Clinical trial NCT04751851: Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia
Official title: Determinants of Optimal Benzodiazepines Withdrawal in Adults With Hypnotic-dependent Insomnia: a Randomised Controlled Trial Evaluating Acceptance and Commitment Therapy in Telepsychology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Hypnotic Dependence
Keywords: Benzodiazepines
Withdrawal
Acceptance and Commitment Therapy
Cognitive Behavioural Therapy
Telepsychology
Lead sponsor: Association Nationale de Promotion des Connaissances sur le Sommeil
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly divided into four arms :

* Group A.1: Medium duration withdrawal programme with ACT
* Group A.2: Long duration withdrawal programme with ACT
* Group B.1: Medium duration withdrawal programme without ACT
* Group B.2: Long duration withdrawal programme without ACT
Primary purpose: TREATMENT

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 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.

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. Nevertheless, between 2 and 5% of the general population uses them for more than 6 months. Prescribing recommendations are unanimous concerning the short-term use of these substances, but do not specify the optimal ways of reducing doses in a withdrawal programme.

Many factors influence the success of withdrawal, including the duration of withdrawal (how quickly doses are reduced), the half-life of the substance, and number of psychological factors. Studies on BZD withdrawal show that, on average, spontaneous cessation of treatment is 5-10%, withdrawal success is 30-40% following brief intervention and 60-80% following Behavioral and Cognitive Therapy (CBT). These are few, and only one study has tested the efficacy of Acceptance and Commitment Therapy (ACT) for benzodiazepine withdrawal. ACT is a contextual behavioral therapy which aims to increase acceptance of the full range of inner experiences including negative thoughts, emotions and sensations, in order to promote values-driven behavior change, leading to an improved quality of life. ACT is notably effective for the treatment of anxiety disorders, depression, psychosis and chronic pain, and some studies have shown the effectiveness of ACT for insomnia.

This study is a four-arms randomized controlled intervention which aims to evaluate the addition to a taper program of an ACT intervention versus a psychological support on one hand, and the duration of withdrawal on the other hand, in patients suffering from hypnotic-dependent insomnia. The entire protocol will be remotely delivered, which no randomized controlled trial has so far evaluated for benzodiazepine withdrawal.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Benzodiazepines use 1
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Benzodiazepines use 2
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Benzodiazepines dependence
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Compliance
timeFrame: Change from 1 month post-treatment at 3 months, 12 months and 24 months post-treatment
measure: Assessment of withdrawal symptoms
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Sleep Improvement
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Psychopathological symptoms improvement
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Quality of life improvement
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Self-confidence in benzodiazepines reduction
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Awareness improvement
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Psychological flexibility improvement
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
measure: Global ACT processes improvement
timeFrame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: PROSOM
Study officials:
affiliation: Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France
name: Benjamin Putois, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France
name: Laure Peter-Derex, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: