Table 2.
Scores on candidate outcome and process measures at baseline and follow-up
| 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 |
– |
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
aCandidate primary outcome measure
bOutcomes are reported as mean (SD) unless otherwise stated
cBetween group mean difference adjusted for site, baseline use of bipolar disorder medications and baseline score