CompletedNot Applicable

Auricular Acupuncture and Cognitive Behavioral Therapy Treatment for Insomnia

Sweden60 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insomnia

Timeframe: five months

Trial details

NCT IDNCT01765959

SponsorUppsala University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

View on ClinicalTrials.gov More Insomnia trials