Integrated behavioral self-management simultaneously targeting obesity and pain: the STOP trial
Background
Primary aim
Secondary aims
Methods and design
Ethical considerations
Study design
Research setting
Study population
Inclusion criteria
Exclusion criteria
Recruitment and screening procedures
Baseline and randomization
Treatment approaches
Intervention sessions
Standard Care Weight Loss (SCW) | Standard Care Pain Management (SCP) | STOP | |
---|---|---|---|
0 | Baseline Goals Setting | ||
1 | Psychoeducation about Weight; Introduction to Calorie Restriction and Self-Monitoring | Psychoeducation about Pain and Theories about Pain | Psychoeducation about Pain and Weight, Self-monitoring |
2 | Review of Calorie Counting, Nutrition Information, and Self-Monitoring | Pleasant Activity Scheduling | Review of Calorie Counting, Nutrition Information, and Self-monitoring |
3 | Stimulus Control and Dietary Behaviors | Understanding Automatic Thoughts and Health, Identifying Automatic Thoughts | Activities Reframed: Pleasant Activities and Physical Activity |
4 | Guiding Thoughts, Motivation, and Problem Solving | Evaluating and Challenging Automatic Thoughts | Time-based Activity Pacing |
5 | Physical Activity | Cognitive Restructuring: Identifying ‘Shoulds’ and Core Beliefs | Stimulus Control, Dietary Behaviors |
6 | Reviewing Weight and Primary Goals | Cognitive Restructuring: Identifying and Challenging Core Beliefs | Thoughts and Health: Identifying Automatic Thoughts and Cognitive Errors |
7 | Identifying and Modifying Automatic Thoughts | Relaxation Techniques | Evaluating and Challenging Automatic Thoughts |
8 | Evaluating and Challenging Automatic Thoughts | Time-based Activity Pacing | Cognitive Restructuring: Identifying and Challenging “Should” Beliefs |
9 | Targeting Thoughts, Feelings, and Behaviors that Influence Diet and Activity | Stress Management and Coping Self-Statements | Cognitive Restructuring: Identifying and Challenging Core Beliefs |
10 | Relaxation Techniques | Assertiveness, Anger Management, Communication | Relaxation Techniques |
11 | Review and Planning for Weight Maintenance | Review, Relapse Prevention, Flare Up Planning | Review, Weight Maintenance, Relapse Prevention, Flare Up Planning |
Standard care weight loss intervention
Standard care chronic pain intervention
STOP intervention
Quantitative data collection
Measures | Baseline | Week 1 & 11 | Wks 2-10 | 3, 6, 12-month follow-up |
---|---|---|---|---|
Health Behavior/Medical/Pain History Questionnaire | X | X | ||
Pain and eating behavior
| ||||
West Haven Yale Multidimensional Pain Inventory (WHYMPI) [30] | X | X | ||
Survey of Pain Attitudes (SOPA) [31] | X | X | ||
Arthritis Self-Efficacy Scale (ASES) [32] | X | X | ||
Pain Catastrophizing Scale (PCS) [33] | X | X | ||
Dutch Eating Behavior Questionnaire (DEBQ) [34] | X | X | ||
Stage of change short forms
| ||||
Exercise [35] | X | X | ||
Weight [36] | X | X | ||
Pain [37] | X | X | ||
Psychological measures
| ||||
Quality of Life (SF-36) [38] | X | X | ||
Primary Care Evaluation of Mental Disorders (PRIME-MD) [39] | X | X | ||
Positive and Negative Affect Scale (PANAS) [40] | X | X | X | X |
Treatment credibility and preference
| ||||
Therapy Evaluation Form [41] | X | |||
Treatment Preference Questionnaire | X |
Sample size and power estimation
Quantitative data analysis
Qualitative data collection
Type | Question |
---|---|
Rapport, priorities, preference | 1. Why were you interested in participating in this study? |
2. Why did you decide to participate after you learned about the study details? | |
3. What were your thoughts when you found out you were randomized to [pain, weight loss, integrated intervention]? | |
4. How did your view of the intervention change as you progressed through the study? | |
Experience | 5. Describe for me the most important or useful ways to manage [weight loss, pain, both] that you learned from your sessions? |
6. What were some things covered in the sessions that were not useful for you? | |
7. What do you do differently now based on what you’ve learned during treatment? | |
8. How did you feel about the weekly homework assignments? | |
9. How will you continue to use the skills you learned? | |
Experience, reflection, priorities | 10. Why do you think you had the outcome you did in treatment [lose weight, experience less pain, both, neither]? |
11. What is the most important thing healthcare providers need to know about treating someone with comorbid pain and overweight? | |
12. What do you think are the most important outcomes for treatment? For you, what would define a ‘good outcome’ to a treatment such as this? |