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

Primary Purpose

Depression, Anxiety, Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Conventional treatment
Integrative treatment
Therapeutic acupuncture
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring 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)

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Fyrbodal Research and Development Council

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Active Comparator

Arm Label

Conventional treatment

Integrative treatment

Terapeutic acupuncture

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Pre-post treatment change in sense of coherence (SOC)
Change in SOC scores between baseline and 8-week follow up
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

Full Information

First Posted
December 8, 2011
Last Updated
August 29, 2012
Sponsor
Göteborg University
Collaborators
Ekhagastiftelsen, Fyrbodal Research and Development Council, Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT01631500
Brief Title
Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Ekhagastiftelsen, Fyrbodal Research and Development Council, Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment
Arm Type
Other
Arm Description
Patients receive usual treatments provided at primary care settings, e.g. antidepressants, sessions with a curator or psychotherapist and physiotherapy.
Arm Title
Integrative treatment
Arm Type
Experimental
Arm Description
Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes
Arm Title
Terapeutic acupuncture
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional treatment
Intervention Description
Conventional treatment
Intervention Type
Other
Intervention Name(s)
Integrative treatment
Intervention Description
Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes
Intervention Type
Other
Intervention Name(s)
Therapeutic acupuncture
Intervention Description
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 Outcome Measure Information:
Title
Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD)
Description
Change in HAD Anxiety between baseline and 8-week follow up
Time Frame
Baseline and after eight weeks of treatment completion
Secondary Outcome Measure Information:
Title
Pre-post treatment change in health-related quality of life (assessed with the SF-36 Mental Component Summary score(MCS))
Description
Change in SF-36 MCS scores between baseline and 8-week follow up.
Time Frame
Baseline and after eight weeks of treatment completion
Title
Pre-post treatment change in sense of coherence (SOC)
Description
Change in SOC scores between baseline and 8-week follow up
Time Frame
Baseline and after eight weeks of treatment completion
Title
Pre-post treatment change in depression as assessed with the Hospital Anxiety and Depression scale (HAD)
Description
Change in HAD Depression scores between baseline and 8-week follow up
Time Frame
Baseline and after eight weeks of treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Taft, associate professor
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fyrbodal Research and Development Council
City
Vänersborg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25928131
Citation
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.
Results Reference
derived
PubMed Identifier
24980440
Citation
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.
Results Reference
derived
PubMed Identifier
24200100
Citation
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.
Results Reference
derived

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

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