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Table 2 Scores on candidate outcome and process measures at baseline and follow-up

From: Psychological therapy for mood instability within bipolar spectrum disorder: a randomised, controlled feasibility trial of a dialectical behaviour therapy-informed approach (the ThrIVe-B programme)

Outcomeb

Baseline

3-month follow-up

6-month follow-up

9-month follow-up

15-month follow-up

SMC (Med, range)

ThrIVe-B

TAU

ThrIVe-B

TAU

ThrIVe-B

TAU

ThrIVe-B

TAU

ThrIVe-B–TAUc (95% CI)

ThrIVe-B

TAU

 

PHQ-9a

15.5 (6.6)

n = 21

12.9 (5.2)

n = 20

10.4 (5.4)

n = 12

11.4 (6.1)

n = 16

10.6 (5.6)

n = 14

12.3 (7.7)

n = 17

10.3 (6.5)

n = 12

9.8 (4.9)

n = 17

− 0.2 (− 4.6; 4.2)

10.7 (7.2)

n = 11

8.9 (5.5)

n = 17

2 (0–20)

n = 20

BRQa

2036 (342)

n = 19

1923 (369)

n = 16

1969 (503)

n = 13

1988 (416)

n = 17

1951 (493)

n = 11

1927 (427)

n = 14

2124 (327)

n = 13

1886 (404)

n = 16

349 (107; 591)

2238 (483)

n = 9

1929 (350)

n = 16

447 (2–1903)

n = 19

QoL-BDa

33.2 (7.5)

n = 20

36.6 (6.8)

n = 20

34.2 (9.7)

n = 13

34.0 (7.9)

n = 17

34.1 (8.3)

n = 14

34.1 (9.6)

n = 17

35.1 (8.3)

n = 14

34.0 (10.7)

n = 17

2.4 (− 5.2; 9.9)

35.0 (10.7)

n = 10

34.5 (9.8)

n = 16

4 (0–38)

n = 20

ALS totala

37.3 (6.1)

n = 22

31.5 (13.1)

n = 21

23.8 (13.3)

n = 13

27.2 (11.7)

n = 15

24.9 (8.1)

n = 14

27.0 (12.0)

n = 17

26.0 (13.5)

n = 14

23.5 (12.2)

n = 17

− 1.6 (− 8.4; 5.3)

26.6 (15.2)

n = 10

21.6 (11.1)

n = 16

5 (0–37)

n = 21

ALS depression-elation subscale

17.5 (3.3)

n = 22

14.9 (6.7)

n = 21

10.2 (6.0)

n = 13

12.9 (5.7)

n = 15

10.8 (5.4)

n = 14

13.3 (5.8)

n = 17

12.8 (6.8)

n = 13

12.2 (5.5)

n = 17

− 1.5 (− 4.6; 1.6)

13.1 (7.1)

n = 10

11.1 (5.7)

n = 16

–

GAD-7

11.2 (4.7)

n = 19

10.4 (5.1)

n = 20

11.3(4.9)

n = 13

9.2 (5)

n = 17

11.5 (5.1)

n = 14

8.1 (4.6)

n = 17

9.3 (5.4)

n = 14

7.5 (5.9)

n = 17

1.4 (− 2.9; 5.6)

7.8 (4.5)

n = 10

8.7 (7.3)

n = 16

2 (0–11)

n = 20

HDRS

12.8 (8.1)

n = 22

6.6 (4.2)

n = 19

NR

NR

NR

NR

8.5 (4.8)

n = 13

9.5 (5.8)

n = 16

− 2.6 (− 7.6; 2.3)

8.2 (7.8)

n = 11

6.1 (3.0)

n = 17

–

Mean SRM

5.1 (2.9)

n = 17

4.6 (2.1)

n = 17

5.6 (0.8)

n = 11

5.5 (2.8)

n = 14

3.9 (2.0)

n = 10

3.6 (2.1)

n = 12

5.5 (1.9)

n = 11

4.9 (1.0)

n = 10

0.5 (− 1.5; 2.5)

5.0 (1.2)

n = 8

5.5 (0.8)

n = 13

–

BMRS

1.8 (2.4)

n = 21

1.7 (1.8)

n = 21

NR

NR

NR

NR

1.8 (3.2)

n = 13

1.9 (2.5)

n = 17

0.4 (− 1.6; 2.4)

1.8 (3.6)

n = 11

1.0 (1.8)

n = 17

–

BARS

2.8 (0.7)

n = 18

2.9 (0.5)

n = 19

NR

NR

NR

NR

3.8 (0.8)

n = 10

3.9 (0.4)

n = 15

0.0 (− 0.5; 0.5)

3.9 (0.2)

n = 8

3.8 (0.8)

n = 14

–

MEPS

3.1 (2.4)

n = 21

3.4 (2.2)

n = 19

NR

NR

NR

NR

3.7 (2.6)

n = 11

2.6 (1.2)

n = 16

1.6 (− 0.1; 3.3)

4.1 (2.6)

n = 11

2.6 (1.4)

n = 17

–

UPPS-P

160.9 (23.8)

n = 20

164.3 (25.0)

n = 19

158.6 (23.3)

n = 13

152.8 (23.0)

n = 17

156.8 (22.5)

n = 13

158.1 (21.9)

n = 17

149.5 (25.7)

n = 14

153.5 (21.8)

n = 17

− 6.7 (− 16.0; 2.6)

147.5 (28.7)

n = 10

154.3 (24.8)

n = 16

–

BADS

71.4 (23.4)

n = 20

78.5 (26.5)

n = 19

81.9 (24.5)

n = 13

73.5 (25.1)

n = 16

74.5 (33.1)

n = 12

72.9 (27.4)

n = 16

80.2 (21.5)

n = 14

75.1 (33.1)

n = 17

7.4 (− 13.3; 28.2)

85.6 (30.3)

n = 10

76.6 (30.6)

n = 16

–

KIMS total

114.5 (19.1)

n = 20

114.8 (21.3)

n = 20

117.2 (22.7)

n = 12

117.1 (24.7)

n = 17

116.2 (24.2)

n = 13

116.3 (21.9)

n = 16

125.4 (22.9)

n = 14

117.9 (25.9)

n = 16

13.1 (4.9; 21.3)

128.1 (21.3)

n = 10

115.4 (25.7)

n = 16

–

  1. TAU = Treatment as usual arm; ThrIVe-B = intervention arm; PHQ-9 = Patient Health Questionnaire; BRQ = Bipolar Recovery Questionnaire; QoL-BD = brief Quality of Life in Bipolar Disorder Scale; GAD-7 = Generalised Anxiety Disorder; HDS = Hamilton Depression Rating Scale; SRM = Social Rhythm Metric; BMRS = Bech Mania Rating Scale; BARS = Brief Adherence Rating Scale; MEPS = Means-Ends Problem-Solving task; UPPS-P = Positive and Negative Urgency, Premeditation, Perseverance, Sensation-Seeking impulsive behaviour scales; BADS = Behavioural Activation in Depression Scale; KIMS = Kentucky Inventory of Mindfulness Scale; SMC = smallest meaningful change according to participant report
  2. aCandidate primary outcome measure
  3. bOutcomes are reported as mean (SD) unless otherwise stated
  4. cBetween group mean difference adjusted for site, baseline use of bipolar disorder medications and baseline score