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Staying Positive With Arthritis Study (SPA)

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ClinicalTrials.gov Identifier: NCT02223858
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : February 11, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Arthritis
Interventions Behavioral: Positive Activities (PA) Program
Behavioral: Attention Control (AC) Program
Enrollment 360
Recruitment Details Patients with symptomatic knee OA from Veterans Affairs (VA) medical centers in Pittsburgh and Philadelphia, Pennsylvania, were recruited by mail and telephone. Mailings were sent to patients meeting basic eligibility criteria based on their VA medical records Recruitment for the study ran from July 2015 to February 2017.
Pre-assignment Details Eligible patients attended an in-person baseline visit where they provided written informed consent, completed a staff-administered baseline assessment, and were randomized to a 6-week positive psychological intervention or neutral control program.
Arm/Group Title Positive Activities (PA) Attention Control (AC)
Hide Arm/Group Description Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation). Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
Period Title: Overall Study
Started 180 180
1-month Follow-up 156 150
3-month Follow-up 155 154
6-month Follow-up 156 154
Completed 156 154
Not Completed 24 26
Reason Not Completed
Death             1             1
Lost to Follow-up             6             11
Withdrawal by Subject             8             5
Refused             9             9
Arm/Group Title Positive Activities (PA) Attention Control (AC) Total
Hide Arm/Group Description Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation). Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6. Total of all reporting groups
Overall Number of Baseline Participants 180 180 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
95
  52.8%
100
  55.6%
195
  54.2%
>=65 years
85
  47.2%
80
  44.4%
165
  45.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Female
44
  24.4%
41
  22.8%
85
  23.6%
Male
136
  75.6%
139
  77.2%
275
  76.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
180
 100.0%
180
 100.0%
360
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
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
90
  50.0%
90
  50.0%
180
  50.0%
White
90
  50.0%
90
  50.0%
180
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 180 participants 180 participants 360 participants
180
 100.0%
180
 100.0%
360
 100.0%
Self-reported pain, physical functioning, and global assessment of pain at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Pain (Western Ontario McMaster Index;100=worst)* Number Analyzed 179 participants 178 participants 357 participants
50.24  (16.95) 47.42  (18.07) 48.83  (17.55)
Physical functioning (WOMAC; 100=worst)* Number Analyzed 177 participants 174 participants 351 participants
47.94  (17.73) 45.70  (18.53) 46.82  (18.14)
Global assessment (0-10; higher=worse)* Number Analyzed 180 participants 180 participants 360 participants
5.13  (2.14) 4.89  (1.96) 5.01  (2.06)
[1]
Measure Analysis Population Description:

For Pain and Physical Functioning, those who skipped >20% of items within a scale (>1 or >3 items, respectively) were excluded.

*WOMAC score range: 0-100; higher=worse symptoms. Global assessment was measured by participants considering their knee arthritis pain condition over the past week (0-10; higher=worse pain).

1.Primary Outcome
Title Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention
Hide Description Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.
Time Frame Baseline to 6 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.
Arm/Group Title Positive Activities (PA) Attention Control (AC)
Hide Arm/Group Description:
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
Overall Number of Participants Analyzed 180 180
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 179 participants 178 participants
50.24  (16.95) 47.42  (18.07)
1 month Number Analyzed 156 participants 149 participants
45.42  (18.58) 43.57  (20.93)
3 month Number Analyzed 155 participants 153 participants
43.87  (19.16) 43.32  (19.13)
6 month Number Analyzed 156 participants 153 participants
43.22  (20.97) 41.59  (19.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Positive Activities (PA), Attention Control (AC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.
Statistical Test of Hypothesis P-Value 0.791
Comments [Not Specified]
Method Mixed Models Analysis
Comments All models adjusted for site.
2.Primary Outcome
Title Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention
Hide Description Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.
Time Frame Baseline to 6 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.
Arm/Group Title Positive Activities (PA) Attention Control (AC)
Hide Arm/Group Description:
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
Overall Number of Participants Analyzed 180 180
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 177 participants 174 participants
47.94  (17.73) 45.70  (18.53)
1 month Number Analyzed 156 participants 142 participants
44.61  (19.81) 43.08  (20.97)
3 month Number Analyzed 153 participants 147 participants
43.39  (19.01) 43.32  (19.80)
6 month Number Analyzed 152 participants 148 participants
43.89  (20.02) 41.91  (20.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Positive Activities (PA), Attention Control (AC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.
Statistical Test of Hypothesis P-Value 0.880
Comments [Not Specified]
Method Mixed Models Analysis
Comments All models adjusted for site.
3.Other Pre-specified Outcome
Title Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention
Hide Description Self-reported global assessment of pain in the last week using a numeric rating scale. Global assessment of pain is on a scale of 0-10; higher scores mean worse pain.
Time Frame Baseline to 6 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs from the overall number analyzed.
Arm/Group Title Positive Activities (PA) Attention Control (AC)
Hide Arm/Group Description:
Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation).
Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
Overall Number of Participants Analyzed 180 180
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 180 participants 180 participants
5.13  (2.14) 4.89  (1.96)
1 month Number Analyzed 156 participants 150 participants
4.77  (2.16) 4.71  (2.21)
3 month Number Analyzed 155 participants 154 participants
4.83  (2.10) 4.69  (2.06)
6 month Number Analyzed 155 participants 153 participants
4.82  (2.27) 4.60  (2.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Positive Activities (PA), Attention Control (AC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power.
Statistical Test of Hypothesis P-Value 0.901
Comments [Not Specified]
Method Mixed Models Analysis
Comments All models adjusted for site.
Time Frame From baseline through 6-months post intervention.
Adverse Event Reporting Description All adverse events that occurred with the participants fell under the definition of "serious adverse events" as they were all hospitalizations. There are no "other (not including serious) adverse events" to report.
 
Arm/Group Title Positive Activities (PA) Attention Control (AC)
Hide Arm/Group Description Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation). Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6.
All-Cause Mortality
Positive Activities (PA) Attention Control (AC)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/180 (0.56%)      1/180 (0.56%)    
Show Serious Adverse Events Hide Serious Adverse Events
Positive Activities (PA) Attention Control (AC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/180 (6.67%)      8/180 (4.44%)    
Cardiac disorders     
Hospitalizations unrelated to the study *  3/180 (1.67%)  3 2/180 (1.11%)  2
Endocrine disorders     
Hospitalizations unrelated to the study *  0/180 (0.00%)  0 1/180 (0.56%)  1
Gastrointestinal disorders     
Hospitalizations unrelated to the study *  3/180 (1.67%)  3 0/180 (0.00%)  0
General disorders     
Hospitalizations unrelated to the study *  4/180 (2.22%)  4 1/180 (0.56%)  1
Injury, poisoning and procedural complications     
Hospitalizations unrelated to the study *  0/180 (0.00%)  0 1/180 (0.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hospitalizations unrelated to the study *  1/180 (0.56%)  1 0/180 (0.00%)  0
Psychiatric disorders     
Hospitalizations unrelated to the study *  0/180 (0.00%)  0 1/180 (0.56%)  1
Renal and urinary disorders     
Hospitalizations unrelated to the study *  0/180 (0.00%)  0 1/180 (0.56%)  1
Surgical and medical procedures     
Hospitalizations unrelated to the study *  0/180 (0.00%)  0 1/180 (0.56%)  1
Vascular disorders     
Hospitalizations unrelated to the study *  1/180 (0.56%)  1 0/180 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Positive Activities (PA) Attention Control (AC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/180 (0.00%)      0/180 (0.00%)    
Included patients with knee osteoarthritis from 2 VA medical centers; did not assess pain conditions other than arthritis; adherence and outcomes were self-reported.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Leslie R.M. Hausmann
Organization: Veterans Affairs Pittsburgh Healthcare System
Phone: 412-360-2112
EMail: leslie.hausmann@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02223858     History of Changes
Other Study ID Numbers: IIR 13-080
First Submitted: August 18, 2014
First Posted: August 22, 2014
Results First Submitted: September 20, 2018
Results First Posted: February 11, 2019
Last Update Posted: April 3, 2019