Trial Outcomes & Findings for Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas (NCT NCT03429166)

NCT ID: NCT03429166

Last Updated: 2025-04-25

Results Overview

Clinician Administered PTSD Scale for the Diagnostic Statistical Manual Fifth Edition (DSM-5) (CAPS-5) Total Severity CAPS-5 is a clinician administered interview which assesses DSM-5 symptom severity and diagnosis. The measure includes 20 items rated on a 5-point Likert scale which ranges from 0 to 80 where higher scores mean worse outcomes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 204 participants
• Primary outcome timeframe: Baseline, 16, 24 and 32 weeks
• Results posted on: 2025-04-25

Participant Flow

Of 305 candidates who completed screens, 204 completed baseline and 161 met study criteria and were randomized.

Participant milestones

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy PCT , a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment
Overall Study STARTED	79	82
Overall Study COMPLETED	66	70
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas

Baseline characteristics by cohort

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation n=79 Participants STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy n=82 Participants Present Centered Therapy (PCT) a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment	Total n=161 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	79 Participants n=5 Participants	82 Participants n=7 Participants	161 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	82 Participants n=7 Participants	161 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	48 Participants n=7 Participants	93 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	79 Participants n=5 Participants	82 Participants n=7 Participants	161 Participants n=5 Participants
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity	41.74 units on a scale STANDARD_DEVIATION 11.88 • n=5 Participants	43.06 units on a scale STANDARD_DEVIATION 11.43 • n=7 Participants	42.41 units on a scale STANDARD_DEVIATION 11.70 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 16, 24 and 32 weeks

Population: Intent to Treat Analysis is complete for 16 weeks (immediately posttreatment) and 24 weeks (2 month follow-up) and 32 weeks (4 month follow-up)

Clinician Administered PTSD Scale for the Diagnostic Statistical Manual Fifth Edition (DSM-5) (CAPS-5) Total Severity CAPS-5 is a clinician administered interview which assesses DSM-5 symptom severity and diagnosis. The measure includes 20 items rated on a 5-point Likert scale which ranges from 0 to 80 where higher scores mean worse outcomes.

Outcome measures

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation n=79 Participants STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy n=82 Participants PCT , a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment
Clinician Assessed Severity of PTSD Baseline (week 0)	41.74 score on a scale Standard Error 11.88	43.06 score on a scale Standard Error 11.43
Clinician Assessed Severity of PTSD Post-treatment (week 16)	27.78 score on a scale Standard Error 7.69	34.00 score on a scale Standard Error 7.47
Clinician Assessed Severity of PTSD 2-Month Follow-Up (week 24)	28.88 score on a scale Standard Error 7.87	34.05 score on a scale Standard Error 7.64
Clinician Assessed Severity of PTSD 4-Month Follow-Up (week 32)	29.98 score on a scale Standard Error 7.87	34.10 score on a scale Standard Error 7.64

SECONDARY outcome

Timeframe: Baseline, 8, 16, 24 and 32 weeks

PTSD Checklist for DSM-5 (PCL-5) is a 20 item measure with a Likert scale from 0 to 4. Possible total scores range from 0 to 80, where higher scores indicate more severe symptoms.

Outcome measures

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation n=79 Participants STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy n=82 Participants PCT , a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment
PTSD Symptom Severity (Self-Report) Baseline (week 0)	47.52 score on a scale Standard Error 7.43	49.12 score on a scale Standard Error 7.23
PTSD Symptom Severity (Self-Report) Midtreatment (week 8)	38.17 score on a scale Standard Error 9.09	41.88 score on a scale Standard Error 8.80
PTSD Symptom Severity (Self-Report) Posttreatment (week 16)	28.82 score on a scale Standard Error 9.09	34.64 score on a scale Standard Error 8.80
PTSD Symptom Severity (Self-Report) 2-month Follow-Up (week 24)	30.36 score on a scale Standard Error 9.20	36.57 score on a scale Standard Error 8.89
PTSD Symptom Severity (Self-Report) 4-month Follow-up (week 32)	31.90 score on a scale Standard Error 9.20	38.49 score on a scale Standard Error 8.89

SECONDARY outcome

Timeframe: Baseline, 8, 16, 24 and 32 weeks

Interpersonal Support Evaluation List -12 (ISEL-12) is a 12 item measure of social support with a Likert scale from 0 to 3. Possible total scores range from 0 to 120 with higher scores indicate greater perceived support.

Outcome measures

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation n=79 Participants STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy n=82 Participants PCT , a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment
Social Support Baseline (week 0)	68.16 score on a scale Standard Error 9.81	65.49 score on a scale Standard Error 9.55
Social Support Midtreatment (week 8)	72.30 score on a scale Standard Error 11.77	66.92 score on a scale Standard Error 11.42
Social Support Posttreatment (week 16)	76.44 score on a scale Standard Error 11.77	68.34 score on a scale Standard Error 11.42
Social Support 2-Month Follow-Up (week 24)	74.65 score on a scale Standard Error 11.90	68.01 score on a scale Standard Error 11.52
Social Support 4-Month Follow-Up (week 32)	72.86 score on a scale Standard Error 11.90	67.67 score on a scale Standard Error 11.52

SECONDARY outcome

Timeframe: Baseline, 8, 16, 24 and 32 weeks

Difficulties in Emotion Regulation Scale-36 (DERS-36) is a 36 item self-report measure of emotion regulation difficulties that is rated on a scoe of 0 to 5. Possible total scores range from 0 to 180 where higher scores indicate more difficulties.

Outcome measures

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation n=79 Participants STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy n=82 Participants PCT , a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment
Emotion Regulation Difficulties Baseline (week 0)	107.31 score on a scale Standard Error 9.92	109.51 score on a scale Standard Error 9.37
Emotion Regulation Difficulties Midtreatment (week 8)	96.79 score on a scale Standard Error 11.95	103.48 score on a scale Standard Error 11.61
Emotion Regulation Difficulties Posttreatment (week 16)	86.26 score on a scale Standard Error 11.95	97.45 score on a scale Standard Error 11.61
Emotion Regulation Difficulties 2-Month Follow-Up (week 24)	85.67 score on a scale Standard Error 12.14	97.63 score on a scale Standard Error 11.76
Emotion Regulation Difficulties 4-Month Follow-Up (week 32)	85.07 score on a scale Standard Error 12.14	97.80 score on a scale Standard Error 11.76

SECONDARY outcome

Timeframe: Baseline, 8, 16, 24 and 32 weeks

Beck Depression Inventory-11 (BDI-11) is an 11 item measure. Possible total scores can range from 0 to 63 where higher scores mean more depression.

Outcome measures

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation n=79 Participants STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy n=82 Participants PCT , a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment
Depression Baseline (week 0)	35.50 score on a scale Standard Error 4.97	36.13 score on a scale Standard Error 4.84
Depression Midtreatment (week 8)	29.27 score on a scale Standard Error 6.14	32.10 score on a scale Standard Error 5.95
Depression Posttreatment (week 16)	23.04 score on a scale Standard Error 6.14	28.06 score on a scale Standard Error 5.95
Depression 2-Month Follow-Up (Week 24)	23.78 score on a scale Standard Error 6.24	28.37 score on a scale Standard Error 6.03
Depression 4-Month Follow-Up (week 32)	24.51 score on a scale Standard Error 6.24	28.67 score on a scale Standard Error 6.03

SECONDARY outcome

Timeframe: Baseline, 8, 16, 24 and 32 weeks

Posttraumatic Maladaptive Belief Scale (PMBS) is a 15 item self-report measure. Responses are measured on a 7-point scale from 0 to 6. Possible total scores range from 0 to 90 where higher scored indicate strong maladaptive beliefs.

Outcome measures

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation n=79 Participants STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy n=82 Participants PCT , a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment
Posttraumatic Maladaptive Beliefs Baseline (week 0)	46.73 score on a scale Standard Error 13.15	48.44 score on a scale Standard Error 14.56
Posttraumatic Maladaptive Beliefs Midtreatment (week 8)	41.79 score on a scale Standard Error 7.72	45.99 score on a scale Standard Error 7.49
Posttraumatic Maladaptive Beliefs Posttreatment (week 16)	36.74 score on a scale Standard Error 7.72	43.01 score on a scale Standard Error 7.49
Posttraumatic Maladaptive Beliefs 2-Month Follow-Up (week 24)	37.47 score on a scale Standard Error 7.80	42.87 score on a scale Standard Error 7.55
Posttraumatic Maladaptive Beliefs 4-Month Follow-Up (week 32)	38.19 score on a scale Standard Error 7.80	42.73 score on a scale Standard Error 7.55

SECONDARY outcome

Timeframe: Baseline, 8, 16, 24 and 32 weeks

The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Life Activities Subscale is an 8 item measure of how difficult daily life activities are to complete. Responses range from 0 to 4. Possible total scores range from 0 to 32 with higher scores indicating greater difficulties.

Outcome measures

Measure	STAIR Stands for Skills Training in Affective and Interpersonal Regulation n=79 Participants STAIR stands for Skills Training in Affective and Interpersonal Regulation a non-trauma-focused treatment Skills Training in Affective and Interpersonal Regulation: A non-trauma-focused treatment	Present Centered Therapy n=82 Participants PCT , a non-trauma-focused treatment Present Centered Therapy: A non-trauma-focused treatment
Psychosocial Functioning Baseline (week 0)	14.88 score on a scale Standard Error 3.48	15.10 score on a scale Standard Error 3.39
Psychosocial Functioning Midtreatment (week 8)	13.07 score on a scale Standard Error 4.31	13.47 score on a scale Standard Error 4.18
Psychosocial Functioning Posttreatment (week 16)	11.26 score on a scale Standard Error 4.31	11.84 score on a scale Standard Error 4.18
Psychosocial Functioning 2-Month Follow-Up (week 24)	11.61 score on a scale Standard Error 4.37	12.32 score on a scale Standard Error 4.23
Psychosocial Functioning 4-Month Follow-Up (week 32)	11.96 score on a scale Standard Error 4.37	12.80 score on a scale Standard Error 4.23

Adverse Events

STAIR Stands for Skills Training in Affective and Interpersonal Regulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Present Centered Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Borsky, PhD

VA HSR&D

Phone: 2024435739

Email: amanda.borsky@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place