Background
Objectives
Methods
Design
Intervention
CBT-i Intervention
Description of the intervention
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 |
Description of usual care
Subject recruitment
Group allocations and blinding
Measurements
Feasibility dimensions
CBT-i training
Acceptability of the intervention by GPs and nurses
Pilot study measurements
Patient recruitment, follow-up, and adherence to the intervention
Statistical analysis
Results
Acceptability and assessment of the training
-
The training sessions should be longer, more practical advice should be given, and there should be more discussion of different cases.
-
There is a need to provide a theoretical context for CBT-i.
-
The different components of the therapy (sleep diary, identification of sleep problems, stimulus control, and relaxation) need more complete coverage.
-
There is a need for more training on how to teach patients to restructure their thoughts and develop the ability to achieve concrete goals.
-
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
Both groups | One group only |
---|---|
Positive aspects | |
• 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
Effect of the intervention
Variable | Intervention group N (%) | Control Group N (%) |
---|---|---|
Sex | ||
Male | 4 (21.1) | 2 (15.4) |
Female | 15 (78.9) | 11 (84.6) |
Marital status | ||
Single/separated/divorced/widower | 6 (31.6) | 2 (154) |
Married/couple | 13 (68.4) | 11 (84.6) |
Level of education | ||
No secondary school | 2 (10.5) | 3 (23.1) |
Secondary school | 6 (31.6) | 6 (45.2) |
University | 11 (57.9) | 4 (30.8) |
Job status | ||
Employed | 11 (57.9) | 4 (30.8) |
Unemployed | 8 (42.1) | 9 (69.2) |
Insomnia grade (ISI score) | ||
Subclinical insomnia (8–14) | 2 (10.5) | 0 (0.0) |
Moderate insomnia (15–21) | 14 (73.4) | 11 (84.6) |
Severe insomnia (≥ 22) | 3 (15.8) | 2 (15.4) |
Variable | Intervention group n (%) | Control Group n (%) | P value |
---|---|---|---|
Subjective sleep quality | |||
Very good/quite good | 10 (62.5) | 3 (30.0) | 0.107 |
Very bad/quite bad | 6 (37.5) | 7( 70.0) | |
Sleep latency (min) | |||
0–4 | 14 (82.4) | 5 (45.5) | 0.041 |
5–6 | 3 (17.6) | 6 (54.5) | |
Sleep duration (h) | |||
5 h or more | 11 (68.8) | 1 (11.1) | 0.006 |
< 5 h | 5 (31.3) | 8 (88.9) | |
Sleep disruptions | |||
1–9 | 15 (88.2) | 6 (54.5) | 0.044 |
10–27 | 2 (11.8) | 5 (45.5) | |
Use of a hypnotica | |||
None in the last month | 10 (58.8) | 4 (36.4) | 0.408 |
1 or 2 times per week | 2 (11.8) | 1 (9.1) | |
3 or more times per week | 5 (29.4) | 6 (54.5) | |
Day dysfunction | |||
0 | 5 (29.4) | 4 (36.4) | 0.249 |
1–2 | 8 (47.1) | 2 (18.2) | |
3–6 | 4 (23.5) | 5 (45.5) | |
HADS depressiona | |||
None (0–7) | 14 (82.4) | 9 (81.8) | 0.971 |
Possible (≥ 8) | 3 (17.6) | 2 (18.3) | |
HADS anxiety | |||
None (0–7) | 9 (52.9) | 6 (54.5) | 0.934 |
Possible (≥ 8) | 8 (47.1) | 5 (45.5) | |
Hypnotic usea | |||
No | 6 (42.9) | 2 (28.6) | 0.276 |
Yes | 6 (42.9) | 5 (42.9) | |
< 4 doses/months | 2 (14.3) | 0 (0.0) | |
Beginning hypnotic usea | |||
Yes | 0 (0.0) | 1 (33.3) | 0.117 |
No | 6 (100.0) | 2 (66.7) | |
Beginning antidepressant usea | |||
Yes | 1 (7.1) | 3 (33.3) | 0.107 |
No | 13 (92.9) | 6 (66.7) |