Background
Methods
Participants
Study design
Study setting
Interventions
Training and fidelity assessment
Assessment measures
State-trait anxiety inventory (STAI)
K6
Japanese version of the Zarit burden interview Short version (J-ZBI_8)
Family attitude scale (FAS)
Link’s stigma scale (LSS)
Global assessment of functioning (GAF)
Sample size
Statistical analysis
Results
Enrolment and baseline characteristics of the participants
Characteristics (caregivers) | SM-FPE + TAU | TAU alone | All participants | |||
---|---|---|---|---|---|---|
(n = 36) | (n = 37) | (n = 73) | ||||
Age, mean (SD), years | 58.9 | (6.4) | 58.2 | (9.4) | 58.4 | (8.0) |
Sex, n (%) | ||||||
Female | 30 | (83.3) | 30 | (81.1) | 60 | (82.2) |
Male | 6 | (16.7) | 7 | (18.9) | 13 | (17.8) |
Relationship, n (%) | ||||||
Mother | 30 | (83.3) | 29 | (78.4) | 58 | (80.8) |
Father | 6 | (16.7) | 6 | (16.2) | 12 | (16.4) |
Spouse | 0 | 1 | (2.7) | 1 | (1.4) | |
Sibling | 0 | 1 | (2.7) | 1 | (1.4) | |
Education, n (%) | ||||||
< High school | 0 | 1 | (2.7) | 1 | (1.4) | |
High school | 22 | (61.1) | 16 | (43.2) | 38 | (52.1) |
Two-year college | 10 | (27.8) | 12 | (32.4) | 22 | (30.1) |
University | 4 | (11.1) | 8 | (21.6) | 12 | (16.4) |
Occupation, n (%) | ||||||
Employed, full-time | 12 | (33.3) | 15 | (40.5) | 27 | (37.0) |
Employed, part-time | 8 | (22.2) | 9 | (24.3) | 17 | (23.3) |
Homemaker | 12 | (33.3) | 8 | (21.6) | 20 | (27.4) |
Retirement | 4 | (11.1) | 5 | (13.5) | 9 | (12.3) |
Marital status, n (%) | ||||||
Unmarried | 1 | (2.8) | 1 | (2.7) | 2 | (2.7) |
Married | 29 | (80.6) | 28 | (75.7) | 57 | (78.1) |
Divorced | 3 | (8.3) | 6 | (16.2) | 9 | (12.3) |
Widowed | 3 | (8.3) | 2 | (5.4) | 5 | (6.8) |
Psychotropic use/psychiatrist’s visit, n (%) | 4 | (11.1) | 7 | (18.9) | 11 | (15.1) |
Self-help group, n (%) | 6 | (16.7) | 6 | (16.2) | 12 | (16.4) |
K6 ≥ 9, n (%) | 13 | (36.1) | 14 | (37.8) | 27 | (37.0) |
Age, mean (SD), years | 29.7 | (5.6) | 30.5 | (5.7) | 30.1 | (5.6) |
Sex, n (%) | ||||||
Female | 11 | (30.6) | 14 | (37.8) | 25 | (34.2) |
Male | 25 | (69.4) | 23 | (62.2) | 48 | (65.8) |
Education, n (%) | ||||||
< High school | 8 | (22.2) | 11 | (29.7) | 19 | (26.0) |
High school | 12 | (33.3) | 12 | (32.4) | 24 | (32.9) |
Two-year college | 6 | (16.7) | 6 | (16.2) | 12 | (16.5) |
University | 10 | (27.8) | 8 | (21.6) | 18 | (24.7) |
Occupation, n (%) | ||||||
Unemployed | 27 | (75.0) | 29 | (78.4) | 56 | (76.7) |
Employed, full-time | 2 | (5.6) | 2 | (5.4) | 4 | (5.5) |
Employed, part-time | 4 | (11.1) | 4 | (10.8) | 8 | (11.0) |
Homemaker | 1 | (2.8) | 1 | (2.7) | 2 | (2.7) |
Sheltered work | 2 | (5.6) | 1 | (2.7) | 3 | (4.1) |
Marital status, n (%) | ||||||
Unmarried | 34 | (94.4) | 36 | (97.3) | 70 | (95.9) |
Married | 1 | (2.8) | 1 | (2.7) | 2 | (2.7) |
Divorced | 1 | (2.8) | 0 | 1 | (1.4) | |
Living status, n (%) | ||||||
Living alone | 0 | 3 | (8.1) | 3 | (4.1) | |
Living with a participating caregiver | 33 | (91.7) | 33 | (89.2) | 66 | (90.4) |
Living with someone not engaging in care | 2 | (5.6) | 1 | (2.7) | 3 | (4.1) |
Group home | 1 | (2.8) | 0 | 1 | (1.4) | |
Diagnosis, n (%) | ||||||
Schizophrenia | 35 | (97.2) | 36 | (97.3) | 71 | (97.3) |
Brief psychotic disorder | 1 | (2.8) | 0 | 1 | (1.4) | |
Schizoaffective disorder | 0 | 1 | (2.7) | 1 | (1.4) | |
Duration of the disorders | ||||||
Mean (SD), months | 86.6 | (67.1) | 101 | (69.5) | 93.9 | (68.2) |
< 59 months | 13 | (36.1) | 13 | (35.1) | 26 | (35.6) |
≥ 60 months | 23 | (63.9) | 24 | (64.9) | 47 | (64.4) |
Number of hospitalisations, mean (SD) | 1.7 | (1.2) | 1.8 | (1.7) | 1.8 | (1.5) |
Attrition and study integrity
Attrition
Fidelity assessment
GAF assessment
Patient hospitalisation
Primary and other outcomes
Baseline | 10 Weeks | 14 Weeks | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Measure | SM-FPE + TAU | TAU alone | SM-FPE + TAU | TAU alone |
F
|
p
| SM-FPE + TAU | TAU alone |
F
|
p
| ||||||
Caregivers | ||||||||||||||||
Trait anxiety | 46.6 | (1.7) | 49.4 | (1.9) | 42.9 | (1.5) | 46.0 | (1.7) | 1.73 | 0.19 | 41.6 | (1.6) | 44.2 | (1.6) | 1.68 | 0.20 |
State anxiety | 48.5 | (1.8) | 49.0 | (1.5) | 41.0 | (1.8) | 46.4 | (1.7) | 1.84 | 0.18 | 41.7 | (1.7) | 45.2 | (1.8) | 2.06 | 0.16 |
K6 | 6.8 | (0.8) | 7.2 | (0.9) | 4.9 | (0.7) | 5.1 | (0.7) | 0.11 | 0.74 | 4.3 | (0.6) | 5.7 | (0.7) | 0.58 | 0.45 |
J-ZBI_8 | 12.3 | (1.3) | 10.9 | (1.2) | 9.3 | (1.1) | 10.9 | (1.2) | < 0.01 | 0.94 | 9.1 | (1.1) | 9.1 | (1.1) | 0.01 | 0.95 |
FAS | 46.8 | (4.2) | 46.9 | (3.5) | 36.6 | (3.6) | 45.4 | (3.7) | 0.75 | 0.39 | 37.8 | (3.9) | 42.2 | (3.4) | 0.79 | 0.38 |
LSS | 35.7 | (6.0) | 35.7 | (0.8) | 34.0 | (0.9) | 35.9 | (1.0) | 0.57 | 0.45 | 34.4 | (1.1) | 35.2 | (1.0) | 0.50 | 0.48 |
Patients | ||||||||||||||||
GAF | 46.6 | (2.4) | 48.5 | (1.9) | 47.5 | (2.3) | 50.1 | (2.2) | 0.60 | 0.44 | 47.1 | (2.5) | 50.6 | (2.4) | 0.77 | 0.38 |
Kinds of APs | 1.8 | (0.2) | 1.9 | (0.2) | 1.8 | (0.2) | 1.8 | (0.2) | 0.14 | 0.71 | 1.8 | (0.2) | 1.8 | (0.2) | 0.11 | 0.75 |
Amount of APs, mg | 810 | (112) | 780 | (96) | 806 | (116) | 760 | (95) | 0.07 | 0.80 | 795 | (116) | 744 | (94) | 0.08 | 0.77 |
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1. Assignment (1, SM-FPE + TAU, 2 TAU alone) | – | −.21 | .00 | −.21 | .08 | .13 | .10 | .00 | .15 | .01 | .17 | −.11 | .04 |
2. State anxiety, base line | .15 | – | .45* | .60** | .56** | .69*** | .57** | .71*** | .57** | .66*** | .57** | .68*** | .55** |
3. K6, base line | .08 | .58** | – | .61** | .64*** | .28 | .38 | .52** | .50* | .52** | .43* | .51** | .62** |
4. J-ZBI, base line | −.01 | .61*** | .61*** | – | .58** | .45* | .47* | .72*** | .49* | .44* | .35 | .83*** | .57** |
5. FAS, base line | −.05 | .50*** | .48** | .74*** | – | .25 | .30 | .51** | .89*** | .26 | .41* | .67*** | .88*** |
6. State anxiety, week 10 | .35* | .55*** | .41** | .40** | .45** | – | .78*** | .77*** | .45* | .84*** | .74*** | .57** | .36 |
7. K6, week 10 | −.02 | .54*** | .71*** | .54*** | .60*** | .52*** | – | .78*** | .48* | .76*** | .86*** | .59** | .37 |
8. J-ZBI_8, week 10 | .18 | .54*** | .55*** | .76*** | .60*** | .58*** | .69*** | – | .69*** | .77*** | .77*** | .83*** | .61** |
9. FAS, week 10 | .22 | .51*** | .45** | .63*** | .81*** | .63*** | .73*** | .79*** | – | .39* | .60** | .65*** | .87** |
10. State anxiety, week 14 | .29* | .57*** | .48** | .38** | .44** | .79*** | .57*** | .55*** | .61*** | – | .81** | .52** | .40* |
11. K6, week 14 | .21 | .47** | .61*** | .34* | .39** | .62*** | .68*** | .52*** | .54*** | .68*** | – | .56** | .49* |
12. J-ZBI_8, week 14 | .06 | .48** | .49*** | .78*** | .64*** | .50*** | .61*** | .89*** | .74*** | .54*** | .50*** | – | .71*** |
13. FAS, week 14 | .14 | .34* | .38** | .54*** | .78*** | .55*** | .65*** | .70*** | .89*** | .60*** | .50*** | .76*** | – |
Mean | 1.5 | 52.0 | 8.2 | 12.4 | 46.7 | 47.4 | 6.2 | 10.8 | 42.3 | 49.4 | 6.8 | 9.7 | 43.6 |
1.5 | 46.9 | 6.3 | 11.1 | 47.0 | 41.7 | 4.3 | 9.7 | 40.3 | 40.2 | 4.0 | 8.8 | 38.0 | |
SD | 0.5 | 9.3 | 5.3 | 8.3 | 25.2 | 11.3 | 4.3 | 7.1 | 22.8 | 10.6 | 4.5 | 6.3 | 23.5 |
0.5 | 9.8 | 4.8 | 7.0 | 22.3 | 10.0 | 3.6 | 7.0 | 22.6 | 9.4 | 3.3 | 6.6 | 21.0 |