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

Göteborg University

Status: Completed

Conditions: Fibromyalgia; Irritable Bowel Syndrome; Depression; Anxiety

Treatments: Behavioral: Conventional treatment; Other: Therapeutic acupuncture; Other: Integrative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01631500

University of Gothenburg

VGFOUREG-82511 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 120 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Conventional treatment

Other group

Description:

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

Treatment:

Behavioral: Conventional treatment

Integrative treatment

Experimental group

Description:

Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes

Treatment:

Other: Integrative treatment

Terapeutic acupuncture

Active Comparator group

Description:

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.

Treatment:

Other: Therapeutic acupuncture