Efficacy of low dose amitriptyline vs. cognitive behavioural therapy for chronic insomnia and medical comorbidity: a randomized controlled non inferiority trial.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 190

Inclusion Criteria

- Adults aged 18 - 85 years and older visiting the outpatient clinic department
of neurology.
- Presence of insomnia disorder conform DSM-5, i.e. sleep problems in at least
3 nights a week, for at least 3 months with consequences for daytime
functioning, the sleep problem cannot be better explained by or occurs
exclusively during the course of another sleep disorder (e.g. sleep related
breathing disorder, parasomnia)
- Score of >=10 on the Insomnia Severity Index (ISI)
- Have a medical condition and / or chronic pain (> 3 months).

Exclusion Criteria

- Habitual night shift worker
- Untreated sleep related breathing disorder
- Wish to continue over-the-counter sleep aids as melatonin and medicinal
cannabis
- Use of off-label amitriptyline for insomnia in the past year
- Being unable to follow study instructions and fill out the study
questionnaires (in Dutch)
- A known diagnosis of dementia
- History of delirium
- Pregnancy, lactation or wish to become pregnant in the coming 6 months
- Terminal illness (prognosis < 1 year)
- Suicide risk
- Epilepsy
- Ocular Hypertension / Glaucoma
- The presence of a severe psychiatric disorder not in remission or adequately
treated.
- Current alcohol or drug abuse/addiction (benzodiazepine excluded).
- Participation in other interventional medical scientific studies
- Current use of psychopharmaceuticals other than benzodiazepine (
antidepressants including St John*s wort, anticonvulsants)
- Current use of antimycotica
- Allergy for amitriptyline
- Cardiac arrhythmia / blockade / Long QT syndrome / Brugada syndrome
- Family history of acute cardiac death
- Recent myocardial infarction (within the past 90 days)
- Angina pectoris / coronary insufficiency
- Severe renal insufficiency (GFR <10)
- Severe liver dysfunction

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the mean subjective insomnia severity score,<br /><br>measured by the insomnia severity index (ISI). Primary endpoint is at 12 weeks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>During the follow-up period maintenance of the treatment response assessed<br /><br>operationalized as having a >= 8 point reduction on the ISI Secondary<br /><br>outcomes include sleep quality quantified by sleep efficiency, questionnaires<br /><br>on daytime functioning and symptoms (fatigue, emotional complaints, physical<br /><br>functioning impairment of functioning). Possible moderators are type of<br /><br>insomnia, dysfunctional attitudes and beliefs about sleep, pre sleep arousal.<br /><br>Furthermore adverse events and treatment evaluation (side effects, withdrawal<br /><br>symptoms, and adherence) are assessed. </p><br>