Table 2.
Outcomes in the BAM Group and Usual Care Group at Various Time Points
| Outcome | Time Point | BAM Group, Mean (SD) (n=115) | Usual Care Group, Mean (SD) (n=116) | Modified Intention-to-Treat Analysis | Imputed Data Analysis | Per-Protocol Analysis | |||
|---|---|---|---|---|---|---|---|---|---|
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| Between-Group Difference (95% CI) | P Value | Between-Group Difference (95% CI) | P Value | Between-Group Difference (95% CI) | P Value | ||||
| BDI-II scorea,b | T0 | 19.18 (8.35) | 17.68 (9.52) | – | – | – | |||
| T1 | 15.41 (9.53) | 17.28 (9.83) | −3.57 (−5.38 to −1.78) | <.001 | −3.21 (−5.02 to −1.40) | <.001 | −3.78 (−5.93 to −1.63) | .001 | |
| T2 | 15.04 (10.29) | 16.57 (10.47) | −2.97 (−5.35 to −0.59) | .02 | −2.32 (−4.65 to 0.01) | .051 | −3.29 (−5.84 to −0.74) | .01 | |
| T3 | 14.45 (10.40) | 16.90 (10.84) | −3.85 (−6.36 to −1.34) | .003 | −3.06 (−5.48 to −0.64) | .01 | −3.96 (−6.58 to −1.35) | .003 | |
| SF-12: PCS scoreb,c | T0 | 40.19 (8.66) | 41.75 (9.75) | – | – | – | – | ||
| T1 | 40.16 (8.86) | 41.26 (9.96) | 0.22 (−1.70 to 2.13) | .82 | −0.03 (−1.92 to 1.86) | .97 | 0.50 (−1.89 to 2.88) | .68 | |
| T2 | 39.61 (8.98) | 40.00 (9.46) | 0.72 (−1.68 to 3.13) | .55 | 0.21 (−2.04 to 2.45) | .86 | 0.29 (−2.31 to 2.90) | .83 | |
| T3 | 39.19 (8.67) | 40.15 (10.20) | 0.18 (−2.30 to 2.65) | .89 | −0.10 (−2.44 to 2.25) | .94 | −0.10 (−2.71 to 2.51) | .94 | |
| SF12: MCS scoreb,c | T0 | 40.24 (8.81) | 40.99 (10.11) | – | – | – | |||
| T1 | 42.96 (9.62) | 40.95 (9.84) | 3.22 (1.09 to 5.35) | .003 | 2.99 (0.85 to 5.13) | .006 | 3.09 (0.48 to 5.70) | .02 | |
| T2 | 42.02 (9.27) | 41.33 (8.87) | 1.43 (−1.05 to 3.91) | .26 | 1.12 (−1.24 to 3.48) | .35 | 1.85 (−0.87 to 4.58) | .18 | |
| T3 | 42.81 (10.00) | 42.24 (9.14) | 1.41 (−1.22 to 4.04) | .29 | 1.12 (−1.33 to 3.58) | .37 | 1.27 (−1.50 to 4.04) | .37 | |
| ACCQ scored | T0 | 13.87 (6.58) | 13.31 (5.90) | – | – | – | |||
| T1 | 17.30 (6.14) | 14.63 (6.44) | 2.62 (1.13 to 4.11) | .001 | 2.47 (0.98 to 3.97) | .001 | 2.41 (0.59 to 4.24) | .01 | |
| T2 | 16.20 (6.62) | 16.09 (7.31) | 0.13 (−1.75 to 2.00) | .90 | 0.42 (−1.43 to 2.28) | .65 | −0.26 (−2.34 to 1.82) | .81 | |
| T3 | 17.07 (7.11) | 16.11 (7.26) | 1.01 (−1.08 to 3.09) | .34 | 1.15 (−0.87 to 3.17) | .26 | 1.12 (−1.12 to 3.36) | .32 | |
| SDS scoreb,e | T0 | 11.70 (9.23) | 11.03 (8.68) | – | – | – | |||
| T1 | 11.58 (9.39) | 10.87 (8.69) | 0.24 (−1.98 to 2.46) | .83 | 0.37 (−1.80 to 2.54) | .74 | 0.49 (−2.14 to 3.11) | .71 | |
| T2 | 9.14 (8.14) | 9.92 (8.59) | −1.27 (−3.63 to 1.08) | .29 | −0.38 (−2.59 to 1.84) | .74 | −1.72 (−4.28 to 0.84) | .19 | |
| T3 | 10.58 (9.30) | 11.15 (9.91) | −1.23 (−3.83 to 1.37) | .35 | −0.62 (−2.99 to 1.76) | .61 | −1.21 (−3.93 to 1.50) | .38 | |
| STAI-S scoref | T0 | 48.03 (9.42) | 47.71 (10.17) | – | – | – | |||
| T1 | 46.26 (11.54) | 47.68 (9.33) | −2.18 (−4.44 to −0.08) | .059 | −1.87 (−4.15 to 0.41) | .11 | −1.19 (−3.83 to 1.46) | .38 | |
| T2 | 46.27 (10.54) | 47.37 (9.41) | −1.64 (−4.17 to 0.89) | .20 | −1.30 (−3.73 to 1.13) | .29 | −1.65 (−4.45 to 1.15) | .25 | |
| T3 | 45.99 (10.43) | 47.70 (10.56) | −2.50 (−5.20 to 0.19) | .07 | −1.72 (−4.30 to 0.86) | .19 | −2.08 (−4.97 to 0.81) | .16 | |
| STAI-T scoref | T0 | 47.76 (8.18) | 46.87 (8.70) | – | – | – | |||
| T1 | 46.75 (9.38) | 47.43 (8.15) | −1.56 (−3.48 to 0.36) | .11 | −1.25 (−3.13 to 0.63) | .19 | −1.73 (−3.98 to 0.53) | .13 | |
| T2 | 46.47 (8.92) | 47.22 (8.52) | −1.69 (−3.87 to 0.49) | .13 | −1.15 (−3.18 to 0.88) | .26 | −1.97 (−4.31 to 0.38) | .099 | |
| T3 | 47.17 (8.97) | 48.14 (8.48) | −1.99 (−4.27 to 0.30) | .09 | −1.40 (−3.65 to 0.84) | .22 | −1.80 (−4.14 to 0.53) | .13 | |
ACCQ = Activity and Circumstantial Change Questionnaire; BAM = behavioral activation with mindfulness; BDI-II: Beck Depression Inventory-II; MCS = mental component summary; PCS = physical component summary; SDS = Sheehan Disability Scale; SF-12 = 12-item Medical Outcomes Study Short-Form Health Survey; STAI-S = State Trait Anxiety Inventory–State; STAI-T = State Trait Anxiety Inventory–Trait; T0 = baseline; T1 = end of intervention; T2 = 5-month follow-up; T3=12-month follow-up.
Note: Major depressive disorder at T3 was present in 9 patients (10.8%) in the BAM group and 26 patients (26.8%) in the usual care group (P =.01). Analysis conducted using observed data, and P value obtained by logistic regression analysis with cancer history and marital status as covariates.
Possible range for total scores is 0 to 63; higher scores indicate more severe depression.
P values for group effect were calibrated by analysis of covariance (ANCOVA) approach, with baseline value, cancer history, and marital status as covariates.
Possible range is 0 to 100; higher scores indicate better self-reported health.
Possible range is 8 to 40; higher scores indicate greater positive change.
Possible range is 0 to 40; higher scores indicate more functional impairment.
Possible range is 20 to 80; higher scores indicate greater anxiety.