Feasibility and Acceptability of Cognitive Behavioral Therapy for Chronic Insomnia in a Primary Care
Condition: Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This pilot-feasibility study of a cluster parallel randomized design comparing CBT-i against
      usual care (UC) was performed at two primary health care centers in Majorca, Spain. Patients
      were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to
      the Insomnia Severity Index (ISI more than 8) and had insomnia longer than 3 months; and did
      or did not use a hypnotic medication. 25 GPs and nurses and 32 patients were randomly
      allocated to two groups: The outcome of the trial was improving the quality of sleep. Other
      primary outcomes on feasibility and applicability of the intervention were collected through
      nominal groups. Description of usual care was described through previous studies. Moreover we
      assessed recruitment process, compliance with the intervention sessions, and patient's
      retention.
    

Detailed description: 
      Objectives

      The primary objectives of this pilot-feasibility study were:

        1. To design and adapt a brief CBT-i intervention to be provided by PCPs for the treatment
           of chronic insomnia in individuals who are 18 to 65 years-old.

        2. To define usual care (UC) for the treatment of chronic insomnia provided by PCPs as a
           comparative intervention (control group).

        3. To assess the training activities for the CBT-i intervention by determining GPs' and
           nurses' satisfaction with the content and applicability of the intervention.

        4. To determine the acceptability of the intervention by GPs and nurses.

        5. To assess PCPs and patient recruitment, follow-up, and adherence to the intervention The
           secondary objective was to assess the quality of sleep in patients after 3 months of the
           CBT-i.

      Methods Design This pilot-feasibility study of a cluster parallel randomized design comparing
      CBT-I against usual care (UC) was performed from September 2014 to April 2015 at two primary
      health care centers of Majorca (Spain) with 56,000 registered inhabitants.

      Collection of information and follow up Intervention The CBT-i intervention was developed by
      two family physicians (IT and CV) and two psychologists (ET and MRP-P). First, a review of
      the literature on the use of CBT-i was performed, with a focus on interventions applied in
      primary care. After the literature review, the CBT-i created by Morin [24] was adapted to our
      setting, in which there were fewer sessions and shorter sessions. The CBT-i included sleep
      hygiene counseling, stimulus control, cognitive restructuring, relaxation techniques, and
      benzodiazepine therapy or withdrawal (when needed). To conduct the intervention, guidelines
      for GPs and nurses and graphic and written materials for patients (sleep diary, registry of
      behavior habits, and cognitive problems) were developed.

      Usual care The usual treatment for persistent insomnia in a primary care setting was
      previously described in two cross-sectional studies performed by general practitioners and
      family nurses of the Primary Care Majorca Department during 2011 and 2015
    

Intervention name(s): Cognitive behavioral therapy for insomnia
Intervention type(s): Behavioral
Intervention description(s): is a multicomponent intervention which focuses on cognitive and behavioral factors that contribute to sleep disorders , The CBT-i included sleep hygiene counseling, stimulus control, cognitive restructuring, relaxation techniques, and benzodiazepine therapy or withdrawal (when needed). To conduct the intervention, guidelines for GPs and nurses and graphic and written materials for patients (sleep diary, registry of behavior habits, and cognitive problems) were developed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary care; cognitive behavioral therapy; clinical trial; feasibility-pilot study