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Kallesøe, Schröder, Fink: Comparing group-based ACT with enhanced usual care for adolescents w/ FSS

Discussion in 'Active Clinical Studies' started by mango, Sep 20, 2016.

  1. mango

    mango Senior Member

    Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial

    Karen Hansen Kallesøe1, Andreas Schröder1, Rikard K Wicksell2, Per Fink1, Eva Ørnbøl1, Charlotte Ulrikka Rask1,3

    Author Affiliations
    1. Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark
    2. Behavior Medicine Pain Treatment Services, Karolinska, Stockholm, Sweden
    3. Regional Centre for Child and Adolescent Psychiatry, Risskov, Aarhus University Hospital, Aarhus, Denmark
    Published 15 September 2016

    Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS).

    Methods and analysis A total of 120 adolescents aged 15–19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours).

    The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility.

    Ethics and dissemination The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals.

    Discussion This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a range of severe FSS.

    Trial registration number NCT02346071; Pre-results.

    Strengths and limitations of this study
    • Large-scale study in an area with limited knowledge.
    • Evaluation of psychosocial and biological predictors and moderators of outcomes.
    • Thorough assessment of all patients providing them with evidence-based understanding of their illness.
    • Assessment and treatment are carried out in a specialised setting which might affect generalisation.
    • Results not automatically applicable to younger adolescents given the developmental perspective, with multiple symptoms being less common in children and younger adolescents.
    Functional somatic syndromes (FSS), including chronic fatigue syndrome, juvenile fibromyalgia, functional gastrointestinal disorders and idiopathic pain syndromes, are well-known conditions in adolescents. FSS are diagnostic unities representing clusters of related functional somatic symptoms. [...]

    Last edited: Sep 20, 2016
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  2. mango

    mango Senior Member

    There's a similar ME/CFS study happening in Sweden too, where Wicksell is also involved:

    Last edited: Sep 20, 2016
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  3. sarah darwins

    sarah darwins I told you I was ill

    Cornwall, UK
    They seem to be listing that as a 'strength' of the study. Presumably that actually means showing participants test results and 'evidence' (from other bps researchers, no doubt) to 'show' them that they're not really ill before proceeding with the babble.
    Hutan, Valentijn, Effi and 1 other person like this.
  4. Hugo

    Hugo Senior Member

    Insane, and it shows what kind of circle reasoning that sometimes dominate the psychiatric field. Just look at the some of the bullcrap of attachment theory (Im not disgarding the theory as a whole but its just a lot of circle reasoning in that kind of research). Sad that karolinska is wasting research on this.
  5. alex3619

    alex3619 Senior Member

    Logan, Queensland, Australia
    FSS do not exist except by dogmatic diagnostic fiat. They basically assert it exists without evidence. So how can everything after that be evidence-based? This is so very much like how comedians treat the Spanish Inquisition, sans comfy chair.

    Let them do the actual science, and provide biomarkers (which HAVE to exist or the entire thing is utter babble), before they proceed on treating patients using experimental unproven diagnoses and therapies.

    Now I anticipate some may claim I am a dualist, even though I am a monist on theory of mind. Let me remind them that under a lot of BPS doctrine the mind and body are interlocked, so physical evidence pertaining to any specific syndrome should exist. Otherwise its a bogus syndrome.
    Snowdrop, sarah darwins and Valentijn like this.

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