Figure 1 [ Fig. The presentation discards the item "painful menstruation", as this pain quality is not relevant for all age groups.
The figure shows that even younger adults reported an average of one somatoform pain symptom, and those aged over 70 years reported an average of two somatoform pain symptoms, i. As Table 5 [ Tab. Only "painful menstruation" decreased with an increasing age according to expectations. The presence of a partnership, according to this survey, showed no relationship to the intensity of pain complaints. Somatoform pain complaints are very frequent in the general population. Thus These findings are very impressive as they only came from persons who reported that their pain had no organic correlate.
It is to be conjectured, however, that another significant proportion of persons with somatoform pain did not report the symptoms as fixation on an organic symptom is characteristic for somatoform disorders.
The neglect of this organic fixation in somatoform disorders is a significant criticism of the SOMS-2 questionnaire  , because the insistence on the organogenesis of complaints represents an obligatory diagnostic criterion of somatoform disorders. Careful clinical interviews are therefore necessary for the diagnosis of somatoform disorders in the clinical sector. However, such a procedure is not practicable within a frame representative for the whole population and thus an approach towards diagnostic findings is aimed, using the described questionnaire. Further, these reports are descriptive and do not allow conclusions regarding etiologic or pathogenic mechanisms of somatization.
In its descriptive orientation the SOMS-2 follows the classification systems DSM-IV and ICD which both defined somatoform complaints by counting symptoms based on symptom lists taking inclusion and exclusion criteria particularly the demand for a lack of the defined physical disorder into account. These diagnostic algorithms by the classification systems have been questioned repeatedly. Particularly the disregard of significant etiologic and pathogenic aspects of somatoform disorders e.
The diagnostic procedures of the diagnosis systems imply that somatoform disorders are not diagnosed according to positive characteristics, but rather by negative characteristics lack of an organic finding. In addition, this procedure subsumes a heterogeneous, only superficially similar collection of disorders . In spite of these critical aspects, the SOMS-2 has been proved as a suitable screening procedure for assessing prevalence data.
The etiologic and pathogenic aspects of somatoform disorders, however, can only be determined by more detailed inquiry interviews. The high prevalence of somatoform pain disorders is known to be reflected in the high prevalence of the consumption of pain medication.
Thus in the federal health survey in , 0. It can be assumed that there is a direct relationship between the high prevalence of somatoform pain disorders in the general population and a high utilisation of somatic treatments  as well as a strong consumption of pain medication.
The treatment of patients with a somatoform pain disorder in a somatically oriented health system is clearly inadequate. It becomes a major cause for the chronic course of this disease and results in a strong financial demand on the health system. Still psychotherapeutic procedures are only utilised in a small proportion of the general population, which has a high proportion of persons with somatoform pains.
According to our representative survey of persons in  , psychosocial professionals psychiatrists, psychotherapists, psychologists have only been consulted by a small segment of the population, with about the same frequency as nonmedical naturopathic practitioners, community nurses and clergy. Only 1. Women reported more somatoform pain than men.
This corresponds to estimates from the literature showing a clearly higher prevalence for women, particularly for back and head pains than for men. In addition, women complained about stronger and more enduring pain . This sex difference also corresponded to other studies showing that women reported more psychological and body complaints than men and described themselves as sicker  ,  ,  ,  ,  , .
The sex difference we found also corresponded to studies on the prevalence of somatoform complaints. List By Health Topic. List By Countries. UTN request. UTN validation. In English. In French. In Spanish. In Arabic. In Chinese. In Russian. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. Last refreshed on:. Main ID:. Date of registration:. Prospective Registration:.
Primary sponsor:. Charite University, Berlin, Germany. Public title:. For example, when it comes to sample size, most studies should be considered as mere pilot trials, with 25 or fewer participants randomized per group [ 11 , 12 , 18 , 19 , 20 ]. Only three recent trials evaluated large enough samples [ 9 , 16 , 17 ].
These three trials were the only ones with blind outcome assessment, too.
Somatoforme Störungen: Diagnostik, Konzepte und Therapie bei Körpersymptomen ohne Organbefund (German Edition): Medicine & Health. Somatoforme Störungen: Diagnostik, Konzepte und Therapie bei Körpersymptomen Ohne Organbefund German Edition, 2. Auflage: Diagnostik, Konzepte Und.
Altogether, about half of the trials since tested against waiting list, which is also true for ongoing trials registered on the International Clinical Trials Registry platform. Apart from insufficient evidence for the relative efficacy of PGD treatments, knowledge of predictors of treatment success is also incomplete.
When it comes to treatment outcomes, the findings are even less clear. One study could not confirm any moderator [ 16 ], while another [ 24 ] found that a lower educational level and losing a child or partner predicted worse outcomes whereas initial levels of comorbidity did not. In our pilot study, patients seeking additional treatment after post assessment had a higher probability of having been diagnosed with a somatoform disorder at baseline [ 25 ]. Although somatization improved significantly from pre to post, there was no significant difference between the treatment group and the waiting-list group in contrast to depressive symptoms; [ 12 ].
Apart from somatoform symptoms and other baseline comorbidity that should be addressed in therapy, several other possible predictors of treatment outcome warrant more research. For example, dysfunctional cognitions, grief-related avoidance, rumination and worry have been shown to predict poorer adjustment to loss in longitudinal studies e. The major goal of this trial on PROlonged GRIef Disorder — PROGRID — is to substantiate the positive results of our pilot-tested intervention [ 12 ] while remedying the methodological shortcomings of the pilot trial: 1 PGD symptoms are assessed in a structured interview by independent blind raters, 2 additional attention is paid to comorbidity and somatic symptoms in particular, 3 further predictors of treatment outcome are addressed as well as therapeutic process and change trajectories.
Finally 4 , we compare our intervention with an active, yet unspecific, treatment in order to evaluate the relative efficacy of grief-specific cognitive behavioral therapy CBT. While one trial suggested that non-specific behavioral activation might suffice to improve PGD [ 11 ], Bryant and colleagues [ 9 ] showed that individual exposure sessions enhanced effectiveness, pointing to the relevance of some kind of emotional processing.
The experimental treatment, PG-CBT, is an integrative cognitive behavioral approach that includes structured exposure and cognitive restructuring. Altogether, PG-CBT consists of 20 individual sessions plus four optional sessions within 6 months of manualized treatment.
We chose present-centered therapy as the comparator PCT; [ 27 , 28 ]. PCT was developed as a control condition for non-specific treatment factors such as empathic listening and therapeutic support in treatment trials evaluating CBT in PTSD. It achieved moderate to high pre- to post-treatment effect sizes for primary outcomes and was well tolerated e.
A recent meta-analysis, including six trials, found PCT to be slightly inferior to other therapies regarding PTSD symptom severity, but equally effective concerning secondary outcomes [ 32 ]. PCT does not include any trauma-focused components i. In addition, it resembles the mostly supportive approach taken with grieving patients in usual care or in self-help groups.
Because of its integrative and comprehensive approach and based on the results from the pilot trial, we expect PG-CBT to be found to be not only superior to PCT regarding prolonged grief symptoms, but also regarding all secondary outcomes. Furthermore, the trial adds to existing knowledge by exploring possible moderators e. Randomization is performed independently by a Clinical Trials Coordination Center CTCC , employing block randomization with randomly varying block sizes stratified by study center and type of kinship child vs.
See Fig. Participant flow. Treatment is offered at four university outpatient mental health clinics in four German cities, Frankfurt, Ingolstadt, Marburg and Leipzig. Treatment-seeking individuals are routinely screened for having experienced the loss of a significant other.
Additional recruitment efforts will include a study website, advertisements in public and social media e. Eligible participants must meet the criteria of a primary diagnosis of PGD as assessed in the PG interview Interview for Prolonged Grief, see below. If patients are taking antidepressant medication, the treatment regime needs to be stable for at least 4 weeks before joining the trial.
Exclusion criteria are: 1 current psychotic or severe substance use disorder, or acute suicidality; 2 ongoing psychotherapy; 3 participation in another treatment trial; and 4 continuous treatment with benzodiazepines, antipsychotics, or opioids. Therefore, power calculation for the primary endpoint of this trial is based on the assumption that PG-CBT is more effective, if a minimal clinical relevant difference of 5.
Interested participants, who are potentially eligible i. If an individual does not present severe mental symptoms that warrant immediate clinical attention e. Self-report measures are given to the participants to be completed at home. If an individual is eligible, randomization is requested of the CTCC before a third appointment. The potential participant is then informed about the randomization result.