Cognitive behavioural therapy for insomnia (CBTi) as a treatment for tinnitus-related insomnia: a randomised controlled trial

Figures & data

Figure 1. Consort flow diagram.

Table 1. Demographics and baseline characteristics for each group.

	CBT insomnia (CBTi) (n = 33)	ABC (n = 34)	SSG (n = 35)
Age^a, years	54 (17)	52.5 (19.5)	51 (14)
Sex Female Male	14 19	18 16	17 18
Ethnicity Asian Black Mixed Other White	3 1 0 1 28	1 2 1 3 27	2 2 2 0 29
Educational level Secondary Tertiary Other	5 4 24	0 6 28	2 9 24
Tinnitus duration (months)	30 (42)	35 (73.5)	48 (81)
Self-reported hearing loss (yes)	15	17	13
Other audiology conditions present	4	4	4
Other health conditions present	22	17	15
Previous tinnitus treatment	12	7	12
Previous sleep treatment	15	10	16
Mean number sessions attended	5 (2)	2 (1)	5 (1.5)
Treatment non-completer	2	0	3
Usefulness of treatment^b	9.64 (0.64) (n = 25)	6.48 (1.96) (n = 29)	7.67 (1.60) (n = 30)
Relevance of Treatment^b	9.64 (0.70) (n = 25)	6.76 (1.90) (n = 29)	8.13 (1.25) (n = 30)
Acceptability of Treatment^b	9.68 (0.63) (n = 25)	7.41 (2.16) (n = 29)	8.60 (1.19) (n = 30)

Values reported as n, unless otherwise indicated. ^aValues are median (IQR). ^bValues are mean (SD).

Table 2. Outcomes reported as comparison between groups.

	Time point	Adjusted mean differences CBTi vs ABC	Adjusted mean differences CBTi vs SSG	Adjusted mean differences ABC vs SSG	CBTi Mean (SD)	ABC Mean (SD)	SSG Mean (SD)
ISI—Insomnia Severity Index	T1				19.09 (2.82)	18.06 (3.08)	19.04 (3.3)
	T2	−6.9 [−9.1, −.4.4]*	−10.3 [−12.6, −8]*	−3.4 [−5.6, −1.2]*	7.1 (4.41)	13.76 (5.97)	17.19 (4.09)
	T3	−6.4 [−8.9, −4]*	−9.6 [−12, −7.2]*	−3.2 [−5.7, −0.8]*	5.7 (4.99)	12.15 (5.64)	15.48 (4.77)
	T4	−5.5 [−7.9, −3]*	−9.7 [−11.9, −7.1]*	−4.2 [−6.5, −1.9]*	5.45 (3.8)	10.83 (6.57)	15.29 (5.26)
TST—Total Sleep Time (min)	T1				343.85 (58.44)	347.24 (49.36)	335.66 (70.16)
	T2	14.9 [−39.8, 11.6]	14.5 [−10.8, 40.3]	29.3 [4.4, 56.1]*	361.25 (60.17)	374.47 (64.04)	345.5 (72.65)
	T3	29.3 [4.1, 54.6]*	50.3 [23.8, 76.2]*	21 [−3.6, 46.7]	404.52 (52.8)	377.14 (55.63)	354.78 (63.61)
	T4	25.9 [−1, 53.4]	67 [38.9, 92.9]*	41.1 [12.4, 67.8]*	409.63 (50.75)	377.62 (50.98)	340.59 (69.58)
SE—Sleep Efficiency	T1				66.59 (10.32)	69.41 (8.86)	64.09 (11.97)
	T2	9.5 [5.2, 13.9]*	18.7 [13.9, 23.5]*	9.2 [4.1, 14.2]*	85.62 (9.97)	76.14 (11.57)	66.98 (13.78)
	T3	12.9 [8.6, 16.8]*	20.2 [15.3, 24.8]*	7.3 [1.9, 12.6]*	88.52 (7.07)	76.06 (9.99)	68.8 (13)
	T4	8.8 [4.3, 14]*	18.3 [13.5, 23.1]*	9.5 [4.1, 14.9]*	86.3 (8.87)	76.97 (9.39)	67.9 (11.49)
SOL—Sleep Onset Latency	T1				41.94 (33.52)	40.03 (19.31)	33.94 (23.21)
	T2	−10.9 [−17.5, −4.7]*	−14.4 [−22, −7.4]*	−3.6 [−12.1, −4.5]	18.21 (23.43)	28.47 (19.61)	29.14 (15.35)
	T3	−15.7 [−23, −9.6]*	−18.9 [−26.8, −12.3]*	−3.2 [−12.7, −6.1]	13.46 (13.59)	31.69 (21.28)	31.7 (21.02)
	T4	−14.5 [−22.6, −7.7]*	−19.4 [−28.8, −12.6]*	−4.9 [−15.4, −4.6]	16.19 (26.01)	31 (26.49)	33.15 (21.56)
PSQI—Pittsburgh Sleep Quality Index	T1				11.83 (2.78)	10.97 (2.82)	11.21 (2.93)
	T2	−3.5 [−4.7, −2.3]*	−5.6 [−6.9, −4.2]*	−2.1 [−3.2, −0.9]*	5.48 (2.76)	8.9 (3.33)	11.03 (3.3)
	T3	−3.9 [−5.2, −2.6]*	−5.2 [−6.5, −3.9]*	−1.3 [−2.6, −0.1]*	5.46 (3.04)	9.02 (3.42)	10.56 (3.26)
	T4	−2.7 [−4.1, −1.3]*	−3.8 [−5, −2.4]*	−1.1 [−2.3, 0.3]	4.54 (2.96)	7.42 (3.68)	8.56 (2.89)
DBAS—Dysfunctional Beliefs about Sleep Scale	T1				5.66 (1.67)	5.68 (1.38)	5.35 (1.53)
	T2	−2.1 [−2.7, −1.4]*	−2.9 [−3.6, −2.2]*	−0.8 [−1.4, −0.2]*	2.44 (1.4)	4.44 (1.56)	5.28 (1.5)
	T3	−2.1 [−2.8, −1.5]*	−2.6 [−3.3, −1.9]*	−0.4 [−1.1, 0.3]	2.17 (1.51)	4.23 (1.67)	4.78 (1.69)
	T4	−2.3 [−3, −1.5]*	−3 [−3.6, −2.2]*	−0.7 [−1.4, 0]	1.73 (1.26)	3.95 (1.89)	4.79 (1.32)
CORE-OM	T1				11.73 (6.19)	10.3 (6.05)	11.69 (6.05)
	T2	−2.9 [−4.7, −1]*	−4.9 [−6.8, −2.9]*	−2 [−4.1, −0.1]*	5.52 (4.28)	8.08 (5.51)	10.22 (5.35)
	T3	−0.8 [−2.8, 1.2]	−2.2 [−4.2, −0.2]*	−1.4 [−3.5, −0.8]	6.17 (5.51)	6.97 (5.16)	8.35 (4.69)
	T4	0.6 [−2.7, 1.4]	−2.9 [−4.7, −0.8]*	−2.3 [−4.5, −0.1]*	5.75 (4.94)	6.54 (5.8)	8.82 (5.28)
TQ—Tinnitus Questionnaire	T1				46.36 (13.44)	42.79 (13.49)	44.63 (13.38)
	T2	−10.2 [−15.3, −4.9]*	−17.4 [−22.9, −12.4]*	−7.1 [−12.5, −1.8]*	23.08 (12.5)	31.94 (16.06)	39.6 (13.26)
	T3	−9 [−14.2, −3.6]*	−15.5 [−20.9, −9.5]*	−6.5 [−12.2, −1]*	20.61 (12.44)	29.81 (15.04)	35.72 (11.71)
	T4	−6.1 [−11.6, −0.8]*	−15.5 [−20.5, −10.1]*	−9.4 [−14.8, −3.9]*	19.57 (12.21)	25.85 (16.06)	35.26 (9.5)
Tinnitus Loudness (VAS)	T1				6.15 (3.09)	6.46 (2.24)	6.95 (1.81)
	T2	−1.4 [−2.5, −0.3]*	−2.8 [−3.8, −1.8]*	−1.4 [−2.4, −0.3]*	4.24 (3.07)	5.61 (2.51)	7.03 (1.67)
	T3	−0.9 [−2.1, 0.2]	−1.9 [−2.9, −0.7]*	−0.9 [−2, 0.2]	4.96 (3.19)	5.8 (2.72)	6.72 (1.89)
	T4	−0.5 [−1.6, 0.7]	−1.6 [−2.8, −0.5]*	−1.1 [−2.4, 0.1]	4.8 (3.28)	5.34 (2.48)	6.48 (1.9)
TCS Tinnitus Catastrophizing Scale	T1				27.23 (10.78)	24.07 (10.7)	23.15 (11.44)
	T2	−5.9 [−9.8, −1.7]*	−8.7 [−12.9, −4.6]*	−2.8 [−6.7, 1.2]	11.27 (9.17)	16.43 (10.43)	19.43 (9.55)
	T3	−6 [−10.1, −1.8]*	−7.2 [−11.1, −2.9]*	−1.2 [−5.4, 2.6]	9.18 (9.85)	14.86 (9.77)	16.12 (9.3)
	T4	−2.6 [−6.5, 1.5]	−7.1 [−11.3, −2.8]*	−4.5 [−8.6, 0.2]	9.21 (12.09)	11.29 (10.29)	15.8 (8.72)
PHQ9 (Depression)	T1				10.9 (5.68)	10.06 (5.65)	11 (5.25)
	T2	−2.2 [−4.4, −0.1]*	−5.4 [−7.4, −3.2]*	−3.1 [−5.3, −1.1]*	4.6 (4.66)	6.6 (4.09)	9.83 (5.13)
	T3	−2.5 [−4.5, −0.2]*	−3.9 [−6.1, −1.9]*	−1.5 [−3.6, 0.7]	4.04 (5.41)	6.38(4.46)	7.67 (3.56)
	T4	−2.5 [−4.8, −0.5]*	−4.5 [−6.7, −2.3]*	−2 [−4.3, 0.2]	3.44 (4.89)	6.13 (5.74)	8 (5.35)
GAD7 (Anxiety)	T1				8.45 (5.13)	6.82 (4.86)	7.66 (4.78)
	T2	−1.4 [−3.3, 0.5]	−3.1 [−5, −1.2]*	−1.7 [−3.6, 0.3]	3.81 (4.7)	4.97 (4.33)	6.73 (4.25)
	T3	−0.4 [−2.4, 1.5]	−0.6 [−2.4, 1.3]	−0.2 [−2, 1.9]	4.25 (5.58)	4.42 (3.42)	4.81 (3.48)
	T4	−0.7 [−2.6, 1.4]	−3.2 [−5.1, −1.3]*	−2.6 [−4.6, −0.6]*	2.81 (4.7)	3.61 (3.55)	6.32 (4.74)
EQ-5D	T1				0.78 (0.16)	0.81 (0.16)	0.79 (0.13)
	T2	0.011 [−0.055, 0.077]	0.003 [−0.064, 0.069]	0.007 [−0.057, 0.071]	0.82 (0.13)	0.84 (0.13)	0.82 (0.13)
	T3	0.03 [−0.034, 0.097]	0.027 [−0.036, 0.092]	0.003 [−0.064, 0.073]	0.79 (0.17)	0.82 (0.14)	0.83 (0.14)
	T4	−0.037 [−0.102, 0.029]	−0.055 [−0.119, 0.015]	0.019 [−0.051, 0.092]	0.86 (0.16)	0.81 (0.15)	0.80 (0.12)
EQ VAS	T1				67.94 (19.77)	65.69 (19.26)	71.62 (16.12)
	T2	11.7 [4.8, 18.1]*	11 [3.9, 17.6]*	0.7 [−6.6, 8.6]	82.32 (11.26)	70.93 (16.12)	70.17 (20.29)
	T3	9.1 [1.4, 16.7]*	4.5 [−3.5, 11.6]	−4.6 [−12.6, 3.5]	78.81 (15.22)	70.61 (13.35)	75.56 (12.83)
	T4	7.2 [0.1, 14.5]*	6.1 [−1.4, 13.6]	−1.1 [−9.3, 7.2]	79 (16.85)	72.27 (14.91)	73.48 (16.15)
WSAS -Work and Social Adjustment Scale	T1				14.75 (11.12)	15.16 (9.96)	17.5 (11.23)
	T2	−5.3 [−8.3, −2]*	−11.2 [−14.4, −8.1]*	−5.9 [−8.9, −2.9]*	4.9 (6.86)	9.68 (8.58)	15.91 (9.95)
	T3	−2.7 [−5.9, 0.5]	−6.6 [−9.8, −3.6]*	−3.9 [−6.8, −0.9]*	5.41 (7.04)	8.09 (7.37)	11.82 (8.95)
	T4	−4.2 [−7.4, 0.9]*	−9.9 [−12.9, −6.9]*	−5.7 [−9.29, −2.3]*	2.94 (5.15)	7.03 (7.75)	12.79 (9.41)

Values indicate changes in mean adjusted for baseline [95% Confidence Intervals] unless otherwise indicated. Time point: T2, post treatment; T3, one-month follow-up; T4, six-month follow-up.

Table 3. Proportion showing reliable change (RC) on each measure and adverse change (AC) proportions on each measure ISI – Insomnia Severity Index (RC > 6 points); TQ – Tinnitus Questionnaire (RC > 11 points); CORE – Clinical Outcomes in Routine Evaluation (RC > 5 points).

Measure	Time point	CBTi	ABC	SSG	Odds ratio [95% CI] CBTi vs ABC	Odds ratio [95% CI] CBTi vs SSG	Odds ratio [95% CI] ABC vs SSG
ISI RC	T2	82%	24%	9%	14.6 [4.5,47.9]*	48 [11,210.3]*	0.3 [0.1,1.2]
ISI RC	T4	82%	47%	20%	5.1 [1.7,15.5]*	18 [5.4,60.5]*	0.3 [0.1,0.9]*
ISI AC	T4	0%	0%	0%	-	-	-
TQ RC	T2	61%	32%	6%	3.2 [1.2, 8.7]*	25.4 [5.2, 124.4]*	0.1 [0,0.5]*
TQ RC	T4	76%	47%	26%	3.5 [1.2,9.9]*	9 [3, 27]*	0.4 [0.1,1.1]
TQ AC	T4	0%	0%	0%	-	-	-
CORE RC	T2	30%	18%	11%	2 [0.6,6.3]	3.4 [0.9,12.2]	0.6 [0.2,2.3]
CORE RC	T4	36%	15%	9%	3.3 [1,10.8]*	6.1 [1.5,24.2]*	0.5 [0.1,2.3]
CORE AC	T4	0%	0%	3%	-	-	-

Odds ratio for reliable change are reported and *indicates significant difference.

Data availability statement

Due to the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data is not available.