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| ID | Type | Description | Link |
|---|---|---|---|
| VGFOUREG-82511 | Other Grant/Funding Number | Ekhagastiftelsen 2009-6, RDU Fyrbodal VGFOUFBD-70831 |
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| Name | Class |
|---|---|
| Ekhagastiftelsen | OTHER |
| Fyrbodal Research and Development Council | UNKNOWN |
| Vastra Gotaland Region | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment | Other | Patients receive usual treatments provided at primary care settings, e.g. antidepressants, sessions with a curator or psychotherapist and physiotherapy. |
|
| Integrative treatment | Experimental | Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes |
|
| Terapeutic acupuncture | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional treatment | Behavioral | Conventional treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pre-post treatment change in sense of coherence (SOC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Taft, associate professor | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fyrbodal Research and Development Council | Vänersborg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25928131 | Derived | Arvidsdotter T, Marklund B, Taft C, Kylen S. Quality of life, sense of coherence and experiences with three different treatments in patients with psychological distress in primary care: a mixed-methods study. BMC Complement Altern Med. 2015 Apr 26;15:132. doi: 10.1186/s12906-015-0654-z. | |
| 24980440 | Derived | Arvidsdotter T, Marklund B, Taft C. Six-month effects of integrative treatment, therapeutic acupuncture and conventional treatment in alleviating psychological distress in primary care patients--follow up from an open, pragmatic randomized controlled trial. BMC Complement Altern Med. 2014 Jun 30;14:210. doi: 10.1186/1472-6882-14-210. |
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| Integrative treatment |
| Other |
Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes |
|
| Therapeutic acupuncture | Other | 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. |
|
Change in SOC scores between baseline and 8-week follow up |
| Baseline and after eight weeks of treatment completion |
| 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 |
| 24200100 | Derived | Arvidsdotter T, Marklund B, Taft C. Effects of an integrative treatment, therapeutic acupuncture and conventional treatment in alleviating psychological distress in primary care patients--a pragmatic randomized controlled trial. BMC Complement Altern Med. 2013 Nov 7;13:308. doi: 10.1186/1472-6882-13-308. |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D043183 | Irritable Bowel Syndrome |
| D005356 | Fibromyalgia |
| D000071896 | Medically Unexplained Symptoms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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