Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia
NCT04751851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2025-05-01
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.
Conditions
- Chronic Insomnia
- Hypnotic Dependence
Interventions
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
Medium duration withdrawal programme without ACT
10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
- BEHAVIORAL
-
Long duration withdrawal programme without ACT
10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.
Sponsors & Collaborators
-
Association Nationale de Promotion des Connaissances sur le Sommeil
lead OTHER
Principal Investigators
-
Benjamin Putois, MD, Ph.D · Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France
-
Laure Peter-Derex, MD, Ph.D · Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-03
- Primary Completion
- 2024-08-01
- Completion
- 2025-04-04
Countries
- Switzerland
Study Locations
More Related Trials
-
Stopping Benzodiazepines and Related Molecules Among Elderly Living in Residential Institutions
NCT02715440 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
NCT02839200 ·Status: COMPLETED ·Phase: PHASE2
-
Non-pharmacological Treatments for Parasomnias
NCT05953207 ·Status: UNKNOWN ·Phase: NA
-
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
NCT00295386 ·Status: COMPLETED ·Phase: PHASE4
-
Insomnia Behavioral Intervention Study
NCT05301543 ·Status: RECRUITING ·Phase: NA
-
Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines
NCT02127411 ·Status: COMPLETED ·Phase: NA
-
The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) and Non-BZD Hypnotics on Chronic Insomnia
NCT03461042 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
NCT02841709 ·Status: COMPLETED ·Phase: PHASE2
-
The Contribution of Melatonin Vs. Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients
NCT00261183 ·Status: UNKNOWN ·Phase: PHASE3
-
Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance
NCT02820441 ·Status: TERMINATED ·Phase: PHASE4
-
SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.
NCT03331042 ·Status: COMPLETED ·Phase: PHASE3
-
i-Sleep: Internet-based Treatment for Insomnia
NCT03110263 ·Status: TERMINATED ·Phase: NA
-
Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons
NCT00707915 ·Status: COMPLETED ·Phase: PHASE4
-
Non-pharmacological Treatment of Insomnia in Nursing Homes.
NCT01091987 ·Status: COMPLETED ·Phase: NA
-
Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
NCT00247390 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
NCT01348542 ·Status: COMPLETED ·Phase: NA
-
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
NCT01430754 ·Status: COMPLETED ·Phase: PHASE3
-
Imaging the Effects of Zolpidem and Alprazolam in Healthy Volunteers at 3T
NCT01747590 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Behavioral and Pharmacological Treatment for Insomnia
NCT00042146 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Chronic Hypnotic Use 2
NCT02456532 ·Status: COMPLETED ·Phase: PHASE4
-
Appraising Clinical Trial Experiences of Patients With Insomnia
NCT05978271 ·Status: NOT_YET_RECRUITING
-
Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
NCT00716521 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia
NCT00237497 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
NCT03375203 ·Status: COMPLETED ·Phase: PHASE2
-
Hypnotic Medications and Memory: Effect of Drug Exposure During the Night
NCT01159652 ·Status: COMPLETED ·Phase: PHASE4