Determinants of Optimal Benzodiazepines Withdrawal in Adults With Hypnotic-dependent Insomnia: a Randomised Controlled Trial Evaluating Acceptance and Commitment Therapy in Telepsychology
Sponsor study identifier
interventional
128
1 country
1
Study Start
June 3, 2021
Actual (reported)Primary Completion
August 1, 2024
Actual (reported)Study Completion
April 4, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 4, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2021
Actual (reported)February 12, 2021
Actual (reported)June 3, 2021
Actual (reported)August 1, 2024
Actual (reported)April 4, 2025
Actual (reported)Proportion of participants having successfully stopped their benzodiazepine use
Proportion of participants who successfully discontinue benzodiazepines (i.e., no benzodiazepine used for 2 weeks preceding assessment and negative on the urine test for BZD) at 4 weeks posttreatment, 6 months posttreatment, 12 months posttreatment and 24 months posttreatment. Successful discontinuation is defined as completion of the taper schedule without significant deviation and no use of benzodiazepine medications beyond "minimal Pro re nata. use" during the month following the zero-dose date. Minimal BZD use (not considered discontinuation failures): use of no more than 2 Pro Re Nata doses of medication (each not exceeding 0.5 mg diazepam) during the 2 weeks period starting at the zero-dose date. This criterion ensures that taking a minimal P.R.N. dose in extraordinary circumstances will not be considered discontinuation failures.
Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
Benzodiazepines use 1
Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
Benzodiazepines use 2
Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
Benzodiazepines dependence
Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
Compliance
Change from 1 month post-treatment at 3 months, 12 months and 24 months post-treatment
Assessment of withdrawal symptoms
Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
Medium duration withdrawal programme with Acceptance and Commitment Therapy
Long duration withdrawal programme with Acceptance and Commitment Therapy
Medium duration withdrawal programme without Acceptance and Commitment Therapy
* 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.
PROSOM
Lausanne, Switzerland
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
128 participants (actual enrollment reported by the registry).
First Submitted
February 2, 2021
First Posted
February 12, 2021
Study Start
Insomnia Behavioral Intervention Study
Long duration withdrawal programme without Acceptance and Commitment Therapy
* 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.
10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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June 3, 2021
Actual (reported)Primary Completion
August 1, 2024
Actual (reported)Study Completion
April 4, 2025
Actual (reported)Last Updated
May 1, 2025
Record last verified: 2025-04
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Source: ClinicalTrials.gov.
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