Telepsychology for Benzodiazepines Withdrawal in Adults Suffering From Hypnotic-dependent Insomnia

NCT04751851 | Completed

• 1 other identifier: BENZOSTOP
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia; Hypnotic Dependence

Keywords

Benzodiazepines; Withdrawal; Acceptance and Commitment Therapy; Cognitive Behavioural Therapy; Telepsychology

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

Study Arms (4)

A.1: Medium duration withdrawal programme with ACT

EXPERIMENTAL

Medium duration withdrawal programme with Acceptance and Commitment Therapy

Behavioral: Medium duration withdrawal programme with ACT

A.2: Long duration withdrawal programme with ACT

EXPERIMENTAL

Long duration withdrawal programme with Acceptance and Commitment Therapy

Behavioral: Long duration withdrawal programme with ACT

B.1: Medium duration withdrawal programme without ACT

ACTIVE COMPARATOR

Medium duration withdrawal programme without Acceptance and Commitment Therapy

Behavioral: Medium duration withdrawal programme without ACT

B.2: Long duration withdrawal programme without ACT

ACTIVE COMPARATOR

Long duration withdrawal programme without Acceptance and Commitment Therapy

Behavioral: Long duration withdrawal programme without ACT

Interventions

Medium duration withdrawal programme with ACT BEHAVIORAL

* 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.1: Medium duration withdrawal programme with ACT

Long duration withdrawal programme with ACT BEHAVIORAL

* 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.

A.2: Long duration withdrawal programme with ACT

Medium duration withdrawal programme without ACT BEHAVIORAL

10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.

B.1: Medium duration withdrawal programme without ACT

Long duration withdrawal programme without ACT BEHAVIORAL

10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.

B.2: Long duration withdrawal programme without ACT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Nationale de Promotion des Connaissances sur le Sommeil: lead

Study Sites (1)

PROSOM

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Benjamin Putois, MD, Ph.D

  Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France

  PRINCIPAL INVESTIGATOR

• Laure Peter-Derex, MD, Ph.D

  Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 12, 2021
• Study Start: June 3, 2021
• Primary Completion: August 1, 2024
• Study Completion: April 4, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

CH (1)