Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01631500
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2011-12-08
Brief Title:
Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 40arm were needed to achieve a power of 83 at p 005 Treatment effects were calculated as the difference between values at baseline after four weeks and after the complete intervention period ie after eight weeks Nonparametric analyses were carried out to test differences between independent samples Kruskal-Wallis and Mann-Whitney U and related samples Wilcoxon
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 40arm were needed to achieve a power of 83 at p 005 Treatment effects were calculated as the difference between values at baseline after four weeks and after the complete intervention period ie after eight weeks Nonparametric analyses were carried out to test differences between independent samples Kruskal-Wallis and Mann-Whitney U and related samples Wilcoxon
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VGFOUREG-82511 | OTHER_GRANT | Ekhagastiftelsen 2009-6 RDU Fyrbodal VGFOUFBD-70831 | None |