Internet-CBT for Insomnia

Depression Clinical Trial

— IpsyInsomni  

Official title:

Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256099
• Other study ID #: 2009/1810-31/3
• Status: Completed
• Phase: N/A
• First received: October 12, 2010
• Last updated: April 1, 2015
• Start date: January 2010
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Insomnia

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index (ISI)	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.	Post-treatment (9 weeks)	No
Primary	MADRS-S	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.	Post-treatment (9 weeks)	Yes
Primary	ISI		6-month follow-up	No
Primary	ISI		1-year follow-up	No
Primary	ISI		3-years follow-up	No
Primary	MADRS-S		6-month follow-up	Yes
Primary	MADRS-S		1-year follow-up	Yes
Primary	MADRS-S		3-years follow-up	Yes
Secondary	Sleep Diary	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	Same as primary outcomes	No
Secondary	Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	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	Same as Primary outcomes	No
Secondary	EQ-5D	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.	Same as primary outcomes	No

External Links

•   The public page of the Internet-CBT treatment platform