Condition category
Mental and Behavioural Disorders
Date applied
16/05/2018
Date assigned
27/03/2019
Last edited
27/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients frequently report persistent physical symptoms (PPS) despite the fact that doctors did not identify a specific organic disease to explain those symptoms. Those symptoms are of great concern for patients, they can cause significant distress and often have negative consequences on patient’s quality of life. Despite developments for better access to integrated health care a substantial proportion of patients with those conditions are not responding to standard treatments. This is partially a result of the fact that patients often feel their symptoms are misunderstood as if the complaints are “all in the mind”. Research established that these physical complaints are complex in nature and that many factors are relevant for the development of these persistent physical symptoms.
PPS (also labelled as “Medically unexplained symptoms”, or “Somatic distress disorder”) are often characterised by multiple complaints in different locations of the body and patients present not only to primary care but in multiple medical specialist settings. Patients with PPS often experience their bodies as problematic and lack confidence in their normal bodily functions. The symptoms pose challenges to clinicians and patients alike, resulting in significant cost pressure on health care systems.
Talking therapies, predominantly those with a Cognitive Behaviour Therapy background, have been tested in various studies and were found to be effective mainly for some specific PPS conditions such as ‘fibromyalgia’ and ‘irritable bowel syndrome’. Only few studies were carried out in patients with more general PP and a systematic review of findings concluded that the effects of talking therapies tested in those studies was small.
For those reasons and in order to achieve better outcomes for patients, new effective treatments are required that are also better accepted by patients. Previous research findings demonstrated that so-called body-oriented therapies (BPT) can be effective; those treatments – as tested in this study - offer interventions where the body remains the main focus, aiming to improve patients’ understanding of bodily functioning and their coping with persistent physical symptoms to alleviate stress and improve the quality of life of patients. Description of what happened to the participants taking part in the study
Patients who have been diagnosed as suffering from PPS by their physicians were contacted by those and offered to participate in this study. They received study information including a description of the treatment that the study was aiming to test. Half of the patients referred at the beginning received the body oriented treatment and the other half after they waited for the duration of the treatment (so called randomised-controlled study design). Another group of patients was offered to undergo treatment immediately after they had been referred.
This study was aiming to assess the acceptability, the potential benefits, and associated change processes of the BPT therapy for outpatients with PPS.

Who can participate?
Patients with over 6 months persistent bodily complaints without sufficient explanatory organ pathology.

What does the study involve?
We used specific questionnaires on physical symptoms, health-related subjective quality of life and also in respect of patients’ acceptance of treatment pre and post therapy participation.

What are the possible benefits and risks of participating?
This study and previous research suggests that patients participating in group body psychotherapy might benefit through a significant reduction of the severity of persistent physical symptoms and experience an increase in their subjective quality of life; participating in group body psychotherapy does not appear to pose any risks to participant.

Where is the study run from?
Department of Psychosomatic Medicine and Psychotherapy, Rechts der Isar Hospital, Munich

When is the study starting and how long is it expected to run for?
January 2011 to December 2015

Who is funding the study?
German Association of Body Psychotherapy (DBK)

Who is the main contact?
Prof. Frank Röhricht, frank.rohricht@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Prof Frank Rohricht

ORCID ID

http://orcid.org/0000-0001-7487-7970

Contact details

East London NHS Foundation Trust
Trust Headquarter
9 Alie Street
London
E1 8DE
United Kingdom
+44 (0)20 7655 4000
frank.rohricht@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.0

Study information

Scientific title

Group body psychotherapy for the treatment of somatoform disorder - a partly randomised-controlled feasibility study

Acronym

Study hypothesis

Clinical outcomes for patients with heterogeneous somatoform disorder (bodily distress disorder, including medically unexplained symptoms) are suboptimal, new treatments are required to improve acceptance. Body-oriented psychological therapy approaches have been identified as potentially beneficial additions to the portfolio of treatments.
This study aims to assess the acceptability, the potential benefits, and associated change processes of manualised group body psychotherapy (BPT) for outpatients with Somatoform Disorder.

Ethics approval

Approved 15/01/2009, Ethics committee of the Technische Universität München (Ismaninger Straße 22
81675 München; ethikkommission@mri.tum.de), ref: 2268-08

Study design

Randomised controlled feasibility pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Somatoform disorder (ICD−10 (F45.x) (compatible with diagnosis of somatic symptom disorder DSM-5 (300.82)

Intervention

1. The manualised group body psychotherapy intervention for somatoform disorder (BPT-SD)
The group body psychotherapy manual for somatoform disorder (BPT-SD) was developed based upon aethio-pathogenetic models of the disorder [e.g. 3], taking into account the specific phenomenological presentation and health beliefs of this group of patients, by addressing the complex phenomena in Somatoform Disorders simultaneously across the interacting symptom domains: emotional (worrying, fear, negative cathexis), physiological (hyperarousal, somatic amplification), perceptive (bodily distress as disorder of perception) and cognitive (misinterpretation, negative cognitions). The manual includes interventions aiming to activate resources (capabilities, bodily strength and creativity) and to strengthen (bodily, autonomic) self-regulation. Gradually, a range of alternative motor responses in relation to unpleasant mental states and or psychologically relevant events/conflicts is introduced in therapy, directly addressing the habituated, amplifying somatic reinforcement styles, shifting the attention away from dysfunctional aspects of the body image (constant checking, stimulus entrapment).
The central guiding principle in BPT for somatoform disorder patients is that the body remains the main focus of the therapeutic work throughout. The therapist will not address directly any psychological processes involved in bodily experiences, unless the patient specifically brings them up first.
BPT-SD is delivered as a group therapy with up to 10 participants over a period of 20 weeks (4-6 months) with one session weekly a 90 mins. Pre-therapy each participant is seen individually for one hour to conduct a specific preparation session, outlining the specific body-oriented nature of the intervention.
The first group therapy session facilitates basic group cohesion, familiarization with therapeutic environment and materials. Sessions 2-20 follow a systematic structure with repetitive session elements (opening circle, warm-up and mobilization movement section, structured embodied task section, creative enactments and movement section, closing circle and narratives). For the group process in BPT-SD three distinct phases can be distinguished as follows:
The first phase of the therapy (session 2-5) concentrates on the therapeutic relationship and on achieving a fundamental shift towards a more positive body cathexis: focusing on bodily awareness and perceptions and supporting the verbalising of these experiences. Concurrent with the body oriented exercises in the beginning phase the therapist aims to foster therapeutic alliance whilst working with and through bodily sensations (somatisation) without challenging patient’s explanatory beliefs. Psychological processes are only addressed in the context of body based experiential work in therapy and as they emerge in relation to patient’s direct accounts. The main/middle phase (sessions 6-13) will aim to emphasise the contextual factors in relation to perceived bodily sensations, the patient will be gradually supported in understanding the situational nature of bodily sensations and how these change according to external and internal stimuli. Moreover, patients are also likely to remember and clarify their conflicts and traumatic experiences through bodily experiences. Invariably, this occurs when reconstructing memory through expressive behaviour, movements, mimic, and the various aspects of nonverbal communication.
Further intensive exploration of the bodily experiences in the context of interpersonal interactions with both participants and therapists aims to foster an awareness and understanding of the bodily existence as a diverse source of neutrally, positively and negatively evaluated impacts on self-experiences. The role of the therapist here is to help the patients to develop an alternative conceptualization of the body, shifting from a judgemental perspective (body being perceived as a mere hostile object, causing trouble and controlling the self) to a more holistic perspective of self-respect and acceptance. The final phase (session 14-20) of therapy is characterised by narrative re-configuration. Patients are trained/guided to reduce the catastrophic effects of somatic sensations and to increase the acceptance of psychosocial causal attributions. In this way, they gradually shift the discussion from somatic symptoms to related personal issues.
BPT-SD was delivered by a body psychotherapist with a specific training background in one body psychotherapy modality, Concentrative Movement Therapy [18]; the therapist received training to use the manual and adherence to the manualized intervention strategy was tested through regular supervision provided by the authors of the manual (after sessions 4, 8, 12, and 16).
2. The waiting control arm:
Patients received treatment as usual, consisting of medical appointments as required with their primary care physician; no other specific therapies
Recruitment and randomisation procedures:
Following identification by clinicians all potentially suitable patients were contacted by a research assistant via telephone and invited to attend a baseline assessment. At the first appointment a research assistant (doctor in training) provided potential participants with detailed information about the study, obtained written consent and asked those who agreed to participate to complete the baseline questionnaires. 16 initially recruited patients were then randomly assigned to BPT or Treatment As Usual (TAU), using a computer-generated randomization table. Another group of 8 patients was consecutively recruited and directly allocated to BPT.
Duration of treatment:
After randomization, all patients received the questionnaires to assess baseline characteristics. All patients participating in the trial were asked to complete the questionnaires at baseline, at the end of the intervention (at ~3 months) and at 6 months. The number of patients identified and recruited as well as retention and attrition rates, the number of patients who completed the questionnaires and the clinical outcomes were systematically evaluated. Both the Group Therapy and the waiting list condition for those receiving TAU lasted 20 weeks (4-6 months).

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Mental health is assessed using the Primary Health Questionnaire (PHQ) at baseline, 3-months and 6-months
2. Somatic symptom burden is assessed using the Somatic Symptom Screening Scale (SOMS-7) at baseline, 3-months and 6-months

Secondary outcome measures

1. Quality of life is assessed using the Short-Form Health Survey-36 (SF-36) at baseline, 3-months and 6-months
2. Body image is measured using the Dresden Body Image Questionnaire at baseline, 3-months and 6-months
3. Acceptance and satisfaction with treatment: The Helping Alliance Scale [range 0-10] at baseline, 3-months and 6-months

Overall trial start date

01/07/2008

Overall trial end date

31/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Persistent (>=6 months) bodily complaints without sufficient explanatory organ pathology
2. Diagnosis of any somatoform disorder ICD−10 (F45.x) (compatible with diagnosis of somatic symptom disorder DSM-5 (300.82))

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

As the aim of this study was to establish the feasibility of undertaking a full-scale RCT by assessing recruitment of patients, safety of intervention and therefore only to estimate the (preliminary) effect size of the BPT intervention, we did not undertake a formal sample size calculation.

Total final enrolment

24

Participant exclusion criteria

1. Somatic symptoms attributable to identified physical disease (nature and degree)
2. Primary diagnosis of anxiety or depressive disorder, psychosis, substance misuse, psychoorganic disorder and patients considered actively suicidal
3. Insufficient language skills leading to inability to complete the questionnaires

Recruitment start date

01/01/2011

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Germany

Trial participating centre

Rechts der Isar Hospital
Department of Psychosomatic Medicine and Psychotherapy Klinikum rechts der Isar Langerstr. 3
Munich
81675
Germany

Sponsor information

Organisation

Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar,

Sponsor details

Langerstr. 3
München
Munich
81675
Germany
+49-(0)89 4140-4313
claas.kahmenn@tum.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

German Association of Body Psychotherapy (DBK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study has been completed and submitted for publication to peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

01/07/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/03/2019: Internal review.