Auricular Acupuncture and Cognitive Behavioral Therapy Treatment for Insomnia

NCT01765959 | Completed

• 1 other identifier: AA2011-59
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Quality of Life

Keywords

Insomnia; Auricular acupuncture; CBT

Outcome Measures

Primary Outcomes (1)

• Insomnia

  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)

  five months

Secondary Outcomes (1)

• Quality of life

  five months

Study Arms (2)

Auricular acupuncture (AA)

ACTIVE COMPARATOR

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)

Cognitive behavioral therapy (CBT)

ACTIVE COMPARATOR

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)

Interventions

Auricular acupuncture (AA) OTHER

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.

Auricular acupuncture (AA)

cognitive behavioral therapy (CBT) OTHER

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

Cognitive behavioral therapy (CBT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women (n=40)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (1)

• Bergdahl L, Broman JE, Berman AH, Haglund K, von Knorring L, Markstrom A. Auricular Acupuncture and Cognitive Behavioural Therapy for Insomnia: A Randomised Controlled Study. Sleep Disord. 2016;2016:7057282. doi: 10.1155/2016/7057282. Epub 2016 May 8.

  PMID: 27242930 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture, Ear; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Agneta Markström, MD, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 11, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

SE (1)