Auricular Acupuncture and Cognitive Behavioral Therapy Treatment for Insomnia
Condition: Insomnia; Quality of Life
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

Detailed description: 
      INTRODUCTION During the 1960s benzodiazepines were introduced in the health care. The
      benzodiazepines replaced the barbiturates because of their low toxicity and their anxiety
      reducing effect. During the 1990s the benzodiazepines were replaced with benzodiazepine-like
      drugs to treat insomnia. In Swedish health care two out of three recipes of hypnotics are
      prescribed to women, more than 50% of these are prescribed to persons of age > 65. To
      minimize the risk of drug tolerance a short time use of benzodiazepine-like drugs are
      recommended, and only after careful consideration from the prescriber. The risk of developing
      addiction is increased for people with prior substance dependence issues, people suffering
      from other psychiatric of mental health issues and for people with a high-dose intake.

      Insomnia is a common symptom for people who suffer from substance dependence, especially when
      the intake has ended. During this time, the withdrawal phase, risk for relapse is high. The
      protracted withdrawal phase can go on for 6-12 months. General symptoms during this time,
      except insomnia, are sensitivity to stress, emotional over- and under reactions and memory
      dysfunctions.

      Insomnia and drug dependence Insomnia is a common health problem in Sweden, which increases
      with age and is more prevalent among women.

      Insomnia 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.

      Sleep quality is, according to the National Board of Health and Welfare, a measurement of
      life quality among the population. 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.

      Sleeping disorders is treated by identifying the root cause, which can for instance be
      circadian disruption, life style factors, physiological- and psychological disease or side
      effects from drug treatment. Usually sleep medicine combined with general sleeping advices is
      the first-hand treatment. 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.

      Acupuncture Acupuncture is a complementary (non-pharmacological) treatment method with roots
      in Traditional Chinese Medicine (TCM). The method is used as a stand alone treatment or as a
      complementary treatment for several types of health problems, for example to relieve pain, as
      a support for assisted conception, in chronic asthma treatment, and in schizophrenia
      treatment. In Sweden it is a part of the integrative methods within the health care, mostly
      used to relive pain or as assisting treatment during child birth.

      Auricular acupuncture (AA) A later branch of traditional acupuncture is auricular
      acupuncture. The auricular method can be used to treat a wide variety of conditions, among
      others depression and insomnia. Auricular acupuncture involves inserting thin solid needles
      at selected points of the outer ear. In the late 1970's a specific auricular acupuncture
      protocol was developed to alleviate acute- and protracted withdrawal symptoms from opiate
      dependence and/or while adjusting methadone dose, now defined as the NADA (National
      Acupuncture Detoxification Association)-protocol. In Sweden, the NADA protocol is used as a
      complement to ordinary treatment in psychiatric care and in the context of protracted
      withdrawal symptoms from usage of alcohol and benzodiazepines.

      Cognitive Behavior Therapy (CBT) CBT is a collective term for theories and techniques based
      upon learning psychology principles. By using different techniques the therapist and the
      patient can work with both situational- and/or long-term behavioral problems, for instance
      sleeping disorders. Treating sleeping disorders with CBT can be done through manual based
      group sessions.

      Actigraphy Actigraphy is a way to measure sleep, circadian rhythm and activity and the
      measurement is done by the wrist of the persons' non-dominant hand. The device, which is
      similar to a wrist watch, registers the carriers' activity pattern during the days and
      nights. It can distinguish between sleep and activity and the information is processed
      through computer.

      Present status report The Cochrane Library present a meta analyse in which auricular
      acupuncture has been used to treat insomnia. According to the result both auricular
      acupuncture and acupressure can improve sleep quality compared to placebo. However no firm
      conclusions could be made because of the low methodological quality of the studies. In order
      to draw conclusions, further research in the field is needed. In Sweden further research
      regarding complementary treatment methods to treat insomnia are requested by the SBU. Since
      insomnia is an increasing health problem in Sweden, the SBU also emphasize the importance of
      developing non-pharmacological treatment methods for insomnia in order to decrease substance
      dependence.

      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.

      Question formulations

        1. How are the sleep pattern, day/night activity and subjective sleep quality affected by
           AA treatment, alternative CBT, among women and men with a substance dependence of a
           prescribed therapeutic dose of benzodiazepine-like sleeping drugs?

        2. Does the subjective quality of life change among women and men with a substance
           dependence of a prescribed therapeutic dose of benzodiazepine-like sleeping drugs, after
           treatment with AA or CBT, and if so, are there gender differences?

        3. Is there a remaining effect of treatment 3 months after intervention has ended?

      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 out-patient clinic specialized in sleeping disorders and
      also by add in the local news paper. Once respondents are included in the study baseline will
      be measured regarding prevalence of insomnia, anxiety and depression. Other measurements are
      subjective perception of sleep- and life quality. Actigraphy will be used to monitor the
      respondents' activity pattern 24 hours a day for 7 days. The respondents will also use
      sleeping diaries. After baseline measurements the respondents end their sleeping medicine
      treatment. They will be randomized to one out of two groups.

      Group I will receive AA and group II will receive CBT.

      Inclusion criteria's: 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's: 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.

      Questionnaires:

      Hospital Anxiety Depression scale (HADs) prevalence of anxiety and depression, Insomnia
      Severity Index (ISI) prevalence of insomnia and effect of treatment, Minimal Insomnia Symptom
      Scale (MISS) prevalence of insomnia and effect of treatment, Functional Outcome of Sleep
      Questionnaire (FOSQ) measure consequences of sleepiness, Ep-worth Sleepless scale (ESS)
      measure sleepiness during day time, Form SF-12 measure quality of life, Dysfunctional Belief
      About Sleep (DBAS-16) measurement of subjective perception of sleep/lack of sleep.

      After three months there will be a long-time follow up with actigraphy monitoring, sleeping
      diary and all questionnaires, in order to investigate a potential long-term effect.

      Importance of the project Despite lack of scientific evidence AA is used nationally and
      internationally to treat conditions of substance dependence and of insomnia. According to
      patients and medical staff AA is perceived as at treatment method with positive and sometimes
      remaining results in the conditions mentioned above. The benefits of AA are the lack of
      severe side effects and the method is easy for the medical staff to learn how to perform. It
      is also a low cost method. Previous Swedish study within the substance dependence care showed
      that patients who had received AA treatment during protracted withdrawal, experienced that
      their subjective perceived sleep quality was improved. Since sleeping problems in many cases
      can lead to relapse in substance abuse, AA may be an eligible, non-pharmacological option for
      patients with high-risk profiles of developing substance dependence from sleeping drugs. If
      AA can contribute to a decreased risk of relapse in substance dependence and increase quality
      of life, the treatment can be of importance not only for individuals, but also in a health
      economical perspective and for society in general. The result of this project may contribute
      to strengthen the evidence for using AA to treat insomnia. From a public health perspective
      the method could, because of its lack of side effects, be an alternative treatment method
      that could be provided from the public health care.
    

Intervention name(s): Auricular acupuncture (AA); cognitive behavioral therapy (CBT)
Intervention type(s): Other; Other
Intervention description(s): 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.; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Auricular acupuncture; CBT