Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Depression Anxiety Irritable Bowel Syndrome Fibromyalgia |
Behavioral: Conventional treatment Other: Integrative treatment Other: Therapeutic acupuncture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD) [ Time Frame: Baseline and after eight weeks of treatment completion ] [ Designated as safety issue: No ]Change in HAD Anxiety between baseline and 8-week follow up
- Pre-post treatment change in health-related quality of life (assessed with the SF-36 Mental Component Summary score(MCS)) [ Time Frame: Baseline and after eight weeks of treatment completion ] [ Designated as safety issue: No ]Change in SF-36 MCS scores between baseline and 8-week follow up.
- Pre-post treatment change in sense of coherence (SOC) [ Time Frame: Baseline and after eight weeks of treatment completion ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline and after eight weeks of treatment completion ] [ Designated as safety issue: No ]Change in HAD Depression scores between baseline and 8-week follow up
| Enrollment: | 120 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Conventional treatment
Patients receive usual treatments provided at primary care settings, e.g. antidepressants, sessions with a curator or psychotherapist and physiotherapy.
|
Behavioral: Conventional treatment
Conventional treatment
|
|
Experimental: Integrative treatment
Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes
|
Other: Integrative treatment
Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes
|
|
Active Comparator: Terapeutic acupuncture
Therapeutic acupuncture alone, eight individual sessions, once a week. The participants received acupuncture needles in the appropriate acupuncture points, in the same way as the integrative treatment model, but without person-centred dialogue.
|
Other: Therapeutic 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.
|
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Sweden | |
| Fyrbodal Research and Development Council | |
| Vänersborg, Sweden | |
| Principal Investigator: | Charles Taft, associate professor | Göteborg University |
More Information
No publications provided
| Responsible Party: | Göteborg University |
| ClinicalTrials.gov Identifier: | NCT01631500 History of Changes |
| Other Study ID Numbers: | University of Gothenburg, VGFOUREG-82511 |
| Study First Received: | December 8, 2011 |
| Last Updated: | August 29, 2012 |
| Health Authority: | Sweden: Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg |
Keywords provided by Göteborg University:
|
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) |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Fibromyalgia Myofascial Pain Syndromes Irritable Bowel Syndrome Mental Disorders Behavioral Symptoms Mood Disorders Muscular Diseases |
Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013