A multisite randomized controlled trial of Seeking Safety vs. Relapse Prevention Training for women with co-occurring posttraumatic stress disorder and substance use disorders

Figures & data

Figure 1. CONSORT diagram of participant flow through the protocol. RPT = Relapse Prevention Training, TAU = treatment as usual.

Table 1. Demographic and baseline clinical characteristics by treatment group.

	n (%)^1
Characteristic	Seeking Safety (n = 111)	RPT (n = 115)	TAU (n = 117)	Total (n = 343)
Demographic
Age, mean (SD)	41.5 (11.7)	40.3 (11.3)	41.1 (11.2)	40.9 (11.4)
School years complete, median (range)	10 (7–13)	10 (7–13)	11 (7–13)	10 (7–13)
Born in Germany	101 (91.0)	108 (93.9)	101 (86.3)	310 (90.4)
Married	17 (15.3)	21 (18.3)	18 (15.4)	56 (16.3)
Unemployed or marginally employed	89 (80.2)	90 (78.3)	88 (75.2)	267 (77.8)
Monthly household net income < €1000	59 (53.2)	61 (53.5)^a	66 (56.4)	186 (54.4)
Substance use disorder
Alcohol	88 (79.3)	100 (87.0)	102 (87.2)	293 (85.4)
Sedatives	40 (37.0)^b	38 (33.0)	28 (23.9)	106 (31.2)
Cannabis	53 (49.1)^b	58 (50.4)	54 (46.2)	165 (48.5)
Stimulants	30 (27.5)^c	25 (21.7)	41 (35.0)	96 (28.2)
Opiates	24 (21.8)^d	26 (22.6)	23 (19.7)	73 (21.3)
Cocaine	34 (31.5)^b	29 (25.2)	34 (29.1)	97 (28.5)
30-day abstinence	28 (25.2)	22 (19.1)	23 (19.7)	73 (21.3)
Prior substance abuse treatment	74 (66.7)	75 (65.2)	77 (66.4)^e	226 (66.1)
Childhood trauma^f
Emotional abuse	84 (77.1)^c	99 (86.1)	84 (72.4)^e	267 (78.5)*
Physical abuse	51 (45.9)	71 (61.7)	57 (48.7)	179 (52.2)*
Sexual abuse	80 (72.1)	91 (79.1)	78 (67.2)^e	249 (72.8)
Emotional neglect	77 (70.0)^d	98 (86.0)^a	86 (73.5)	261 (76.5)*
Physical neglect	64 (58.2)^d	79 (68.7)	66 (56.4)	209 (61.1)
Lifetime traumatic experiences
Serious accident	43 (38.7)	37 (32.5)^a	36 (31.3)^g	116 (34.1)
Natural disaster	1 (0.9)	2 (1.8)^h	7 (6.1)^a	10 (3.0)
Family non-sexual assault	80 (72.1)	83 (72.8)^a	87 (75.0)^e	250 (73.3)
Stranger non-sexual assault	57 (51.8)^d	53 (46.5)^a	48 (41.7)^g	158 (46.6)
Family sexual assault	70 (63.1)	79 (69.3)^a	61 (52.6)^e	210 (61.6)*
Stranger sexual assault	69 (62.7)^d	61 (53.5)^a	64 (55.2)^e	194 (57.1)
Military combat	1 (0.9)	1 (0.9)^h	2 (1.7)^g	4 (1.2)
Sexual contact (< 18 years/partner 5+ years older)	75 (67.6)	89 (78.1)^a	77 (65.8)	241 (70.5)
Captivity/Imprisonment	13 (11.8)^d	19 (16.7)^a	14 (12.2)^g	46 (13.6)
Torture	7 (6.4)^d	15 (13.3)^h	11 (9.6)^g	33 (9.8)
Life-threatening illness	27 (24.3)	23 (20.2)^a	28 (24.3)^g	78 (22.9)
Other traumatic event	70 (64.2)^c	69 (62.2)^i	68 (60.7)^j	207 (62.3)
PTSD/Treatment
Subthreshold PTSD	26 (23.4)	28 (24.3)	31 (26.5)	85 (24.8)
Prior trauma treatment	30 (27.0)	31 (27.0)	19 (16.4)^e	80 (23.4)
Current mental health comorbidity
Major depression	44 (40.0)^d	56 (49.1)^a	53 (45.3)	153 (44.9)
Anxiety disorder	69 (62.2)	73 (63.5)	79 (67.5)	221 (64.4)
Ever attempted suicide	63 (56.8)	67 (58.3)	67 (58.3)^g	197 (57.8)
No. of suicide attempts, median (range)	2 (1–25)^k	2 (1–20)^l	2 (1–50)	2 (1–50)

¹If not otherwise specified. ^a n = 114. ^b n = 108. ^c n = 109. ^d n = 110. ^e n = 116. ^f At least moderate to severe (Childhood Trauma Questionnaire). ^g n = 115. ^h n = 113. ⁱ n = 111. ^j n = 112. ^k n = 62. ^l n = 66. * Significant between-group difference with p < .05. RPT = Relapse Prevention Training, TAU = treatment as usual.

Table 2. Means and standard deviations (observed values) for the primary and secondary outcomes over the study course and model based effect sizes (d) with 95%-confidence intervals for baseline-adjusted between-group differences at post-treatment and follow-up assessments for the intention-to-treat sample (n = 343).

	M (SD)			d (95% CI)
Outcome	SeSa	RPT	TAU	SeSa-TAU	SeSa-RPT	RPT-TAU
PSS-I				ptime x group = .277, pgroup comparison = .748
Baseline	25.4 (9.7)	27.5 (9.8)	28.9 (9.4)
Post-treatment	22.9 (12.4)	24.3 (11.9)	26.1 (10.3)	−0.15 (−0.45, 0.16)	−0.08 (−0.41, 0.24)	−0.06 (−0.37, 0.25)
Three-month follow-up	22.1 (12.2)	23.7 (11.5)	24.5 (11.8)	−0.06 (−0.38, 0.25)	−0.11 (−0.44, 0.23)	0.05 (−0.26, 0.35)
Six-month follow-up	22.1 (11.5)	20.7 (11.0)	24.3 (11.4)	−0.04 (−0.35, 0.27)	0.20 (−0.13, 0.53)	−0.24 (−0.55, 0.07)
PDS				ptime x group = .441, pgroup comparison = .153
Baseline	25.7 (11.2)	27.6 (10.0)	27.7 (10.2)
Post-treatment	20.8 (12.0)	23.0 (11.2)	24.0 (10.7)	−0.21 (−0.51, 0.10)	−0.13 (−0.46, 0.19)	−0.07 (−0.38, 0.24)
Three-month follow-up	20.9 (13.8)	22.5 (11.5)	24.3 (12.5)	−0.23 (−0.54, 0.08)	−0.05 (−0.38, 0.28)	−0.18 (−0.49, 0.12)
Six-month follow-up	19.4 (11.9)	19.9 (11.7)	23.7 (12.5)	−0.27 (−0.58, 0.04)	0.08 (−0.25, 0.41)	−0.35* (−0.66, −0.04)
Drug and alcohol free days				ptime x group = .249, pgroup comparison = .019
Baseline	16.6 (12.1)	15.6 (11.9)	15.6 (12.3)
Post-treatment	18.3 (11.9)	19.4 (11.7)	16.3 (12.4)	0.13 (−0.17, 0.44)	−0.06 (−0.38, 0.27)	0.19 (−0.12, 0.50)
Three-month follow-up	19.5 (11.6)	21.1 (10.2)	17.6 (11.9)	0.14 (−0.17, 0.46)	−0.17 (−0.50, 0.17)	0.31* (0.00, 0.62)
Six-month follow-up	20.5 (11.3)	22.4 (10.7)	16.4 (12.7)	0.30 (−0.01, 0.61)	−0.27 (−0.59, 0.06)	0.57*** (0.25, 0.88)
ASI alcohol severity				ptime x group = .163, pgroup comparison = .018
Baseline	0.28 (0.25)	0.33 (0.29)	0.32 (0.27)
Post-treatment	0.22 (0.24)	0.25 (0.24)	0.30 (0.28)	−0.32* (−0.63, −0.01)	0.01 (−0.32, 0.34)	−0.33* (−0.64, −0.02)
Three-month follow-up	0.20 (0.23)	0.25 (0.26)	0.28 (0.28)	−0.27 (−0.58, 0.05)	−0.03 (−0.36, 0.31)	−0.24 (−0.55, 0.07)
Six-month follow-up	0.24 (0.26)	0.19 (0.22)	0.27 (0.28)	−0.12 (−0.43, 0.19)	0.37* (0.04, 0.70)	−0.49** (−0.80, −0.18)
ASI drug severity				ptime x group = .703, pgroup comparison = .479
Baseline	0.09 (0.11)	0.10 (0.14)	0.09 (0.11)
Post-treatment	0.07 (0.12)	0.06 (0.11)	0.08 (0.11)	−0.05 (−0.36, 0.25)	0.08 (−0.25, 0.41)	−0.13 (−0.44, 0.18)
Three-month follow-up	0.06 (0.11)	0.06 (0.12)	0.06 (0.10)	0.11 (−0.20, 0.42)	0.18 (−0.15, 0.52)	−0.07 (−0.38, 0.23)
Six-month follow-up	0.05 (0.10)	0.04 (0.10)	0.07 (0.11)	−0.07 (−0.38, 0.24)	0.16 (−0.17, 0.49)	−0.24 (−0.55, 0.08)
BDI-II				ptime x group = .748, pgroup comparison = .018
Baseline	25.3 (13.2)	29.4 (11.7)	28.6 (10.9)
Post-treatment	19.0 (12.4)	26.2 (12.0)	25.8 (12.6)	−0.42** (−0.72, −0.11)	−0.33 (−0.66, 0.00)	−0.09 (−0.39, 0.22)
Three-month follow-up	19.9 (14.4)	25.0 (14.0)	25.2 (13.0)	−0.37* (−0.68, −0.05)	−0.28 (−0.62, 0.05)	−0.08 (−0.39, 0.22)
Six-month follow-up	18.5 (12.5)	22.3 (13.3)	24.1 (14.0)	−0.34* (−0.65, −0.03)	−0.12 (−0.45, 0.21)	−0.22 (−0.52, 0.09)
DERS				ptime x group = .966, pgroup comparison = .018
Baseline	100.5 (26.9)	110.7 (24.6)	111.9 (25.3)
Post-treatment	95.6 (24.7)	102.9 (26.4)	109.1 (24.5)	−0.36* (−0.67, −0.05)	−0.14 (−0.47, 0.19)	−0.22 (−0.52, 0.09)
Three-month follow-up	94.1 (27.2)	100.9 (27.8)	106.8 (26.1)	−0.33* (−0.64, −0.01)	−0.07 (−0.40, 0.26)	−0.26 (−0.56, 0.05)
Six-month follow-up	92.7 (24.7)	100.0 (25.2)	107.3 (25.4)	−0.41* (−0.71, −0.10)	−0.10 (−0.43, 0.22)	−0.30 (−0.61, 0.01)

SeSa = Seeking Safety, RPT = Relapse Prevention Training, TAU = treatment as usual, CI = Confidence Interval, PSS-I = PTSD Symptom Scale Interview (Foa et al., 1993), PDS = Posttraumatic Diagnostic Scale (Foa et al., 1997), ASI = Addiction Severity Index-lite (Kokkevi & Hartgers, 1995; McLellan et al., 1992), BDI-II = Beck Depression Inventory II (Beck et al., 1996), DERS = Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004).

Figure 2. Observed courses of PSS-I PTSD severity scores (upper left), numbers of drug- and alcohol-free days (upper right), BDI-II depression scores (lower left) and DERS emotion dysregulation scores (lower right). PSS-I = PTSD Symptom Scale Interview (Foa et al., 1993), BDI-II = Beck Depression Inventory II (Beck et al., 1996), DERS = Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004), SeSa = Seeking Safety, RPT = Relapse Prevention Training, TAU = treatment as usual.

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