Effectiveness of an internet-delivered treatment for insomnia

Internet-delivered Therapist-assisted Cognitive Behavioral Therapy for Insomnia: A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10185189

Enrollment

Registered

2016-06-22

Start date

2012-09-01

Completion date

Unknown

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary insomnia Mental and Behavioural Disorders Primary insomnia

Interventions

Recruited and eligible participants are randomly assigned to one of two groups using a computerised random number generator (www.random.org). Block randomisation with 10 subjects was used to optimize

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Meeting the criteria of a clinically relevant primary insomnia (according to ISI score and DSM-IV criteria). 2. Aged 18 years and over 3. Swiss residency

Exclusion criteria

Exclusion criteria: 1. No regular internet access 2. No full ability to read and write German. 3. Presence of another sleep disorder (sleep related breathing disorders, sleep related movement disorders, parasomnias) 4. Presence of psychiatric disorders (mood disorders, anxiety disorders, somatoform disorders, psychotic disorders, substance-related disorders), or history of such disorders in the past 5. Presence of suicidal tendencies 6. Regular use of sleep medication 7. Shift-work 8. Current psychological treatment 9. Somatic conditions that are known to cause insomnia. 10. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. Insomnia Severity is measured by the Insomnia Severity Index (ISI) at baseline, post-treatment (8-12 weeks) and 6 months post-treatment 2. Sleep parameters (Total Sleep Time (TST), Wake after Sleep Onset (WASO), Sleep Onset Latency (SOL), Sleep Efficiency (SE)) are measured by an online sleep diary which the subjects are keeping on the treatment website daily throughout the 8-12 weeks. The means of the first seven entries serve as baseline measurement, means of seven entries before post-treatment (8-12 weeks) serve as post-treatment measure and seven entries at follow up after 6 month post-treatment as follow up measure.	—

Measure

Time frame

1. Insomnia Severity is measured by the Insomnia Severity Index (ISI) at baseline, post-treatment (8-12 weeks) and 6 months post-treatment 2. Sleep parameters (Total Sleep Time (TST), Wake after Sleep Onset (WASO), Sleep Onset Latency (SOL), Sleep Efficiency (SE)) are measured by an online sleep diary which the subjects are keeping on the treatment website daily throughout the 8-12 weeks. The means of the first seven entries serve as baseline measurement, means of seven entries before post-treatment (8-12 weeks) serve as post-treatment measure and seven entries at follow up after 6 month post-treatment as follow up measure.

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Secondary

Measure	Time frame
1. Depression is measured using the Becks Depression Inventory (BDI questionnaire) at baseline, post-treatment (8-12 weeks) and 6 months post-treatment 2. Psychological Strain is measured using the Global Symptom Index of the Brief Symptom Inventory (BSI questionnaire) at baseline, post-treatment (8-12 weeks) and 6 months post-treatment 3. Quality of Life is measured using a single direct question to provide subjective estimate on a scale of 1-10 (Likert scale) at baseline, post-treatment (8-12 weeks) and 6 months post-treatment 4. Dysfunctional beliefs and attitudes about sleep is measured using the DBAS questionnaire at baseline, post-treatment (8-12 weeks) and 6 months post-treatment Participants in the waiting list group receive treatment after 8 weeks waiting period and do not have to wait until the 6 month follow up period. Follow-up measurements are compared in a pooled fashion (no controlled comparison between groups).	—

Measure

Time frame

1. Depression is measured using the Becks Depression Inventory (BDI questionnaire) at baseline, post-treatment (8-12 weeks) and 6 months post-treatment 2. Psychological Strain is measured using the Global Symptom Index of the Brief Symptom Inventory (BSI questionnaire) at baseline, post-treatment (8-12 weeks) and 6 months post-treatment 3. Quality of Life is measured using a single direct question to provide subjective estimate on a scale of 1-10 (Likert scale) at baseline, post-treatment (8-12 weeks) and 6 months post-treatment 4. Dysfunctional beliefs and attitudes about sleep is measured using the DBAS questionnaire at baseline, post-treatment (8-12 weeks) and 6 months post-treatment Participants in the waiting list group receive treatment after 8 weeks waiting period and do not have to wait until the 6 month follow up period. Follow-up measurements are compared in a pooled fashion (no controlled comparison between groups).

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Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026