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

Sponsor

Association Nationale de Promotion des Connaissances sur le Sommeil (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04751851

Collaborator

(none)

128

Enrollment

Location

Arms

35.9

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Insomnia Hypnotic Dependence	Behavioral: Medium duration withdrawal programme with ACT Behavioral: Long duration withdrawal programme with ACT Behavioral: Medium duration withdrawal programme without ACT Behavioral: Long duration withdrawal programme without ACT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 ACTThe 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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 3, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A.1: Medium duration withdrawal programme with ACT Medium duration withdrawal programme with Acceptance and Commitment Therapy	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.
Experimental: A.2: Long duration withdrawal programme with ACT Long duration withdrawal programme with Acceptance and Commitment Therapy	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.
Active Comparator: B.1: Medium duration withdrawal programme without ACT Medium duration withdrawal programme without Acceptance and Commitment Therapy	Behavioral: Medium duration withdrawal programme without ACT 10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
Active Comparator: B.2: Long duration withdrawal programme without ACT Long duration withdrawal programme without Acceptance and Commitment Therapy	Behavioral: Long duration withdrawal programme without ACT 10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.

Outcome Measures

Primary Outcome Measures

Proportion of participants having successfully stopped their benzodiazepine use [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.

Secondary Outcome Measures

Benzodiazepines use 1 [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
Proportion of participants who were able to reduce the dose by 50% or more BZD (over the two weeks prior to the assessments)
Benzodiazepines use 2 [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
Number of nights per week without BZD (over the two weeks preceding the assessments)
Benzodiazepines dependence [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.
Compliance [Change from 1 month post-treatment at 3 months, 12 months and 24 months post-treatment]
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.
Assessment of withdrawal symptoms [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.
Sleep Improvement [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.
Psychopathological symptoms improvement [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.
Quality of life improvement [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.
Self-confidence in benzodiazepines reduction [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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).
Awareness improvement [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.
Psychological flexibility improvement [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.
Global ACT processes improvement [Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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
Pregnant or lactating