Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 5440 for:    veterans

Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01678196
Recruitment Status : Completed
First Posted : September 3, 2012
Results First Posted : February 24, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Conditions PTSD
Alcohol Abuse
Interventions Behavioral: VA-CRAFT
Other: Control
Enrollment 66
Recruitment Details Participants were partners of Veterans who had screened positive for PTSD or alcohol use disorders in prior surveys with the study team. Of 287 identified eligible partners, 190 were successfully reached and 66 consented to be in the study.
Pre-assignment Details  
Arm/Group Title VA-CRAFT Control
Hide Arm/Group Description

Family participants complete an on-line training course (VA-CRAFT) over a 3 month period

VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Period Title: Overall Study
Started 34 32
Completed 34 [1] 32 [1]
Not Completed 0 0
[1]
Primary outcome data was from the electronic medical record and was available for all participants.
Arm/Group Title VA-CRAFT Control Total
Hide Arm/Group Description

Family participants complete an on-line training course (VA-CRAFT) over a 3 month period

VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Total of all reporting groups
Overall Number of Baseline Participants 34 32 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
 100.0%
32
 100.0%
66
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
Female
34
 100.0%
32
 100.0%
66
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
American Indian or Alaska Native
0
   0.0%
1
   3.1%
1
   1.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
21
  61.8%
21
  65.6%
42
  63.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
13
  38.2%
10
  31.3%
23
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 32 participants 66 participants
34 32 66
1.Primary Outcome
Title Veteran Engagement in VA Mental Health Services
Hide Description Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.
Time Frame 3 months after initiation of the intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VA-CRAFT Control
Hide Arm/Group Description:

Family participants complete an on-line training course (VA-CRAFT) over a 3 month period

VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Overall Number of Participants Analyzed 34 32
Measure Type: Number
Unit of Measure: participants
4 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VA-CRAFT, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18
Hide Description Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).
Time Frame 3 months after initiation of the intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Group sample sizes are smaller than total sample sizes due to missing data.
Arm/Group Title VA-CRAFT Control
Hide Arm/Group Description:

Family participants complete an on-line training course (VA-CRAFT) over a 3 month period

VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Overall Number of Participants Analyzed 32 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.46  (0.52) 0.58  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VA-CRAFT, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA reflects change from Time 1 scores (entered as covariate) to Time 2 Scores.
3.Secondary Outcome
Title Family Functioning
Hide Description Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.
Time Frame 3 months after the initiation of the intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Sample sizes are smaller than the overall sample due to missing questionnaire data.
Arm/Group Title VA-CRAFT Control
Hide Arm/Group Description:

Family participants complete an on-line training course (VA-CRAFT) over a 3 month period

VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Overall Number of Participants Analyzed 32 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.92  (1.78) 5.75  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VA-CRAFT, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.743
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA results include Time 1 scores as a covariate, thus reflecting change over time
4.Secondary Outcome
Title Caregiver Burden
Hide Description Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).
Time Frame 3 months post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Sample sizes are smaller than total sample size due to missing questionnaire data.
Arm/Group Title VA-CRAFT Control
Hide Arm/Group Description:

Family participants complete an on-line training course (VA-CRAFT) over a 3 month period

VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Overall Number of Participants Analyzed 32 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.56  (0.49) 1.84  (0.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VA-CRAFT, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA reflects change for Time 1 values (entered as the covariate) to Time 2 values (entered as the DV)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VA-CRAFT Control
Hide Arm/Group Description

Family participants complete an on-line training course (VA-CRAFT) over a 3 month period

VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.

Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention

All-Cause Mortality
VA-CRAFT Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VA-CRAFT Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VA-CRAFT Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/32 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Christopher Erbes, PhD
Organization: Minneapolis VA Healthcare Service Center
Phone: 612-725-2000 ext 2125
Publications of Results:
Other Publications:
Tran T, Kuhn ER, Walser R, Drescher K. The relationship between religiosity, PTSD, and depressive symptoms in veterans in PTSD residential treatment. Journal of psychology and theology. 2012 Oct 1; 40(Winter 2012):313-322.
Kuhn ER, Landes S. Mental and Behavioral Health Apps for Service Members, Veterans, and Providers. Society for Media Psychology & Technology: The Amplifier. 2013 Apr 1; Spring/Summer(2013):8-10.
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01678196     History of Changes
Other Study ID Numbers: CRE 12-024
First Submitted: August 29, 2012
First Posted: September 3, 2012
Results First Submitted: January 27, 2016
Results First Posted: February 24, 2016
Last Update Posted: October 25, 2016