Trial Outcomes & Findings for Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain (NCT NCT01055639)
NCT ID: NCT01055639
Last Updated: 2016-08-12
Results Overview
The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland \& Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).
COMPLETED
PHASE2
126 participants
8 weeks
2016-08-12
Participant Flow
Participant milestones
| Measure |
In-person ACT
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
60
|
|
Overall Study
COMPLETED
|
45
|
31
|
|
Overall Study
NOT COMPLETED
|
21
|
29
|
Reasons for withdrawal
| Measure |
In-person ACT
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
11
|
|
Overall Study
Protocol Violation
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
11
|
Baseline Characteristics
Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain
Baseline characteristics by cohort
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThe primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland \& Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
Brief Pain Inventory-interference Subscale
|
5.3 units on a scale
Standard Deviation 2.4
|
5.8 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 8 weeksThe Brief Pain Inventory Short Form (BPI; Cleeland \& Ryan, 1994) includes a 4-item pain severity subscale measuring the level of pain over the past week on average, at its worst, at its least, and currently. This measure is recommended by the IMMPACT group as a pain assessment tool (Dworkin et al., 2005). Scores range from 0 (least pain severity) to 10 (most pain severity).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
Brief Pain Inventory-severity Subscale
|
5.2 units on a scale
Standard Deviation 1.7
|
5.7 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 8 weeksThe West Haven-Yale Multidimensional Pain Inventory (MPI; Kerns et al., 1985) contains 52 items forming 12 subscales. For this study, we used four subscales assessing various types of activities. Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items). The MPI has been used extensively in outcome research with heterogeneous samples of chronic pain patients, including veterans, and has demonstrated sensitivity to treatment change (Altmaier et al., 1992; Mikail et al., 1993). Individual items are rated on a 7-point Likert scale from 0-6, and subscales are scored by averaging items together. Therefore, the score for Part III, General Activity, is composed of an average of the 18 items in the Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items) subscales. The final score ranges from 0 (lowest level of activity) to 6 (highest level of activity).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
|
2.4 units on a scale
Standard Deviation 1.0
|
2.2 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 8 weeks6-item self-report measure of mental health-related quality of life. Subscale of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
SF-12 MCS
|
41.5 units on a scale
Standard Deviation 12.9
|
41.6 units on a scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 8 weeksPhysical health-related quality of life will be measured using the Physical Component Summary score of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
SF-12 PCS
|
32.6 units on a scale
Standard Deviation 9.3
|
30.9 units on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 8 weeksThe PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the scoring severity index. Scores range from 0 (lowest level of depressive symptoms) to 27 (highest level of depressive symptoms).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
Patient Health Questionnaire-9
|
9.6 units on a scale
Standard Deviation 6.3
|
10.2 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 8 weeksAnxiety will be assessed with the 20-item Pain Anxiety Symptoms Scale-Short Form (PASS-20; McCracken \& Dhingra, 2002). Pain anxiety captures fears patients associate with their symptoms, which are typically associated with the belief that their pain signals harm. High levels of pain anxiety compromise patient's activity levels, participation in rehabilitation, and performance on functional tests. The instrument is a valid and reliable measure of anxiety symptoms in pain populations (McCracken et al., 1996; Roelofs et al., 2004). The PASS-20 items are scored on a 6-point Likert scale and assess cognitive, escape/avoidance, fear, and physiological anxiety dimensions. Internal consistency is high and correlation between the short and long form is excellent (alpha=.81; r=.97). This measure has been recommended by the VA and demonstrated sensitivity to treatment in the pilot sample (National VA Pain Outcomes Working Group, 2003). Scores range from 0 (least anxiety) to 100 (most anxiety).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
Pain Anxiety Symptom Scale - 20
|
39.8 units on a scale
Standard Deviation 24.4
|
43.5 units on a scale
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: 8 weeksThe 17-item PTSD Checklist (Weathers et al., 1994) will be used to assess PTSD symptoms. In combat veterans, this questionnaire has high test-retest reliability (0.96) and validity as indicated by a kappa of 0.64 for diagnosis of PTSD using the SCID (Weathers et al., 1993). Scores range from 17 (low PTSD) to 85 (high PTSD).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
PTSD Checklist
|
42.7 units on a scale
Standard Deviation 17.2
|
42.5 units on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: 8 weeksThe 19-item Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) is the most commonly used measure of self-rated sleep quality, with good reliability (alpha = .83, test-retest = .85) and validity (kappa = 0.75) for distinguishing good and poor sleepers. A survey recently conducted by the IMMPACT group indicated that sleep is one of the domains most important to patients with chronic pain (Turk et al., 2008), and the PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients (Cole et al., 2007). Scores range from 0 (good sleep) to 42 (poor sleep).
Outcome measures
| Measure |
In-person ACT
n=66 Participants
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 Participants
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
|
11.8 units on a scale
Standard Deviation 4.6
|
11.8 units on a scale
Standard Deviation 4.1
|
Adverse Events
In-person ACT
Telehealth ACT
Serious adverse events
| Measure |
In-person ACT
n=66 participants at risk
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
Telehealth ACT
n=60 participants at risk
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
|
|---|---|---|
|
Psychiatric disorders
hospitalization
|
0.00%
0/66 • 8 weeks (duration of intervention)
|
1.7%
1/60 • Number of events 1 • 8 weeks (duration of intervention)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place