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

• ClinicalTrials.gov Identifier: NCT01631500
• Recruitment Status: Completed
• First Posted: June 29, 2012
• Last Update Posted: August 30, 2012
• Sponsor: Göteborg University
• Collaborators: Ekhagastiftelsen; Fyrbodal Research and Development Council; Vastra Gotaland Region
• Information provided by (Responsible Party): Göteborg University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Depression; Anxiety; Irritable Bowel Syndrome; Fibromyalgia	Behavioral: Conventional treatment; Other: Integrative treatment; Other: Therapeutic acupuncture	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: January 2010
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arvidsdotter T, Marklund B, Taft C, Kylén 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.

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.

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.

• Responsible Party: Göteborg University
• ClinicalTrials.gov Identifier: NCT01631500
• Other Study ID Numbers: University of Gothenburg; VGFOUREG-82511 ( Other Grant/Funding Number: Ekhagastiftelsen 2009-6, RDU Fyrbodal VGFOUFBD-70831 )
• First Posted: June 29, 2012
• Last Update Posted: August 30, 2012
• Last Verified: June 2012

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:

Fibromyalgia; Myofascial Pain Syndromes; Irritable Bowel Syndrome; Medically Unexplained Symptoms; Depression; Depressive Disorder; Anxiety Disorders; Behavioral Symptoms; Mood Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms