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

This study has been completed.
Sponsor:
Collaborators:
Ekhagastiftelsen
Fyrbodal Research and Development Council
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01631500
First received: December 8, 2011
Last updated: August 29, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631500

Locations
Sweden
Fyrbodal Research and Development Council
Vänersborg, Sweden
Sponsors and Collaborators
Göteborg University
Ekhagastiftelsen
Fyrbodal Research and Development Council
Vastra Gotaland Region
Investigators
Principal Investigator: Charles Taft, associate professor Göteborg University
  More Information

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 01, 2014