Description of the intervention
We developed the CBT-i program for implementation by PC family doctors, nurses, and even primary care psychologists. The intervention requires active participation of patients for the treatment of insomnia. There were 5 individual sessions of approximately 20 min each, with one session per week or every two weeks (based on patient preference) and an additional session for patients undergoing withdrawal of hypnotic medications [35]. Table 1 describes the content of each session.
Table 1
Summary of the intervention sessions.
| T0 | Session 1 | Session 2 | Session 3 | Session 4 | Session 5 (hypnotic withdrawal) | Session 5/6 | T3 |
Objectives | 1. Baseline evaluation 2. Provide information on the intervention | 1.Identify the factors that perpetuate insomnia (behavior-problem) 2. Identify beliefs and predispositions to change 3. Establish objectives (behavior-goal) | 1. Review difficulties and changes during the week 2. Identify factors in the patient’s environment related with going to sleep 3.Establish objectives of sleep hygiene modification | 1. Review difficulties and changes during the week 2. Identify the times a patient gives to certain habits and develop a timetable 3. Establish objectives of sleep hygiene modification | 1. Review difficulties and changes during the week 2. Identify distorting beliefs 3. Transform and implement realistic thinking | 1. Review problems related to benzodiazepine consumption 2. Negotiate with the patient to implement a gradual dose reduction | 1. Review the Sleep Diary 2. Assess the sessions and identify what has been accomplished 3.Assess what was not accomplished and the next goals | 1.Follow up assessment at 3 months after the end of CBT-i |
Techniques | | Structured interview Relaxation | Sleep hygiene Stimulus Control Relaxation | Restriction of bed time Paradoxical intention Relaxation | Cognitive restructuring Relaxation | Structured interview | Structured interview | |
Spreadsheet of tasks | | Sleep diary | How are my routines? | How are my times? | How they interfere my thinking’s | To release of written information on gradual reduction of benzodiazepines | Sleep diary | |
Duration (min) | 20–30 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
This intervention aims to change the habits of the affected patients, and to encourage them to undergo a cognitive and physical deactivation before going to sleep. It aims to help patients to identify and assess how they react before, during, and after sleep and to consider thoughts and behaviors that contribute to insomnia (Behavior-Problem) with the help of a sleep diary. The intervention offers patients a wide range of structured strategies, based on their possible impact (Behavior-Goal). The patient and therapist agreed on the therapeutic objectives before commencement of treatment. These objectives determine the content of the intervention sessions. After each session, patients have a task to work on at home, in which they try to achieve different goals and use different techniques. During treatment, the therapist was available to address doubts and difficulties that the patients may experience. During the sessions, therapists were suggested to record relevant information and to administer the questionnaire.
The sleep diary contains a 2-week registry that records the following data: sleeping hours, sleep latency, duration of awakening and number of awakenings, number of times getting out of bed, naps, medication use, and sleep quality. Patients also identified the main difficulties experience during the night and reported desired objectives and how they can be achieved.
Description of usual care
The professionals in the control group followed their usual care in treatment of insomnia patients. A previous descriptive study of insomnia treatments used by GPs in Majorca from 2001 to 2012 indicated that more than 95% of them asked patients about habits related to sleep hygiene that might lead to insomnia, 85.1% provided to advice on sleep hygiene measures, 15.1% suggested the use of herbal remedies, and 14.2% suggested CBT-i. More than 33% of GPs prescribed a pharmacological treatment. Benzodiazepines were the most prescribed drugs (33.4%) followed by the Z drugs (25.7%). Six of 10 GPs requested a review of the treatment after 1 month of medication use [24].
The usual care provided by nurses was based on a 2014 descriptive study (performed simultaneously with the present study). This study reported that 69.6% of nurses asked patients about their sleeping habits and 48.5% asked about the consequences of their insomnia. A total of 46.4% considered pharmacological interactions and 45.6% gave special consideration to elderly patients. The non-pharmacological treatments they recommended were sleep hygiene measures (76%), herbal remedies (44.9%), and CBT-i (22.4%). About 25% of nurses offered written advice and 81% gave oral advice on sleep hygiene [25].
Acceptability and assessment of the training
PCPs assessed the intervention training during a group session. This group consisted of 12 doctors (6 in the IG and 6 in the UCG), 3 nurses (2 in the IG and 1 in the UCG), and 2 psychologists.
This group’s assessment of the training had several general conclusions:
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The training sessions should be longer, more practical advice should be given, and there should be more discussion of different cases.
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There is a need to provide a theoretical context for CBT-i.
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The different components of the therapy (sleep diary, identification of sleep problems, stimulus control, and relaxation) need more complete coverage.
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There is a need for more training on how to teach patients to restructure their thoughts and develop the ability to achieve concrete goals.
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The case reports described during the training sessions generated extensive input, and was considered important in clarification of some key concepts.
Acceptability and assessment of the intervention
Regarding the recruitment of patients, both groups highlighted the difficulty in identification of eligible patients with chronic insomnia, and that most patients with insomnia symptoms had other mental disorders. GPs and nurses suggested use of no age limit, increasing the ISI cut-off to 14, and consideration of clinical assessments (i.e., poor quality of life). Also, participants in the nominal groups suggested that apart from personal invitations by PCPs, invitation posters should be installed throughout the health center and in the community. All professionals agreed that time constraints were a problem for some patients. Table 2 summarizes the positive and negative aspects of the intervention in the nominal groups.
Table 2
Positive aspects and difficulties of the intervention that were reported in both nominal groups or only in one nominal group.
POSITIVE ASPECTS |
Both groups | One group only |
• PCPs provided valuable non-pharmacological treatment. • There were opportunities to go deeper into the causes of insomnia. • Other sociological and sleep hygiene problems were identified. • The patient-therapist relationship improved. | • There was positive support for treatment of insomnia. • The relaxation sessions had high value. • The “Manual of Interventions” was very helpful. |
DIFFICULTIES |
• Doctors considered the goals of the intervention as too ambitious. • It required PCPs to change their roles, in that it they had to address emotional issues. • The intervention did not permit deep examination of other problems that emerged during the sessions. • There were too many sessions, and some patients withdrew for this reason. • The sessions were too short. • Some concepts were repeated in the different sessions. • A reorganization of agendas is needed to continue the intervention. • The tutorial material for PCPs was considered essential to structure the therapy, but was too dense. More simplified materials are needed. • Written material for the patient about sleep hygiene, and control of stimuli and thoughts is needed. | • More time and energy are required than a normal consultation. Therapy should be given when the therapist is less tired. • There was a need for preparations prior to the consultations. • There were many difficulties in the session on cognitive restructuring (Session 4). • Simultaneous intervention and data collection was difficult. • The intervention was more feasible for nurses, because they have more time for consultation. • Patients were reluctant to work on a health problem if there is no immediate solution. • Patients who had little education had difficulties completing the sleep diary. |
Assessment of the recruitment process and study acceptance
Figure 1 summarizes our assessment of the recruitment process and study acceptance by PCPs and patients. After study presentation in the two health centers, 25 PCPs agreed to participate (15 in the IG and 10 in the UCG). Four PCPs in each group did not recruit any eligible patients. Thus, 32 patients were recruited, 19 in the IG and 13 in the UCG. Two patients were lost to follow-up in the IG and 2 were lost to follow-up in the UCG.
Assessing the adherence to intervention
Five of the 19 patients in the IG did not complete all the scheduled sessions (1 attended no sessions, 1 attended one session, 2 attended two sessions, and 1 attended 3 sessions). The other 14 attended the entire schedule of 5 sessions, with a benzodiazepine withdrawal session if needed.
Table 3 shows the socio demographic characteristics of the two groups of patients. The most notable differences were that the IG had fewer married patients and fewer patients with university level education.
Table 3
Baseline sociodemographic characteristics and ISI scores in the intervention group (n = 19) and control group (n = 13).
Variable | Intervention group N (%) | Control Group N (%) |
Sex Male female | 4 (21.1) 15 (78.9) | 2 (15.4) 11 (84.6) |
Marital status Single/separated/divorced/widower Married/couple | 6 (31.6) 13 (68.4) | 2 (154) 11 (84.6) |
Level of education No secondary school Secondary school University | 2 (10.5) 6 (31.6) 11 (57.9) | 3 (23.1) 6 (45.2) 4 (30.8) |
Job status Employed Unemployed | 11 (57.9) 8 (42.1) | 4 (30.8) 9 (69.2) |
Insomnia grade (ISI score) Subclinical insomnia (8–14) Moderate insomnia (15–21) Severe insomnia (≥ 22) | 2 (10.5) 14 (73.4) 3 (15.8) | 0 (0.0) 11 (84.6) 2 (15.4) |
Table 4 shows the effects of the intervention in the two groups. Significantly higher proportions of patients in the IG had short sleep latency; slept for longer than 5 hours.
Table 4
PSQI results, HADS results, and use of hypnotics and anti-depressants after 3 months in the intervention group (n = 19) and the control group (n = 13).
Variable | Intervention group n (%) | Control Group n (%) | P value |
Subjective sleep quality Very good/quite good Very bad/quite bad | 10 (62.5) 6 (37.5) | 3 (30.0) 7( 70.0) | 0.107 |
Sleep latency (min) 0–4 5–6 | 14 (82.4) 3 (17.6) | 5 (45.5) 6 (54.5) | 0.041 |
Sleep duration (h) 5 h or more < 5 h | 11 (68.8) 5 (31.3) | 1 (11.1) 8 (88.9) | 0.006 |
Sleep disruptions 1–9 10–27 | 15 (88.2) 2 (11.8) | 6 (54.5) 5 (45.5) | 0.044 |
Use of a hypnotic* None in the last month 1 or 2 times per week 3 or more times per week | 10 (58.8) 2 (11.8) 5 (29.4) | 4 (36.4) 1 (9.1) 6 (54.5) | 0.408 |
Day dysfunction 0 1–2 3–6 | 5 (29.4) 8 (47.1) 4 (23.5) | 4 (36.4) 2 (18.2) 5 (45.5) | 0.249 |
HADS depression* None (0–7) Possible (≥ 8) | 14 (82.4) 3 (17.6) | 9 (81.8) 2 (18.3) | 0.971 |
HADS anxiety None (0–7) Possible (≥ 8) | 9 (52.9) 8 (47.1) | 6 (54.5) 5 (45.5) | 0.934 |
Hypnotic use* No Yes < 4 doses/months | 6 (42.9) 6 (42.9) 2 (14.3) | 2 (28.6) 5 (42.9) 0 (0.0) | 0.276 |
Beginning hypnotic use* Yes No | 0 (0.0) 6 (100.0) | 1 (33.3) 2 (66.7) | 0.117 |
Beginning antidepressant use* Yes No | 1 (7.1) 13 (92.9) | 3 (33.3) 6 (66.7) | 0.107 |
*Likelihood ratio test for contingency tables |