Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms

Study Overview
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Brief Summary
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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).

Conditions
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Depression, Anxiety, Irritable Bowel Syndrome, Fibromyalgia

Intervention / Treatment
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* Behavioral: Conventional treatment
* Other: Integrative treatment
* Other: Therapeutic acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional treatment<br>Patients receive usual treatments provided at primary care settings, e.g. antidepressants, sessions with a curator or psychotherapist and physiotherapy. | Behavioral: Conventional treatment<br>* Conventional treatment<br>|
| Experimental: Integrative treatment<br>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<br>* Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes<br>|
| Active Comparator: Terapeutic acupuncture<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)