DepressionNCT01631500
Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms
A study testing Conventional treatment, Integrative treatment and Therapeutic acupuncture in people with Depression and Anxiety, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Depression, Anxiety, Irritable Bowel Syndrome
- What is being tested?
- Conventional treatment, Integrative treatment and Therapeutic acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- one or more symptoms of emotional and physical fatigue
- worry
- anxiety
- depression
- sleep disturbances or somatic pain
Who cannot join
- 100% sick leave > 2,5 years
- pregnancy
- cancer
- personality disorders
- substance use disorders or prescribed sedative drugs
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Conventional treatment, Integrative treatment, Therapeutic acupuncture
- 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)
- Medical subject headings
- Depression, Anxiety Disorders, Irritable Bowel Syndrome, Fibromyalgia, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentBehavioural
Conventional treatment
Integrative treatmentOther
Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes
Therapeutic acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Other | Patients receive usual treatments provided at primary care settings, e.g. antidepressants, sessions with a curator or psychotherapist and physiotherapy. Receives: 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 Receives: 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. Receives: Other: Therapeutic acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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))
Change in SF-36 MCS scores between baseline and 8-week follow up.
Measured: Baseline and after eight weeks of treatment completion
Pre-post treatment change in sense of coherence (SOC)
Change in SOC scores between baseline and 8-week follow up
Measured: Baseline and after eight weeks of treatment completion
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
Measured: Baseline and after eight weeks of treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Ekhagastiftelsen, Fyrbodal Research and Development Council, Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Charles Taft, associate professor, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631500
- Sponsor's protocol ID
- University of Gothenburg
- Other IDs
- VGFOUREG-82511
- Status last verified
- Jun 2012
- First submitted
- 8 Dec 2011
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25928131Arvidsdotter 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.
PubMed 24980440Arvidsdotter 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.
PubMed 24200100
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms
- ClinicalTrials.gov ID
- NCT01631500
- Acronym / sponsor ID
- University of Gothenburg
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Ekhagastiftelsen, Fyrbodal Research and Development Council, Vastra Gotaland Region
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Other | Behavioral: Conventional treatmentPatients receive usual treatments provided at primary care settings, e.g. antidepressants, sessions with a curator or psychotherapist and physiotherapy. |
| Integrative treatment | Experimental | Other: Integrative treatmentPerson-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes |
| Terapeutic acupuncture | Active comparator | Other: Therapeutic acupunctureTherapeutic 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- one or more symptoms of emotional and physical fatigue
- worry
- anxiety
- depression
- sleep disturbances or somatic pain
Key exclusion criteria (5 listed)
- 100% sick leave > 2,5 years
- pregnancy
- cancer
- personality disorders
- substance use disorders or prescribed sedative drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional treatmentConventional treatment | Behavioural | Conventional treatment |
| Integrative treatmentPerson-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes | Other | Integrative treatment |
| Therapeutic acupunctureEight 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. | Other | Terapeutic acupuncture |
Primary outcome
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
3 secondary outcomes
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
Pre-post treatment change in sense of coherence (SOC)
Time frame: Baseline and after eight weeks of treatment completion
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Derived from this study: PubMed 25928131Arvidsdotter 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.
- Derived from this study: PubMed 24980440Arvidsdotter 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.
- Derived from this study: PubMed 24200100Arvidsdotter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Taft, associate professor principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment, Integrative treatment and Therapeutic acupuncture in people with Depression and Anxiety, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631500, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2012.