Trial Outcomes & Findings for Compassion Training and Pain (NCT NCT01776645)

Results Overview

Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

Baseline and end of 9-week treatment protocol

Results posted on

2013-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Compassion Cultivation Training Compassion Cultivation Training Course - Participants with Chronic Pain	Significant Others Group Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
Overall Study STARTED	28	28
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	14	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compassion Training and Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Compassion Cultivation Training - Participants With Chronic Pa n=28 Participants Compassion Cultivation Training Course - Participants with Chronic Pain	Significant Others Group n=28 Participants Significant Others of Participants with Chronic Pain	Total n=56 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	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	49.61 years STANDARD_DEVIATION 10.59 • n=5 Participants	50.71 years STANDARD_DEVIATION 12.59 • n=7 Participants	50.16 years STANDARD_DEVIATION 11.75 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	7 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	21 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and end of 9-week treatment protocol

Population: 2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain

Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable

Outcome measures

Outcome measures
Measure	Compassion Cultivation Training n=12 Participants Compassion Cultivation Training Course - Participants with Chronic Pain
Change in Brief Pain Inventory	-1.46 units on a scale Standard Deviation 1.29

PRIMARY outcome

Timeframe: Baseline and end of 9-week treatment protocol

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to end of 9-week treatment protocol

Population: 2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain

Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes

Outcome measures

Outcome measures
Measure	Compassion Cultivation Training n=12 Participants Compassion Cultivation Training Course - Participants with Chronic Pain
Change in Brief Pain Inventory	-1.18 units on a scale Standard Deviation 1.94

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

As assessed by the Hospital Anxiety and Depression Scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

As assessed by Ryff's psychological well-being scales

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

As assessed by Neff's Self-Compassion Scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

Qualitative analysis of interviews

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

As Assessed by the PROMIS Anger Scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

As assessed by the PROMIS Social Isolation Scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

As assessed by PROMIS Global Health Scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

As assessed by Compassionate Love Scale adapted for close other

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 9-week treatment protocol

As assessed by Pommier's Compassion for Other's Scale

Outcome measures

Outcome data not reported

Adverse Events

Compassion Cultivation Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Significant Others Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sean Mackey

Stanford University

Phone: 650-724-2795

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place