Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms
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ClinicalTrials.gov Identifier: NCT01631500 |
Recruitment Status :
Completed
First Posted : June 29, 2012
Last Update Posted : August 30, 2012
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression Anxiety Irritable Bowel Syndrome Fibromyalgia | Behavioral: Conventional treatment Other: Integrative treatment Other: Therapeutic acupuncture | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
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Conventional treatment
Patients receive usual treatments provided at primary care settings, e.g. antidepressants, sessions with a curator or psychotherapist and physiotherapy.
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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
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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.
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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. |
- 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 ]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 ]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 ]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 ]Change in HAD Depression scores between baseline and 8-week follow up

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Ages Eligible for Study: | 20 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631500
Sweden | |
Fyrbodal Research and Development Council | |
Vänersborg, Sweden |
Principal Investigator: | Charles Taft, associate professor | Göteborg University |
Responsible Party: | Göteborg University |
ClinicalTrials.gov Identifier: | NCT01631500 |
Other Study ID Numbers: |
University of Gothenburg VGFOUREG-82511 ( Other Grant/Funding Number: Ekhagastiftelsen 2009-6, RDU Fyrbodal VGFOUFBD-70831 ) |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | August 30, 2012 |
Last Verified: | June 2012 |
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) |
Fibromyalgia Myofascial Pain Syndromes Irritable Bowel Syndrome Medically Unexplained Symptoms Depression Depressive Disorder Anxiety Disorders Behavioral Symptoms Mood Disorders Mental Disorders |
Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |