Trial Outcomes & Findings for Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence (NCT NCT04625465)
NCT ID: NCT04625465
Last Updated: 2025-07-14
Results Overview
Proportion of reporting days on which alcohol was consumed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
474 participants
Primary outcome timeframe
Burst 1, Daily for 14 days
Results posted on
2025-07-14
Participant Flow
Participant milestones
| Measure |
No Intervention, No Intervention (AA)
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
76
|
40
|
40
|
80
|
80
|
80
|
|
Overall Study
COMPLETED
|
36
|
36
|
71
|
36
|
36
|
78
|
80
|
80
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
5
|
4
|
4
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
No Intervention, No Intervention (AA)
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
4
|
4
|
4
|
0
|
0
|
0
|
Baseline Characteristics
Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence
Baseline characteristics by cohort
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=36 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
75 Participants
n=42 Participants
|
|
Age, Continuous
|
32.69 Years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
27.28 Years
STANDARD_DEVIATION 4.41 • n=7 Participants
|
29.81 Years
STANDARD_DEVIATION 7.92 • n=5 Participants
|
27.47 Years
STANDARD_DEVIATION 5.07 • n=4 Participants
|
28.61 Years
STANDARD_DEVIATION 9.77 • n=21 Participants
|
28.86 Years
STANDARD_DEVIATION 7.04 • n=8 Participants
|
30.36 Years
STANDARD_DEVIATION 8.66 • n=8 Participants
|
28.25 Years
STANDARD_DEVIATION 6.87 • n=24 Participants
|
29.21 Years
STANDARD_DEVIATION 7.85 • n=42 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
52 Participants
n=8 Participants
|
59 Participants
n=24 Participants
|
327 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
125 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
61 Participants
n=24 Participants
|
329 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
53 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
71 Participants
n=24 Participants
|
399 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Gender minority status
Gender minority
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
145 Participants
n=42 Participants
|
|
Gender minority status
Cisgender
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
56 Participants
n=24 Participants
|
307 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Burst 1, Daily for 14 daysPopulation: 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Proportion of reporting days on which alcohol was consumed
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=36 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Alcohol Use (Burst 1)
|
.45 Proportion of reporting days
Standard Deviation .29
|
.40 Proportion of reporting days
Standard Deviation .23
|
.41 Proportion of reporting days
Standard Deviation .30
|
.31 Proportion of reporting days
Standard Deviation .27
|
.45 Proportion of reporting days
Standard Deviation .27
|
.41 Proportion of reporting days
Standard Deviation .23
|
.44 Proportion of reporting days
Standard Deviation .31
|
.42 Proportion of reporting days
Standard Deviation .28
|
PRIMARY outcome
Timeframe: Burst 2, Daily for 14 daysPopulation: Only 448 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Proportion of reporting days on which alcohol was consumed
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=33 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=77 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Alcohol Use (Burst 2)
|
.49 Proportion of reporting days
Standard Deviation .31
|
.42 Proportion of reporting days
Standard Deviation .21
|
.41 Proportion of reporting days
Standard Deviation .29
|
.30 Proportion of reporting days
Standard Deviation .26
|
.42 Proportion of reporting days
Standard Deviation .27
|
.38 Proportion of reporting days
Standard Deviation .24
|
.48 Proportion of reporting days
Standard Deviation .32
|
.42 Proportion of reporting days
Standard Deviation .29
|
PRIMARY outcome
Timeframe: Burst 3, Daily for 14 daysPopulation: Only 429 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Proportion of reporting days on which alcohol was consumed
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=35 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=33 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=63 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=77 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=73 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Alcohol Use (Burst 3)
|
.45 Proportion of reporting days
Standard Deviation .31
|
.41 Proportion of reporting days
Standard Deviation .24
|
.42 Proportion of reporting days
Standard Deviation .30
|
.35 Proportion of reporting days
Standard Deviation .27
|
.39 Proportion of reporting days
Standard Deviation .27
|
.39 Proportion of reporting days
Standard Deviation .29
|
.43 Proportion of reporting days
Standard Deviation .32
|
.36 Proportion of reporting days
Standard Deviation .28
|
PRIMARY outcome
Timeframe: Burst 4, Daily for 14 daysPopulation: Only 435 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Proportion of reporting days on which alcohol was consumed
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=35 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=32 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=66 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=76 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=79 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=77 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Alcohol Use (Burst 4)
|
.45 Proportion of reporting days
Standard Deviation .35
|
.43 Proportion of reporting days
Standard Deviation .26
|
.41 Proportion of reporting days
Standard Deviation .32
|
.34 Proportion of reporting days
Standard Deviation .27
|
.40 Proportion of reporting days
Standard Deviation .29
|
.34 Proportion of reporting days
Standard Deviation .24
|
.41 Proportion of reporting days
Standard Deviation .36
|
.36 Proportion of reporting days
Standard Deviation .29
|
PRIMARY outcome
Timeframe: Burst 1, Daily for 14 daysPopulation: 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Proportion of reporting days on which IPV perpetration occurred
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=36 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Intimate Partner Violence (IPV) Perpetration (Burst 1)
|
.019 Proportion of reporting days
Standard Deviation .034
|
.035 Proportion of reporting days
Standard Deviation .066
|
.031 Proportion of reporting days
Standard Deviation .058
|
.031 Proportion of reporting days
Standard Deviation .062
|
.017 Proportion of reporting days
Standard Deviation .036
|
.024 Proportion of reporting days
Standard Deviation .050
|
.022 Proportion of reporting days
Standard Deviation .051
|
.041 Proportion of reporting days
Standard Deviation .070
|
PRIMARY outcome
Timeframe: Burst 2, Daily for 14 daysPopulation: Only 448 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Proportion of reporting days on which IPV perpetration occurred
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=33 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=77 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
IPV Perpetration (Burst 2)
|
.047 Proportion of reporting days
Standard Deviation .113
|
.013 Proportion of reporting days
Standard Deviation .039
|
.015 Proportion of reporting days
Standard Deviation .041
|
.026 Proportion of reporting days
Standard Deviation .057
|
.018 Proportion of reporting days
Standard Deviation .038
|
.026 Proportion of reporting days
Standard Deviation .046
|
.025 Proportion of reporting days
Standard Deviation .050
|
.035 Proportion of reporting days
Standard Deviation .066
|
PRIMARY outcome
Timeframe: Burst 3, Daily for 14 daysPopulation: Only 429 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Proportion of reporting days on which IPV perpetration occurred
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=35 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=33 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=63 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=77 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=73 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
IPV Perpetration (Burst 3)
|
.042 Proportion of reporting days
Standard Deviation .101
|
.049 Proportion of reporting days
Standard Deviation .081
|
.018 Proportion of reporting days
Standard Deviation .043
|
.019 Proportion of reporting days
Standard Deviation .056
|
.015 Proportion of reporting days
Standard Deviation .050
|
.021 Proportion of reporting days
Standard Deviation .050
|
.014 Proportion of reporting days
Standard Deviation .041
|
.053 Proportion of reporting days
Standard Deviation .139
|
PRIMARY outcome
Timeframe: Burst 4, Daily for 14 daysPopulation: Only 435 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Proportion of reporting days on which IPV perpetration occurred
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=35 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=32 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=66 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=76 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=79 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=77 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
IPV Perpetration (Burst 4)
|
.042 Proportion of reporting days
Standard Deviation .135
|
.020 Proportion of reporting days
Standard Deviation .039
|
.017 Proportion of reporting days
Standard Deviation .048
|
.014 Proportion of reporting days
Standard Deviation .032
|
.045 Proportion of reporting days
Standard Deviation .139
|
.026 Proportion of reporting days
Standard Deviation .069
|
.011 Proportion of reporting days
Standard Deviation .036
|
.033 Proportion of reporting days
Standard Deviation .070
|
PRIMARY outcome
Timeframe: Bursts 1 and 2 (daily for 14 x 2 days)Population: The Study Aims, as funded, sought to compare combinations of intervention arms. Thus, per this proposed analytic strategy, arms corresponding to control or intervention status were combined as appropriate to permit the analysis of hypothesized intervention main effects.
Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2).
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=144 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=308 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Alcohol Use --> IPV Perpetration (Pre-Intervention)
|
1.26 Odds Ratio
Interval 0.87 to 1.82
|
1.32 Odds Ratio
Interval 0.95 to 1.82
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Bursts 3 and 4 (daily for 14 x 2 days)Population: The Study Aims, as funded, sought to compare combinations of intervention arms. Thus, per this proposed analytic strategy, arms corresponding to control or intervention status were combined as appropriate to permit the analysis of hypothesized intervention main effects.
Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2).
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=144 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=308 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Alcohol Use --> IPV Perpetration (Post-Intervention)
|
1.48 Odds Ratio
Interval 0.91 to 2.41
|
1.06 Odds Ratio
Interval 0.82 to 1.37
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Burst 1, Daily for 14 daysPopulation: Only 451 of 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Total daily count across 15 daily sexual minority stress (SMS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=36 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=79 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Sexual Minority Stress (Burst 1)
|
.48 Average daily count of SMS indicators
Standard Deviation .53
|
.54 Average daily count of SMS indicators
Standard Deviation .56
|
.55 Average daily count of SMS indicators
Standard Deviation .71
|
.59 Average daily count of SMS indicators
Standard Deviation .64
|
.32 Average daily count of SMS indicators
Standard Deviation .37
|
.42 Average daily count of SMS indicators
Standard Deviation .57
|
.50 Average daily count of SMS indicators
Standard Deviation 1.23
|
.58 Average daily count of SMS indicators
Standard Deviation .82
|
SECONDARY outcome
Timeframe: Burst 2, Daily for 14 daysPopulation: Only 447 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Total daily count across 15 daily sexual minority stress (SMS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=33 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=77 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=79 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Sexual Minority Stress (Burst 2)
|
.39 Average daily count of SMS indicators
Standard Deviation .46
|
.32 Average daily count of SMS indicators
Standard Deviation .40
|
.53 Average daily count of SMS indicators
Standard Deviation .62
|
.42 Average daily count of SMS indicators
Standard Deviation .65
|
.32 Average daily count of SMS indicators
Standard Deviation .36
|
.36 Average daily count of SMS indicators
Standard Deviation .69
|
.43 Average daily count of SMS indicators
Standard Deviation 1.26
|
.37 Average daily count of SMS indicators
Standard Deviation .49
|
SECONDARY outcome
Timeframe: Burst 3, Daily for 14 daysPopulation: Only 428 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Total daily count across 15 daily sexual minority stress (SMS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=35 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=33 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=63 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=76 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=73 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Sexual Minority Stress (Burst 3)
|
.31 Average daily count of SMS indicators
Standard Deviation .39
|
.29 Average daily count of SMS indicators
Standard Deviation .35
|
.41 Average daily count of SMS indicators
Standard Deviation .69
|
.42 Average daily count of SMS indicators
Standard Deviation .65
|
.31 Average daily count of SMS indicators
Standard Deviation .44
|
.30 Average daily count of SMS indicators
Standard Deviation .59
|
.31 Average daily count of SMS indicators
Standard Deviation 1.02
|
.30 Average daily count of SMS indicators
Standard Deviation .53
|
SECONDARY outcome
Timeframe: Burst 4, Daily for 14 daysPopulation: Only 434 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Total daily count across 15 daily sexual minority stress (SMS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=35 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=32 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=66 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=76 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=78 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=77 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Sexual Minority Stress (Burst 4)
|
.34 Average daily count of SMS indicators
Standard Deviation .63
|
.37 Average daily count of SMS indicators
Standard Deviation .44
|
.34 Average daily count of SMS indicators
Standard Deviation .48
|
.32 Average daily count of SMS indicators
Standard Deviation .53
|
.39 Average daily count of SMS indicators
Standard Deviation .72
|
.33 Average daily count of SMS indicators
Standard Deviation .74
|
.26 Average daily count of SMS indicators
Standard Deviation 1.16
|
.30 Average daily count of SMS indicators
Standard Deviation .38
|
SECONDARY outcome
Timeframe: Burst 1, Daily for 14 daysPopulation: Only 162 of 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Total daily count across 14 daily gender minority stress (GMS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=10 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=14 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=28 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=12 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=14 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=28 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=27 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=29 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Gender Minority Stress (Burst 1)
|
.80 Average daily count of GMS indicators
Standard Deviation .79
|
.73 Average daily count of GMS indicators
Standard Deviation .50
|
1.17 Average daily count of GMS indicators
Standard Deviation 1.04
|
1.13 Average daily count of GMS indicators
Standard Deviation .88
|
.73 Average daily count of GMS indicators
Standard Deviation .44
|
1.09 Average daily count of GMS indicators
Standard Deviation .87
|
.94 Average daily count of GMS indicators
Standard Deviation 2.17
|
1.14 Average daily count of GMS indicators
Standard Deviation .99
|
SECONDARY outcome
Timeframe: Burst 2, Daily for 14 daysPopulation: Only 162 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Total daily count across 14 daily gender minority stress (GMS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=10 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=14 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=28 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=12 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=14 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=28 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=28 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=28 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Gender Minority Stress (Burst 2)
|
.82 Average daily count of GMS indicators
Standard Deviation 1.04
|
.64 Average daily count of GMS indicators
Standard Deviation .48
|
1.05 Average daily count of GMS indicators
Standard Deviation 1.09
|
.73 Average daily count of GMS indicators
Standard Deviation 1.07
|
.91 Average daily count of GMS indicators
Standard Deviation .74
|
.95 Average daily count of GMS indicators
Standard Deviation .85
|
.97 Average daily count of GMS indicators
Standard Deviation 2.14
|
.95 Average daily count of GMS indicators
Standard Deviation .92
|
SECONDARY outcome
Timeframe: Burst 3, Daily for 14 daysPopulation: Only 145 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Total daily count across 14 daily gender minority stress (GMS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=10 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=14 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=21 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=11 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=13 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=28 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=25 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=23 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Gender Minority Stress (Burst 3)
|
.50 Average daily count of GMS indicators
Standard Deviation .77
|
.80 Average daily count of GMS indicators
Standard Deviation .82
|
.77 Average daily count of GMS indicators
Standard Deviation 1.02
|
.73 Average daily count of GMS indicators
Standard Deviation 1.16
|
.73 Average daily count of GMS indicators
Standard Deviation .63
|
.98 Average daily count of GMS indicators
Standard Deviation 1.06
|
.89 Average daily count of GMS indicators
Standard Deviation 2.13
|
.87 Average daily count of GMS indicators
Standard Deviation .98
|
SECONDARY outcome
Timeframe: Burst 4, Daily for 14 daysPopulation: Only 153 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Total daily count across 14 daily gender minority stress (GMS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=10 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=13 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=25 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=11 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=13 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=27 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=26 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=28 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
Gender Minority Stress (Burst 4)
|
.24 Average daily count of GMS indicators
Standard Deviation .42
|
.46 Average daily count of GMS indicators
Standard Deviation .59
|
.70 Average daily count of GMS indicators
Standard Deviation .70
|
.41 Average daily count of GMS indicators
Standard Deviation .53
|
.76 Average daily count of GMS indicators
Standard Deviation .81
|
.93 Average daily count of GMS indicators
Standard Deviation 1.52
|
.88 Average daily count of GMS indicators
Standard Deviation 2.33
|
.65 Average daily count of GMS indicators
Standard Deviation .73
|
SECONDARY outcome
Timeframe: Burst 1, Daily for 14 daysPopulation: 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Average daily count of COVID stress (CS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=36 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
COVID Stress (Burst 1)
|
1.88 Average daily count of CS indicators
Standard Deviation 1.11
|
2.07 Average daily count of CS indicators
Standard Deviation 1.07
|
1.81 Average daily count of CS indicators
Standard Deviation .83
|
1.87 Average daily count of CS indicators
Standard Deviation 1.00
|
1.61 Average daily count of CS indicators
Standard Deviation .99
|
1.69 Average daily count of CS indicators
Standard Deviation .85
|
1.72 Average daily count of CS indicators
Standard Deviation .98
|
1.84 Average daily count of CS indicators
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Burst 2, Daily for 14 daysPopulation: Only 447 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Average daily count of COVID stress (CS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=36 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=33 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=70 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=36 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=77 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=79 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=80 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
COVID Stress (Burst 2)
|
1.88 Average daily count of CS indicators
Standard Deviation 1.11
|
2.07 Average daily count of CS indicators
Standard Deviation 1.07
|
1.81 Average daily count of CS indicators
Standard Deviation .83
|
1.88 Average daily count of CS indicators
Standard Deviation 1.00
|
1.61 Average daily count of CS indicators
Standard Deviation .99
|
1.69 Average daily count of CS indicators
Standard Deviation .85
|
1.72 Average daily count of CS indicators
Standard Deviation .98
|
1.84 Average daily count of CS indicators
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Burst 3, Daily for 14 daysPopulation: Only 427 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Average daily count of COVID stress (CS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=34 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=33 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=63 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=78 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=76 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=73 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
COVID Stress (Burst 3)
|
2.20 Average daily count of CS indicators
Standard Deviation 1.22
|
1.93 Average daily count of CS indicators
Standard Deviation .99
|
1.80 Average daily count of CS indicators
Standard Deviation .79
|
1.88 Average daily count of CS indicators
Standard Deviation 1.06
|
1.64 Average daily count of CS indicators
Standard Deviation .97
|
1.70 Average daily count of CS indicators
Standard Deviation .88
|
1.77 Average daily count of CS indicators
Standard Deviation 1.01
|
1.85 Average daily count of CS indicators
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Burst 4, Daily for 14 daysPopulation: Only 432 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.
Average daily count of COVID stress (CS) indicators
Outcome measures
| Measure |
No Intervention, No Intervention (AA)
n=33 Participants
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=32 Participants
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
No Intervention, CBT Texts (AC)
n=66 Participants
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
Attention-Control Texts, No Intervention (BA)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=35 Participants
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
Attention-Control Texts, CBT Texts (BC)
n=76 Participants
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
|
CBT Texts, No Intervention (CA)
n=78 Participants
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
|
CBT Texts, Attention-Control Texts (CB)
n=77 Participants
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
|
|---|---|---|---|---|---|---|---|---|
|
COVID Stress (Burst 4)
|
2.09 Average daily count of CS indicators
Standard Deviation 1.25
|
2.00 Average daily count of CS indicators
Standard Deviation 1.03
|
1.87 Average daily count of CS indicators
Standard Deviation .91
|
1.82 Average daily count of CS indicators
Standard Deviation 1.03
|
1.65 Average daily count of CS indicators
Standard Deviation .97
|
1.65 Average daily count of CS indicators
Standard Deviation .80
|
1.71 Average daily count of CS indicators
Standard Deviation .99
|
1.87 Average daily count of CS indicators
Standard Deviation 1.02
|
Adverse Events
No Intervention, No Intervention (AA)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
No Intervention, Attention-Control Texts (AB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention, CBT Texts (AC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention-Control Texts, No Intervention (BA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention-Control Texts, Attention-Control Texts (BB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention-Control Texts, CBT Texts (BC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CBT Texts, No Intervention (CA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CBT Texts, Attention-Control Texts (CB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Intervention, No Intervention (AA)
n=40 participants at risk
Participants do not receive text messages during Interval 2 or Interval 3.
|
No Intervention, Attention-Control Texts (AB)
n=38 participants at risk
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.
|
No Intervention, CBT Texts (AC)
n=76 participants at risk
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
CBT Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).
|
Attention-Control Texts, No Intervention (BA)
n=40 participants at risk
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.
|
Attention-Control Texts, Attention-Control Texts (BB)
n=40 participants at risk
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.
|
Attention-Control Texts, CBT Texts (BC)
n=80 participants at risk
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
CBT Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).
Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.
|
CBT Texts, No Intervention (CA)
n=80 participants at risk
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
CBT Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).
|
CBT Texts, Attention-Control Texts (CB)
n=80 participants at risk
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
CBT Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).
Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Death
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
|
0.00%
0/38 • Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
|
0.00%
0/76 • Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
|
0.00%
0/40 • Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
|
0.00%
0/40 • Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
|
0.00%
0/80 • Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
|
0.00%
0/80 • Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
|
0.00%
0/80 • Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Dominic Parrott, Distinguished University Professor of Psychology
Georgia State University
Phone: +1 (404) 413-6287
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place