Clinical trial NCT01631500: Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Irritable Bowel Syndrome
Fibromyalgia
Keywords: 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)
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Ekhagastiftelsen
name: Fyrbodal Research and Development Council
name: Vastra Gotaland Region
First posted: 2012-06-29
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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).


Eligibility criteria: 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

Primary outcomes:
measure: Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD)
timeFrame: Baseline and after eight weeks of treatment completion
Secondary outcomes:
measure: Pre-post treatment change in health-related quality of life (assessed with the SF-36 Mental Component Summary score(MCS))
timeFrame: Baseline and after eight weeks of treatment completion
measure: Pre-post treatment change in sense of coherence (SOC)
timeFrame: Baseline and after eight weeks of treatment completion
measure: Pre-post treatment change in depression as assessed with the Hospital Anxiety and Depression scale (HAD)
timeFrame: Baseline and after eight weeks of treatment completion
Other outcomes:
Locations:
city: Vänersborg
country: Sweden
facility: Fyrbodal Research and Development Council
Study officials:
affiliation: Göteborg University
name: Charles Taft, associate professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.