Internet-CBT for Insomnia (IpsyInsomni)
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Purpose
This study includes two sub-trials.
In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews.
Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.
Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.
| Condition | Intervention |
|---|---|
|
Insomnia Depression |
Behavioral: Therapist guided Internet-CBT for insomnia Behavioral: Brief Internet-CBT for insomnia, without support Behavioral: Therapist Guided Internet-CBT for depression |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression |
- Insomnia Severity Index (ISI) [ Time Frame: Post-treatment (9 weeks) ] [ Designated as safety issue: No ]7-item, self-rated questionnaire measuring insomnia severity. Bastien, C. H., Vallières, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.
- MADRS-S [ Time Frame: Post-treatment (9 weeks) ] [ Designated as safety issue: Yes ]
The use of two primary outcomes are motivated since the purpose is to look at effects on both insomnia and depression. In trial 1 the former is used to predict the latter, and in Trial 2 the patientents suffer from both conditions.
The MADRS-S is a 9-item self-rated measure of depression severity and screens for suicidality.
Mattila-Evenden, M., Svanborg, P., Gustavsson, P., & Åsberg, M. (1996). Determinants of self-rating and expert rating concordance in psychiatric out-patients, using the affective subscales of CPRS. Acta Psychiatr Scand, 94, 386-396.
- ISI [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
- ISI [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
- ISI [ Time Frame: 3-years follow-up ] [ Designated as safety issue: No ]
- MADRS-S [ Time Frame: 6-month follow-up ] [ Designated as safety issue: Yes ]
- MADRS-S [ Time Frame: 1-year follow-up ] [ Designated as safety issue: Yes ]
- MADRS-S [ Time Frame: 3-years follow-up ] [ Designated as safety issue: Yes ]
- Sleep Diary [ Time Frame: Same as primary outcomes ] [ Designated as safety issue: No ]One week of self-ratings on a number of sleep parameters, resluting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjecitve sleep quality and daytime functioning
- Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: Same as Primary outcomes ] [ Designated as safety issue: No ]
Health economic questionnaire evalutation cost for health care, abscence of work capacity and related costs.
Hakkaart-Van Roijen, L.,Van Straten, A., & Donker, M. (2002). Manual: Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness. Rotterdam: Erasmus University
- EQ-5D [ Time Frame: Same as primary outcomes ] [ Designated as safety issue: No ]
General quality of life measure to complement the TIC-P in health economic analysis.
Hinz, A., Klaiberg, A., Brahler, E., & Konig, H.H. (2006). The Quality of Life Questionnaire EQ-5D: modelling and norm values for the general population. Psychother.Psychosom.Med.Psychol., 56, 42-48.
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Guided Internet-CBT for insomnia |
Behavioral: Therapist guided Internet-CBT for insomnia
An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia
|
| Placebo Comparator: Control treatment |
Behavioral: Brief Internet-CBT for insomnia, without support
No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms
|
|
Experimental: Guided Internet-CBT for insomnia (9)
(9 weeks instead of 8)
|
Behavioral: Therapist guided Internet-CBT for insomnia
An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia
|
| Active Comparator: Guided Internet-CBT for depression |
Behavioral: Therapist Guided Internet-CBT for depression
An 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. Information and methods regarding sleep difficulties removed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical level of Insomnia (more than 10 on ISI)
- Meets criteria for Insomnia according to DSM-IV-TR
- Enough language skills
- Only Trial 2: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
Exclusion Criteria:
- Sleep disorders requiring other treatment
- High consumption of alcohol/drugs that affect sleep
- Started to use or changed the dose of antidepressant drug during the last 2 months
- Somatic or psychiatric conditions requiring acute care
- Working night shifts
- Only Trial 1: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Viktor Kaldo, Principal Investigator, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01256099 History of Changes |
| Other Study ID Numbers: | 2009/1810-31/3 |
| Study First Received: | October 12, 2010 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska Institutet:
|
Self-help treatment Internet treatment CBT Prevention Comorbidity |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Sleep Initiation and Maintenance Disorders Behavioral Symptoms Mood Disorders |
Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013