Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia
NCT ID: NCT04751851
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2021-06-03
2025-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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
TREATMENT
NONE
Study Groups
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A.1: Medium duration withdrawal programme with ACT
Medium duration withdrawal programme with Acceptance and Commitment Therapy
Medium duration withdrawal programme with ACT
* 10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
* 8 individual weekly ACT sessions. The ACT programme includes mindfulness, acceptance and thoughts defusion exercises, identification of personal values and promotion of actions committed to these values. It also includes sleep restriction, a component of CBT for insomnia, used in this protocol to carry out committed-actions, according to the principles of ACT.
A.2: Long duration withdrawal programme with ACT
Long duration withdrawal programme with Acceptance and Commitment Therapy
Long duration withdrawal programme with ACT
* 10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.
* 8 individual weekly ACT sessions. The ACT programme includes mindfulness, acceptance and thoughts defusion exercises, identification of personal values and promotion of actions committed to these values. It also includes sleep restriction, a component of CBT for insomnia, used in this protocol to carry out committed-actions, according to the principles of ACT.
B.1: Medium duration withdrawal programme without ACT
Medium duration withdrawal programme without Acceptance and Commitment Therapy
Medium duration withdrawal programme without ACT
10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
B.2: Long duration withdrawal programme without ACT
Long duration withdrawal programme without Acceptance and Commitment Therapy
Long duration withdrawal programme without ACT
10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.
Interventions
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Medium duration withdrawal programme with ACT
* 10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
* 8 individual weekly ACT sessions. The ACT programme includes mindfulness, acceptance and thoughts defusion exercises, identification of personal values and promotion of actions committed to these values. It also includes sleep restriction, a component of CBT for insomnia, used in this protocol to carry out committed-actions, according to the principles of ACT.
Long duration withdrawal programme with ACT
* 10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.
* 8 individual weekly ACT sessions. The ACT programme includes mindfulness, acceptance and thoughts defusion exercises, identification of personal values and promotion of actions committed to these values. It also includes sleep restriction, a component of CBT for insomnia, used in this protocol to carry out committed-actions, according to the principles of ACT.
Medium duration withdrawal programme without ACT
10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
Long duration withdrawal programme without ACT
10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Association Nationale de Promotion des Connaissances sur le Sommeil
OTHER
Responsible Party
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Principal Investigators
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Benjamin Putois, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France
Laure Peter-Derex, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France
Locations
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PROSOM
Lausanne, , Switzerland
Countries
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Other Identifiers
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BENZOSTOP
Identifier Type: -
Identifier Source: org_study_id
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