The main objective was to inform the design of an adequately powered randomised controlled trial and to estimate the effects of manualised group body psychotherapy (BPT) for patients with somatoform disorder in an outpatient setting. Accordingly, we conducted a feasibility pilot trial in two stages:
(1) randomised controlled feasibility trial of patients attending manualised body psychotherapy with those in waiting group receiving treatment as usual (TAU).
(2) for an estimation of treatment effects based on a larger sample of patients we evaluated preliminary clinical outcomes for all patients undergoing BPT: the patients randomised to BPT, the patients randomised to TAU who received BPT after their post-TAU/waiting group assessments and an additional group of patients (N = 8) directly allocated to BPT.
Ethical approval to conduct the study was granted by the Ethics committee of the Technische Universität München, approval number: 2268–08.
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 (Fig. 1).
Potentially eligible patients were identified from the outpatient clinics of the department of Psychosomatic Medicine and the Centre for Interdisciplinary Pain Therapy at the University Medical Center “Klinikum rechts der Isar” in Munich / Germany (initial information about the study project and verbal consent to be referred was obtained by the clinicians).
Eligible patients comprised adults aged 18–75 years who met the inclusion criteria:
- persistent (> = 6 months) bodily complaints without sufficient explanatory organ pathology.
- a diagnosis of any somatoform disorder ICD − 10 (F45.x) (compatible with diagnosis of somatic symptom disorder DSM-5 (300.82)).
- somatic symptoms attributable to identified physical disease (nature and degree).
- primary diagnosis of anxiety or depressive disorder, psychosis, substance misuse, psychoorganic disorder; and patients considered being actively suicidal.
- insufficient language skills, inability to complete the questionnaires.
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. Sixteen initially recruited patients were then randomly assigned to BPT or TAU, using a computer-generated randomization table. Another group of eight patients was consecutively recruited and directly allocated to BPT.
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 ten 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 1 h 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 ; 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).
Potential treatment effects were measured at baseline (t1), the end of treatment (t2) and to evaluate longer-term effects at a follow-up assessment 6 months after the end of treatment (t3). All instruments have been validated and proven to be reliable, and all psychopathological measures are commonly used in related research for patients with somatoform disorder.
Primary Health Questionnaire PHQ-9 , self-reporting screening tool for depressive symptoms, range 0–27; cut-off point of 10.
Perceived symptom severity of somatic complaints
1. Primary Health Questionnaire PHQ-15 ; range 0–30; scores of > = 5 / 10 / 15 are defined as cut-off points for low, medium, high somatic symptom severity. 2. Screening for Somatoform Symptoms SOMS-7 ; patients are asked to rate the existence and intensity of 53 typical somatoform symptoms during the last 7 day, composed indices are computed for the symptom count (number of agreed symptoms in total) and the symptom severity (mean score of all responses, a value of 42 or more represents a percentile range of 100).
Health-related quality of life
Health Survey Form SF-36 , including physical and mental components (range 0–100, mean of the normal population: 50, with a standard deviation of 10); higher scores indicate a better quality of life.
Dresdner Body Image Questionnaire DBIQ [23, 24]; five aspects of body image are captured by 35 items: vitality, self-acceptance, self-aggrandisement, physical closeness, and sexual fulfilment. The subscales cover ranges of 1–5 with higher values representing a more pronounced characteristic of the dimension under question.
Acceptance and satisfaction with treatment
The Helping Alliance Scale [range 0–10; Client Version, ].
We performed the analyses using SPSS 23 based on the intent-to-treat method for all the participants. Sensitivity analyses confirmed that the missing data for the primary and secondary outcomes were missing at random. Multiple imputations were used then, to replace missing data, which consisted mainly of patients who were lost to follow-up (N = 2).
We compared the baseline clinical and demographic variables of the two treatment groups using Fisher’s Exact test for dichotomous or nominally distributed variables and T-tests for continuous variables. In order to determine bias between randomized and non-randomized participants we executed additional sensivity analyses. We compared all sociodemographic and clinical characteristics between 1) the randomized vs. non-randomized groups receiving BPT directly and 2) all participants receiving BPT directly vs those after a waiting period. All comparisons were non-significant, apart from DKB-Domains vitality and sexuality, both post-treatment (all post-treatment comparisons were controlled for baseline scores).
Clinical outcomes for all patients immediately before and after receiving BPT were compared using dependent t-tests for paired samples. Effect sizes were determined according to Hedges’ g, with 0.2–0.5 indicating a small, 0.5–0.8 a medium strength treatment effect and are amended by their confidence intervals. We compared treatment across t1 and t2 by applying linear mixed models (LMM) and analysed differences between t1 / baseline and t2 post treatment, controlling for initial values of the dimension under question.
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.