Trial Outcomes & Findings for Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms (NCT NCT05407935)
NCT ID: NCT05407935
Last Updated: 2026-09-03
Results Overview
Minutes of physical activity weighted by intensity, expressed in metabolic equivalent (MET) minutes per week as determined by accelerometers (Actigraph \[model wGT3x-BT\]) worn during one-week periods.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Baseline; Post-Treatment (week 8); Month 6 (week 26)
Results posted on
2026-09-03
Participant Flow
Participants who were randomized into the study were counted as enrolled.
Participant milestones
| Measure |
Phase 1 ACTivity Group
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Baseline
STARTED
|
15
|
13
|
24
|
23
|
|
Baseline
COMPLETED
|
15
|
13
|
24
|
23
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Mid-Treatment (week 4)
STARTED
|
15
|
13
|
24
|
23
|
|
Mid-Treatment (week 4)
COMPLETED
|
14
|
12
|
24
|
23
|
|
Mid-Treatment (week 4)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Post-Treatment (week 8)
STARTED
|
14
|
12
|
24
|
23
|
|
Post-Treatment (week 8)
COMPLETED
|
14
|
10
|
24
|
22
|
|
Post-Treatment (week 8)
NOT COMPLETED
|
0
|
2
|
0
|
1
|
|
Month 3 (week 12)
STARTED
|
14
|
10
|
24
|
22
|
|
Month 3 (week 12)
COMPLETED
|
14
|
10
|
23
|
22
|
|
Month 3 (week 12)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Month 6 (week 26)
STARTED
|
14
|
10
|
23
|
22
|
|
Month 6 (week 26)
COMPLETED
|
11
|
9
|
21
|
21
|
|
Month 6 (week 26)
NOT COMPLETED
|
3
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Phase 1 ACTivity Group
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Mid-Treatment (week 4)
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Post-Treatment (week 8)
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
|
Month 3 (week 12)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Month 6 (week 26)
Lost to Follow-up
|
3
|
1
|
2
|
1
|
Baseline Characteristics
Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.13 Years
STANDARD_DEVIATION 12.65 • n=136 Participants
|
48.77 Years
STANDARD_DEVIATION 10.88 • n=136 Participants
|
45.83 Years
STANDARD_DEVIATION 9.30 • n=272 Participants
|
44.17 Years
STANDARD_DEVIATION 9.80 • n=60 Participants
|
45.29 Years
STANDARD_DEVIATION 10.42 • n=58 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
2 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
5 Participants
n=58 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
13 Participants
n=136 Participants
|
13 Participants
n=136 Participants
|
19 Participants
n=272 Participants
|
22 Participants
n=60 Participants
|
67 Participants
n=58 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=58 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=58 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=136 Participants
|
12 Participants
n=136 Participants
|
19 Participants
n=272 Participants
|
20 Participants
n=60 Participants
|
64 Participants
n=58 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=136 Participants
|
13 Participants
n=136 Participants
|
23 Participants
n=272 Participants
|
23 Participants
n=60 Participants
|
73 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: Baseline; Post-Treatment (week 8); Month 6 (week 26)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Minutes of physical activity weighted by intensity, expressed in metabolic equivalent (MET) minutes per week as determined by accelerometers (Actigraph \[model wGT3x-BT\]) worn during one-week periods.
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Accelerometry
Month 6 (week 26)
|
160.25 Minutes per week of MVPA
Standard Deviation 336.03
|
48.89 Minutes per week of MVPA
Standard Deviation 72.48
|
46.16 Minutes per week of MVPA
Standard Deviation 71.78
|
17.50 Minutes per week of MVPA
Standard Deviation 38.05
|
|
Accelerometry
Baseline
|
38.07 Minutes per week of MVPA
Standard Deviation 46.89
|
7.54 Minutes per week of MVPA
Standard Deviation 18.46
|
31.92 Minutes per week of MVPA
Standard Deviation 47.45
|
37.52 Minutes per week of MVPA
Standard Deviation 56.78
|
|
Accelerometry
Post-Treatment (week 8)
|
114.36 Minutes per week of MVPA
Standard Deviation 186.82
|
33.00 Minutes per week of MVPA
Standard Deviation 31.92
|
58.00 Minutes per week of MVPA
Standard Deviation 65.33
|
39.43 Minutes per week of MVPA
Standard Deviation 54.33
|
SECONDARY outcome
Timeframe: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)Population: The number analyzed in one or more rows differs from overall number analyzed because some participants failed to complete follow-up assessments.
Self-reported minutes of leisure time physical activity per week weighted by intensity.
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Self-report Physical Activity (Godin)
Mid-Treatment (week 4)
|
161.15 Minutes per week of MVPA
Standard Deviation 140.21
|
157.27 Minutes per week of MVPA
Standard Deviation 148.20
|
113.48 Minutes per week of MVPA
Standard Deviation 87.95
|
156.36 Minutes per week of MVPA
Standard Deviation 155.99
|
|
Self-report Physical Activity (Godin)
Month 6 (week 26)
|
187.73 Minutes per week of MVPA
Standard Deviation 307.99
|
111.67 Minutes per week of MVPA
Standard Deviation 149.79
|
108.81 Minutes per week of MVPA
Standard Deviation 121.28
|
64.05 Minutes per week of MVPA
Standard Deviation 77.13
|
|
Self-report Physical Activity (Godin)
Post-Treatment (week 8)
|
201.79 Minutes per week of MVPA
Standard Deviation 215.55
|
138.18 Minutes per week of MVPA
Standard Deviation 161.17
|
134.35 Minutes per week of MVPA
Standard Deviation 126.96
|
180.71 Minutes per week of MVPA
Standard Deviation 232.52
|
|
Self-report Physical Activity (Godin)
Month 3 (week 12)
|
188.46 Minutes per week of MVPA
Standard Deviation 188.74
|
113.50 Minutes per week of MVPA
Standard Deviation 120.28
|
133.81 Minutes per week of MVPA
Standard Deviation 189.10
|
191.00 Minutes per week of MVPA
Standard Deviation 307.16
|
|
Self-report Physical Activity (Godin)
Baseline
|
74.00 Minutes per week of MVPA
Standard Deviation 80.52
|
35.77 Minutes per week of MVPA
Standard Deviation 52.16
|
72.50 Minutes per week of MVPA
Standard Deviation 89.02
|
31.74 Minutes per week of MVPA
Standard Deviation 52.61
|
SECONDARY outcome
Timeframe: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Score on the Center for Epidemiological Studies Depression Scale (CES-D): CESD SCORE , 20 items (Range 0 to 60, higher score = higher depressive symptoms)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Self-reported Depression Symptoms (CES-D)
Baseline
|
21.13 Scores on a scale
Standard Deviation 9.21
|
22.85 Scores on a scale
Standard Deviation 9.02
|
22.88 Scores on a scale
Standard Deviation 8.88
|
23.83 Scores on a scale
Standard Deviation 9.36
|
|
Self-reported Depression Symptoms (CES-D)
Mid-Treatment (week 4)
|
16.46 Scores on a scale
Standard Deviation 5.95
|
15.45 Scores on a scale
Standard Deviation 6.98
|
18.74 Scores on a scale
Standard Deviation 10.31
|
20.82 Scores on a scale
Standard Deviation 13.10
|
|
Self-reported Depression Symptoms (CES-D)
Post-Treatment (week 8)
|
14.57 Scores on a scale
Standard Deviation 6.96
|
15.91 Scores on a scale
Standard Deviation 5.58
|
16.17 Scores on a scale
Standard Deviation 9.23
|
18.19 Scores on a scale
Standard Deviation 11.33
|
|
Self-reported Depression Symptoms (CES-D)
Month 3 (week 12)
|
13.92 Scores on a scale
Standard Deviation 7.63
|
15.40 Scores on a scale
Standard Deviation 6.95
|
18.67 Scores on a scale
Standard Deviation 11.80
|
18.60 Scores on a scale
Standard Deviation 11.07
|
|
Self-reported Depression Symptoms (CES-D)
Month 6 (week 26)
|
11.91 Scores on a scale
Standard Deviation 7.20
|
14.89 Scores on a scale
Standard Deviation 8.02
|
20.10 Scores on a scale
Standard Deviation 14.07
|
19.90 Scores on a scale
Standard Deviation 11.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Measures how a person's values align with physical activity: 5 items (Range 0 to 30, higher score=closer alignment between internal values and actions)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Physical Activity Values Clarification (Progress)
Baseline
|
17.60 Scores on a scale
Standard Deviation 5.79
|
15.15 Scores on a scale
Standard Deviation 5.58
|
14.22 Scores on a scale
Standard Deviation 5.64
|
14.83 Scores on a scale
Standard Deviation 6.35
|
|
Physical Activity Values Clarification (Progress)
Mid-Treatment (week 4)
|
17.62 Scores on a scale
Standard Deviation 4.74
|
18.64 Scores on a scale
Standard Deviation 6.00
|
16.95 Scores on a scale
Standard Deviation 6.88
|
17.70 Scores on a scale
Standard Deviation 5.30
|
|
Physical Activity Values Clarification (Progress)
Post-Treatment (week 8)
|
19.14 Scores on a scale
Standard Deviation 5.30
|
18.36 Scores on a scale
Standard Deviation 4.78
|
16.90 Scores on a scale
Standard Deviation 7.11
|
18.48 Scores on a scale
Standard Deviation 5.23
|
|
Physical Activity Values Clarification (Progress)
Month 3 (week 12)
|
19.54 Scores on a scale
Standard Deviation 6.60
|
19.60 Scores on a scale
Standard Deviation 5.89
|
17.86 Scores on a scale
Standard Deviation 5.21
|
17.20 Scores on a scale
Standard Deviation 6.54
|
|
Physical Activity Values Clarification (Progress)
Month 6 (week 26)
|
19.00 Scores on a scale
Standard Deviation 6.94
|
18.22 Scores on a scale
Standard Deviation 6.12
|
17.19 Scores on a scale
Standard Deviation 6.54
|
16.90 Scores on a scale
Standard Deviation 6.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Measures the extent to which a person can tolerate any distress associated with physical activity: 10 items (Range 10 to 70, higher score= greater acceptance)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Acceptance of Physical Activity-related Distress (Physical Activity Acceptance Questionnaire)
Baseline
|
40.87 Scores on a scale
Standard Deviation 11.80
|
42.00 Scores on a scale
Standard Deviation 10.98
|
42.78 Scores on a scale
Standard Deviation 9.06
|
38.58 Scores on a scale
Standard Deviation 8.12
|
|
Acceptance of Physical Activity-related Distress (Physical Activity Acceptance Questionnaire)
Mid-Treatment (week 4)
|
42.38 Scores on a scale
Standard Deviation 8.73
|
40.36 Scores on a scale
Standard Deviation 7.90
|
43.41 Scores on a scale
Standard Deviation 8.83
|
40.61 Scores on a scale
Standard Deviation 8.68
|
|
Acceptance of Physical Activity-related Distress (Physical Activity Acceptance Questionnaire)
Post-Treatment (week 8)
|
42.79 Scores on a scale
Standard Deviation 10.49
|
41.27 Scores on a scale
Standard Deviation 11.04
|
45.19 Scores on a scale
Standard Deviation 8.85
|
42.09 Scores on a scale
Standard Deviation 10.76
|
|
Acceptance of Physical Activity-related Distress (Physical Activity Acceptance Questionnaire)
Month 3 (week 12)
|
42.31 Scores on a scale
Standard Deviation 11.47
|
42.90 Scores on a scale
Standard Deviation 9.45
|
42.14 Scores on a scale
Standard Deviation 11.16
|
44.65 Scores on a scale
Standard Deviation 8.49
|
|
Acceptance of Physical Activity-related Distress (Physical Activity Acceptance Questionnaire)
Month 6 (week 26)
|
40.73 Scores on a scale
Standard Deviation 11.83
|
42.56 Scores on a scale
Standard Deviation 11.40
|
41.76 Scores on a scale
Standard Deviation 10.51
|
43.33 Scores on a scale
Standard Deviation 9.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Measures the extent to which a person is motivated to engage in physical activity: 16 items Range ( -18 to 18, with a higher score=greater autonomous motivation to exercise)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Physical Activity-related Motivation (Treatment Self-Regulation Questionnaire - Exercise Version)
Baseline
|
7.17 Scores on a scale
Standard Deviation 4.19
|
8.52 Scores on a scale
Standard Deviation 3.02
|
8.19 Scores on a scale
Standard Deviation 3.64
|
8.21 Scores on a scale
Standard Deviation 4.85
|
|
Physical Activity-related Motivation (Treatment Self-Regulation Questionnaire - Exercise Version)
Mid-Treatment (week 4)
|
6.21 Scores on a scale
Standard Deviation 3.91
|
7.82 Scores on a scale
Standard Deviation 3.04
|
8.15 Scores on a scale
Standard Deviation 3.74
|
7.63 Scores on a scale
Standard Deviation 3.92
|
|
Physical Activity-related Motivation (Treatment Self-Regulation Questionnaire - Exercise Version)
Post-Treatment (week 8)
|
7.36 Scores on a scale
Standard Deviation 4.21
|
8.80 Scores on a scale
Standard Deviation 3.76
|
7.87 Scores on a scale
Standard Deviation 4.52
|
7.35 Scores on a scale
Standard Deviation 4.22
|
|
Physical Activity-related Motivation (Treatment Self-Regulation Questionnaire - Exercise Version)
Month 3 (week 12)
|
7.85 Scores on a scale
Standard Deviation 4.16
|
8.78 Scores on a scale
Standard Deviation 3.20
|
8.10 Scores on a scale
Standard Deviation 4.44
|
7.64 Scores on a scale
Standard Deviation 3.64
|
|
Physical Activity-related Motivation (Treatment Self-Regulation Questionnaire - Exercise Version)
Month 6 (week 26)
|
7.98 Scores on a scale
Standard Deviation 3.59
|
8.39 Scores on a scale
Standard Deviation 4.22
|
8.15 Scores on a scale
Standard Deviation 4.30
|
7.52 Scores on a scale
Standard Deviation 4.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Measures the extent to which a person can tolerate uncomfortable experiences: 5 items (Range 0 to 30, higher score =greater discomfort intolerance)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Discomfort Intolerance (Discomfort Intolerance Scale)
Baseline
|
13.73 Scores on a scale
Standard Deviation 4.37
|
9.54 Scores on a scale
Standard Deviation 5.43
|
14.62 Scores on a scale
Standard Deviation 6.70
|
8.83 Scores on a scale
Standard Deviation 4.96
|
|
Discomfort Intolerance (Discomfort Intolerance Scale)
Mid-Treatment (week 4)
|
14.08 Scores on a scale
Standard Deviation 4.17
|
10.82 Scores on a scale
Standard Deviation 5.90
|
13.17 Scores on a scale
Standard Deviation 6.28
|
10.18 Scores on a scale
Standard Deviation 4.97
|
|
Discomfort Intolerance (Discomfort Intolerance Scale)
Post-Treatment (week 8)
|
13.57 Scores on a scale
Standard Deviation 4.31
|
11.00 Scores on a scale
Standard Deviation 5.83
|
13.96 Scores on a scale
Standard Deviation 6.17
|
9.76 Scores on a scale
Standard Deviation 4.64
|
|
Discomfort Intolerance (Discomfort Intolerance Scale)
Month 3 (week 12)
|
14.77 Scores on a scale
Standard Deviation 2.59
|
10.90 Scores on a scale
Standard Deviation 6.03
|
14.62 Scores on a scale
Standard Deviation 7.11
|
8.55 Scores on a scale
Standard Deviation 4.71
|
|
Discomfort Intolerance (Discomfort Intolerance Scale)
Month 6 (week 26)
|
14.45 Scores on a scale
Standard Deviation 3.96
|
10.56 Scores on a scale
Standard Deviation 6.21
|
14.29 Scores on a scale
Standard Deviation 7.66
|
10.05 Scores on a scale
Standard Deviation 5.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Mid-Treatment (week 4); Post-Treatment (week 8); Month 3 (week 12); Month 6 (week 26)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Measures the extent to which a person enjoys physical activity: 18 items (Range 18 to 126, higher score = greater PA enjoyment)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Physical Activity Enjoyment (PACES Questionnaire)
Mid-Treatment (week 4)
|
85.15 Scores on a scale
Standard Deviation 17.63
|
75.40 Scores on a scale
Standard Deviation 25.55
|
78.96 Scores on a scale
Standard Deviation 18.20
|
76.00 Scores on a scale
Standard Deviation 21.75
|
|
Physical Activity Enjoyment (PACES Questionnaire)
Post-Treatment (week 8)
|
77.08 Scores on a scale
Standard Deviation 22.99
|
79.30 Scores on a scale
Standard Deviation 24.71
|
82.96 Scores on a scale
Standard Deviation 22.98
|
74.19 Scores on a scale
Standard Deviation 21.14
|
|
Physical Activity Enjoyment (PACES Questionnaire)
Month 3 (week 12)
|
80.08 Scores on a scale
Standard Deviation 23.73
|
76.30 Scores on a scale
Standard Deviation 28.06
|
79.05 Scores on a scale
Standard Deviation 21.09
|
78.25 Scores on a scale
Standard Deviation 20.59
|
|
Physical Activity Enjoyment (PACES Questionnaire)
Month 6 (week 26)
|
86.91 Scores on a scale
Standard Deviation 23.52
|
77.78 Scores on a scale
Standard Deviation 28.53
|
78.33 Scores on a scale
Standard Deviation 24.65
|
74.33 Scores on a scale
Standard Deviation 25.41
|
|
Physical Activity Enjoyment (PACES Questionnaire)
Baseline
|
80.20 Scores on a scale
Standard Deviation 19.28
|
77.31 Scores on a scale
Standard Deviation 21.30
|
74.20 Scores on a scale
Standard Deviation 21.66
|
71.52 Scores on a scale
Standard Deviation 23.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Start of Treatment (week 1)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Measures perceived credibility and expected benefits of treatment CREDIBILITY AND EXPECTANCY (Range 1 to 9, higher score= higher credibility)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=14 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=23 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Credibility and Expectancy Questionnaire
|
6.82 Scores on a scale
Standard Deviation 1.43
|
6.94 Scores on a scale
Standard Deviation 1.11
|
6.63 Scores on a scale
Standard Deviation 1.30
|
6.51 Scores on a scale
Standard Deviation 1.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Mid-Treatment (week 4); Post-Treatment (week 8)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Measures perceived cohesiveness of the treatment group: 13 items (Range 13 to 91, higher score = greater perceived positive group bonds)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=15 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Group Cohesion - Positive Bonds
Post-Treatment (week 8)
|
78.21 Scores on a scale
Standard Deviation 11.00
|
73.09 Scores on a scale
Standard Deviation 20.90
|
58.69 Scores on a scale
Standard Deviation 7.69
|
60.76 Scores on a scale
Standard Deviation 6.48
|
|
Group Cohesion - Positive Bonds
Mid-Treatment (week 4)
|
77.92 Scores on a scale
Standard Deviation 13.33
|
76.82 Scores on a scale
Standard Deviation 16.15
|
57.65 Scores on a scale
Standard Deviation 5.41
|
56.59 Scores on a scale
Standard Deviation 7.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-Treatment (week 8)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants failed to complete follow-up assessments.
Measures satisfaction with treatment: 8 items (frequency and % who at least mostly agree with recommending the program)
Outcome measures
| Measure |
Phase 1 ACTivity Group
n=14 Participants
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=11 Participants
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=23 Participants
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=21 Participants
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Client Satisfaction
|
12 Participants
|
9 Participants
|
22 Participants
|
20 Participants
|
Adverse Events
Phase 1 ACTivity Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Relaxercise Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2 ACTivity Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2 Relaxercise Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1 ACTivity Group
n=15 participants at risk
Phase 1 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 1 Relaxercise Group
n=13 participants at risk
Phase 1 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 ACTivity Group
n=24 participants at risk
Phase 2 of Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
Phase 2 Relaxercise Group
n=23 participants at risk
Phase 2 of Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)
|
|---|---|---|---|---|
|
Nervous system disorders
Fibromyalgia flare
|
6.7%
1/15 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/13 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/24 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/23 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory illnesses including COVID; Flu; Pneumonia; Asthma
|
0.00%
0/15 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/13 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
12.5%
3/24 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
4.3%
1/23 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
|
General disorders
Medication side effect
|
0.00%
0/15 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/13 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/24 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
8.7%
2/23 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
|
Musculoskeletal and connective tissue disorders
Minor toe injury
|
0.00%
0/15 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
7.7%
1/13 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/24 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/23 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
|
Eye disorders
Retina surgery
|
6.7%
1/15 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/13 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/24 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/23 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
|
Musculoskeletal and connective tissue disorders
Ankle sprains
|
6.7%
1/15 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
15.4%
2/13 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/24 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
0.00%
0/23 • Adverse event data was collected starting the date of consent and ending 7 days (non-serious adverse events) or 30 days (serious adverse events) after the 6-month follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place