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Completed

NCT Number: NCT01631500

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional treatment

Behavioral

Conventional treatment

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Ekhagastiftelsen
  • Fyrbodal Research and Development Council
  • Vastra Gotaland Region

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2012
Registry last updated
Aug 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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