Telepsychology for the withdrawal of benzodiazepines and related substances in adults suffering from chronic insomnia.
Descrizione riassuntiva dello studio
Benzodiazepine-type hypnotics and related substances (BZD) remain, despite official recommendations, the most common treatment for insomnia. They are indicated in cases of acute insomnia but contraindicated for chronic insomnia due to their numerous side effects. They lead to physical and psychological dependence that contributes to the chronicity of their consumption. Stopping their use can provoke a withdrawal syndrome, characterized in particular by a resurgence of insomnia, anxiety, and mood disorders, which promotes psychological dependence. Health authorities recommend the deprescribing of BZD in cases of chronic insomnia, but data is lacking regarding their withdrawal modalities. Studies on BZD withdrawal show an average of 5% abstinence success without any intervention, 30-40% with a brief intervention, and 60-80% with Cognitive Behavioral Therapy (CBT). This benefit is explained by the fact that CBT targets one of the causes of BZD consumption: insomnia, for which they are the reference treatment. Studies evaluating their effectiveness on BZD withdrawal are, however, few. Moreover, the latest generations of CBT, also promising for the treatment of insomnia, have only been tested for BZD withdrawal in a pilot study published by our team in 2020. Finally, while CBT is also effective when delivered remotely, no other study has tested a remote support device for BZD withdrawal. The duration of withdrawal, which can influence the intensity of the withdrawal syndrome, varies greatly in recommendations and studies (between 1 month and one year) and has never been experimentally tested. There are many psychological factors influencing the success of a withdrawal program and the relapse rate, but no study characterizes the withdrawal modalities based on patient profiles.
(BASEC)
Intervento studiato
This European monocentric interventional study is entirely conducted in telepsychology: all interviews are conducted individually via videoconference. It is a randomized controlled study comparing orthogonally, on one hand, a gradual withdrawal program from BZD of medium or long duration depending on the experimental group, and on the other hand, the addition to the withdrawal program of a CBT intervention (Acceptance and Commitment Therapy, "ACT") in 8 sessions.
The withdrawal program is common to all participants: the monitoring of withdrawal is done through 10 support and evaluation interviews for possible withdrawal symptoms, spaced 2 to 3 weeks apart depending on the condition.
Regarding the psychological intervention present in 2 of the 4 experimental conditions, it combines the behavioral instructions of CBT-I and work in Acceptance and Commitment Therapy (ACT), an approach belonging to the latest wave of CBT, targeting the withdrawal symptoms of insomnia.
Evaluations at 1 month, 3 months, 12 months, and 24 months post-withdrawal will assess the long-term effectiveness of the treatment on maintaining abstinence from benzodiazepines, improving insomnia, and the quality of life of participants.
(BASEC)
Malattie studiate
Chronic insomnia and dependence on sleeping pills
(BASEC)
- Being a native French speaker or speaking French well enough. - Being aged 18 to 70 years. - Suffering from chronic insomnia (difficulty falling asleep and/or maintaining sleep, at least 3 nights per week and for at least 6 months) and consuming one or more benzodiazepines or related substances to promote sleep, more than four nights per week and for at least six months. (BASEC)
Criteri di esclusione
• Consuming sedative-hypnotics not belonging to the class of BZD and related substances to treat insomnia or associated sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, diphenhydramine, dimenhydrinate), alcohol or cannabis 3 nights or more per week for sleep problems or more than 3 alcoholic drinks per day. • Being in acute treatment for psychological or psychiatric problems (e.g., current participation in psychotherapy). • Presenting another untreated diagnosed sleep disorder (e.g., obstructive sleep apnea syndrome, periodic limb movements during sleep), a terminal illness (e.g., cancer, palliative care), an unstable cardiovascular, respiratory, or endocrinological disease, major depression, or another untreated severe psychopathology (e.g., bipolar disorder, psychosis, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, specific phobia, social phobia, or obsessive-compulsive disorder), or a history of psychosis. (BASEC)
Luogo dello studio
Friburgo, Losanna, Neuchâtel, Sion
(BASEC)
Sponsor
Benjamin Putois
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Mélinée Chapoutot
+41775352205
mel.chapoutot@cluttergmail.comSleep center, CHVR, Av. du Grand-Champsec 80, 1951 Sion, Switzerland Lyon Neuroscience Research Center, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, 95 Bd Pinel, 69500 Bron, France
(BASEC)
Informazioni scientifiche
Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, FranceLyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
23.12.2021
(BASEC)
ID di studio ICTRP
NCT04751851 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Télépsychologie pour le sevrage des benzodiazépines et apparentées chez l’adulte souffrant d’insomnie chronique. (BASEC)
Titolo accademico
Determinants of Optimal Benzodiazepines Withdrawal in Adults With Hypnotic-dependent Insomnia: a Randomised Controlled Trial Evaluating Acceptance and Commitment Therapy in Telepsychology (ICTRP)
Titolo pubblico
Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia (ICTRP)
Malattie studiate
Chronic InsomniaHypnotic Dependence (ICTRP)
Intervento studiato
Behavioral: Medium duration withdrawal programme with ACTBehavioral: Long duration withdrawal programme with ACTBehavioral: Medium duration withdrawal programme without ACTBehavioral: Long duration withdrawal programme without ACT (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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, 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 (ICTRP)
non disponibile
Endpoint primari e secondari
Proportion of participants having successfully stopped their benzodiazepine use (ICTRP)
Benzodiazepines use 1;Benzodiazepines use 2;Benzodiazepines dependence;Compliance;Assessment of withdrawal symptoms;Sleep Improvement;Psychopathological symptoms improvement;Quality of life improvement;Self-confidence in benzodiazepines reduction;Awareness improvement;Psychological flexibility improvement;Global ACT processes improvement (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Benjamin Putois, Ph.D, benjamin.putois@inserm.fr, +33663287178 (ICTRP)
ID secondari
BENZOSTOP (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT04751851 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile