Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia (NCT04751851) | Clinical Trial Compass
CompletedNot Applicable
Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia
Switzerland128 participantsStarted 2021-06-03
Plain-language 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 support versus a psychotherapeutic intervention (Acceptance and Commitment Therapy, ACT) added to a withdrawal program on the reduction of benzodiazepines use in adults suffering from insomnia and hypnotic dependence.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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, tri…
What they're measuring
1
Proportion of participants having successfully stopped their benzodiazepine use
Timeframe: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
Trial details
NCT IDNCT04751851
SponsorAssociation Nationale de Promotion des Connaissances sur le Sommeil