Depression in patients with fibromyalgia: evidence-based treatment approaches

Fibromyalgia

More than 50% of patients diagnosed with fibromyalgia (FM) suffer from major depression. In light of this significant statistic, this Evidence-based Practice (EBP) study explores the problem of depression in patients diagnosed with fibromyalgia, the clinical problem selected for this study.

In fibromyalgia, Antai-Otong (2005) stresses, pain management purports a pivotal treatment aspect for patients contending with the disease. To effectively treat FM, a holistic and interdisciplinary team approach focusing on pain management and mitigation of depression, along with other psychiatric symptoms proves pertinent. The most successful treatment strategies integrate: "pharmacotherapy, a graded exercise program, and cognitive behavioral therapy." (Hassett, Cone, Patella, & Sigal, 2000; Millea & Holloway, 2000; Thieme, Turk, & Flor, 2004; cited by Antai-Otong, 2005) Fibromyalgia, not deemed to be a distinct syndrome, reportedly affects approximately five million individuals, primarily women, in the U.S. (APA, 2000; Hudson, Arnold, Keck, Auchenbach, & Pope, 2004; cited by Antai-Otong, 2005) North American research indicates the prevalence estimate of FM to average 3.4% for women and 0.5% for men.

These percentages increase to 7.1 and 1.1%, respectively, for individuals in the 60-69-year age range. (Costal et al., 2005, p. 1422) as a chronic, recurrent, and potentially debilitating syndrome characterized by pain, fatigue and sleep problems, FM appears to constitute "part of an intricate spectrum of other medical conditions classified as somataform disorders," numerous clinicians frequently minimize or misdiagnose and/or under-treated patients. (Antai-Otong, 2005; "FDA Approves First Drug," 2007) in 2005, the FDA had not yet approved any drug for the treatment of FMS. (Antai-Otong, 2005) on June 21, 2007, however, the U.S. Food and Drug Administration approved the first drug to treat fibromyalgia - Lyrica (pregabalin), a disorder characterized by pain, fatigue and sleep problems. "Lyrica reduces pain and improves daily functions for some patients with fibromyalgia."("FDA Approves First Drug," 2007) Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, albeit, stresses that more progress needs to be made for treatment of FM, as a number of patients did not experience a pain relief with Lyrica in clinical trials. ("FDA Approves First Drug," 2007) for the diagnoses of fibromyalgia, which affects approximately three to six million to 6 million people (primarily women in early-to-middle adulthood) in the U.S., doctors conduct physical examinations, evaluate symptoms, and rule out other conditions. "Individuals with fibromyalgia have been shown to experience pain differently from other people." ("FDA Approves First Drug," 2007) Diagnostic criteria for FMS include:

Widespread pain for at least 3 months and not localized in one area -- involves both side of body, over and above the waist, and axial skeletal pain

Presence of 11 out of 18 tender points, including Designated occipital sites Lower cervical trapezius, gluteal area Greater trochanter and knees

Sleep disturbances during non-rapid eye movement (NREM) sleep, reduced delta sleep, and increased arousal, leading to sleep deprivation or unrestful sleep

Depression, emotional distress

Fatigue (American Psychiatric Association, 2000; cited by Antai-Otong, 2005)

The specific cause of FMS is not clearly confirmed, albeit, researchers currently suspect abnormalities in neuroendocrine systems such as hypothalamic-pituitary -- adrenal axis (HPA axis) as contributing causes. "Inquiries into FMS indicate the relationship between neurobiologic, psychosocial, and behavioral factors in pain syndromes." (Antai-Otong, 2005)

In addition, ongoing evidence reveals doctors routinely recommend antidepressants in the treatment of FMS. As FM is significantly associated with depression (or symptoms of depression), this researcher contends this consideration merits exploration and serves as significant rationale for further study. Increasing evidence suggests that an individual experiencing depression related to FM may also contend with increased pain, consequently adversely affecting his/her to cope with everyday activities. "Exercise training has been used successfully to address a number of conditions that are also commonly experienced by individuals with FMS. Aerobic and strength training have been shown to improve depression in individuals with clinical depression."(Brosse (2002, Dunn 2001; cited by Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 3) When individuals with sleep complaints exercise moderately, this practice can reportedly improve their sleep. (King 1997, Singh 1997; Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 3) Training-induced improvements in cardio-respiratory fitness appears to suggest fatigue may also be decreased with moderate exercise. As one's maximal aerobic capacity improves, a person will be able to perform activities of daily living at lower absolute percentages of maximal capacity. (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 3)

Place for participants here ____ treats FM patients or where participants for this study are selected from. During the course of their treatments, nurses fulfill their responsibility to ____ for FM patients, while or something similar? simultaneously seeking to ease pain and decrease depression.

Utilizing the PICO form, this study proposes the relevant practice question: Does the implementation of group therapy sessions contribute to more effective pain management for individuals diagnosed with FM? In the quest to answer this pertinent clinical question, the population (P) is defined as FM patients requiring prescribed medications; the intervention (I) consists of weekly group therapy (support) sessions for 12 weeks; the comparison - constitutes current FM patients not attending weekly group therapy (support) sessions; the outcome (0) denotes decreased pain as a result of participation in the weekly group therapy (support) sessions

II. Methodology

Self-report can be erroneous if the participant wants to be viewed positively by others, or if there is recall bias." (Dobkin, et al., 2006)

To research literature utilized in this study, this researcher chose to utilize Ovid Medline, the Cumulative Index to Nursing and Allied Health and literature one (one CINAHL), and the Cochrane Collection. These databases contain credible, research studies, containing an excellent level of evidence, necessary mandated for evidence-based practice decisions in medicine, as well as in nursing. This researcher initially searched Ovid for information/data for this study. Key words and/or phrases for information/data included "fibromyalgia," "treatment of fibromyalgia," and "fibromyalgia and depression." These key search words and phrases were then connected in a variety of ways, consequently yielding ____ results.

English constituted the language for research studies. Studies completed within last 10 years were selected to review the most contemporary evidence. This researcher purposely focused on studies relating to pain associated with FM as a dearth of literature exists on group thereapy (support) for FM patients. Criteria for exclusion stipulated studies not matching that defined in the PICO question, as well as, studies ____ (need to add what other criteria used to exclude studies). From results retrieved through the literature search, this researcher defined the intervention as the implementation of group therapy (support) with participant journaling.

Ultimately, from retrieved researched results, this researcher identified four studies that met all the established inclusion and exclusion criteria previously identified. An identical search performed in the Cochrane database only yielded one result, which had had been obtained through prior research. This researcher conducted a more intensive search of the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials utilizing the following terms: "____,"

____," and "____," yet found no relevant results such as, meta-analyses, systematic reviews or randomized-controlled clinical trials.

III. Literature Review

Fibromyalgia (FMS) is a syndrome characterized by widespread musculoskeletal pain and multiple tender points (TP)."

Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, (1994)

Study

The first study matching the criteria established for this study: "Exercise for treating fibromyalgia syndrome, an updated systematic review (initially published during 2002), proposes to assess effects evolving from exercise training "including cardio-respiratory (aerobic), muscle strengthening, and/or flexibility exercise on global well-being, selected signs and symptoms, and physical function in individuals with FMS." (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 1) the research design utilized for this study included the analysis of researched literature secured from "MEDLINE, EMBASE, CINAHL, SportDiscus, PubMed, PEDro, and the Cochrane Central Register for Controlled Trials (CENTRAL, Issue 3, 2005) up to and including July 2005." (Busch, Barber, Overend, Peloso, and Schachter, 2007) in addition, Busch, Barber, Overend, Peloso, and Schachter (2007, p. 1) reviewed

Reference List s, retrieved from reviews and meta-analyses of treatment studies.

The procedure for the study by Busch, Barber, Overend, Peloso, and Schachter (2007, p. 1) consisted of the authors selecting, collecting and analyzing randomized trials focusing on "cardio-respiratory endurance, muscle strength and/or flexibility as treatment for FMS.... Two of four reviewers independently extracted data for each study." The reviewers additionally rechecked any/all observed discrepancies noted in trials and subsequently achieved consensus via discussions. Busch, Barber, Overend, Peloso, and Schachter (2007, p. 1)) assessed the reviewed studies methodological quality utilizing two credible instruments: the Jadad, along with, the van Tulder methodological quality criteria. The authors utilized the American College of SportMedicine (ACSM) guidelines to evaluate whether interventions provided a training stimulus to effect changes in physical fitness. The significant clinical heterogeneity among the studies the authors examined contributed to the inclusion of meta-analyze six aerobic-only studies and two strength-only studies.

The initial 2276 total subjects across the 34 included studies were narrowed to 1264 subjects assigned to exercise interventions.

In this review, 47 interventions included exercise in 34 studies. Utilizing standardized mean differences (SMD), the authors then summarized effects of numerous dissimilar interventions on global well-being, selected signs and symptoms, and physical function in individuals with FMS. (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 8)

Results from this study relate a moderate quality evidence that aerobic-only exercise training at recommended intensity levels produces positive effects "global well-being (SMD 0.44, 95% confidence interval (CI 0.13 to 0.75) and physical function (SMD 0.68, 95% CI 0.41 to 0.95) and possibly on pain (SMD 0.94, 95% CI -0.15 to 2.03) and tender points (SMD 0.26, 95% CI -0.28 to 0.79)." Results noted that flexibility and strength and flexibility remain under assessed. (Busch, Barber, Overend, Peloso, and Schachter, 2007, pp. 11-13)

According to criteria Melnyk Fineout-Overholt (2005) present, this study is a Level II study. From the Cochrane review, the following relates what research notes regarding the effect of exercise for FMS:

moderate intensity aerobic training for 12 weeks may improve overall well-being slightly and physical function.; moderate intensity aerobic exercise probably leads to little or no difference in pain or tender points.

A strength training for 12 weeks may result in large reductions in pain, tender points and depression, and large improvement in overall well-being but may not lead to any difference in physical function.

A the exercises programs that were studied were safe for most. The intensity of aerobic exercise training should be increased slowly aiming for a moderate level. If exercisers experience increased symptoms, they should cut back until symptoms improve. If in doubt about adverse effects, they should check with a health care professional.

A it is not known whether exercise training for more than 12 weeks improves other symptoms such as fatigue, stiffness or poor sleep.

It is not known whether flexibility training, programs combining types of exercise, and programs combining exercise with nonexercise strategies improve the symptoms of fibromyalgia. (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 2)

The primary results of the review by Busch, Barber, Overend, Peloso, and Schachter (2007, pp. 13-14) includes the following:

Moderate quality evidence exists that aerobic-only exercise training at recommended intensity levels has medium-size positive effects on pain, small to medium-sized positive effects on global outcome measures and medium-sized positive effects on measures of physical function; the effect of such exercise on tender points is less certain but we cannot rule out the possibility that aerobic exercise has a large positive effect;

Strength and flexibility remain under-evaluated as exercise prescriptions for people with FMS;

Despite the increasing number of studies investigating the effect of combination treatments with exercise, this question has also received inadequate study, principally because there is underutilization of appropriate research designs;

There is limited evidence on a variety of other outcomes including stiffness, fatigue, and depression;

The analysis of percentage change reinforced the results of metaanalysis. In aerobics-only interventions, clinically significant improvements were found sporadically in six variables: depression, tender points, global well-being, physical function, self-efficacy and symptoms. (Busch, Barber, Overend, Peloso, and Schachter, 2007, pp. 13-14)

One particular strength noted in this study links to the reported "gold" level evidence (www.cochranemsk.org) thatwhen FM patients receive directed support to complete regular aerobic exercise training; the exercise efforts prove to produce positive effects on their physical capacity and FMS symptoms. (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 16) Several limitations included the fact that as a number of people with FMS experienced difficulty continuing an exercise program, no specific plans to ensure individuals exercise regularly were measured in these studies.

The researchers state that along with anticipated positive results from supervised regular aerobic exercise training, strength training may additionally contribute to benefits on numerous FMS symptoms.

Along with more research on long-term benefit of exercise for FMS, albeit, Busch, Barber, Overend, Peloso, and Schachter (2007, p. 17) recommend additional study relating to muscle strengthening and flexibility be conducted.

Study

During the second study reviewed, "A randomized clinical trial of an individualized home-based exercise programme (sic) for women with fibromyalgia, in their randomized clinical trial of an individualized home-based exercise program for women with fibromyalgia, conducted by Costal, Abrahamowicz, Lowensteyn, Bernatsky, Dritsa1, Fitzcharles, and Dobki (2005, p. 1422), the authors purposed to determine "the efficacy of a 12-week individualized home-based exercise program on physical functioning, pain severity and psychological distress for women with fibromyalgia (FM)." The research design utilized for this study consisted of the assessment of participants constituting a sample of seventy-nine women with a primary diagnosis of FM, "randomized to a 12-week individualized home-based moderate-intensity exercise programme (sic) or to a usual care control group." (Costal et al., 2005, p. 1422)

Researchers selected participants from two sources:

hospital or community rheumatologists, either directly or by invitation letters, and newspaper ads

Criteria for exclusion of participants included: "(i) concomitant diseases which precluded participation in exercise, (ii) contraindication to exercise identified by the examining physician, (iii) recent change in medication (in the previous 2 weeks) and (iv) regular participation in moderate-intensity exercise (more than 30 min three times per week) at the time of study entry." (Costal et al., 2005, p. 1422) to measure functional capacity, participants completed a "Fibromyalgia Impact Questionnaire" denoting their pain severity and psychological distress. For the procedure, researchers measured outcomes at initial study entry, at the end of the 12-week intervention, and again at three and nine months following completion of the intervention. A rheumatologist examined each consenting subject to confirm diagnosis of FM at study entry. Later, at nine months post-treatment, the same rheumatologist (blinded to randomization status) re-examined the participants. "Eligible participants completed a graded maximal exercise stress test, using the Bruce protocol [19] prior to randomization. This test was used to screen participants, determine baseline fitness and individualize the exercise prescription for participants assigned to the exercise group." Researchers evaluated participants' fitness via time on test, along with maximal metabolic equivalents (METs) capacity.

Results for this study indicate that following treatment, based on the intention-to-treat analyses, the participants who more functionally disabled in the exercise group at study entry experienced a significant improvement in functional capacity at three and nine months for participants. Outcomes for the female FM participants, compared with the control group at the end of the 12-week intervention, and at the three and none month intervals, after the intervention ended, noted statistically significant improvements in participants' upper body pain at post-treatment. The group of study participants, albeit, did not reveal any statistically significant differences regarding lower body pain and/or psychological distress. (Costal et al., 2005, p. 1422)

The key messages from this study, according to Costal et al. (2005, p. 1427) purport:

Home-based moderate intensity exercise improves upper body pain in womenwith fibromyalgia after 12-weeks and overall health status within 6 months of initiation.

The benefits observed were maintained at 9 months post-treatment.

The authors note that, as the primary outcome measures were obtained through participants' self reports, the occurrence of effects relating to subject expectancy cannot be ruled out. In addition, his study y did not include an attention control group.

This researcher purports that the fact the principal outcome measures were acquired through participants' self reports simultaneously serves as a strength and weakness. (Costal et al., 2005, p. 1426)

Study

Most [patients with fibromyalgia] have impaired functional ability, reduced ability to sustain intensive exercise and low levels of aerobic fitness." (Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 714) in the fourth study, "A Randomized, Controlled Clinical Trial of Education and Physical Training for Women with Fibromyalgia," published in. The Journal of Rheumatology, authored by Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, (1994, p. 714) set out to verify "the effectiveness of self-management education and physical training in decreasing fibromyalgia (FMS) symptoms and increasing physical and psychological well being."

The research design utilized for this study included a pretest-posttest control group design. For the participants, researchers solicited and randomly assigned 99 women with FMS to one of three groups. For the procedure, the "education only group received a 6-week self-management course. The education plus physical training group received the course and 6 h of training designed to assist them to exercise independently. The control group got treatment after 3 months." (Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 714) Baseline comparisons were made between groups to look for pretreatment differences form computations of descriptive statistics of all variables in the study. (Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 715) Initially, researchers screened 128 female patients physicians had diagnosed with FMS, using the 1990 criteria for classification of FIMS22 at the occupational health and primary health clinics in Gothenburg, Sweden, as potential participants for the study. These women must have experienced widespread pain in three of four quadrants of the body for longer than three months, along with, "at least 11 of 18 TP, normal results on the following laboratory tests: hemoglobin, free thyroxine, erythrocyte sedimentation rate (ESR), antinuclear antibodies, rheumatoid factor (RF), and creative phosphokinase, and no other rheumatic diseases." Of the 128 original potential participants, 99 were selected.

Out of the 99 selected to participated 86 women completed the study. The results note participants in the experimental programs experienced a significant positive impact on their quality of life and self-efficacy. When participants were retested six weeks after the end of the program, in one or both the treated groups, they reported that helplessness, number of days feeling bad, physical dysfunction, and pain in the tender points had significantly decreased significantly. Additionally, primarily in the physical training group, long-term follow-up of 67 treated subjects "showed significant positive changes on the Fibromyalgia Impact Questionnaire." (Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 714) at the end of the study by Burckhardt, Mannerkorpi, Hedenberg, and Bjelle (1994, p. 714), 87% of participants were exercising at least 3 times/week for at least 20 minutes, while 46% reported increased exercise levels since they began to participate in the program. Of the participants, 70% practiced relaxation strategies as needed, with 46% working at least half time, compared to 37% at pretest. The treated group of participants experienced significant, enhanced self-efficacy from their involvement in the program. Other changes, albeit, proved not as significant and arrived later than anticipated.

This study's primary strength appears to be that the implemented exercises proved to such that numerous participants determined to continue to implement them One limitation, this researcher notes, includes the fact that a number a longer follow-up period could potentially relate more significant results. (According to the authors, their clinical trial of education and exercise find that both treatments benefit patients with FMS. They stress that the most notable changes patients with FMS experienced were in self-efficacy. Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 719)

IV. Synthesis of Current Knowledge & Description of Guidelines

Compatible with other exercise intervention studies, subjects' psychological distress did not change

It has been suggested that the psychological benefits of exercise are dependent on improvements in aerobic fitness...." (Costal et al., 2005, p. 1426)

Level II studies proffer significant support for making evidence-based practice (EBP) changes. The strength or each of the four studies this researcher reviewed may be described as level II evidence, as each of the four studies was randomized. Each study presents an exceptional level of evidence, albeit, the small number of studies (four) mandates careful consideration be attributed prior to consideration of employing a practice change. Study 3, "the study by Dobkin, Costa, Abrahamowicl, Dritsa, Du Rger, Fitzcharles, and Lowensteyn (2006), which examines the efficacy of various exercise regimes for FM patients in regard to the physical and psychological realms, this researcher contends.

The study by Dobkin, et al. (2006) is the only one of the four examined in this study to explore both uptake and persistence in exercise behaviors in women with FM. (Dobkin, et al., 2006)

Specifically relating mental

Busch, Barber, Overend, Peloso, and Schachter (2007) noted "aerobic-only exercise training at recommended intensity levels has positive effects global well-being (SMD 0.44, 95% confidence interval (CI 0.13 to 0.75) and physical function (SMD 0.68, 95% CI 0.41 to 0.95) and possibly on pain

Positive pain relation

Busch, Barber, Overend, Peloso, and Schachter (2007 (Costal et al., 2005, p. 1422)

Two of the studies

Three of the studies.

Each of the four studies focused on some aspect of exercise.

Study 2 (Costal et al., 2005, p. 1426) subjects' psychological distress

Study 3 a series of randomized clinical trials (RCT), utilized self-report

Study 4 a Randomized, Controlled Clinical Trial

Study 2 Fibromyalgia Impact Questionnaire (FIQ) [questionnaire (Costal et al., 2005, p. 1422)

Study 4, by Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, (1994, psychological well being

Fibromyalgia (FMS) is a syndrome characterized by widespread musculoskeletal pain and multiple tender points (TP).(Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, (1994)

Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, (1994,

When assessing the evidence presented in this study, this researcher contends it to be vital to note that none of the studies analyzed in this research effort included a sample identical to the population of participants identified in this study's PICO question. Two of the studies' participants included.

As none of the studies included populations identical to that indicated and this study's PICO question, of careful consideration of individual FM patient's unique circumstances should be employed.

Despite concerns, results of this study

Despite these concern the results of the study conducted by Research findings from the four studies addressed by this research effort include:

studies which were critiqued

2. Based on the synthesis, states strength of evidence for instituting the intervention as a practice change with the specific population in the specific setting

Describes guidelines which are consistent with research base and will be used for implementing the intervention as a practice change

V. Outcome Identification and Measurement

Currently, no treatment for FM is consistently successful.

Exercise has become increasingly recognized as an important component for the comprehensive management of FM...." (Costal et al., 2005, p. 1422)

1. Theoretical definition of outcome and relevance of this outcome to the identified population and setting

Justification of this outcome as consistent with the research base

Operational definition of the outcome and justification of why instrument is an appropriate measure of this outcome in the identified population & setting

Critique of instrument reliability, validity, precision, sensitivity, and specificity

VI. Practice Change

Guidelines to be used to implement research-based intervention in the practice setting with the FM population will when, how, by whom outcome measurement will be completed

Results will be used to make practice decisions

VII. CONCLUSION

Nurses practicing in a hospital or clinical setting, as well as nurses conducting research, one are professionally and ethically obligated to advocate for relief of not only physical, but also respite from mental pain for their patients. Individuals with FMS may not realize that exercise can contribute in a number of ways to help them potentially secure a decrease in the intensity of and/or respite from both episodes of physical and mental pain.

This paper illustrates a number of one ways to exercise can contribute to improving the quality of life for patients diagnosed with FM.

Consequently, the research project this researcher proposes for a study focusing on the benefits of exercise relating to decreasing incidents and intensity of depression will increase understanding of non-medicinal treatments for FM, as well as, strengthen research evidence in the base of treatment modalities for this contemporary, challenging syndrome.