Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

Uppsala University

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Cognitive behavior therapy for insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT01655797

RFR-10276

Details and patient eligibility

About

The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach. The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL). Following an active treatment-control period, the control group were re-assigned to CBT. The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group. Primary outcome measure was a brief self-report screening form, Insomnia severity index.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fulfilled research criteria for chronic insomnia

Exclusion criteria

• other untreated sleep disturbance
• pregnancy
• shift work
• concurrent medical or psychiatric condition that could be negatively affected by the treatment
• drug abuse
• severe depression
• dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

CBT

Experimental group

Description:

The treatment group received manualized CBT-I using a adapted version of a manual designed for use by primary care personnel. Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.

Treatment:

Behavioral: Cognitive behavior therapy for insomnia

Wait-list

No Intervention group

Description:

A deferred treatment wait-list condition, with no restrictions placed on the usual care.