Somatic Symptom Disorder (DSM-V)ENCERTNCT01908855
Cognitive-Behavioral Therapy Enriched With Emotion Regulation Training for Multiple Somatoform Symptoms
A study testing Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms and Cognitive-behavioral therapy for patients with multiple somatoform symptoms in people with Somatic Symptom Disorder (DSM-V), run by Philipps University Marburg at 7 sites in Germany.
Trial summary
The purpose of this study is to evaluate whether cognitive-behavioral therapy enriched with strategies from emotion regulation training leads to better improvement in somatic symptoms and comorbid problems than cognitive-behavioral therapy alone. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Somatic Symptom Disorder (DSM-V)
- What is being tested?
- Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms and Cognitive-behavioral therapy for patients with multiple somatoform symptoms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 7 sitesGermany
- Study dates
- Oct 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Severe alcohol/drug addiction
- Acquired brain injuries
- Psychoses (history of schizophrenia spectrum disorders; bipolar disorders)
- Primary disorder requesting other treatments (e.g., suicidality)
- Biomedical etiology of major symptoms (also if detected during treatment course
- Ongoing psychotherapy
Show all 10Show fewer
- Continuous or intermittent, high-dosage (on average more than once per 2 weeks) benzodiazepine treatment
- Continuous antipsychotic treatment
- Continuous opioid treatment
- For patients on medication with antidepressants: treatment regime changes during the time between 4 weeks prior to treatment until follow-up
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Justus-Liebig-University, CBT Outpatient Clinic
Giessen, D-35394
University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine
Hamburg, D-20246
University Koblenz-Landau, Department of Clinical Psychology and Psychotherapy
Koblenz-Landau, D-76829
Central Institute of Mental Health, Department of Clinical Psychology
Mannheim, D-68159
Philipps-University, Department of Clinical Psychology and Psychotherapy
Marburg, D-35032
Rechts der Isar Hospital, University of Technology, Department of Psychosomatic Medicine and Psychotherapy
München, D-81675
Bergische University, Department of Clinical Psychology and Psychotherapy
Wuppertal, D-42097
About this study
Official title: Enriching Cognitive-Behavioral Therapy With Emotion Regulation Training in Patients With Chronic Multiple Somatoform Symptoms (ENCERT): A Randomized Controlled Trial
The purpose of this study is to evaluate whether cognitive-behavioral therapy enriched with strategies from emotion regulation training leads to better improvement in somatic symptoms and comorbid problems than cognitive-behavioral therapy alone.
Read the detailed description
Somatic symptoms not caused by a known biomedical condition ("somatoform disorders") are highly prevalent, involve a high risk of chronicity, are one of the major reasons for doctor visits, and are a tremendous burden for health care systems. Despite the economic relevance, research activities are disproportionately low. The only intervention with an evidence grade I is cognitive-behavioral therapy (CBT). However, average effect sizes for CBT in somatization syndromes are only moderate (Cohen's d < 0.5), and more powerful interventions are needed.
There is convincing evidence that patients with somatoform disorders have emotion regulation deficits, which are not addressed by current CBT approaches. Based on positive results of a small pilot study it is expected that enriching CBT programs with emotion regulation techniques improves treatment outcome. The primary goal of the proposed project is therefore to evaluate this hypothesis in a randomized design.
Patients will be primarily recruited via referrals by primary care doctors. After a screening phase a baseline assessments with different self- and clinician-rating scales (see Outcome Measures) follows. If participants fulfill the eligibility criteria they will be randomized to one of the two study arms: cognitive-behavioral therapy vs. cognitive-behavioral therapy enriched with emotion regulation strategies. After every therapy session patients will be screened in regard to aspects of therapeutic alliance, adverse events, and symptom intensity/annoyance. The post assessment takes place after the 20th session and a follow-up is planned six months after post treatment.
Different methods will be applied to prevent bias and to assure a high quality level of the current study. Data handling, data monitoring and statistical analyses will be supervised by the Coordinating Center for Clinical Trials (KKS) of Philipps-University of Marburg; data quality and safety principles will be applied. Additionally an independent Data Safety Monitoring Board will be nominated. The study center will visit all study sites regularly to verify correct procedures, data sampling, and data management. Randomisation occurs and is controlled centrally through the randomisation's central office in KKS Marburg. Furthermore the current study constitutes a single-blinded trial. Assessment interviews are conducted and analyzed by people blinded to the treatment condition. Additionally, treatments are manualized, and therapists receive an intense training. Treatment fidelity/integrity is analyzed with rating schemes for 5% randomly selected videotaped treatment sessions. Allowed additional treatments during study inclusion are thoroughly monitored and analyzed.
The sample size calculation is based on the primary outcome variable "somatization severity index" of the Screening of Somatoform Disorders (SOMS-7T). Based on results of the main validation study of SOMS-7T, meta-analytic estimations, and results of a pilot study of the efficacy of ENCERT, the power calculations yield a necessary total sample size of N=194 to detect a clinical relevant difference of 4 points symptom reduction on SOMS-7T between the two treatments with a power of 0.80 and an alpha=.05. With regard to an estimated drop-out rate of 20%, N=244 patients are to be recruited.
As main efficacy analysis the primary outcome shall be analyzed with linear mixed-effect models. It will be done according to the Intention-to-Treat (ITT) principle: to consider missing values as a potential source of bias, they will be handled according to the framework by Rubin. Secondary statistical analyses focus on establishing longer term treatment efficacy and describing the pattern of change. For this purpose the mean response will be modeled as a function of time with a separate mixed effects linear model over all assessments. Furthermore, interindividual differences in intraindividual change will be modeled using multilevel analysis for longitudinal data. Multilevel longitudinal mediation analyses will be conducted in order to test whether the effect of treatment condition on intraindividual changes in somatic symptom severity can be explained by intraindividual changes in emotion regulation skills.
- Conditions
- Somatic Symptom Disorder (DSM-V)
- Being tested
- Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms, Cognitive-behavioral therapy for patients with multiple somatoform symptoms
- Keywords
- somatoform symptoms, somatic symptoms, somatoform disorder, somatic symptom disorder, cognitive-behavioral therapy, emotion regulation training
- Medical subject headings
- Medically Unexplained Symptoms, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptomsBehavioural
Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms:
20 weekly sessions individual therapy (à 50) minutes
Cognitive-behavioral therapy for patients with multiple somatoform symptomsBehavioural
Cognitive-behavioral therapy for patients with multiple somatoform symptoms:
20 weekly sessions individual therapy (à 50) minutes
| Study group | Role | What they receive |
|---|---|---|
| ENCERT | Experimental | ENCERT contains 1) psychoeducation (session1), 2) relaxation techniques for coping with stress (sessions 2-4), 3) non-judgmental awareness of body perceptions, (sessions 5-7), 4) modifying illness behavior and accepting unpleasant body perceptions (sessions 8-13), 5) attention defocusing on positive perceptions plus emotional self-support (sessions 14- 15), 6) analyzing interpretation processes to understand situational cues (sessions 16-17), and 7) change of behavior and interpretations (sessions 18-20). The innovative elements of ENCERT are: improving the awareness for the association of somatic symptoms with emotions, learning non-judgmental awareness and acceptance of unpleasant body perceptions, achieving high-frequent skill exercising with the emotion regulation audio training. Receives: Behavioral: Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms |
| CBT | Active comparator | This arm is based on traditional cognitive-behavioral therapy that can be considered the current "treatment of choice", being the only intervention with an evidence grade 1a (Kroenke, 2007). As such, it presents the reference of efficacy and safety for new regimen. The strictly manualized program includes the following components focusing on the special needs of chronic somatoform patients: psychoeducation providing a framework for psychotherapy, attention defocusing, reduction of over-interpretation of symptoms, increase of physical activity, stress reduction. Receives: Behavioral: Cognitive-behavioral therapy for patients with multiple somatoform symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in somatic symptom severity (Screening of Somatoform Disorders, SOMS-7T) from pre-assessment to four in-between assessments to post-assessment to follow-up
Assessment of somatic symptom severity during the last 7 days (self-rating)
Measured: From pre-assessment (admission) to four in-between assessments (9, 13, 17, 21 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Secondary outcomes (11)
Change in depressive symptoms (Beck Depression Inventory-II, BDI-II) from pre-assessment to one in-between assessment to post-assessment to follow-up
Assessment of depressive symptoms (self-rating)
Measured: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in emotion regulation skills (Emotion Regulation Skills Questionnaire, ERSQ) from pre-assessment to one in-between assessment to post-assessment to follow-up
Assessment of emotion regulation skills (self-rating)
Measured: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in symptom-focussed coping strategies (Pain Coping Questionnaire, FESV; Geissner, 2003) from pre-assessment to one in-between assessment to post-assessment to follow-up
Assessment of symptom-focused coping strategies (self-rating)
Measured: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in general psychopathological symptoms (Symptom Checklist-90, SCL-90) from pre-assessment to one in-between assessment to post-assessment to follow-up
Assessment of general psychopathological symptoms (self-rating)
Measured: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in symptom-caused disability (Pain Disability Index, PDI) from pre-assessment to one in-between assessment to post-assessment to follow-up
Assessment of symptom-caused disability in different areas of life (self-rating)
Measured: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in health-related quality of life (EuroQoL-5D, EQ-5D) from pre-assessment to one in-between assessment to post-assessment to follow-up
Assessment of health-related quality of life (self-rating)
Measured: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in health anxiety (Whiteley Index, WI) from pre-assessment to one in-between assessment to post-assessment to follow-up
Assessment of health anxiety (self-rating)
Measured: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in social competence, emotion regulation, relaxation abilities, stress management, etc., in different areas of life (The Operationalized Assessment of Abilities, OFD) from pre-assessment to post-assessment to follow-up
Observer-based assessment of scores for social competence, emotion regulation, relaxation abilities, stress management, etc., in different areas of life (job, family, leisure)
Measured: From pre-assessment (admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in health care utilization and indirect costs (Structured Interview for the Assessment of Health Care Utilization, HCU) from pre-assessment to follow-up
Observer-based assessment of HCU and indirect costs. HCU will be transformed to costs using health economy tables
Measured: From pre-assessment (admission) to follow-up (12 months after admission)
Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at post-assessment
Assessment of psychotherapy-induced side effects (self-rating)
Measured: Post-assessment (25 weeks after admission)
Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at follow-up
Assessment of psychotherapy-induced side effects (self-rating)
Measured: Follow-up (12 months after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Somatic Symptom Disorder (DSM-V)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, Central Institute of Mental Health, Mannheim, University of Giessen, University of Wuppertal, Universitätsklinikum Hamburg-Eppendorf, University of Kaiserslautern-Landau, German Research Foundation
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
- Investigators
- Winfried Rief, Ph.D., Principal investigator, Philipps University MarburgMathias Berking, Ph.D., Study chair, Philipps University MarburgMaria Kleinstäuber, Ph.D., Study chair, Philipps University MarburgJaphia-Maria Gottschalk, M.Sc., Study chair, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908855
- Sponsor's protocol ID
- ENCERT-130313
- Other IDs
- Ri 574/24-1
- Acronym
- ENCERT
- Status last verified
- Aug 2017
- First submitted
- 19 Jul 2013
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barsky AJ, Orav EJ, Bates DW. Somatization increases medical utilization and costs independent of psychiatric and medical comorbidity. Arch Gen Psychiatry. 2005 Aug;62(8):903-10. doi: 10.1001/archpsyc.62.8.903.
PubMed 16061768Geissner E. Pain Coping Questionnaire FESV. Göttingen, Germany: Hogrefe; 2003.
Göllner R, Gollwitzer M, Heider J, Zaby A, Schröder A. Analyzing longitudinal data with hierarchical linear models. Zeitschrift für Klinische Psychologie und Psychotherapie 39(3):179-88, 2010.
Gottschalk JM, Bleichhardt G, Kleinstäuber M, Berking M, Rief W. Treatment efficacy of multiple somatoform symptoms? Enriching cognitive behavioral therapy with emotion regulation training: Results of a controlled pilot study. In preparation.
Jacobi F, Wittchen H-U, Holting C, Hofler M, Pfister H, Muller N, Lieb R. Prevalence, co-morbidity and correlates of mental disorders in the general population: results from the German Health Interview and Examination Survey (GHS). Psychol Med. 2004 May;34(4):597-611. doi: 10.1017/S0033291703001399.
PubMed 15099415Kleinstauber M, Witthoft M, Hiller W. Efficacy of short-term psychotherapy for multiple medically unexplained physical symptoms: a meta-analysis. Clin Psychol Rev. 2011 Feb;31(1):146-60. doi: 10.1016/j.cpr.2010.09.001. Epub 2010 Sep 16.
PubMed 20920834Kroenke K. Efficacy of treatment for somatoform disorders: a review of randomized controlled trials. Psychosom Med. 2007 Dec;69(9):881-8. doi: 10.1097/PSY.0b013e31815b00c4.
PubMed 18040099Molenberghs G, Kenward MG.Missing Data in Clinical Studies. Chichester, UK: Whiley; 2007.
Moscovitch DA, Hofmann SG, Suvak MK, In-Albon T. Mediation of changes in anxiety and depression during treatment of social phobia. J Consult Clin Psychol. 2005 Oct;73(5):945-952. doi: 10.1037/0022-006X.73.5.945.
PubMed 16287394Rief W, Hiller W. A new approach to the assessment of the treatment effects of somatoform disorders. Psychosomatics. 2003 Nov-Dec;44(6):492-8. doi: 10.1176/appi.psy.44.6.492.
PubMed 14597684Rief W, Rojas G. Stability of somatoform symptoms--implications for classification. Psychosom Med. 2007 Dec;69(9):864-9. doi: 10.1097/PSY.0b013e31815b006e.
PubMed 18040096Rieffe C, Terwogt MM, Bosch JD, Kneepkens CMF, Douwes AC, Jellesma FC. Interaction between emotions and somatic complaints in children who did or did not seek medical care. Cognition Emotion 21(8):1630-1646, 2007.
Waller E, Scheidt CE. Somatoform disorders as disorders of affect regulation: a study comparing the TAS-20 with non-self-report measures of alexithymia. J Psychosom Res. 2004 Sep;57(3):239-47. doi: 10.1016/S0022-3999(03)00613-5.
PubMed 15507250Witthoft M, Rist F, Bailer J. Abnormalities in cognitive-emotional information processing in idiopathic environmental intolerance and somatoform disorders. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):70-84. doi: 10.1016/j.jbtep.2008.04.002. Epub 2008 May 23.
PubMed 18501333Senger K, Rubel JA, Kleinstauber M, Schroder A, Kock K, Lambert MJ, Lutz W, Heider J. Symptom change trajectories in patients with persistent somatic symptoms and their association to long-term treatment outcome. Psychother Res. 2022 Jun;32(5):624-639. doi: 10.1080/10503307.2021.1993376. Epub 2021 Oct 29.
PubMed 34711141
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enriching Cognitive-Behavioral Therapy With Emotion Regulation Training in Patients With Chronic Multiple Somatoform Symptoms (ENCERT): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01908855
- Acronym / sponsor ID
- ENCERT / ENCERT-130313
- Conditions
- Somatic Symptom Disorder (DSM-V)
- Keywords
- somatoform symptoms, somatic symptoms, somatoform disorder, somatic symptom disorder, cognitive-behavioral therapy, emotion regulation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Technical University of Munich, Central Institute of Mental Health, Mannheim, University of Giessen, University of Wuppertal, Universitätsklinikum Hamburg-Eppendorf, University of Kaiserslautern-Landau, German Research Foundation
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether cognitive-behavioral therapy enriched with strategies from emotion regulation training leads to better improvement in somatic symptoms and comorbid problems than cognitive-behavioral therapy alone.
Detailed description
Somatic symptoms not caused by a known biomedical condition ("somatoform disorders") are highly prevalent, involve a high risk of chronicity, are one of the major reasons for doctor visits, and are a tremendous burden for health care systems. Despite the economic relevance, research activities are disproportionately low. The only intervention with an evidence grade I is cognitive-behavioral therapy (CBT). However, average effect sizes for CBT in somatization syndromes are only moderate (Cohen's d < 0.5), and more powerful interventions are needed.
There is convincing evidence that patients with somatoform disorders have emotion regulation deficits, which are not addressed by current CBT approaches. Based on positive results of a small pilot study it is expected that enriching CBT programs with emotion regulation techniques improves treatment outcome. The primary goal of the proposed project is therefore to evaluate this hypothesis in a randomized design.
Patients will be primarily recruited via referrals by primary care doctors. After a screening phase a baseline assessments with different self- and clinician-rating scales (see Outcome Measures) follows. If participants fulfill the eligibility criteria they will be randomized to one of the two study arms: cognitive-behavioral therapy vs. cognitive-behavioral therapy enriched with emotion regulation strategies. After every therapy session patients will be screened in regard to aspects of therapeutic alliance, adverse events, and symptom intensity/annoyance. The post assessment takes place after the 20th session and a follow-up is planned six months after post treatment.
Different methods will be applied to prevent bias and to assure a high quality level of the current study. Data handling, data monitoring and statistical analyses will be supervised by the Coordinating Center for Clinical Trials (KKS) of Philipps-University of Marburg; data quality and safety principles will be applied. Additionally an independent Data Safety Monitoring Board will be nominated. The study center will visit all study sites regularly to verify correct procedures, data sampling, and data management. Randomisation occurs and is controlled centrally through the randomisation's central office in KKS Marburg. Furthermore the current study constitutes a single-blinded trial. Assessment interviews are conducted and analyzed by people blinded to the treatment condition. Additionally, treatments are manualized, and therapists receive an intense training. Treatment fidelity/integrity is analyzed with rating schemes for 5% randomly selected videotaped treatment sessions. Allowed additional treatments during study inclusion are thoroughly monitored and analyzed.
The sample size calculation is based on the primary outcome variable "somatization severity index" of the Screening of Somatoform Disorders (SOMS-7T). Based on results of the main validation study of SOMS-7T, meta-analytic estimations, and results of a pilot study of the efficacy of ENCERT, the power calculations yield a necessary total sample size of N=194 to detect a clinical relevant difference of 4 points symptom reduction on SOMS-7T between the two treatments with a power of 0.80 and an alpha=.05. With regard to an estimated drop-out rate of 20%, N=244 patients are to be recruited.
As main efficacy analysis the primary outcome shall be analyzed with linear mixed-effect models. It will be done according to the Intention-to-Treat (ITT) principle: to consider missing values as a potential source of bias, they will be handled according to the framework by Rubin. Secondary statistical analyses focus on establishing longer term treatment efficacy and describing the pattern of change. For this purpose the mean response will be modeled as a function of time with a separate mixed effects linear model over all assessments. Furthermore, interindividual differences in intraindividual change will be modeled using multilevel analysis for longitudinal data. Multilevel longitudinal mediation analyses will be conducted in order to test whether the effect of treatment condition on intraindividual changes in somatic symptom severity can be explained by intraindividual changes in emotion regulation skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENCERT | Experimental | Behavioral: Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptomsENCERT contains 1) psychoeducation (session1), 2) relaxation techniques for coping with stress (sessions 2-4), 3) non-judgmental awareness of body perceptions, (sessions 5-7), 4) modifying illness behavior and accepting unpleasant body perceptions (sessions 8-13), 5) attention defocusing on positive perceptions plus emotional self-support (sessions 14- 15), 6) analyzing interpretation processes to understand situational cues (sessions 16-17), and 7) change of behavior and interpretations (sessions 18-20). The innovative elements of ENCERT are: improving the awareness for the association of somatic symptoms with emotions, learning non-judgmental awareness and acceptance of unpleasant body perceptions, achieving high-frequent skill exercising with the emotion regulation audio training. |
| CBT | Active comparator | Behavioral: Cognitive-behavioral therapy for patients with multiple somatoform symptomsThis arm is based on traditional cognitive-behavioral therapy that can be considered the current "treatment of choice", being the only intervention with an evidence grade 1a (Kroenke, 2007). As such, it presents the reference of efficacy and safety for new regimen. The strictly manualized program includes the following components focusing on the special needs of chronic somatoform patients: psychoeducation providing a framework for psychotherapy, attention defocusing, reduction of over-interpretation of symptoms, increase of physical activity, stress reduction. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Severe alcohol/drug addiction
- Acquired brain injuries
- Psychoses (history of schizophrenia spectrum disorders; bipolar disorders)
- Primary disorder requesting other treatments (e.g., suicidality)
- Biomedical etiology of major symptoms (also if detected during treatment course
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptomsCognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50) minutes | Behavioural | ENCERT |
| Cognitive-behavioral therapy for patients with multiple somatoform symptomsCognitive-behavioral therapy for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50) minutes | Behavioural | CBT |
Primary outcome
Change in somatic symptom severity (Screening of Somatoform Disorders, SOMS-7T) from pre-assessment to four in-between assessments to post-assessment to follow-up
Time frame: From pre-assessment (admission) to four in-between assessments (9, 13, 17, 21 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Assessment of somatic symptom severity during the last 7 days (self-rating)
11 secondary outcomes
Change in depressive symptoms (Beck Depression Inventory-II, BDI-II) from pre-assessment to one in-between assessment to post-assessment to follow-up
Time frame: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in emotion regulation skills (Emotion Regulation Skills Questionnaire, ERSQ) from pre-assessment to one in-between assessment to post-assessment to follow-up
Time frame: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in symptom-focussed coping strategies (Pain Coping Questionnaire, FESV; Geissner, 2003) from pre-assessment to one in-between assessment to post-assessment to follow-up
Time frame: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in general psychopathological symptoms (Symptom Checklist-90, SCL-90) from pre-assessment to one in-between assessment to post-assessment to follow-up
Time frame: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in symptom-caused disability (Pain Disability Index, PDI) from pre-assessment to one in-between assessment to post-assessment to follow-up
Time frame: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in health-related quality of life (EuroQoL-5D, EQ-5D) from pre-assessment to one in-between assessment to post-assessment to follow-up
Time frame: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in health anxiety (Whiteley Index, WI) from pre-assessment to one in-between assessment to post-assessment to follow-up
Time frame: From pre-assessment (admission) to one in-between assessment (13 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in social competence, emotion regulation, relaxation abilities, stress management, etc., in different areas of life (The Operationalized Assessment of Abilities, OFD) from pre-assessment to post-assessment to follow-up
Time frame: From pre-assessment (admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Change in health care utilization and indirect costs (Structured Interview for the Assessment of Health Care Utilization, HCU) from pre-assessment to follow-up
Time frame: From pre-assessment (admission) to follow-up (12 months after admission)
Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at post-assessment
Time frame: Post-assessment (25 weeks after admission)
Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at follow-up
Time frame: Follow-up (12 months after admission)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Background: PubMed 16061768Barsky AJ, Orav EJ, Bates DW. Somatization increases medical utilization and costs independent of psychiatric and medical comorbidity. Arch Gen Psychiatry. 2005 Aug;62(8):903-10. doi: 10.1001/archpsyc.62.8.903.
- BackgroundGeissner E. Pain Coping Questionnaire FESV. Göttingen, Germany: Hogrefe; 2003.
- BackgroundGöllner R, Gollwitzer M, Heider J, Zaby A, Schröder A. Analyzing longitudinal data with hierarchical linear models. Zeitschrift für Klinische Psychologie und Psychotherapie 39(3):179-88, 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, Ph.D. principal investigator
Philipps University Marburg
Mathias Berking, Ph.D. study chair
Philipps University Marburg
Maria Kleinstäuber, Ph.D. study chair
Philipps University Marburg
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms and Cognitive-behavioral therapy for patients with multiple somatoform symptoms in people with Somatic Symptom Disorder (DSM-V), run by Philipps University Marburg at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in somatic symptom severity (Screening of Somatoform Disorders, SOMS-7T) from pre-assessment to four in-between assessments to post-assessment to follow-up (time frame: From pre-assessment (admission) to four in-between assessments (9, 13, 17, 21 weeks after admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908855, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.