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

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631500
• Other study ID #: University of Gothenburg
• Secondary ID: VGFOUREG-82511
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: August 29, 2012
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder
• Fibromyalgia
• Irritable Bowel Syndrome
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Conventional treatment
Conventional treatment

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
• 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.

Locations

Country	Name	City	State
Sweden	Fyrbodal Research and Development Council	Vänersborg

Sponsors (4)

Lead Sponsor	Collaborator
Göteborg University	Ekhagastiftelsen, Fyrbodal Research and Development Council, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No