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

NCT01631500 | Completed DMC

• 2 other identifiers: University of GothenburgVGFOUREG-82511
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pre-post treatment change in health-related quality of life (assessed with the SF-36 Mental Component Summary score(MCS))

  Baseline and after eight weeks of treatment completion

• Pre-post treatment change in sense of coherence (SOC)

  Baseline and after eight weeks of treatment completion

• Pre-post treatment change in depression as assessed with the Hospital Anxiety and Depression scale (HAD)

  Baseline and after eight weeks of treatment completion

Study Arms (3)

Conventional treatment

OTHER

Patients receive usual treatments provided at primary care settings, e.g. antidepressants, sessions with a curator or psychotherapist and physiotherapy.

Behavioral: Conventional treatment

Integrative treatment

EXPERIMENTAL

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

Terapeutic acupuncture

ACTIVE COMPARATOR

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

Interventions

Conventional treatment BEHAVIORAL

Conventional treatment

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

Integrative treatment

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.

Terapeutic acupuncture

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• one or more symptoms of emotional and physical fatigue
• worry
• anxiety
• depression
• sleep disturbances or somatic pain

You may not qualify if:

• % sick leave \> 2,5 years
• pregnancy
• cancer
• personality disorders
• substance use disorders or prescribed sedative drugs

Sponsors & Collaborators

• Göteborg University: lead
• Ekhagastiftelsen: collaborator
• Fyrbodal Research and Development Council: collaborator
• Vastra Gotaland Region: collaborator

Study Sites (1)

Fyrbodal Research and Development Council

Vänersborg, Sweden

Location

Related Publications (3)

• 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.

  PMID: 25928131 DERIVED

• 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.

  PMID: 24980440 DERIVED

• 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.

  PMID: 24200100 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Irritable Bowel Syndrome; Fibromyalgia; Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Taft, associate professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: June 29, 2012
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 30, 2012

Record last verified: 2012-06

Locations

SE (1)