Introduction
Methods
Participants
Study design
Study intervention
Assessments
Outcome measures
The Digit Span and the Span Board
Similarities
The Conners’ Continuous Performance Test II
The QbTest
Institutional behaviour
The Quality of Life Inventory
The Conners’ Adult ADHD Rating Scale-Observer: Screening Version
The Adult ADHD Self-Report Scale
The Clinical Global Impression Severity of Illness Scale
The Global Assessment of Functioning Scale
Statistical analysis
Results
Participants
Randomized participants (n = 30) | |
---|---|
Age (years) | |
Mean, SD | 34.4 (10.67) |
Range | 21–61 |
Gender, male, n (%) | 30 (100) |
Educational level, 9 year compulsory school, or less, n (%) | 25 (83) |
Educational support during childhood, n (%) | 24 (80) |
Full scale IQ, (N = 22) | |
Mean, SD | 95.18 (9.99) |
Range | 78–113 |
Adult ADHD subtypea, n (%) | |
Combined type | 28 (93) |
Predominantly inattentive | 2 (7) |
Autism-spectrum disordera,b, n (%) | 7 (23) |
Mood- and/or anxiety disordera, lifetime, n (%) | 22 (73) |
Conduct disordera
| 30 (100) |
Personality disordersa,c, (N = 23) | |
Antisocial, n (%) | 22 (96) |
Borderline, n (%) | 17 (74) |
Paranoid, n (%) | 17 (74) |
Narcissistic, n (%) | 15 (65) |
Obsessive-compulsive, n (%) | 12 (52) |
Passive-aggressive, n (%) | 11 (48) |
Avoidant, n (%) | 11(48) |
Depressive, n (%) | 8 (35) |
Dependent, n (%) | 7 (30) |
Schizotypal, n (%) | 5 (22) |
Schizoid, n (%) | 2 (9) |
Histrionic, n (%) | 0 (0) |
Substance use disordera, lifetime, n (%) | 30 (100) |
Preferred drug of choice, n (%) | |
Alcohol | 4 (13) |
Amphetamine | 18 (60) |
Cocaine | 4 (13) |
Cannabis | 1 (7) |
Opioids | 1 (7) |
Anabolic steroids | 1 (7) |
Other | 1 (7) |
Psychopathyd
| 3 (10) |
Treatment for psychiatric disorders at baseline visit, n (%) | 13 (43) |
CAARS: O-SVe, baseline sum-score, mean, 95 % CI | 40.0 (38.1–41.8) |
ASRSf, baseline sum-score, mean, 95 % CI | 55.3 (52.0–58.6) |
GAFg, baseline total score; mean, 95 % CI | 35.2 (33.3–37.1) |
CGI-Severityh, baseline score, mean, 95 % CI | 5.9 (5.7–6.1) |
Marked, n (%) | 6 (20) |
Severe, n (%) | 21 (70) |
Extremely severe, n (%) | 3 (10) |
Outcome measures
The Digit Span and the Span Board
n = 25 (n = 30 ITT/LOCF) |
F (F ITT) |
P (P ITT) | η
p
2
(η
p
2
ITT) | Within-subject contrasts | |
---|---|---|---|---|---|
P
T1 vs. T3 |
P
T2 vs. T3 | ||||
Digit Span Scaled Scores | 6.33 (7.00)
|
0.004
(0.002)
| 0.21 (0.19)
|
0.007
| 0.198 |
Digits forward | 1.91 (2.71)
| 0.167 (0.086)
| 0.07 (0.09)
| 0.318 | 0.424 |
Digits backwards | 4.45 (4.73)
|
0.017
(0.013)
| 0.16 (0.14)
|
0.005
| 0.518 |
Span Board Scaled Scores | 5.16 (5.72)
|
0.009
(0.005)
| 0.18 (0.17)
|
0.004
| 0.162 |
Span forward | 0.39 (0.64)
| 0.680 (0.529)
| 0.02 (0.02)
| 0.584 | 0.461 |
Span backwards | 3.03 (3.24)
| 0.057 (0.046)
| 0.11 (0.10)
|
0.021
| 0.942 |
Similarities
The Conners’ Continuous Performance Test II
n = 21 (n = 27 ITT/LOCF) |
F (F ITT) |
P (P ITT) | η
p
2
(η
p
2
ITT) | Within-subject contrasts | |
---|---|---|---|---|---|
P
T1 vs. T3 |
P
T2 vs. T3 | ||||
Hit reaction time | 0.05 (0.04)
| 0.951 (0.924)
| 0.00 (0.00)
| 0.806 | 0.742 |
Variability-dependent measures
| |||||
Hit reaction time standard error | 16.38 (8.47)
|
<0.001
(0.003)
| 0.45 (0.25)
|
<0.001
|
0.014
|
Variability | 22.82 (12.27)
|
<0.001
(
<
0.001)
| 0.53 (0.32)
|
<0.001
|
0.004
|
Hit reaction time block change | 7.99 (5.17)
|
0.001
(0.013)
| 0.29 (0.17)
|
0.004
| 0.914 |
Hit standard error block change | 0.45 (0.00)
| 0.640 (0.996)
| 0.02 (0.00)
| 0.388 | 0.948 |
Perseverations | 9.35 (7.50)
|
0.006
(0.011)
| 0.32 (0.22)
|
0.005
|
0.048
|
Hit reaction time inter-stimulus intervals change | 0.43 (0.36)
| 0.651 (0.695)
| 0.02 (0.01)
| 0.529 | 0.386 |
Hit standard error inter-stimulus intervals change | 0.50 (0.064)
| 0.539 (0.854)
| 0.02 (0.00)
| 0.450 | 0.518 |
Accuracy-dependent measures
| |||||
Omission errors | 18.15 (9.46)
|
<0.001
(0.002)
| 0.48 (0.27)
|
<0.001
|
0.032
|
Commission errors | 31.57 (18.66)
|
<0.001
(
<
0.001)
| 0.61 (0.42)
|
<0.001
| 0.071 |
Detectability | 14.32 (9.96)
|
<0.001
(
<
0.001)
| 0.42 (0.28)
|
<0.001
| 0.255 |
Response style | 1.40 (1.03)
| 0.257 (0.341)
| 0.07 (0.04)
| 0.234 | 0.675 |
The QbTest
T1 M (±SD) | T2 M (±SD) | T3 M (±SD) |
F (F ITT) |
P (P ITT) | η
p
2
(η
p
2
ITT) | Within-subject contrasts | ||
---|---|---|---|---|---|---|---|---|
P
T1 vs. T3 |
P
T2 vs. T3 | |||||||
Motor activity n = 24 (n = 30 ITT/LOCF)
| ||||||||
Time active (%) | 42.75 ± 26.83 | 15.13 ± 17.38 | 13.42 ± 15.13 | 22.23 (16.98)
|
<0.001
(
<
0.001)
| 0.49 (0.37)
|
<0.001
| 0.625 |
Distance (m) | 23.33 ± 16.72 | 7.39 ± 5.73 | 8.50 ± 9.90 | 17.50 (18.87)
|
<0.001
(
<
0.001)
| 0.43 (0.39)
|
<0.001
| 0.515 |
Area (cm2) | 86.08 ± 60.10 | 28.04 ± 28.56 | 26.88 ± 32.14 | 23.47 (26.35)
|
<0.001
(
<
0.001)
| 0.51 (0.48)
|
<0.001
| 0.807 |
Micro-events | 10,892.83 ± 6,766.47 | 4,038.42 ± 3,249.16 | 3,996.96 ± 3,984.00 | 21.93 (17.97)
|
<0.001
(
<
0.001)
| 0.49 (0.38)
|
<0.001
| 0.958 |
Motion simplicity | 48.68 ± 13.16 | 38.34 ± 15.74 | 35.75 ± 17.89 | 12.39 (14.62)
|
<0.001
(
<
0.001)
| 0.35 (0.34)
|
<0.001
| 0.261 |
Cognition n = 23 (n = 30 ITT/LOCF)
| ||||||||
Reaction time (ms) | 598.39 ± 144.67 | 537.43 ± 83.71 | 510.83 ± 114.72 | 4.80 (5.54)
|
0.024
(0.014)
| 0.18 (0.16)
|
0.028
| 0.235 |
Reaction time variation (ms) | 218.39 ± 63.58 | 166.70 ± 54.39 | 134.39 ± 47.33 | 23.03 (25.17)
|
<0.001
(
<
0.001)
| 0.51 (0.47)
|
<0.001
|
0.005
|
Normalized variation (%) | 37.13 ± 9.16 | 30.87 ± 8.69 | 26.43 ± 7.20 | 17.50 (20.98)
|
<0.001
(
<
0.001)
| 0.44 (0.42)
|
<0.001
|
0.007
|
Omission errors (%) | 37.75 ± 23.67 | 16.70 ± 21.78 | 8.54 ± 11.22 | 18.93 (18.84)
|
<0.001
(
<
0.001)
| 0.46 (0.34)
|
<0.001
|
0.038
|
Commission errors (%) | 7.46 ± 10.48 | 1.42 ± 1.65 | 1.13 ± 1.50 | 8.36 (7.53)
|
0.007
(0.009)
| 0.28 (0.21)
|
0.005
| 0.483 |
Anticipatory errors (%) | 2.04 ± 3.96 | 0.09 ± 0.29 | 0.00 ± 0.00 | 5.79 (5.36)
|
0.025
(0.027)
| 0.21 (0.16)
|
0.022
| 0.162 |
Error rate (%) | 15.56 ± 10.16 | 5.30 ± 5.98 | 3.00 ± 3.15 | 26.28 (24.93)
|
<0.001
(
<
0.001)
| 0.56 (0.46)
|
<0.001
|
0.027
|
Institutional behaviour
Quality of Life Inventory (QOLI)
T1 M (SD) | T2 M (SD) | T3 M (SD) |
F (F ITT) |
P (P ITT) | η
p
2
(η
p
2
ITT) | Within-subject contrasts | ||
---|---|---|---|---|---|---|---|---|
P
T1 vs. T3 |
P
T2 vs. T3 | |||||||
Weighted item, n = 25 (n = 30 ITT/LOCF)
| ||||||||
1. Health | −0.70 (3.57) | 0.93 (3.56) | 1.16 (3.71) | 4.12 (3.75) | 0.030 (0.036) | 0.26 (0.21) | 0.022 (0.028) | 1.000 (1.000) |
2. Self-regard | −0.27 (3.46) | 1.37 (3.35) | 1.96 (2.91) | 4.07 (3.79) | 0.031 (0.035) | 0.26 (0.21) | 0.024 (0.028) | 1.000 (1.000) |
3. Goals and values | −0.97 (3.34) | 1.41 (3.48) | 2.36 (3.38) | 12.78 (10.41) |
<0.001 (<0.001)
| 0.53 (0.43) |
<0.001 (<0.001)
| 0.613 (0.609) |
4. Standard-of-living | −3.20 (2.98) | −2.11 (2.82) | −2.00 (2.75) | 3.71 (1.50) | 0.040 (0.240) | 0.24 (0.10) | 0.089 (0.445) | 1.000 (1.000) |
5. Work | −1.30 (3.48) | −0.19 (3.22) | 0.48 (3.24) | 4.13 (5.12) | 0.029 (0.013) | 0.26 (0.27) | 0.023 (0.009) | 0.636 (0.632) |
6. Recreation | −0.83 (3.71) | 0.63 (3.42) | 0.36 (2.69) | 0.63 (0.63) | 0.544 (0.541) | 0.05 (0.04) | 1.000 (1.000) | 1.000 (1.000) |
7. Learning | −1.57 (2.98) | 1.89 (2.21) | 1.92 (2.36) | 15.53 (16.23) |
<0.001 (<0.001)
| 0.58 (0.54) |
<0.001 (<0.001)
| 1.000 (1.000) |
8. Creativity | 1.17 (3.63) | 2.56 (2.62) | 2.48 (2.45) | 3.148 (2.990) | 0.062 (0.067) | 0.22 (0.18) | 0.189 (0.186) | 1.000 (1.000) |
9. Social service | 0.07 (2.49) | 1.11 (2.28) | 1.28 (2.64) | 2.864 (3.887) | 0.077 (0.032) | 0.20 (0.22) | 0.184 (0.090) | 1.000 (1.000) |
10. Love relationships | −1.03 (4.06) | −0.33 (3.55) | −0.20 (3.20) | 2.478 (1.837) | 0.106 (0.178) | 0.18 (0.12) | 0.097 (0.185) | 1.000 (1.000) |
11. Friendships | 1.63 (3.00) | 2.52 (2.83) | 2.28 (2.98) | 1.067 (1.170) | 0.360 (0.325) | 0.09 (0.08) | 0.657 (0.570) | 1.000 (1.000) |
12. Relationships with children | −0.17 (3.30) | −0.37 (3.51) | 0.04 (3.55) | 0.284 (0.287) | 0.756 (0.753) | 0.02 (0.02) | 1.000 (1.000) | 1.000 (1.000) |
13. Relationships with relatives | 0.80 (3.42) | 2.00 (3.33) | 2.36 (2.72) | 3.367 (1.681) | 0.052 (0.205) | 0.23 (0.11) | 0.042 (0.224) | 1.000 (1.000) |
14. Home | −1.53 (4.06) | −1.48 (3.85) | −1.88 (3.30) | 0.412 (0.217) | 0.667 (0.806) | 0.04 (0.02) | 1.000 (1.000) | 1.000 (1.000) |
15. Neighbourhood | −0.07 (3.36) | 1.11 (3.06) | 0.48 (2.65) | 1.114 (1.112) | 0.345 (0.343) | 0.09 (0.07) | 1.000 (1.000) | 1.000 (1.000) |
16. Community | −0.77 (2.78) | −1.04 (2.92) | −1.20 (2.74) | 0.272 (0.275) | 0.764 (0.762) | 0.02 (0.02) | 1.000 (1.000) | 1.000 (1.000) |
Associations between symptomatic and functional improvements
GAF Baseline | QOLI Goals and values Baseline | QOLI Learning Baseline | GAF Week 16 | QOLI Goals and values Week 16 | QOLI Learning Week 16 | GAF Week 52 | QOLI Goals and values Week 52 | QOLI Learning Week 52 | |
---|---|---|---|---|---|---|---|---|---|
CAARS: O-SV, baseline, n = 30
| |||||||||
Inattention | −0.340 (0.066) | −0.288 (0.123) | −0.207 (0.272) | ||||||
Hyperactivity/impulsivity | −0.112 (0.555) | −0.071 (0.709) | 0.212 (0.261) | ||||||
CAARS: O-SV, week 16, n = 27
| |||||||||
Inattention | −0.747 (<0.001)**
| 0.318 (0.105) | −0.164 (0.414) | ||||||
Hyperactivity/impulsivity | −0.675 (<0.001)**
| 0.131 (0.515) | −0.104 (0.604) | ||||||
CAARS: O-SV, week 52, n = 25
| |||||||||
Inattention | −0.736 (<0.001)**
| −0.414 (0.040)*
| −0.281 (0.174) | ||||||
Hyperactivity/impulsivity | −0.483 (0.015)*
| −0.074 (0.724) | 0.078 (0.712) | ||||||
ASRS, baseline, n = 30
| |||||||||
Inattention | −0.306 (0.100) | −0.010 (0.959) | 0.084 (0.659) | ||||||
Hyperactivity/impulsivity | −0.275 (0.142) | 0.078 (0.682) | 0.078 (0.683) | ||||||
ASRS, week 16, n = 27
| |||||||||
Inattention | −0.550 (0.003)**
| 0.091 (0.652) | −0.136 (0.498) | ||||||
Hyperactivity/impulsivity | −0.503 (0.007)**
| 0.019 (0.925) | −0.178 (0.374) | ||||||
ASRS, week 52, n = 25
| |||||||||
Inattention | −0.624 (0.001)**
| −0.551 (0.004)**
| −0.296 (0.150) | ||||||
Hyperactivity/impulsivity | −0.577 (0.003)**
| −0.229 (0.271) | −0.140 (0.506) | ||||||
CGI-S, baseline, n = 30 | −0.486 (0.006)**
| −0.319 (0.086) | −0.015 (0.938) | ||||||
CGI-S, week 16, n = 27 | −0.846 (<0.001)**
| 0.145 (0.469) | −0.333 (0.090) | ||||||
CGI-S, week 52, n = 25 | −0.885 (<0.001)**
| −0.320 (0.118) | −0.319 (0.120) |
Associations between investigators’ and self-ratings of ADHD symptoms
CAARS: O-SV, sum-score | ASRS, sum-score baseline | ASRS, change in sum-score from baseline to week 16 | ASRS, sum-score week 16 | ASRS, change in sum-score from baseline to week 52 | ASRS, sum-score week 52 |
---|---|---|---|---|---|
Baseline, n = 30 | 0.473 (0.008)** | ||||
Changes from baseline to week 16 | 0.545 (0.003)** | ||||
Week 16, n = 27 | 0.599 (0.001)** | ||||
Changes from baseline to week 52 | 0.697 (<0.001)** | ||||
Week 52, n = 25 | 0.730 (<0.001)** |