Background
The somatoform disorders
International Classification of Diseases, 10th version (ICD-10) | Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) | ||
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F45
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Somatoform disorders
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Somatoform disorders
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F45.0 | Somatization disorder | 300.81 | Somatization disorder |
F45.1 | Undifferentiated somatoform disorder | 300.82 | Undifferentiated somatoform disorder |
F45.2 | Hypochondriacal disorders | 300.7 | Hypochondriasis |
F45.3 | Somatoform autonomic dysfunction | 300.7 | Body Dysmorphic Disorder |
.30 | Heart and cardiovascular system | ||
.31 | Upper gastrointestinal tract | 307.8 | Pain Disorder Associated with Psychological Features |
.32 | Lower gastrointestinal tract | 300.11 | Conversion Disorder |
.34 | Genitourinary system | ||
.38 | Other organ or system | ||
F45.4 | Persistent somatoform pain disorder | ||
F45.8 | Other somatoform disorders | ||
F45.9 | Somatoform disorder, unspecified |
Approach to the somatoform disorders
1. To plan regular appointments every 4–6 weeks in order to treat them clinically during the first year / 6 months, or if a new symptom comes up (in worsening periods, appointments could be more frequent). |
2. To give the patient a detailed document on the origin of the symptoms |
3. To establish high-priority objectives |
4. To restrict complementary examinations to the most indispensable ones |
5. To control the visits to specialists |
6. To have the patient treated by only one doctor |
7. To calm down and to reassure |
8. To identify the psychosocial stimuli that are involved as well as their link to the worsening of the symptomatology |
9. To avoid ambiguous information about the findings that come up |
10. To avoid spurious diagnostics |
11. Not to treat what the patients do not suffer from |
12. To avoid dichotomy explanations, i.e. (mental-physical nature) |
13. To mediate, when possible, in their psychosocial problems |
14. The best policy is to be sincere on the reports |
15. To approach some problems in a multidisciplinary way |
16. To organize the management/treatment of the difficult cases |
17. To be consistent with the approaches |
18. To properly remit to the psychiatry services |
Aims
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Improve the quality of life measured by SF-12 questionnaire at 3 and 6 months.
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Reduce the drug consumption.
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Reduce the number of medical consultation.
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Reduce the days of sickness absence.
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Raise the perception on improvement (standardized global vision) from the patient's point of view (PGI-I questionnaire) and from the doctor’s (with the CGI-I).
Methods/Design
Design of the study
Subjects of the study
Randomisation
Sample size
Method of calculation
Masking
1. | COGNITIVE REATTRIBUTION |
· Psychological explanation of the symptoms: To explain the objective of the session that is not precisely to heal the symptoms, but rather “to improve doping". To explain that somatization is a common phenomenon resulting from different factors and mechanisms. The patients are asked to talk about the different factors; and stress is introduced as an explanatory element of the symptoms. | |
· The importance of the cognitive issue. They give examples on the role of knowledge and the patients are asked to link them to their own experiences. The objective is to show how the behaviors and the attitude toward the symptoms could change the response to them. | |
2. | RELAXATION AND SYMPTOMATIC RELIEF |
· Once the role of stress in the genesis of pain has been described, techniques are introduced where physical exercising and muscular relaxation are combined. The patients are provided with a CD with spoken instructions. | |
3. | BEHAVIOR-ILLNESS |
· The patients are given details on optional treatments and on the correct use of sanitary services. They are also instructed on the mechanisms to control anomalous behavior toward the illness. | |
4. | AEROBIC EXERCISING |
· To encourage physical exercising: to do away with the bad habit of stating that “pain stops me from doing any kind activity” thus, they avoid doing any kind of activity. An ongoing program on physical exercising is outlined. |
Data collection method
Intervention Group | Control Group | |
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Recruitment visit (V 0)
| Selection criteria | |
Consecutive selection | Request on informed consent | |
PRIME MD Questionnaire | ||
Variables:
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· SF-12 Questionnaire on life quality | ||
· Descriptive variables: sex, cultural level, age, months with symptoms, time on antidepressants consumption, requested tests y specialized derivations to | ||
Training of professionals involved
| Training in management of PRIME-MD survey. Review of Standards of Good Clinical Practice | |
Training in cognitive-behavioral (Only intervention Group) | ||
Baseline visit (V1)
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Variables: | |
· SF-12 Questionnaire | ||
· Prescribed medicine | ||
· Requested tests | ||
· Derivations to secondary level | ||
· Days of sickness absence | ||
· Assessment of compliance with the standards of good clinical practice | ||
· Questionnaire on global clinical impression; both, the doctor and the patient | ||
Intervention
| There will be a weekly group session for 4 weeks (Only intervention Group) | |
Routine clinical practice
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3-months post Intervention visit (V2)
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Variables: | |
· SF-12 Questionnaire | ||
· Prescribed medicine | ||
· Requested tests | ||
· Derivations to secondary level | ||
· Days of sickness absence | ||
· Assessment of compliance with the standards of good clinical practice | ||
· Questionnaire on global clinical impression; both, the doctor and the patient | ||
· Assessment by the nurse subject participation. | ||
· Assessment of cognitive- behavioral module by subject (Only intervention Group) | ||
6-months post Intervention visit (V3) 12-months post Intervention visit (V4)
|
Variables: | |
· SF-12 Questionnaire | ||
· Prescribed medicine | ||
· Requested tests | ||
· Derivations to secondary level | ||
· Days of sickness absence | ||
· Assessment of compliance with the standards of good clinical practice | ||
· Questionnaire on global clinical impression; both, the doctor and the patient | ||
· Assessment of cognitive- behavioral module by subject (Only intervention Group) |
Variables
Outcomes variables
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Questionnaire on Global Clinical Impression. Used to assess the patient's (PGI questionnaire) and the doctor’s (CGI Questionnaire) perceptions on the its improvement with the interventions. Will be administered at 6 months (to assess the effectiveness of the rules of good clinical practice) and at 12 months to evaluate the effectiveness of the intervention group added to the standards of good clinical practice. Will be treated as ordinal qualitative variable.
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Quality of life at 3 and 6 months after the intervention measured by the SF-12 questionnaire.
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Number of consultations during the period of study (broken down between nursing and medicine, each group session will be counted as a nursing consultation).
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Prescribed medicine during the period of study, with doubtful therapeutic value for their processing; related to the MUS. The included medicines are those related to the functional symptomatology:
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Pain: analgesic medicines, Nonsteroidal Anti-inflammatory Drugs and muscular pain reliever.
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Dizziness: vestibular sedatives, peripheral brain and vasodilators.
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Digestive Symptoms: pro-kinetics, anti-emetics.
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Asthenia: vitamin complex, restoratives, derived from ginseng, appetite stimulants.
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Anxiety: anxiolytics, antidepressants.
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Days of sickness absence during the period of study.
Clinical Variables
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Duration of the somatic symptoms before the study. Quantitative variable (number of months).
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Time on anti-depressants consumption (months) before the study.
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Psychiatric Co-morbidity at the beginning of the study. It will be analyzed as a dichotomy qualitative variable (yes/no); assessing the presence/absence of depression, anxiety and somatic-morph disorders (according to the PRIME MD classification).
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PRIME-MD questionnaire; validated in Spain [27] that categorizes the patient into 5 areas of mental disorders with greater incidence on primary care: disorders in the state of mind/mood, anxiety disorders, disorders on nutritional behavior, somatoform disorders and disorders due to alcohol abuse or addiction. There are two components: a questionnaire for the patient that acts as a sifting/testing tool, and an assessment guide for the doctor that allows the diagnostic confirmation on the case. Once the questionnaire has been carried out, the patients diagnosed under anxiety or depression will be treated in a standardized way. Thus a bias is eliminated in the understanding of the study results, i.e. not to have treated the identified anxious-depressive psychiatric co-morbidity in a proper way; an issue that could have positive effect on the somatoform manifestations.
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Derivations carried out at secondary level.
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Complementary Tests, grouped in the following categories: laboratory, image tests, and endoscopies.