Internet-CBT for Insomnia (IpsyInsomni)

Karolinska Institute

Status: Completed

Conditions: Insomnia; Depression

Treatments: Behavioral: Brief Internet-CBT for insomnia, without support; Behavioral: Therapist Guided Internet-CBT for depression; Behavioral: Therapist guided Internet-CBT for insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT01256099

2009/1810-31/3

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

191 participants in 4 patient groups, including a placebo group

Guided Internet-CBT for insomnia

Experimental group

Treatment:

Behavioral: Therapist guided Internet-CBT for insomnia

Control treatment

Placebo Comparator group

Treatment:

Behavioral: Brief Internet-CBT for insomnia, without support

Guided Internet-CBT for insomnia (9)

Experimental group

Description:

(9 weeks instead of 8)

Treatment:

Behavioral: Therapist guided Internet-CBT for insomnia

Guided Internet-CBT for depression

Active Comparator group

Treatment:

Behavioral: Therapist Guided Internet-CBT for depression