Sleep in addiction care

ISRCTN	ISRCTN59953554
DOI	https://doi.org/10.1186/ISRCTN59953554
Protocol serial number	3.000.014
Sponsor	Mental Health Group in North and Middle Limburg (GGZ Noord- en Midden-Limburg) (Netherlands)
Funder	Mental Health Group in North and Middle Limburg (GGZ Noord- en Midden-Limburg) (Netherlands)

Submission date: 21/05/2008
Registration date: 19/08/2008
Last edited: 19/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Ellis Magnee
Scientific

Wanssumseweg 12
Oostrum
5807 EA
Netherlands

Phone	+31 478 527815
Email	emagnee@ggznml.nl

Study information

Primary study design	Interventional
Study design	Randomised, open clinical trial, in two addiction care centres.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Sleep in substance use disordered patients in addiction care
Study objectives	Sleep will improve by a cognitive behavioural therapeutic intervention in patients admitted to an addiction care clinic that show problems in initiating and maintaining sleep in the subacute detoxification phase.
Ethics approval(s)	To be submitted in July 2008 (as of 21/05/2008)
Health condition(s) or problem(s) studied	Insomnia in patients with substance use disorder
Intervention	The study is a randomised controlled trial in a cohort of patients referred to addiction care (2 addiction clinics). The duration of the study for the participating patients is 15 weeks, plus a follow up at 2 months after completion of the intervention. In order to gather a large study population, the research takes 1.5 years. Initially, 600 eligible patients will be enrolled in the study and will undergo various baseline assessments (T0; see primary and secondary outcome measures) and start standard treatment for their sleep problems. During the 4th week in treatment (T1), those who still continue with the treatment will be asked to undergo additional assessments (see primary and secondary outcome measures). In the 5th week of treatment, the patients who show problems in initiating or maintaining sleep at T1 are selected for the next stage of the study. The selected patients (90 patients) are randomly assigned to one of the two treatment groups. The participants allocated to the intervention group receive sleep training, consisting of sleep hygiene, sleep education and cognitive behavioural therapy. Cognitive behavioural therapy will be given in 6 sessions of 2 hours, as developed by I. Verbeek (1999; http://www.ncbi.nlm.nih.gov/pubmed/10616231). The control group receives standard care (and no sleep training). This means a daily programme of cognitive therapy, group meetings, creative therapy, movement therapy, coffee breaks etc., the regular treatment for a normal addiction clinic. The total duration of follow-up per individual is 2 months. On completion of this follow-up assessment, the participants in the control group will also receive the interventions if they wish.
Intervention type	Other
Primary outcome measure(s)	1. Subjective sleep efficiency as measured by a sleep log. The sleep log will be recorded by the participants during the 6-week treatment period. The sleep log has several outcome measures: time in bed (TIB), total sleep time (TST), sleep onset latency (SOL), sleep efficiency (SE), wake after sleep onset (WASO) and number of awakenings (AWAK). 2. Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) at timepoints T0, T1, T2, T3 and T4 Timepoints: T0 = Day of clinical intake T1 = 4th week of treatment T2 = 6th week of treatment, before randomisation T3 = At the end of sleep training T4 = 2 months after the sleep training
Key secondary outcome measure(s)	Vigilance during the day as measured by the Sustained Attention to Response Task (SART) at T1, T2, T3 and T4. SART will be carried out once a week during the period between T2 and T3. Tertiary outcome measures: 1. Severity of dependency on drugs/ alcohol measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM) at T0 and T4 2. Addiction measured using the addiction scales of the Addiction Severity Index (ASI) at T0 and T4 3. Presence of any psychiatric disorder assessed by the Mini International Neuropsychiatric Interview (MINI) 4. Presence of sleep disorders assessed by the SLEEP-50 at T0, T1, T2, T3 and T4 5. Symptom assessment by the Symptom Check List (SCL-90) at T0, T1, T2, T3 and T4 6. Quality of life assessed by the EQ-5D at T0, T1, T2, T3 and T4 7. Actigraphy at T1, T2, T3 and T4. The actigraph registers movements of the right arm in right handed subjects for 48 hours or more. 8. Go/No-Go response-inhibition task (T1) Timepoints: T0 = Day of clinical intake T1 = 4th week of treatment T2 = 6th week of treatment, before randomisation T3 = At the end of sleep training T4 = 2 months after the sleep training
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	90
Key inclusion criteria	1. Both males and females, age limit: 65 2. Patients who are admitted for at least 5 weeks to an addiction clinic 3. Those who are "clean" i.e. addicted patients that do not use drugs/alcohol anymore 4. Score of 5 or higher in the Pittsburgh Sleep Quality Index (PSQI)
Key exclusion criteria	1. Patients with sleep problems other than problems of initiating or maintaining sleep 2. Diagnosis of severe depression, attention deficit hyperactivity disorder (ADHD) 3. Patients who have a primary benzodiazepine addiction
Date of first enrolment	01/09/2008
Date of final enrolment	01/09/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

Wanssumseweg 12

Oostrum
5807 EA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes