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

No results posted yet for this study

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04751851 on ClinicalTrials.gov