Background
Introduction
Rationale for assessing feasibility through piloting
Methods
Participants and setting
Interventions
Objectives
Objectives and hypotheses of the main study
Objectives of the pilot study
Outcome measures for the main study
Illness management and illness outcomes
Additional illness-management scales
Illness outcomes: symptoms and relapses
Recovery
Cost-utility
Outcomes
Outcome measures for the pilot study
Sample size
Feasibility criteria
Statistical analysis
Ethical aspects
Results
Participant flow
Influx and outflux of participants in IMR
Recruitment
Baseline data
Participants’ characteristics
Total N = 81 | Completers N = 40 | Dropouts from IMR N = 41 | χ2 (df = 1) |
p
|
OR
| 95 % CI | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
gender | male | 48 | 59 % | 19 | 29 | 4.53 | .033* | 2.67 | [1.07, 6.67] | |||
female | 33 | 41 % | 21 | 12 | ||||||||
living situation | ||||||||||||
living alone | 32 | 40 % | 19 | 13 | 2.18 | .139 | 0.48 | [0.18, 1.28] | ||||
living with others | 34 | 42 % | 14 | 20 | ||||||||
missing | 15 | 18 % | ||||||||||
education level | ||||||||||||
low | 31 | 39 % | 14 | 17 | 0.81 | .369 | 1.59 | [0.58, 4.36] | ||||
middle + high | 30 | 37 % | 17 | 13 | ||||||||
missing | 10 | 24 % | ||||||||||
native country | ||||||||||||
born in Holland | 42 | 52 % | 22 | 20 | 0.47 | .492 | 0.70 | [0.25, 1.95] | ||||
immigrant | 23 | 28 % | 10 | 13 | ||||||||
missing | 16 | 20 % | ||||||||||
diagnosis | ||||||||||||
psychotic disorders | 59 | 73 % | 31 | 28 | 0.58 | .446 | 0.68 | [0.25, 1.85] | ||||
All other diagnoses | 21 | 26 % | 9 | 12 | ||||||||
missing | 1 | 1 % | ||||||||||
start of problems | ||||||||||||
<10 years ago | 20 | 25 % | 8 | 12 | 0.55 | .457 | 1.50 | [0.51, 4.38] | ||||
>10 years ago | 44 | 54 % | 22 | 22 | ||||||||
missing | 17 | 21 % | ||||||||||
length of treatment | ||||||||||||
<5 years | 17 | 21 % | 6 | 11 | 1.42 | .234 | 2.01 | [0.63, 6.39] | ||||
>5 years | 44 | 54 % | 23 | 21 | ||||||||
missing | 20 | 25 % | ||||||||||
number of admissions | ||||||||||||
None | 12 | 15 % | 6 | 6 | 0.04 | .837 | 0.88 | [0.25, 3.13] | ||||
≥1 | 45 | 56 % | 21 | 24 | ||||||||
missing | 24 | 29 % | ||||||||||
length hospitalization | ||||||||||||
<1 year | 37 | 46 % | 18 | 19 | 0.01 | .928 | 1.06 | [0.33, 3.41] | ||||
>1 year | 16 | 20 % | 8 | 8 | ||||||||
missing | 28 | 35 % | ||||||||||
source of income | ||||||||||||
employment, unemployment or invalidity benefit | 46 | 57 % | 27 | 19 | 4.26 | .039* | 0.29 | [0.09, 0.97] | ||||
social security benefit | 17 | 21 % | 5 | 12 | ||||||||
missing | 18 | 22 % | ||||||||||
M (SD)
|
N
|
M (SD)
|
N
|
M (SD)
|
t (df)
| Cohen’s d | ||||||
Age | 81 | 100 % | 42.35 (10.12) | 40 | 44.03 (8.70) | 41 | 40.71 (11.20) | 1.49 (75) | .140 | 0.33 | [0.11, 0.77] | |
IMR-scale client version at baseline | 66 | 82 % | 3.36 (0.42) | 36 | 3.46 (0.39) | 30 | 3.24 (0.42) | 2.21 (64) | .031* | 0.55 | [1.04, 0.05] | |
IMR-scale clinician version at baseline | 70 | 86 % | 3.09 (0.50) | 37 | 3.22 (0.44) | 33 | 2.94 (0.53) | 2,41 (68) | .019* | 0.58 | [1.06, 0.10] | |
Recovery Markers Questionnaire [RMQ] | 62 | 77 % | 12.4 (5.76) | 33 | 12.5 (5.55) | 29 | 12.3 (6.1) | 0.14 (60) | .890 | 0.04 | [0.54, 0.46] | |
Mdn/IQR
|
Mdn/IQR
|
Mdn/IQR
|
U
|
p
|
r
| |||||||
GAF | 79 | 98 % | 50/10 | 39 | 55/10 | 40 | 50/10 | 591 | .058 | -.21 | [-0.42, 0.01] |
Outcomes and estimation
Objectives | Outcome measures | Feasibility criteria | Outcomes | |
---|---|---|---|---|
1 | To include sufficient participants | Monitoring; interviews | 60 people | 81 people included of 167, assessed for eligibility (49 %); sufficient for 6 IMR groups |
2 | Clients’ and clinicians’ satisfaction with IMR | Interviews | Satisfaction of most participants and clinicians with IMR | Completers and trainers:(very) positive about IMR |
3 | IMR outcome (pre-post design) | IMR Scale client version (Mueser et al. 2004) IMR Scale clinician version (Mueser et al. 2004) RMQ (Ridgway et al. 2003) | Significant results on our outcome measures | IMRS clinician version (p < 0.001, d = 0.84)a IMRS client version (p = 0.063; d = 0.41) RMQ (p = 0.003, d = 0.52)a. |
4 | Satisfactory fidelity | IMR fidelity scale (Mueser et al. 2009) | Total scores on the fidelity scale of at least 4.0. | Total score (six groups): Mean (SD) = 4.0 (0.20) Three groups: total scores ≥ 4.0 Three groups: total scores < 4.0 |
5 | Trainers' education and supervision | Interviews | Two-day training and Supervision of two hours per week | Two-day course before start of the pilot; Supervision bi-weekly for two hours; Additional training 2 x per year for 4 h. |
6 | Dropout from IMR | Monitoring; interviews | Exploration, no targets set | Dropout from IMR of 51 % |
7 | Duration of the IMR-program | Monitoring; interviews | Predictable; 9–12 months | M = 12.7 months, SD = 3.14 |
A. Primary feasibility outcomes
N
|
M (SD) pre
|
M (SD) post
|
t
|
Df
|
p
|
d
| 95 % CI | |
---|---|---|---|---|---|---|---|---|
IMR-scale client version | 33 | 3.47 (0.39) | 3.66 (0.50) | 1.93 | 32 | .06 | 0.41 | [-0.08, 0.90] |
IMR-scale clinician version | 36 | 3.21 (0.44) | 3.59 (0.48) | 4.73 | 35 | <.001 | 0.84 | [0.36, 1.32] |
RMQ | 31 | 12.23 (5.61) | 14.94 (4.84) | 3.19 | 30 | .003 | 0.52 | [0.01, 1.02] |
B. Secondary feasibility outcomes
Group | A | B | C | D | E | F |
M (SD)
| Mdn (IQR) | |
---|---|---|---|---|---|---|---|---|---|
Item | |||||||||
1 | # of people in a Session or Group | 4 | 5 | 5 | 5 | 4 | 5 | 4.7 (.52) | 5 (.75) |
2 | Program Length | 5 | 5 | 5 | 5 | 5 | 5 | 5 (0) | 5 (0) |
3 | Comprehensiveness of the Curriculum | 5 | 5 | 5 | 5 | 5 | 5 | 5 (0) | 5 (0) |
4 | Provision of Educational Handouts | 5 | 5 | 5 | 5 | 5 | 5 | 5 (0) | 5 (0) |
5 | Involvement of Significant Others | 3 | 1 | 3 | 3 | 3 | 3 | 2.7 (.82) | 3 (0) |
6 | IMR Goal Setting | 5 | 5 | 5 | 5 | 5 | 5 | 5 (0) | 5 (0) |
7 | IMR Goal Follow-up | 5 | 4 | 2 | 5 | 1 | 2 | 3.2 (1.72) | 3 (2.75) |
8 | Motivation-Based Strategies | 5 | 4 | 4 | 5 | 5 | 5 | 4.7 (.52) | 5 (.75) |
9 | Educational Techniques | 5 | 5 | 5 | 5 | 5 | 5 | 5 (0) | 5 (0) |
10 | Cognitive-Behavioral Techniques | 5 | 4 | 4 | 5 | 4 | 4 | 4.3 (.52) | 4 (.75) |
11 | Coping Skills Training | 3 | 2 | 2 | 4 | 3 | 2 | 2.7 (.82) | 2.5 (1) |
12 | Relapse-Prevention Training | 2 | 2 | 3 | 1 | 3 | 3 | 2.3 (.82) | 2.5 (1) |
13 | Behavioral Tailoring for Medication | 2 | 2 | 2 | 2 | 1 | 3 | 2 (.63) | 2 (0) |
Mean fidelity score per group | 4.2 | 3.8 | 3.8 | 4.2 | 3.8 | 4.0 | 4.0 (.20) | 3.9 (.35) | |
Median fidelity score (IQR) | 5 (2) | 4 (3) | 4 (2) | 5 (1) | 4 (2) | 5 (2) |