Introduction
Methods
Study design
Setting and participants
Recruitment
Randomization
Data collection
Interventions
Focused Acceptance and Commitment Therapy treatment
Enhanced treatment as usual
Sample size
Primary outcome measures (quantitative data)
Feasibility
Acceptability
Effectiveness
Secondary outcome measures
Measures of participants’ experiences (qualitative data)
Analyses
Aim 1 analyses
Aim 2 analyses
Aim 3 qualitative analyses
Results
Sample characteristics
FACT N = 13 | TAU N = 13 | Total N = 26 | |
---|---|---|---|
Gender | |||
Female | 61.5% (8) | 46.2% (6) | 53.8% (14) |
Mean age (range) | 54 (26–79) | 50 (32–66) | 52 (26–79) |
Ethnicity | |||
Hispanic/Latino | 46.2% (6) | 46.2% (6) | 46.2% (12) |
Non-Hispanic/Latino | 53.8% (7) | 53.8% (7) | 53.8% (14) |
Race | |||
White | 76.9% (10) | 92.3% (12) | 84.6% (22) |
Other | 15.4% (2) | 7.7% (1) | 11.5% (3) |
Asian | 7.7% (1) | 0.0% (0) | 3.8% (1) |
Relationship status | |||
Married/living with partner | 84.6% (11) | 53.8% (7) | 69.2% (18) |
Single/divorced/widowed | 7.7% (1) | 30.8% (4) | 19.2% (5) |
In a relationship | 7.7% (1) | 15.4% (2) | 11.5% (3) |
Education | |||
GED/High School diploma | 7.7% (1) | 23.1% (3) | 15.4% (4) |
Some college/ Associate’s degree | 30.8% (4) | 23.1% (3) | 27.0% (7) |
4-year college degree | 38.4% (5) | 30.8% (4) | 34.6% (9) |
Master’s degree | 23.1% (3) | 23.1% (3) | 23.0% (6) |
Annual household income | |||
< $10,000 | 0.0% (0) | 7.7% (1) | 3.8% (1) |
$10,000-20,000 | 15.4% (2) | 7.7% (1) | 11.5% (3) |
$20,000–$50,000 | 30.8% (4) | 53.8% (7) | 42.3% (11) |
$45,000-100,000 | 30.8% (4) | 15.4% (2) | 23.0% (6) |
> $100,000 | 23.1% (3) | 15.4% (2) | 19.2% (5) |
Pain Type | |||
Fibromyalgia | 15.4% (2) | 7.7% (1) | 11.5% (3) |
Musculoskeletal | 46.1% (6) | 53.8% (7) | 50.0% (13) |
Multi-type | 23.1% (3) | 30.8% (4) | 27.0% (7) |
Other | 15.4% (2) | 7.7% (1) | 11.5% (3) |
Pain Site | |||
Neck/Head | 15.4% (2) | 0.0% (0) | 7.7% (2) |
Upper Body | 30.8% (4) | 7.7% (1) | 19.2% (5) |
Lower Body | 7.7% (1) | 23.1% (3) | 15.4% (4) |
Back/Lower Back | 7.7% (1) | 15.4% (2) | 11.5% (3) |
Multi-Site/Whole Body | 38.4% (5) | 53.8% (7) | 46.4% (12) |
Mean (SD) | Mean (SD) | p | |
Pain duration (years) | 9.72 (7.38) | 14.03 (13.07) | 0.310 |
Pain severity, past 2 wks (NRS) | 6.54 (1.90) | 7.08 (1.55) | 0.436 |
Physical disability (ODI) | 38.02 (16.76) | 43.57 (13.62) | 0.363 |
Pain acceptance (CPAQ) | 61.38 (15.08) | 60.38 (18.53) | 0.881 |
Values/activities discrepancy (CPVI) | 1.73 (0.71) | 2.34 (0.77) | 0.045 |
Primary analyses
Feasibility
Acceptability
FACT-CP (mean; range; SD) | ETAU (mean; range; SD) | |
---|---|---|
Satisfaction with treatment | 75% (5; 1–7; 1.85) | 88% (5.63; 4–7; 1.19) |
Perceived benefit of treatment | 88% (5.5; 2–7; 1.6) | 75% (5; 1–7; 1.93) |
Ease of learning pain management | 88% (5.5, 1–7; 2) | 88% (5.9; 3–7; 1.64) |
Would recommend to others | 100% (6.63; 6–7; 0.52) | 88% (6.13; 2–7; 1.81) |
Effectiveness of FACT-CP intervention
Variables & Arms | Baseline M (SD) | Post-treatment (Booster, 12 wks) M (SD) | p | d (95% CL) | 6-month Follow-up M (SD) | p | d (95% CL) |
---|---|---|---|---|---|---|---|
Acceptance (CPAQ) | |||||||
FACT-CP Arm (n = 13) | 61.39 (15.1) | 61.7 (18) | 0.512 | 0.18 (− 0.37, 0.73) | 70.6 (17.52) | 0.049 | 0.55 (0.00, 1.10) |
ETAU Arm (n = 13) | 60.39 (18.53) | 56.23 (21.37) | 0.147 | −0.40 (− 0.95, 0.15) | 55.39 (19.7) | 0.082 | − 0.49 (− 1.04, 0.06) |
Between-group differences | – | – | 0.145 | 0.58 (− 0.20, 1.35) | – | 0.009 | 1.04 (0.26, 1.82) |
Disability (ODI) | |||||||
FACT-CP Arm (n = 13) | 38.02 (16.76) | 28.89 (18.25) | 0.002 | −0.89 (−1.44, − 0.34) | 31.53 (17.14) | 0.023 | −0.64 (− 1.19, − 0.09) |
ETAU Arm (n = 13) | 43.57 (13.62) | 38.12 (17.8) | 0.003 | − 0.84 (− 1.39, − 0.29) | 42.47.48 (20.60) | 0.55 | −0.17 (− 0.72, 0.38) |
Between-group differences | – | – | 0.675 | − 0.17 (− 0.94, 0.61) | – | 0.196 | −0.51 (− 1.29, 0.27) |
Values/Action Discrepancy (CPVI) | |||||||
FACT-CP Arm (n = 13) | 1.73 (0.71) | 0.87 (0.87) | 0.0003 | − 1.04 (− 1.59, − 0.49) | 1.15 (0.85) | 0.013 | − 0.70 (− 1.25, − 0.15) |
ETAU Arm (n = 13) | 2.34 (0.77) | 1.52 (0.81) | 0.0009 | − 0.94 (− 1.49, − 0.39) | 1.90 (0.90) | 0.068 | −0.51 (− 1.06, 0.04) |
Between-group differences | – | – | 0.634 | − 0.19 (− 0.96, 0.59) | – | 0.545 | −0.24 (− 1.02, 0.54) |
Exploratory analyses
Secondary outcomes
Qualitative analysis of participant experiences
Domains | Themes & Exemplar Quotes | |
---|---|---|
FACT Arm Participants | ETAU Arm Participants | |
Best/Most Likeable Features | Learned to live with pain | Handouts as reminders of good pain management |
The [ACT] matrix – quite often, they [exercises & classes] were educational and revealing – about how I was thinking about handling the pain | Just having the info and written instructions and could study it and practice what was in there and there were some good ideas in there | |
Mindfulness and meditation | Neutral - information was not new or helpful | |
Trying to focus on other things other than the pain – breathe, meditate, all of it | Been kind of dealing with [pain] for a long time so a lot of these tips/techniques I already learned about – wasn’t really new | |
Small Groups | Great Research Assistant | |
I like that it was just 2 people in the class—more intimate/ personalized/ customized | [RA] was personable, remembered things – very flexible in scheduling | |
Worst/Most Disliked Features | Wanted greater dose | Ineffective intervention |
I wish I could have done more sessions. Need more practicing, more sessions | It was frustrating to just get the paper; just do breathing | |
Paperwork and questionnaires | Paperwork and questionnaires | |
Filling out the forms every time | I don’t know...filling out all the paperwork. Wasn’t that big a deal … just the same questions over and over | |
Nothing | Nothing | |
There wasn’t really anything I disliked … it was good, the mental learning as well as doing | [There was] nothing that I disliked. Thought it was good. | |
Changes in Thinking About or Managing Pain | Changed relationship with pain/how handle pain | Reinforced good self-management |
I know that pain isn’t always going to stop... you can learn to live with it using techniques...[the] mind is a powerful thing, so if you can help your mind to believe it, you can do | Improved a little bit. Made me give more thought to what I do and how I live. Doing prevention rather than treatment | |
Hope | Not much changed | |
There is a next chapter … this won’t go on forever … there are things I can do besides quit or give in | It was something that I was already using, I’m more of the type that would rather read up on it than sit at home and take meds, [so it] didn’t really affect me one way or another because I was doing it already | |
Impact on Quality of Life | Changed perspective | Motivation/accountability |
I was able to stop dwelling on pain and stop being sorry for myself, was able to look at things clearer | Making a choice every day [to follow goal] – I used to lay in bed a whole weekend. That subsided during the study. I had to think to myself, “do you want to be a 7 or a 1?!” on the questionnaires | |
Acquisition of tools to help live with pain | Being more active/using skills | |
[Mindfulness] helped me get rid of the thought process I was in | [I got] a little more active but at my own pace … I focused on a lot of relaxation and sleep. Normally I don’t focus on sleep as much as I need, don’t rest, get busy with projects and won’t let my body rest | |
No changes | ||
It didn’t really change | ||
Additional Feedback | Content of intervention | Benefits of research |
To me it was a good program and think it will help others as well | Happy to advance research. Even though I didn’t get what the other group got. [It was] still valuable | |
Thoughts on medication | Need for more clinical services | |
Meds aren’t everything, giving people strategies [is important], and different people need different things | People like me, we get lost | |
Process | ||
I was looking for excuses not to go places or do things. The intense sessions weekly – that was very helpful |