Trial Outcomes & Findings for Enhancing Delivery of Problem Solving Therapy Using SmartPhone Technology (NCT NCT01891734)
NCT ID: NCT01891734
Last Updated: 2016-11-28
Results Overview
The 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse depression symptoms. The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse anxiety symptoms. The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse stress symptoms.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
6 weeks, 12 weeks
Results posted on
2016-11-28
Participant Flow
Participant milestones
| Measure |
Problem Solving Therapy-Moving Forward
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
|
Problem Solving Therapy
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
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|---|---|---|
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Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Delivery of Problem Solving Therapy Using SmartPhone Technology
Baseline characteristics by cohort
| Measure |
Problem Solving Therapy-Moving Forward
n=17 Participants
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
|
Problem Solving Therapy
n=16 Participants
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
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Total
n=33 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
45.12 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
48.25 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
46.64 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Depression Anxiety and Stress Scale (DASS)-Depression
|
8.24 units on a scale
STANDARD_DEVIATION 4.87 • n=5 Participants
|
9.25 units on a scale
STANDARD_DEVIATION 6.05 • n=7 Participants
|
8.73 units on a scale
STANDARD_DEVIATION 5.41 • n=5 Participants
|
|
Depression Anxiety and Stress Scale (DASS)-Anxiety
|
6.65 units on a scale
STANDARD_DEVIATION 4.51 • n=5 Participants
|
7.13 units on a scale
STANDARD_DEVIATION 5.83 • n=7 Participants
|
6.88 units on a scale
STANDARD_DEVIATION 5.11 • n=5 Participants
|
|
Depression Anxiety and Stress Scale (DASS)-Stress
|
11.00 units on a scale
STANDARD_DEVIATION 4.03 • n=5 Participants
|
11.19 units on a scale
STANDARD_DEVIATION 5.75 • n=7 Participants
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11.09 units on a scale
STANDARD_DEVIATION 4.86 • n=5 Participants
|
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Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score
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36.98 units on a scale
STANDARD_DEVIATION 5.65 • n=5 Participants
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34.83 units on a scale
STANDARD_DEVIATION 6.07 • n=7 Participants
|
35.94 units on a scale
STANDARD_DEVIATION 5.87 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks, 12 weeksThe 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse depression symptoms. The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse anxiety symptoms. The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse stress symptoms.
Outcome measures
| Measure |
Problem Solving Therapy-Moving Forward
n=17 Participants
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
|
Problem Solving Therapy
n=16 Participants
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
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|---|---|---|
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Depression Anxiety and Stress Scale (DASS)
DASS-Depression week 6
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6.14 units on a scale
Standard Deviation 5.76
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5.23 units on a scale
Standard Deviation 5.15
|
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Depression Anxiety and Stress Scale (DASS)
DASS-Anxiety week 6
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7.21 units on a scale
Standard Deviation 4.53
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5.62 units on a scale
Standard Deviation 4.59
|
|
Depression Anxiety and Stress Scale (DASS)
DASS-Stress week 6
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11.29 units on a scale
Standard Deviation 6.59
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8.23 units on a scale
Standard Deviation 5.31
|
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Depression Anxiety and Stress Scale (DASS)
DASS-Depression week 12
|
6.14 units on a scale
Standard Deviation 5.76
|
5.23 units on a scale
Standard Deviation 5.15
|
|
Depression Anxiety and Stress Scale (DASS)
DASS-Anxiety week 12
|
7.21 units on a scale
Standard Deviation 4.53
|
5.62 units on a scale
Standard Deviation 4.59
|
|
Depression Anxiety and Stress Scale (DASS)
DASS-Stress week12
|
11.29 units on a scale
Standard Deviation 6.59
|
8.23 units on a scale
Standard Deviation 5.31
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SECONDARY outcome
Timeframe: 6 weeks, 12 weeksPopulation: These data include all participants who completed the 6-week follow-up assessment. Two participants from the PST-MF group did not complete the 6-week follow-up.
The 12-item Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score is rated on a 0-100 scale. Higher scores represent better mental health functioning.
Outcome measures
| Measure |
Problem Solving Therapy-Moving Forward
n=15 Participants
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
|
Problem Solving Therapy
n=16 Participants
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
|
|---|---|---|
|
Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score
SF-12 V-Mental Composite Score 6 weeks
|
40.00 units on a scale
Standard Deviation 6.77
|
37.19 units on a scale
Standard Deviation 7.50
|
|
Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score
SF-12 V Mental Composite Score 12 weeks
|
39.92 units on a scale
Standard Deviation 8.93
|
40.15 units on a scale
Standard Deviation 10.89
|
SECONDARY outcome
Timeframe: 6 weeksThe 8-item Client Satisfaction Questionnaire (CSQ-8) is rated on an 8-32 scale. Higher scores represent greater satisfaction with the intervention.
Outcome measures
| Measure |
Problem Solving Therapy-Moving Forward
n=17 Participants
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
|
Problem Solving Therapy
n=16 Participants
Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
|
|---|---|---|
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Client Satisfaction Questionnaire (CSQ-8)
|
27.87 units on a scale
Standard Deviation 3.36
|
29.06 units on a scale
Standard Deviation 2.62
|
Adverse Events
Problem Solving Therapy Plus Moving Forward (PST-MF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Problem Solving 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
Kathleen Grubbs
Department of Veterans Affairs San Diego
Phone: 808-383-9757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place