Affective Disorder, Anxiety Disorders, Sleep Problem
Conditions
Keywords
Cognitive Behaviour Therapy, Psychological Intervention
Brief summary
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with PTSD, Anxiety disorders and Depression display high levels of sleep difficulties. Sleep problems are often general, such as insomnia and sleep phase problems. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this mixed psychiatric population. The basis was CBT for insomnia (CBT-i), but also including techniques that would alleviate sleep phase problems (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in psychiatric patients. This treatment was well tolerated and gave large withing-group effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and anxiety and depressive symptoms in patients at the units for Anxiety and Affective disorders and Trauma, Southwest Psychiatry and Northern Stockholm Psychiatry, Stockholm County Council, Sweden.
Interventions
BEHAVIORALAdjusted group CBT-i for Depression, Anxiety and PTSD
Adjusted group CBT-i for Depression, Anxiety and PTSD. CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. Adjustments include the relationship between sleep and the psychiatric conditions at hand and and working with motivational enhancement techniques to increase adherence to treatment.
OTHERCare as usual wait-list control group
Usual care at the clinic. This entails managing pharmacological treatment for the psychiatric problems and/or sleep problems. The clinic also provides different group treatments, such as mindfulness groups and CBT groups for symptoms of worry and depression, and individual therapy.
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being a patient at the clinics involved in the project * Experiencing sleep problems (subjective report) above 10 points on the ISI * Being able to participate in a psychological intervention in group format in Swedish
Exclusion criteria
* Night shift work
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Changes from base-line to 6 weeks | 7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Actigraphy | Changes from two weeks pre treatment (minus two weeks to base-line) to two weeks post treatment (six to eight weeks). | An actigraph is placed on the participant's arm for one week. It measures participants' arm-movements. An algorithm can be used to estimate sleep from movement data. |
| WHO Disability Assessment Schedule (WHODAS) | Changes from base-line to 6 weeks, 4,5 months and 13,5 months | 12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability. |
| Patient Health Questionnaire (PHQ-9) | Changes from base-line to 6 weeks, 4,5 months and 13,5 months | 9-items self-rating questionnaire measuring level of depression. Total score 0-27 with higher score indicating more severe depression |
| Generalized Anxiety Disorder 7-item scale (GAD-7) | Changes from base-line to 6 weeks, 4,5 months and 13,5 months | 7-item self-rating questionnaire measuring level of anxiety. Total score 0-21 with higher score indicating more severe anxiety. |
| Daytime Insomnia Symptoms Scale | Changes from base-line to 6 weeks, 4,5 months and 13,5 months | 7-item self-rating questionnaire regarding daytime symptoms commonly associated with sleep problems. Total score 0-70, with higher score indicating more severe daytime symptoms. |
| Sleep habits and behaviors | Changes from base-line to 6 weeks, 4,5 months and 13,5 months | Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the larger BSIP project and consists of two parts. The first part includes statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7). The second part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning". No total score is obtained. |
| Insomnia Severity Index (ISI) | Changes from base-line to 4,5 months and 13,5 months | 7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORSusanna Jernelöv, PhD
Karolinska Institutet
Outcome results
None listed