Depression Clinical Trial
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).
Status | Completed |
Enrollment | 120 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Fyrbodal Research and Development Council | Vänersborg |
Lead Sponsor | Collaborator |
---|---|
Göteborg University | Ekhagastiftelsen, Fyrbodal Research and Development Council, Vastra Gotaland Region |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD) | Change in HAD Anxiety between baseline and 8-week follow up | Baseline and after eight weeks of treatment completion | No |
Secondary | Pre-post treatment change in health-related quality of life (assessed with the SF-36 Mental Component Summary score(MCS)) | Change in SF-36 MCS scores between baseline and 8-week follow up. | Baseline and after eight weeks of treatment completion | No |
Secondary | Pre-post treatment change in sense of coherence (SOC) | Change in SOC scores between baseline and 8-week follow up | Baseline and after eight weeks of treatment completion | No |
Secondary | Pre-post treatment change in depression as assessed with the Hospital Anxiety and Depression scale (HAD) | Change in HAD Depression scores between baseline and 8-week follow up | Baseline and after eight weeks of treatment completion | No |
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