Internet versus face-to-face group cognitive-behavioral therapy for fibromyalgia: A randomized control trial
Introduction
Fibromyalgia (FM) is a syndrome of unknown etiology that is characterized by widespread pain, fatigue, sleep disturbance, and decline in physical functioning (Wolfe et al. 1995). FM also has an important emotional impact, leading to mood disturbances, anxiety and stress reactions (Thieme and Turk, 2000). Patients must adapt to this chronic condition, which often exerts an overwhelming influence on their lives (Van Middendorp et al. 2008).
In the absence of an etiological treatment, an important goal is to reduce the impact of FM on patients' quality of life. Because of the limitations of pharmacological interventions, patients may require non-pharmacological interventions, including cognitive-behavioral therapy (CBT) and exercise (Goldenberg et al. 2004). CBT is useful in treating emotional disorders, such as depression and anxiety, and it is useful in facilitating coping and reactivating psychosocial activities (Craighead et al. 2007).
Several studies have demonstrated the efficacy of CBT in improving depression and anxiety (Castel et al., 2012, Vázquez-Rivera et al., 2009, Wells-Federman et al., 2003), coping strategies (Vázquez-Rivera et al., 2009, Thieme et al., 2006), pain (Wells-Federman et al., 2003, Lera et al., 2009), cognitive factors such as self-efficacy or catastrophizing (Castel et al., 2012, Thieme et al., 2006), and fatigue and physical health in FM patients (Lera et al., 2009, Williams et al., 2002). There is evidence to suggest that CBT is the best option for reducing the impact of these symptoms on FM patients (García et al. 2006). In terms of Cohen's categories, the effect size of the benefits of CBT are small for depression and high for self-efficacy of pain. There is no impact on pain or fatigue (Bernardy et al., 2010). When CBT is compared with pharmacological treatment such as minalcipran, the psychological treatment has a moderate to large effect in improving physical function (Ang et al., 2013).
The standard care for FM is pharmacological. In most clinical settings (primary care or rheumatology units), there are no psychologists to implement CBT intervention. A better combined treatment could be implemented by using the Internet to deliver CBT to any patient who needs it (Busch et al., 2008, Thieme and Gracely, 2009).
CBT has a psychoeducational style and is configured as a systematic protocol. This characteristic allows it to easily integrate into software programs run on Internet servers. Many controlled studies have shown the efficacy of CBT on the Internet (iCBT) (Cuijpers et al. 2008) for chronic pain (Bender et al., 2011, Palermo et al., 2009). One study (Williams et al. 2010) compared standard care (pharmacological treatment) with iCBT but not with face-to-face conventional CBT.
The present study compares the efficacy of a CBT program for FM delivered in a group face-to-face setting with iCBT using the same treatment protocol. We also used a waiting list (WL) control group to isolate the treatment effects. The study used an intent-to-treat (ITT) randomized design with 3 groups: (a) the WL group, (b) the CBT face-to-face group, and the (c) iCBT group. There were 5 data collection periods: baseline, post-treatment and 3-, 6- and, 12-month follow-ups.
Section snippets
Participants
The study was conducted in the Rheumatology Unit of the Institute of Rehabilitation (Hospital Universitario “Gregorio Marañón,” Madrid, Spain). All participants were patients in this unit. The Internet intervention was delivered by the Faculty of Psychology of the National Distance Education University (UNED), Madrid, Spain. All patients provided written informed consent. The study protocol was approved by the Clinical Research Ethics Committee of the Gregorio Marañón Hospital (Madrid, Spain).
Sample characteristics
The characteristics of the sample are shown in Table 1. The participants were all females, 55.5 years old on average (standard deviation [SD] = 9.8 years), self-reported as married (76.7%), employed (35%), and had a low educational status (51.7%). They were diagnosed with FM an average of 8.6 years prior to the study (SD = 7.3), and generalized pain was present for 13.7 years (SD = 13). There were no significant between-group differences.
There were no significant between-group differences at
Discussion
To our knowledge, this study is the first to compare a standard face-to-face CBT group protocol for FM with an Internet administration of the same protocol. This twelve-month follow-up randomized controlled intent-to-treat study demonstrated that Internet-delivered CBT is an appropriate method of reducing the impact of FM, psychological distress, depression, and some cognitive variables, such as catastrophizing, helplessness, and increased self-efficacy. There were differences between the CBT
Contributors
MV and JO designed the study. JO and JR recruited the FM patients. MC was the therapist of the CBT group and JO was the therapist of the iCBT group. MV was the supervisor of the iCBT group. Data were collected by JO and JR. JO, MV and LV undertook the statistical analysis. MV and LV wrote the first draft of the manuscript. All authors read and approved the final version of the manuscript.
Conflict of interest
All authors declare that the have not conflict of interest.
Acknowledgments
Supported by a grant from the Instituto de la Mujer, Ministerio de Sanidad, Servicios Sociales e Igualdad, Spanish Government (Exp. 2011-INV-00232).
References (48)
- et al.
Can pain be managed through the Internet? A systematic review of randomized controlled trials
Pain
(2011) - et al.
The effectiveness of an online mind-body intervention for older adults with chronic pain
J Pain
(2009) - et al.
Treatment of panic disorder: live therapy vs. self-help via the Internet
Behav Res Ther
(2005) - et al.
Multicomponent cognitive-behavioral group therapy with hypnosis for the treatment of fibromyalgia: long term outcome
J Pain
(2012) International experiences with the Hospital Anxiety and Depression Scale: a review of validation and clinical results
J Psychosom Res
(1997)- et al.
The chronic pain coping inventory: development and preliminary validation
Pain
(1995) - et al.
Changes in pain coping, catastrophizing, and coping efficacy after cognitive-behavioral therapy in children and adolescents with juvenile fibromyalgia
J Pain
(2013) - et al.
Multidisciplinary treatment of fibromyalgia: does cognitive behavior therapy increase the response to treatment?
J Psychosom Med
(2009) - et al.
Intent-to-treat analysis for longitudinal clinical trials: coping with the challenge of missing values
J Psychiatr Res
(1999) - et al.
Randomized controlled trial of an Internet-delivered family cognitive–behavioral therapy intervention for children and adolescents with chronic pain
Pain
(2009)
Emotions and emotional approach and avoidance strategies in fibromyalgia
J Psychosom Res
Brief cognitive-behavioral therapy with fibromyalgia patients in routine care
Compr Psychiatry
A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain
Pain
Internet-enhanced management of fibromyalgia: a randomized controlled trial
Pain
Development and initial validation of a scale to measure self-efficacy beliefs in patients with chronic pain
Pain
Combining cognitive behavioral therapy and minalcepran for fibromyalgia: a feasibility randomized-controlled trial
Clin J Pain
Beck depression inventory manual
Efficacy of cognitive-behavioral therapies in fibromyalgia syndrome. A systematic review and metaanalysis of randomized controlled trials
J Rheumatol
The fibromyalgia impact questionnaire: development and validation
J Rheumatol
Best practice. E-model – prescribing physical activity and exercise for individuals with fibromyalgia
Physiother Theory Pract
La escala hospitalaria de ansiedad y depresión. Su utilización en psicología de la salud
Boletín Psicol
Psychosocial treatments for major depressive disorder
Internet-administered cognitive behavior therapy for health problems: a systematic review
J Behav Med
Introduction to multilevel analysis
Cited by (45)
Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review
2022, Internet InterventionsCitation Excerpt :Regarding limitations of the included studies, guided iCBT was often performed in patients with different chronic pain conditions merged together in the included studies, which impeded subgroup analyses of the effects of iCBT per chronic pain condition in this meta-analysis. Furthermore, this also implied that pain conditions with a potentially different pain intensity and pain frequency (such as headache [Andersson et al., 2003; Devineni and Blanchard, 2005] vs. fibromyalgia [e.g., Simister et al., 2018; Vallejo et al., 2015]) were analyzed as one group in this meta-analysis, which could be viewed as a strength (providing overarching results of iCBT in chronic pain) as well as a limitation. Furthermore, follow-up measurements were not uniformly applied and reported on across studies, which precluded aggregating results.
Guided internet-based cognitive-behavioral therapy for patients with rheumatic conditions: A systematic review
2021, Internet InterventionsCitation Excerpt :Concerning attrition bias, all studies reported intention-to-treat (ITT) analyses except for one study (Shigaki et al., 2013), which resulted in a high risk of attrition bias for this study. Regarding reporting bias, three studies pre-registered their outcomes in a trial register (Ferwerda et al., 2017; Hedman-Lagerlöf et al., 2018; Lorig et al., 2008), whilst the protocols of two other studies could not be found in trial registers (Peters et al., 2017; Vallejo et al., 2015), which resulted in an unclear risk of reporting bias for the latter studies. Moreover, three studies had inconsistencies between the measurement instruments that were pre-specified in the protocol, and those that were reported in the article, which led to a high risk of reporting bias (Friesen et al., 2017; Shigaki et al., 2013; Simister et al., 2018).
Therapist-guided remote versus in-person cognitive behavioural therapy: a systematic review and meta-analysis of randomized controlled trials
2024, CMAJ. Canadian Medical Association JournalPsychological therapies delivered remotely for the management of chronic pain (excluding headache) in adults
2023, Cochrane Database of Systematic Reviews