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Chronic InsomniaNCT04751851

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

A study testing Medium duration withdrawal programme with ACT, Long duration withdrawal programme with ACT and Medium duration withdrawal programme without ACT in people with Chronic Insomnia and Hypnotic Dependence, run by Association Nationale de Promotion des Connaissances sur le Sommeil at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Insomnia, Hypnotic Dependence
What is being tested?
Medium duration withdrawal programme with ACT, Long duration withdrawal programme with ACT and Medium duration withdrawal programme without ACT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteSwitzerland
Study dates
3 Jun 2021to 4 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • PROSOM

    Lausanne

Other trials in Switzerland

About this study

Official title: Determinants of Optimal Benzodiazepines Withdrawal in Adults With Hypnotic-dependent Insomnia: a Randomised Controlled Trial Evaluating Acceptance and Commitment Therapy in Telepsychology

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.

Read the detailed description

Benzodiazepines and related drugs (BZDs) are effective for insomnia and anxiety in the short term. After few months (four weeks regarding insomnia), the benefit/risk ratio is considerably reduced. Nevertheless, between 2 and 5% of the general population uses them for more than 6 months. Prescribing recommendations are unanimous concerning the short-term use of these substances, but do not specify the optimal ways of reducing doses in a withdrawal programme.

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.

Being tested
Medium duration withdrawal programme with ACT, Long duration withdrawal programme with ACT, Medium duration withdrawal programme without ACT, Long duration withdrawal programme without ACT
Keywords
Benzodiazepines, Withdrawal, Acceptance and Commitment Therapy, Cognitive Behavioural Therapy, Telepsychology
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medium duration withdrawal programme with ACTBehavioural

    • 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 ACTBehavioural

    • 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 ACTBehavioural

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

  • Long duration withdrawal programme without ACTBehavioural

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

Study groups in NCT04751851
Study groupRoleWhat they receive
A.1: Medium duration withdrawal programme with ACTExperimentalMedium duration withdrawal programme with Acceptance and Commitment Therapy
Receives: Behavioral: Medium duration withdrawal programme with ACT
A.2: Long duration withdrawal programme with ACTExperimentalLong duration withdrawal programme with Acceptance and Commitment Therapy
Receives: Behavioral: Long duration withdrawal programme with ACT
B.1: Medium duration withdrawal programme without ACTActive comparatorMedium duration withdrawal programme without Acceptance and Commitment Therapy
Receives: Behavioral: Medium duration withdrawal programme without ACT
B.2: Long duration withdrawal programme without ACTActive comparatorLong duration withdrawal programme without Acceptance and Commitment Therapy
Receives: Behavioral: Long duration withdrawal programme without ACT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

Secondary outcomes (12)

  1. Benzodiazepines use 1

    Proportion of participants who were able to reduce the dose by 50% or more BZD (over the two weeks prior to the assessments)

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  2. Benzodiazepines use 2

    Number of nights per week without BZD (over the two weeks preceding the assessments)

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  3. Benzodiazepines dependence

    Benzodiazepine Dependence Questionnaire (i.e. BDEPQ). This questionnaire evaluates the severity of BZD dependence via 30 items in 4 points, divided into 3 subscales: general dependence, pleasurable effect, perception of need.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  4. Compliance

    Significant deviation from the taper schedule (considered treatment failures) = failure to make a scheduled dose decrease for a 10 days period, or falling more than 14 days behind the allowed taper schedule dose for any consecutive three days period, or continued BZD use beyond 14 days from the scheduled zero-dose date.

    Measured: Change from 1 month post-treatment at 3 months, 12 months and 24 months post-treatment

  5. Assessment of withdrawal symptoms

    Clinical Institute Withdrawal Assessment-B (CIWA-B) contains 20 5-point items designed to assess and monitor the type and severity of benzodiazepine-like withdrawal symptoms. The first three items (restlessness, tremor, and sweating) are rated by the treating physician, and the last 17 items are rated by the patient.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  6. Sleep Improvement

    The severity of insomnia as measured by the Insomnia Severity Index (i.e., ISI). The ISI questionnaire assesses satisfaction, daily functioning and anxiety related to sleep problems with 7 5-point items.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  7. Psychopathological symptoms improvement

    Psychological distress as assessed by the Symptom Checklist 90, (i.e., SCL-90). The following 9 psychopathological dimensions are assessed by 90 5-point items: Somatization, Interpersonal sensitivity, Depression, Anxiety, Hostility and aggression, Obsessive-Compulsive, Phobic anxiety, Paranoid ideas, Psychoticism.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  8. Quality of life improvement

    Quality of life as measured by WHOQOL-26 (i.e., WHOQOL-BREF). This abbreviated form of the WHOQOL-100 assesses the following 4 dimensions: "physical health", "mental well-being", "social relationships" and "environment" by 26 5-point items.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  9. Self-confidence in benzodiazepines reduction

    Self-confidence towards change in benzodiazepine use assessed by two questions: "How confident are you in stopping your benzodiazepines" (0% I can't stop my medication; 100% I feel able to stop my benzodiazepines) and "How confident are you in your ability to sleep without benzodiazepines" (0% I can't sleep without benzodiazepines; 100% I feel able to sleep without benzodiazepines).

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  10. Awareness improvement

    Ability to be in contact with the present moment as measured by the Philadelphia Mindfulness Scale (i.e., MAAS) : 15 6-point items assess the capacity for mindfulness, i.e., the ability to pay attention without judgment to the present moment.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  11. Psychological flexibility improvement

    Psychological flexibility as measured by the Acceptance and Action Questionnaire (i.e., AAQ-II) : 10 7-point items assess the ability to not act solely to modify unpleasant psychological experiences.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

  12. Global ACT processes improvement

    Overall assessment of the 6 ACT processes as measured by the Comprehensive assessment of Acceptance and Commitment Therapy processes (i.e., CompACT). This 23-item questionnaire uses a 5-point scale to assess the following 6 dimensions, corresponding to the 6 ACT processes: Acceptance, Defusion, Contact with the present moment, Self as Context, Values, and Committed Actions.

    Measured: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start3 Jun 2021
  3. Primary completion1 Aug 2024
  4. Study completion4 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04751851
Sponsor's protocol ID
BENZOSTOP
Status last verified
Apr 2025
First submitted
2 Feb 2021
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Medium duration withdrawal programme with ACT, Long duration withdrawal programme with ACT and Medium duration withdrawal programme without ACT in people with Chronic Insomnia and Hypnotic Dependence, run by Association Nationale de Promotion des Connaissances sur le Sommeil at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants having successfully stopped their benzodiazepine use (time frame: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04751851.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

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