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Auricular Acupuncture and Cognitive Behavioral Therapy Treatment for Insomnia (NADA)

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ClinicalTrials.gov Identifier: NCT01765959
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

"Auricular acupuncture and cognitive behavioral therapy in the context of insomnia and low dose dependence of benzodiazepine-like drugs and other sleep medicine with addiction risk"

INTRODUCTION: Insomnia is a common health problem in Sweden, which increases with age and is more prevalent among women.

It is defined by unsatisfied sleep quality during more than a month's time. The main symptoms are difficulties falling- and/or maintaining sleep, involuntary awakenings during the night of early morning, day time sleepiness and decreased will for day time activity due to sleepiness. Insomnia is ranked to be the fifth most common cause of prescription of medicine at the outpatient clinics in general health care in Sweden. In 2008 a prevalence study was initiated in Sweden by the Swedish Council on Health Technology Assessment (SBU). The study showed that 24% of the Swedish population suffered from sleep disorders. Sleeping disorders can go on for many years and can therefore entail significant personal suffering.

Usually sleep medicine combined with general sleeping advices is the first-hand treatment for insomnia. However, according to SBU, first treatment should be non-pharmacological, for instance cognitive behavioral therapy (CBT). Despite this recommendation the prescribing of sleep medicine is still high.

There are studies that suggest auricular acupuncture (AA) to be an effective method to treat insomnia. However more evidence is needed to draw firm conclusions.

AIM: The aim of the study is to investigate if AA is as effective as CBT to treat insomnia for patients who have stopped using benzodiazepine-like sleep medicine.

METHOD: This is a randomized controlled study (RTC) including patients suffering from insomnia, with a low dose dependence of benzodiazepine-like drugs. The patients will be recruited from primary care and from an out-patient clinic specialized in sleeping disorders and also by add in the local news paper. The respondents will be randomized to one of two groups; group I will receive AA twice a week for 4 weeks; group II will receive CBT once a week for six weeks. After three months there will be a long-time follow up in order to investigate a potential long-term effect.


Condition or disease Intervention/treatment Phase
Insomnia Quality of Life Other: Auricular acupuncture (AA) Other: cognitive behavioral therapy (CBT) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Auricular Acupuncture and Cognitive Behavioral Therapy in the Context of Insomnia and Low Dose Dependence of Benzodiazepine-like Drugs and Other Sleep Medicine With Addiction Risk"
Study Start Date : December 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Auricular acupuncture (AA)
Auricular acupuncture (AA) group will receive treatment twice a week for four weeks. Each session will take approximately 60 minutes in which there will be active treatment time for 40 minutes. During treatment the respondents will have 5 thin sterile, disposable steel needles superficially placed in each outer ear. Before needle insertion the outer ears will be cleaned with disinfection solution. During treatment the respondents will sit down in silence; with eyes shut and focus on a normal calm breathing. The acupuncturist will not be in the room during treatment. After 40 minutes the respondents remove the needles and put them in a box suited for disposed needles. If needed, assistance to remove needles will be given from the acupuncturist.
 Other: Auricular acupuncture (AA)
Auricular acupuncture (AA) group will receive treatment twice a week for four weeks. Each session will take approximately 60 minutes in which there will be active treatment time for 40 minutes. During treatment the respondents will have 5 thin sterile, disposable steel needles superficially placed in each outer ear. Before needle insertion the outer ears will be cleaned with disinfection solution. During treatment the respondents will sit down in silence; with eyes shut and focus on a normal calm breathing. The acupuncturist will not be in the room during treatment. After 40 minutes the respondents remove the needles and put them in a box suited for disposed needles. If needed, assistance to remove needles will be given from the acupuncturist.
Active Comparator: Cognitive behavioral therapy (CBT)

Cognitive behavioral therapy (CBT) group will receive manual based sessions for sleeping disorders. The group meets once a week during six weeks according to following program:

Session 1 - introduction, self-help concept Session 2 - biology of sleep, sleep restriction, Session 3 - stimulus control Session 4 - visualization as relaxation, Session 5 - how to deal with negative and automatic thoughts, Session 6 How to solve problems, planning for the future

 Other: cognitive behavioral therapy (CBT)

Cognitive behavioral therapy (CBT) group will receive manual based sessions for sleeping disorders. The group meets once a week during six weeks according to following program:

Session 1 - introduction, self-help concept Session 2 - biology of sleep, sleep restriction, Session 3 - stimulus control Session 4 - visualization as relaxation, Session 5 - how to deal with negative and automatic thoughts, Session 6 - how to solve problems, planning for the future


Outcome Measures
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Primary Outcome Measures :
  1. Insomnia [ Time Frame: five months ]

    Outcome will be measured by:

    i)actigraphy ii)evaluated questionary forms: Insomnia Severity Index (ISI) Hospital Anxiety Depression scale (HAD) Minimal Insomnia Symptom Scale (MISS) Ep-worth Sleepless scale (ESS) Dysfunctional Belief About Sleep (DBAS-16) Functional Outcome of Sleep Questionaire (FOSQ)



Secondary Outcome Measures :
  1. Quality of life [ Time Frame: five months ]
    Quality of life will be measured by using "Form SF-12".


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • men and women (n=40)
  • 18-75 years old with: (i) primary or secondary insomnia who have been treated every day for over six months with benzodiazepine-like drugs and developed a low dose drug dependence, and (ii) people suffering from insomnia who use benzodiazepine-like drugs ≥ three nights a week with no effect.

Exclusion Criteria:

  • high dose drug dependence,
  • generalized anxiety disorder (GAD),
  • patients diagnosed with diagnosed psychotic disorders,
  • personality disorders or serious somatic illness,
  • alcohol dependence/abuse,
  • anti psychotic medications,
  • pain reliving treatment with methadone- or methadone like drugs,
  • new onset depression,
  • patients who have initiated or changed their anti-depressant,anxiolytic or pregabalin medication during the last six months,
  • pregnancy.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765959


Locations
Sweden
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Agneta Markström, MD, PhD Uppsala University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01765959     History of Changes
Other Study ID Numbers: AA2011-59
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Uppsala University:
Insomnia
Auricular acupuncture
CBT

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders