238467