Trial Outcomes & Findings for Literacy-Adapted Psychosocial Treatments for Chronic Pain --- "Learning About Mastering/My Pain" (NCT NCT01967342)

NCT ID: NCT01967342

Last Updated: 2017-06-21

Results Overview

Brief Pain Inventory-Intensity indicates level of pain intensity. Higher scores (range 0-10) reflect higher perceived pain severity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 290 participants
• Primary outcome timeframe: Post-treatment (10-weeks) and follow-up (6 months)
• Results posted on: 2017-06-21

Participant Flow

Participant milestones

Measure	Usual Care Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	CBT for Pain Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Ed Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Overall Study STARTED	98	95	97
Overall Study 5-week Follow-up	83	78	76
Overall Study 10-week Follow-up	78	83	80
Overall Study COMPLETED	71	70	68
Overall Study NOT COMPLETED	27	25	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Literacy-Adapted Psychosocial Treatments for Chronic Pain --- "Learning About Mastering/My Pain"

Baseline characteristics by cohort

Measure	Usual Care n=98 Participants Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	CBT for Pain n=95 Participants Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Ed n=97 Participants Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Total n=290 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	96 Participants n=5 Participants	90 Participants n=7 Participants	93 Participants n=5 Participants	279 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Age, Continuous	49.7 years STANDARD_DEVIATION 8.7 • n=5 Participants	52.2 years STANDARD_DEVIATION 8.5 • n=7 Participants	49.9 years STANDARD_DEVIATION 9.2 • n=5 Participants	50.6 years STANDARD_DEVIATION 8.9 • n=4 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	67 Participants n=7 Participants	69 Participants n=5 Participants	205 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	85 Participants n=4 Participants
Race/Ethnicity, Customized Black/African-American	60 Participants n=5 Participants	75 Participants n=7 Participants	59 Participants n=5 Participants	194 Participants n=4 Participants
Race/Ethnicity, Customized White/Caucasian	38 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants	96 Participants n=4 Participants
Brief Pain Inventory (BPI) Severity	6.5 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	6.5 units on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	6.5 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	6.5 units on a scale STANDARD_DEVIATION 1.6 • n=4 Participants
Brief Pain Inventory (BPI) Interference	6.6 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 2.1 • n=7 Participants	6.6 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	6.6 units on a scale STANDARD_DEVIATION 2.0 • n=4 Participants
Patient Health Questionnaire-9 items (PHQ-9)	12.8 units on a scale STANDARD_DEVIATION 6.4 • n=5 Participants	11.7 units on a scale STANDARD_DEVIATION 6.1 • n=7 Participants	11.9 units on a scale STANDARD_DEVIATION 6.8 • n=5 Participants	12.1 units on a scale STANDARD_DEVIATION 6.4 • n=4 Participants

PRIMARY outcome

Timeframe: Post-treatment (10-weeks) and follow-up (6 months)

Population: The predicted mean estimates were based on latent growth modeling from mplus using all participants.

Brief Pain Inventory-Intensity indicates level of pain intensity. Higher scores (range 0-10) reflect higher perceived pain severity.

Outcome measures

Measure	Usual Care n=78 Participants Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	CBT for Pain n=82 Participants Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Ed n=80 Participants Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Brief Pain Inventory-Intensity (BPI-Intensity) Post-treatment (10-weeks)	6.19 units on a scale Standard Deviation 1.81	5.42 units on a scale Standard Deviation 2.29	5.68 units on a scale Standard Deviation 2.04
Brief Pain Inventory-Intensity (BPI-Intensity) Follow-up (6-months)	5.95 units on a scale Standard Deviation 1.84	5.82 units on a scale Standard Deviation 2.22	5.97 units on a scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: Post-treatment (10-weeks) and follow-up (6 months)

Population: The predicted mean estimates were based on latent growth modeling from mplus using all participants.

Brief Pain Inventory-Intensity indicates level of pain interference. Higher scores (range 0-10) reflect higher perceived pain interference.

Outcome measures

Measure	Usual Care n=78 Participants Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	CBT for Pain n=83 Participants Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Ed n=80 Participants Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Brief Pain Inventory-Interference (BPI-Interference) 6-month follow-up	6.32 units on a scale Standard Deviation 2.18	5.55 units on a scale Standard Deviation 2.75	5.98 units on a scale Standard Deviation 2.36
Brief Pain Inventory-Interference (BPI-Interference) 10-week post-treatment	6.11 units on a scale Standard Deviation 2.52	5.01 units on a scale Standard Deviation 2.73	5.46 units on a scale Standard Deviation 2.43

SECONDARY outcome

Timeframe: Post-treatment (10-weeks) and follow-up (6 months)

Population: The predicted mean estimates were based on latent growth modeling from mplus using all participants.

Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).

Outcome measures

Measure	Usual Care n=78 Participants Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	CBT for Pain n=83 Participants Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Ed n=80 Participants Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Patient Health Questionnaire - 9 (PHQ-9) Post-treatment (10-weeks)	11.42 units on a scale Standard Deviation 6.56	9.13 units on a scale Standard Deviation 5.77	9.59 units on a scale Standard Deviation 6.12
Patient Health Questionnaire - 9 (PHQ-9) Follow-up (6-months)	11.58 units on a scale Standard Deviation 7.09	9.73 units on a scale Standard Deviation 6.70	10.53 units on a scale Standard Deviation 6.35

SECONDARY outcome

Timeframe: Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).

Population: Only participants who completed the post-treatment (10-weeks) and follow-up (6-months) assessments were included in the following analyses.

The Patient Global Impression of Change (PGIC) assesses self-perceived changes in pain intensity. Scores were dichotomized such that responses of "very much better" and "much better" were recoded as 1 and all other responses were coded as zero, as performed by Cherkin et al. (2016), in order to indicate clinically meaningful improvement on pain intensity. The following outcome measure data table reports the number of participants per group reporting clinically meaningful improvement at post-treatment (10-weeks) and follow-up (6-months).

Outcome measures

Measure	Usual Care n=78 Participants Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	CBT for Pain n=82 Participants Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Ed n=80 Participants Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Patient Global Impression of Change (PGIC), Pain Intensity Post-treatment (10-weeks)	6 Participants	33 Participants	23 Participants
Patient Global Impression of Change (PGIC), Pain Intensity Follow-up (6-months)	6 Participants	19 Participants	22 Participants

Adverse Events

Usual Care

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

CBT for Pain

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Pain Ed

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=98 participants at risk Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	CBT for Pain n=95 participants at risk Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Ed n=97 participants at risk Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	1.0% 1/98 • Number of events 1 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/95 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/97 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.
Musculoskeletal and connective tissue disorders Gout flare on right knee and foot	1.0% 1/98 • Number of events 1 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/95 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/97 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.
Gastrointestinal disorders Abdominal Pain	0.00% 0/98 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/95 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	1.0% 1/97 • Number of events 1 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.
Gastrointestinal disorders Intestinal Infection	0.00% 0/98 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	1.1% 1/95 • Number of events 1 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/97 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.
General disorders Unknown reason for hospitalization	1.0% 1/98 • Number of events 1 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/95 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/97 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.
Surgical and medical procedures Female organ surgery	0.00% 0/98 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	0.00% 0/95 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	1.0% 1/97 • Number of events 1 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.

Other adverse events

Measure	Usual Care n=98 participants at risk Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	CBT for Pain n=95 participants at risk Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Ed n=97 participants at risk Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Musculoskeletal and connective tissue disorders Musculoskeletal pain exacerbation	12.2% 12/98 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	4.2% 4/95 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.	14.4% 14/97 • 2 years, 11 months and 4 days. Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.

Additional Information

Beverly E. Thorn, Ph.D.

University of Alabama

Phone: (205) 348-8024

Email: bthorn@ua.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place