Status:
COMPLETED
Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia
Lead Sponsor:
Association Nationale de Promotion des Connaissances sur le Sommeil
Conditions:
Chronic Insomnia
Hypnotic Dependence
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Long-term use of benzodiazepines is a long-standing problem, but the optimal withdrawal modalities are not known. The main objective of this study is to compare the effectiveness of a psychological su...
Detailed Description
Benzodiazepines and related drugs (BZDs) are effective for insomnia and anxiety in the short term. After few months (four weeks regarding insomnia), the benefit/risk ratio is considerably reduced. Nev...
Eligibility Criteria
Inclusion
- French speaker
- Had benzodiazepines and related drugs prescribed to improving sleep, for a minimum of 4 nights per week and for at least 6 months
- Pathological Benzodiazepine Dependence Questionnaire (BDEPQ) score (\>34).
- Motivated to stop hypnotic treatment (score \>5 on a 1 to 10 degrees VAS)
- Subjective complaints of difficulties initiating and/or maintaining sleep for a minimum of 3 nights per week and for at least 6 months, and 4) presence of marked distress or impaired daytime functioning (fatigue, impaired attention and/or concentration). Because hypnotic medications may mask an underlying insomnia problem, participants should meet these criteria either currently (while taking medication) or after previous attempts to discontinue the medication. These criteria are consistent with those for primary insomnia and hypnotic-dependent insomnia.
- Present the diagnoses of insomnia (307.42) and sedative, hypnotic and anxiolytic use disorder (304.10) from the DSM V.
- Having e-literacy (being familiar with emails, videoconferencing, online questionnaires and Internet use)
Exclusion
- In acute treatment for psychological or psychiatric problems (e.g., current participation in psychotherapy)
- Be participating in a tapering BZD protocol, or similar
- Currently receiving an active prescription for any antipsychotic medication
- Using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, diphenhydramine, dimenhydrinate)
- Met criteria for a substance use disorder in the last six months (other than nicotine and hypnotics)
- Use of alcohol or cannabis 3 or more nights a week for sleep problems
- Drinking more than 3 alcoholic beverages per day
- Presence of another untreated sleep disorder (e.g., obstructive sleep apnea or periodic limb movements during sleep)
- Presence of major depression or other severe unstabilized psychopathology (e.g., bipolar disorder, psychosis, panic disorder, generalized anxiety disorder, posttraumatic stress disorder, specific phobia, social phobia, or obsessive-compulsive disorder)
- Had a history of psychosis
- Currently suicidal
- Current crisis or with an illness for which the benzodiazepine were required at the time (e.g. acute pain)
- Presence of terminal illness (e.g. cancer, receiving palliative care)
- Unstable cardiovascular, respiratory or endocrinological diseases (clinical interview)
- Had a history of severe cognitive impairment, dementia, seizure disorder (epilepsy either in themselves or in their family), spinal injury
- Pregnant or lactating
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04751851
Start Date
June 3 2021
End Date
April 4 2025
Last Update
May 1 2025
Active Locations (1)
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1
PROSOM
Lausanne, Switzerland