Previously submitted to: Journal of Medical Internet Research (no longer under consideration since Jul 06, 2021)
Date Submitted: May 5, 2021
Open Peer Review Period: May 5, 2021 - May 12, 2021
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Brief Internet-based emotional regulation procedure for fibromyalgia. A randomized controlled trial.
ABSTRACT
Background:
Fibromyalgia (FM) is a disorder of unknown etiology. Emotional factors are particularly important in modulating the disorder and its impact on people's lives. Exposure to words with emotional content shows reactivity and biases that are not present in individuals without the disease and that can enhance pain, fatigue and the negative affective state of patients. The generation of emotions and their potential regulation through exposure to words is a well-established experimental procedure that has proven useful for addressing various problems, such as phobias, generalized anxiety, personality disorders and depression.
Objective:
The present study uses a clinical intervention to evaluate the effect that exposure to words with emotional connotations related to the disease has on fibromyalgia patients, by scores on standardized assessment instruments, the Combined Index of Fibromyalgia Severity (ICAF), the Fibromyalgia Impact Questionnaire (FIQ), and other questionnaires related to the effects of the intervention, the Short Form 12 Health Survey (SF-12), the Acceptance and Action Questionnaire-II (AAQ-II), the Pain Catastrophizing Scale (PCS), the Emotional Regulation Questionnaire (ERQ), and the Credibility and Expectancy Questionnaire (CEQ).
Methods:
Participants are patients from a rheumatology unit of a General Hospital. They were invited to participate for his rheumatologist. Sociodemographic data and outcome measures were obtained online through the Qualtrics platform. A total of 150 patients were randomly assigned to 3 groups: waiting list (WL), brief emotional regulation program (PbRE) and control (PbREc). Patients were informed of the importance of emotional aspects to their disease and how acting on them can reduce the impact of FM on their lives. The PbRE protocol uses an app to expose participants to words with emotional content (PbRE) or neutral content (PbREc) in ten 15-minute sessions for 1 month.
Results:
The results related to the impact and severity of fibromyalgia and on other variables related to emotional factors were evaluated at baseline (n=150), posttreatment (n=150) and follow-up at 3 and 9 months (n=91). The results of the multilevel modeling analysis (MLM) showed improvements in the PbRE group in terms of both the impact (FIQ) and severity (ICAF) of the disease (Ps < .001) and in quality of life, psychological flexibility and catastrophism (Ps < .001). There was an absence of improvement in the WL and PbREc groups. These findings show the usefulness of simple programs delivered via the Internet that promote emotional regulation through exposure to words with emotional content.
Conclusions:
Exposure to words related to emotions in fibromyalgia patients is helpful in reducing the impact and severity of the disease and improving acceptance and catastrophizing. The effect of the intervention lasts over time, and the accessibility through the Internet makes it possible to easily reach a large number of patients. Clinical Trial: Clinical Trials.gov (NCT04084873); https://clinicaltrials.gov/ct2/show/NCT04084873
Citation
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