Psychosomatic Therapy, Feasibility and Cost Analysis

NCT01935258 | Completed DMC

• 1 other identifier: 2012/365
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 8

Brief Summary

Medically unexplained symptoms (MUS) are a common and important problem in primary care. Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful tests, referrals and treatment. Evidence indicate that specific interventions for patients with MUS, such as reattribution therapy and cognitive behavioural therapy are of limited help. According to experts in this field a multi-component approach is most helpful for these patients. This pilot trial aims to test the systematic identification of eligible patients, to assess the acceptability of the intervention and to estimate potential treatment effects for a larger trial. It's a randomised pilot study consisting of patients with MUS in primary care. Patients will be randomized to intervention (usual care and additional psychosomatic therapy) or control condition (usual care alone). Patients will be followed for one year. Participants are patients consulting their GP more than once with MUS and in which the GP presumes that psychosocial distress is an underlying cause. The intervention is the psychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS. Primary outcome measures are: the number of patients identified and recruited, perceived symptom severity, measured on a Visual Analogue Scale (VAS) and patients' self-rated symptoms of distress, depression, anxiety and somatization (4DSQ: The Four Dimensional Symptom Questionnaire). Other primary outcome measures are the time needed to include the eligible patients, the number of withdrawals in the intervention and control group, compliance in the therapy group and the number of patients who complete the questionnaires. Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation List), physical and mental health status and quality of life (SF-36), and level of functioning (MAF: measure of general functioning). Patient satisfaction with the received therapy is rated on a 5-point Likert-type scale. Medical consumption will be measured by the Cost Diary for medical consumption.

Conditions

Medically Unexplained Symptoms; Psychosomatic Therapy

Keywords

Medically unexplained symptoms; Somatization; Psychosomatic therapy

Outcome Measures

Primary Outcomes (5)

• The number of patients identified and recruited

  The number of patients identified and recruited by the GP

  one year

• The time needed to include the eligible patients

  The time needed to include the eligible patients by the GPs

  one year

• The number of withdrawals in both groups

  the number of patients that withdraw from the study in both groups

  one year

• Perceived symptom severity

  Perceived symptoms severity by patients

  one year

• Patients' self-rated symptoms of distress, depression, anxiety and somatization

  Patients' self-rated symptoms of distress, depression, anxiety ansd somatization measured with the Four Dimensional Symptom Questionnaire (4DSQ)

  one year

Secondary Outcomes (3)

• Symptoms of hyperventilation

  at baseline, at 3, 6 and 12 months

• Physical and mental status and quality of life

  at baseline, at 3, 6 and 12 months

• Level of functioning

  at baseline, at 3, 6 and 12 months

Other Outcomes (2)

• Medical consumption

  at baseline, at 3, 6 and 12 months

• Baseline characteristics of the participants

  at baseline, at 3, 6 and 12 months

Study Arms (2)

Psychosomatic therapy

EXPERIMENTAL

Psychosomatic therapy consists of a combination of information and education delivery, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS. Psychosomatic therapy delivered by a psychosomatic therapist.

Other: Psychosomatic therapy; Other: care as usual

care as usual

OTHER

Usual care of the general practitioner

Other: care as usual

Interventions

Psychosomatic therapy OTHER

Psychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education delivery, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS.

Psychosomatic therapy

care as usual OTHER

usual care of the general practitioner

Psychosomatic therapy; care as usual

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with medical unexplained symptoms who consulting the general practitioner more than once for one or more of the 12 most common symptoms:
• stomach-/abdominal pain,
• back/neck/shoulder pain,
• pain in arms/legs/joints,
• headache, chest pain,
• dizziness,
• fainting spells,
• palpitations of the heart,
• shortness of breath,
• nausea/indigestion,
• feeling tired,
• sleeping disorder and psychosocial distress

You may not qualify if:

• patients wich chronic diseases,
• palliative care,
• severe psychiatric disorders,
• long-lasting injury treatment
• patients who are not able to speak, read and write Dutch

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (8)

General Practitioner, Douwes Dekker

Albergen, Overijssel, 7665 AP, Netherlands

Location

General Practitioner, Hesselink

Borne, Overijssel, Borne, Netherlands

Location

General Practitioner,Tuijnenburg

Enschede, Overijssel, 7543 EH, Netherlands

Location

General Practitioner, Kleissen

Haaksbergen, Overijssel, 7482 AR, Netherlands

Location

General Practitioner, van der Waart

Hengelo, Overijssel, 7559 NM, Netherlands

Location

General Practitioner, Van Rijn

Vriezenveen, Overijssel, 7672 GD, Netherlands

Location

M. Oijevaar

Borne, 7622DE, Netherlands

Location

D.J. Jansen

Julianadorp, 1787AE, Netherlands

Location

Related Publications (1)

• Wortman MS, Lucassen PL, van Ravesteijn HJ, Bor H, Assendelft PJ, Lucas C, Olde Hartman TC. Brief multimodal psychosomatic therapy in patients with medically unexplained symptoms: feasibility and treatment effects. Fam Pract. 2016 Aug;33(4):346-53. doi: 10.1093/fampra/cmw023. Epub 2016 Apr 13.

  PMID: 27075027 DERIVED

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tim C. olde Hartman, MD Phd

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr T.C. olde Hartman

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 5, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

NL (8)