Anxiety, Depression, Fibromyalgia, Irritable Bowel Syndrome
Conditions
Keywords
Integrative medicine, Acupuncture, Minor mental health problems, Medically unexplained symptoms, Minor mental health problems (e.g. minor depression and anxiety) and Medically unexplained symptoms (e.g. IBS, fibromyalgia, etc)
Brief summary
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).
Interventions
BEHAVIORALConventional treatment
Conventional treatment
Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes
OTHERTherapeutic acupuncture
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.
Sponsors
Ekhagastiftelsen
Fyrbodal Research and Development Council
Vastra Gotaland Region
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* one or more symptoms of emotional and physical fatigue * worry * anxiety * depression * sleep disturbances or somatic pain
Exclusion criteria
* 100% sick leave \> 2,5 years * pregnancy * cancer * personality disorders * substance use disorders or prescribed sedative drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD) | Baseline and after eight weeks of treatment completion | Change in HAD Anxiety between baseline and 8-week follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post treatment change in health-related quality of life (assessed with the SF-36 Mental Component Summary score(MCS)) | Baseline and after eight weeks of treatment completion | Change in SF-36 MCS scores between baseline and 8-week follow up. |
| Pre-post treatment change in sense of coherence (SOC) | Baseline and after eight weeks of treatment completion | Change in SOC scores between baseline and 8-week follow up |
| Pre-post treatment change in depression as assessed with the Hospital Anxiety and Depression scale (HAD) | Baseline and after eight weeks of treatment completion | Change in HAD Depression scores between baseline and 8-week follow up |
Countries
Sweden
Outcome results
None listed