Fyrbodal Research and Development Council
Vänersborg, Sweden
NCT Number: NCT01631500
Minor mental health problems, MMHP, like mild depression and anxiety, and medically unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly associated to each other. MMHP and MUS have an impact on well-being and quality of life, lead to impaired social and cognitive function and could result in reduced work capacity. The investigators have designed the present study as a pragmatic trial to investigate the effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional treatment in patients with MMHP or MUS in primary care. The investigators examined whether the effects of the integrative treatment model differed from those achieved with therapeutic acupuncture or conventional treatment. Primary endpoints were anxiety and depression (assessed with the Hospital Anxiety and Depression scale), health-related quality of life (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of treatment interventions.
Statistical power was calculated based on an expected 50% reduction in HAD anxiety and depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture; and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a power of 83% at p <0.05. Treatment effects were calculated as the difference between values at baseline, after four weeks and after the complete intervention period, i.e. after eight weeks. Nonparametric analyses were carried out to test differences between independent samples (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).
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Notify Me20 year–55 year
All sexes
Interventional
Not applicable
Vänersborg, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional treatment
Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes
Eight individual sessions, once a week, with therapeutic acupuncture. The participants received acupuncture needles in the appropriate acupuncture points, in the same way as the integrative treatment model, but without person-centred dialogue.
Time frame: Baseline and after eight weeks of treatment completion
Change in HAD Anxiety between baseline and 8-week follow up
Time frame: Baseline and after eight weeks of treatment completion
Change in SF-36 MCS scores between baseline and 8-week follow up.
Time frame: Baseline and after eight weeks of treatment completion
Change in SOC scores between baseline and 8-week follow up
Time frame: Baseline and after eight weeks of treatment completion
Change in HAD Depression scores between baseline and 8-week follow up
Göteborg University
Other
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