Type of study



Duration of Study

Form of analysis of the evolution of the disease


Castel et al., 2009 [17]

Randomized pilot trial

Examine effects of hypnosis in standard cognitive-behavioral

therapy for pain management in patients with fibromyalgia.

N = 39

12 sessions de 90 minutes.

Numerical Pain Rating Scale, Fibromyalgia Impact Questionnaire (FIQ), McGill Pain Questionnaire (MPQ) and Harvard Group Hypnotic Susceptibility Scale-Form A (HGSHS-A).

Patients who received Cognitive Behavioral Therapy (CBT) or CBT associated with hypnosis showed a more significant improvement than those who received only conventional pharmacological

treatment. CBT and hypnosis showed even greater improvement than just CBT.

McCrae et al., 2019 [15]

Randomized controlled trial

Examine the effects of cognitive- behavioral treatments for insomnia and pain in patients with fibromyalgia and insomnia.

N = 113

8 months (8 sessions of treatment of 50 minutes + followup after 6 months).

Self-reported sleep diary, dysfunctional beliefs and attitudes about sleep (DBAS), actigraphy, outpatient polysomnography. Clinical pain intensity diary, MPQ, pain disability inventory (PDI); Beck Depression Inventory—Second Edition (BDI-II), State-Trait Anxiety Inventory-Form Y1 (STAI-YI).

CBT improved self-reported insomnia symptoms. CBT

promoted improvements of greater magnitude that was maintained. Both caused immediate pain reductions in one-third of patients, and are effective for insomnia in patients with fibromyalgia (FM). May reduce pain in some patients.

Karlsson et al., 2019 [16]

Randomized controlled trial

Evaluate the

effect of cognitive- behavioral

therapy on plasma substance (SP) levels in women with

Fibromyalgic Syndrome.

N = 48

18 months. (20 sessions of 3 hours every week + 3 reinforcement session of the same duration for the subsequent 6 months).

Venous blood was analyzed for substance P at baseline and at each follow-up exam + the application of psychometric questionnaires: pain (The West Haven-Yale Multidimensional Pain Inventory), fatigue (Maastricht Questionnaire), stress (The Everyday Life Stress instrument) and depression (The Montgomery-Asberg Depression Rating Scale—Self Reported).

In both groups analyzed, a 33% reduction in substance P levels was observed after 6 months of treatment with CBT. However, at the 1-year follow-up after starting CBT treatment, the reduction in plasma SP levels was no longer significant in either group.

Karlsson et al., 2015 [35]

Randomized clinical trial

To examine whether a stress management cognitive behavioral therapy program could influence stress, well-being, life

management, and pain in women

with fibromyalgia syndrome.

N = 48

18 months. (20 sessions of 3 hours every week + 3 reinforcement session of the same duration for the subsequent 6 months.

Follow-up examination

and psychometric questionnaires: pain (The West Haven-Yale Multidimensional Pain Inventory), fatigue

(Maastricht Questionnaire); stress (The Everyday Life Stress instrument); depression (The Montgomery-Asberg Depression Rating

Scale—Self Reported).

“Life control” improved (20%), as well as “affective suffering” (15%), “Vital exhaustion” (12%), “stress behavior” (15%), “depression” (20%). Pain severity, sleep, interference, support from spouses or significant others’ showed no trend to change.

Luciano et al., 2014 [19]

Randomized controlled trial

To compare the CBT versus the combination pharmacological treatment of pregabalin + duloxetine and usual care groups in the treatment of FM. Also, the 6-month cost-effectiveness.

N = 168

6 months. (9 sessions of CBT).

Utility score + application forms: EQ-5D, EQ VAS and Quality-Adjusted Life-Year.

A group-based form of CBT

is more cost-effective in treating FM than the usual

care and drugs recommended by the FDA.

Thieme et al., 2016 [36]

Randomized clinical trial

Determine the psychosocial effects of cognitive operant and cognitive behavioral therapy in patients with fibromyalgia.

N = 115

1 year and 15 weeks. Once a week with the duration of 2 hours each + follow-ups 6 and 12 months after the end of the sessions.

After each phase, participants were asked to rate pain intensity and perceived stress on visual analogue scales (VAS) with outcomes ranging from “No pain” for “very intense pain” and “not at all” for “very stressed”, respectively.

There was reduced skin

conductance and muscle tension compared to the control, which led to regulation of pain parameters. Diastolic pressure in FM patients tends to be reduced, and was regularized with therapy.


et al., 2017 [32]

Randomized clinical trial

Evaluate the effect of CBT on the cerebral mechanism of hyperalgesia from

the reduction of the catastrophizing mechanism in the patient with fibromyalgia.

N = 16

7 months. (4 sessions, once a month, with the duration of 60 - 70 min).

Generalized Pain Index and Symptom Severity, Short Health Survey Form (SF-36), Visual Analog Scale to Assess the Severity of Fatigue Experienced by Patients in the Past 2 Weeks

(VAS-F 39), Outcome Measures by BPI Questionnaires, BI and PCS. Functional Magnetic Resonance Imaging.

A greater reduction in hyperalgesia and catastrophization was observed in patients undergoing CBT compared to the control group. Significant associations can be seen between brain connectivity and long-term changes in clinical outcomes of patients with fibromyalgia.

Parra-Delgado and Latorre-postigo, 2013 [20]

Randomized clinical trial

Demonstrate the effectiveness of mindfulness-based CBT, depressive symptoms, and pain intensity in women with fibromyalgia.

N = 31

3 months. (8 sessions of 2h30 of duration each).

Interview with patients + application of questionnaires MINI, ANOVA, FIQ, BDI, VAS.

CBT has been shown to be effective to reduce depressive symptoms and the impact of diseases, but there were

no very relevant changes in the level of pain.

Martín et al., 2014 [21]

Randomized controlled clinical trial

Evaluate the effects of an interdisciplinary pharmacological treatment, cognitive-behavioral therapy education, exercise for fibromyalgia compared to standard pharmacological treatment.

N = 110

3 years (12 sessions, six sessions lasting 1 h with a psychologist and 45 min of education activities or physical


Application of: FIQ, HADS, CAD-R, DUKE-UNC, satisfaction scale created by the researchers.

Interdisciplinary intervention promoted pain improvement, perception of social support and quality of life more than standard pharmacological therapy. Furthermore, patients were more satisfied with the interdisciplinary approach. Even though the overall quality of life has improved, no improvement in anxiety and depression symptoms have been observed.

Williams et al., 2002 [14]

Randomized Clinical Trial

Determine if there is improvement in functional physical status on CBT, and identify improvements in pain. Explore adherence to treatment in achieving improvements in physical functional status.

N = 145

6 sessions of 1 hour in the period of 4 weeks + 12 months of follow up.

Questionnaire application: PCS, SF-36 and McGill Pain Questionnaire SF.

Both therapies (pharmacological and unconventional) proved to be beneficial, but the intervention period is considered to be short.

Castel et al., 2012 [18]

Randomized Clinical Trial

Evaluate the result of Cognitive- Behavioral Therapy associated and not associated with hypnosis compared to conventional pharmacological treatment of fibromyalgia.

N = 93

14 weekly sessions of 120 minutes + revaluation in 3 to 6 months.

Questionnaire application: Numerical Pain Rating Scale (NRS), CSQ

(Catastrophizing Subscale of the Coping Strategies Questionnaire), HADS (Hospital Anxiety and Depression Scale), Fibromyalgia Impact Questionnaire (FIQ) and Sleep Scale Medical Outcomes Study (MOS).

Patients who received only CBT or CBT plus hypnosis showed improvements compared to patients who received only standard care. Adding hypnosis increased the effectiveness of CBT. CBT without hypnosis demonstrated changes in pain intensity, catastrophizing psychological stress, functionalities, sleep disturbances in FM patients.

Gelman et al., 2002 [13]

Randomized clinical trial

Determine the

effectiveness of multidisciplinary treatment compared to standard treatment

in patients with fibromyalgia.

N = 30

39 weeks (15 weekly sessions of 90 minutes + evaluation after period of 6 months).

Application of questionnaires: FIQ; the State-Trait Anxiety Inventory (STAI); the Beck Depression Inventory; visual-analog scale (EVA); number of tender points; associated symptomatology (AS); use of medications for FM.

Patients achieved a better coexistence with pain and a better adaptation and acceptance of the disorder and, therefore, a better quality of life from the lessons of cognitive-behavioral coping strategies and physical conditioning. Multidisciplinary treatment provides improved quality of life and psychological adaptation in FM patients.

Ang et al., 2010 [30]

Randomized controlled trial

Explore the possibility of cognitive behavioral therapy to influence fibromyalgia symptoms through the inhibition of the descending nociceptive pathway.

N = 32

12 weeks (6 weekly

sessions of 30 to 50 minutes).

Nociceptive Flexion Reflex (NFR) threshold, participants reported pain sensation for each electrical stimulus using a scale of 0 to 100. The FIQ (Fibromyalgia Impact Questionnaire) was also applied to PHQ-8 (Patient Health Questionnaire 8—item depression scale).

Both groups showed improvement, however, the intervention group was resisting higher levels of pain.

García et al., 2006 [22]

Randomized controlled trial

Compare the difference in the effectiveness of Cognitive- Behavioral Therapy and pharmacological therapy in


N = 28

21 weeks (treatment phase:

9 weeks, 1 weekly session; follow-up: 3 months).

FIQ to assess the severity of the disease and its

interference in the patient’s work and life activities. Number of tender points (NTP). Hospital Anxiety and Depression Scale (HADS).

The results showed the

superiority of CBT in reducing severity by FIQ. Combined therapy (pharmacological and CBT) does not increase efficacy, and CBT alone is more effective. In this study, time-limited CBT seems to be more effective than continuous pharmacological use, considering the side effects and the cost in the medium-long term.

Menga et al., 2014 [31]

Randomized controlled trial

Evaluate the effect of CBT on FM, analyzing pain, anxiety, and depression.

N = 56

12 weeks (6 sessions of CBT).

Analysis of tender points and through the FIQ

(Fibromyalgia Impact Questionnaires).

Despite the significant

difference in results between the two groups at week 12, both forms of treatment were considered to have the

potential to alleviate some FM symptoms (CBT treatment being well regarded for dealing with FM-related anxiety and depression).

Redondo et al., 2004 [23]

Randomized Clinical Trial

To analyze the long-term effectiveness of

Cognitive-Behavioral Therapy and an exercise-based

strategy in patients with fibromyalgia.

N = 56

1 year and

8 weeks (treatment: once a week for 8 weeks, with 2 h 30 minutes). Evaluations: beginning, post- treatment, after 6 months and after 1 year.

Tender points score, Fibromyalgia Impact Questionnaire (FIQ),

Short Form 36 (SF-36), Beck Anxiety Inventory, Beck Depression Inventory, Chronic Pain Self-Efficacy Scale (CPSS), Chronic Pain Coping Inventory (CPCI),

Physical activity of vertebral column and upper and lower limbs e Measure of aerobic exercise capacity.

Both treatments, TCC and EF, showed clinical improvement in patients with FM in the short term,

but there was no improvement one year after treatment. The strategies used by the patient to cope with pain were maintained, using physical activity

in the PE group and relaxation in the CBT group.

Lera et al., 2009 [24]

Randomized Clinical Trial

To analyze the response of patients with fibromyalgia to two multidisciplinary treatments, with or without Cognitive-Behavioral Therapy, observing symptoms and quality of life.

N = 83

4 months (14 sessions, once a week, for 90 minutes) + 6-month follow-up.

The following were used: The Fibromyalgia Impact Questionnaire (FIQ), Short form 36 (SF-36), The Symptom Checklist-90—Revised (SCL-90-R). These data were collected at baseline, post-treatment and at the 6-month follow-up, and variable analysis was

performed using


Both groups had an

improvement in the clinical picture, but there was no

significant difference to affirm that CBT is more effective. There was, however, an improvement in the

Fibromyalgia Impact

Questionnaire in patients with fatigue who received CBT.

Thieme et al., 2006 [39]

Randomized Clinical Trial

To examine the effectiveness of Operant Behavioral Therapy (OBT) and CBT for patients with Fibromyalgia Syndrome,

compared to the control group.

N = 100

12 months (15 weeks of 2 hour-sessions) + 2 reassessments: 1 after 6 months o and another after 1 year of treatment.

Blood chemistry analysis, neurological examination, and evaluation of “tender points (TP)” by the Manual Tender Point Survey: FIQ; West Haven-Yale Multidimensional Pain Inventory (MPI); Pain-Related Self-Statements Scale (PRSS). Tübingen Pain Behavior Scale (TBS). Multivariate variance (MANOVA) for pain, function, and mood. Main effects and significant interactions were followed by post hoc analysis of variance (ANOVA) and t-tests.

Psychological treatments are clinically beneficial to patients. OBT was better for patient functionality, while CBT was better in cognitive terms.

Patients treated with CBT demonstrated a clinically

significant reduction in

sustained pain over 12 months. OBT respondents showed

reduced physical impairment, fewer visits to the doctor, and reduced pain behaviors.

Van Koulil, et al. 2010 [34]

Randomized controlled trial

Analyze the benefits of physical exercise, supported by CBT

in high-risk patients with fibromyalgia.

N = 158

16 sessions twice a week

(2 hours of CBT followed by 2 hours of physical training) + 1 booster session 3 months after completion of treatment.

Scale of the Impact of Rheumatic Diseases on General Health and

Lifestyle (IRGL) instrument e o Pain Coping Inventory.

Treatment effects were significant for all primary outcomes, showing meaningful differences in physical (pain, fatigue, and functional disability) and psychological (negative mood and anxiety).

Langford et al., 2008 [38]

Randomized controlled trial

Develop a


treatment for fibromyalgia and examine the

effectiveness of treatment with

Cognitive- Behavioral Therapy.

N = 105

3 months

(one weekly session, for 8 weeks, of 2 hours each).

Quality of Life Scale (QOLS), FIQ, Numerical pain rating scale (NPRS), Chronic Disease

Questionnaire (CDQ), Health Assessment Questionnaire (HAQ), Arthritis Self-Efficacy (ASES), Symptom Checklist 90-R (SCL90-R), Chronic Pain Coping Inventory (CPCI).

The study showed that the most significant result of CBT was the improvement in self-efficacy, which

contributes to more favorable health behaviors such as exercise, relaxation training, and the continuous practice of adaptive coping strategies.

Ang et al., 2013 [28]

Randomized controlled trial

Compare the effects of Cognitive Therapy Combined and Milnacipran for the Treatment of Fibromyalgia.

N = 48

21 weeks (8 sessions of 35 minutes).

Nonparametric Kruskal-Wallis. Pain

sensitivity was assessed based on self-report evoked pain scores

corresponding to 15 random pressure stimuli resulting from 5 pressure levels, each repeated three times. Repeated measure ANOVA was used to

model this result at week 21.

Compared with milnacipran alone, combination therapy demonstrated a moderate effect in improving physical function and reducing mean weekly pain intensity.

McCrae et al., 2018 [29]

Randomized controlled trial

To examine the effect of

Cognitive- Behavioral Therapy for insomnia and pain on cortical thickness.

N = 37

3 years (weekly

sessions of 50 minutes for 8 weeks).

Analysis of neuroimaging of cortical regions bilaterally through

Magnetic Resonance.

Cognitive-Behavioral Therapy for Insomnia could delay or reverse gray matter cortical atrophy in patients with

fibromyalgia and insomnia.

Jensen et al., 2012 [27]

Randomized Clinical Trial

To investigate the role of the prefrontal cortex of patients with fibromyalgia in response to treatment with CBT.

N = 43

Weekly meetings for 12 weeks

(6 patients in each group— each session took 90


PGIC questionnaire and

the 1) Beck Depression Inventory 2) Spielberg

Anxiety Inventory 3) weekly pain intensity

4) thresholds from pain to pressure before and after treatment. Functional Magnetic Resonance was also used as a parameter.

CBT in FM patients was associated with increased activity of the ventrolateral prefrontal cortex and

orbitofrontal cortex during evoked pain, which are involved in executive cognitive control. CBT has also been associated with reductions in depression and anxiety.

Falcão et al., 2008 [37]

Randomized Clinical Trial

Evaluate the effects of Cognitive Behavioral Therapy in Fibromyalgia Syndrome.

N = 60

3 months

(10 weeks with a weekly meeting, with 3 hours

duration, of CBT combined with muscle relaxation training,

cognitive restructuring, and stress management).

Progression was analyzed by a Generic Questionnaire, FIQ Visual Analog Scale (VAS) Psychological


(State—Subcomponent State of the State-Trait

Anxiety Inventory) Psychological assessment, including the BDI (Beck Depression Inventory) Verbal Improvement Scale (Likert Scale) The amount of acetaminophen used was another parameter used.

Both groups showed

improvement with treatment. However, patients on

Cognitive Behavioral Therapy had better responses regarding depression and mental health.

Van Koulil et al., 2001 [33]

Randomized Clinical Trial

Evaluate the effects of CBT on pain avoidance behaviors, the pace of activities, and treatment with persistent pain.

N = 242

16 weeks of bi-weekly meetings, with 2 hours of CBT, followed by 2 hours of physical exercise + 6 months of follow-up.

A mixed linear model was used to assess physical functions, psychological functions, and the impact of fibromyalgia, taking into account the specific design features of this trial.

Patients showed improvement in all items evaluated.

Alda et al., 2011 [25]

Randomized Clinical Trial

To evaluate the

efficacy of CBT and the recommended pharmacological treatment compared to usual treatment at the primary care level for pain

catastrophizing in patients with


N = 141

10 to 12 weeks of CBT

Pain Catastrophizing Scale. Hamilton Rating Scale for Depression (HAM-D); Hamilton Anxiety Rating Scale (HARS); Visual

Analog Pain Scale (EVAP); FIQ; European Quality of Life Scale 5-D


CBT shows greater efficacy than recommended pharmacological treatment and usual care, not only in the main FM outcomes,

such as function and quality of life, but also in

relevant mediators of treatment effects, such as pain catastrophizing and pain acceptance.

Lami et al., 2018 [26]

Randomized Clinical Trial

To analyze the effectiveness of CBT for insomnia and pain (CBT-IP) compared to CBT for pain (CBT-P)

and usual medical care (UMC) as a means of improving sleep, pain, fatigue, and stress.

N = 126

21 weeks (9 weeks of CBT).

Pittsburgh Sleep Quality Index (PSQI), McGill Pain Questionnaire-Short Form (MPQ-SF),

Multidimensional Fatigue Inventory (MFI), Fibromyalgia Impact

Questionnaire (FIQ), Chronic Pain Self-Efficacy Scale (CPSS), Symptoms Check List 90-Revised (SCL-90-R), Pain Catastrophizing Scale (PCS) e Chronic Pain Acceptance Questionnaire (CPAQ).

CBT-IP didn’t result in full sleep recovery in all patients. However, it has shown

relevant clinical criteria,

improving sleep quality and pain control. Therefore, it could be incorporated into

multidisciplinary treatments.