Trial Outcomes & Findings for Optimizing Psychotherapy for Older Veterans With Chronic Pain (NCT NCT03918642)

Last Updated: 2024-11-04

Results Overview

Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 with higher scores indicating a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

126 participants

Primary outcome timeframe

Change from baseline to 10 weeks

Results posted on

2024-11-04

Participant Flow

Participants were recruited from outpatient clinics at VA Greater Los Angeles, letter-based recruitment based on a search of data from the VA Corporate Warehouse, and self-referral from flyers. The first participants was enrolled on May 16, 2019, and the last participant was enrolled on February 1, 2023. Recruitment was paused from March 20, 2020, until February 4, 2021, due to COVID-19 related administrative holds.

Of 126 enrolled, 126 were randomized to treatment.

Participant milestones

Participant milestones
Measure	Emotional Awareness and Expression Therapy Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Overall Study STARTED	66	60
Overall Study Completed Posttreatment (Week 10) Assessments	57	54
Overall Study COMPLETED	54	50
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Emotional Awareness and Expression Therapy Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Overall Study Lost to Follow-up	12	10

Baseline Characteristics

Optimizing Psychotherapy for Older Veterans With Chronic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.	Total n=126 Participants Total of all reporting groups
Age, Continuous	72.6 years STANDARD_DEVIATION 5.2 • n=93 Participants	71.3 years STANDARD_DEVIATION 6.6 • n=4 Participants	71.9 years STANDARD_DEVIATION 5.9 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants
Sex: Female, Male Male	59 Participants n=93 Participants	57 Participants n=4 Participants	116 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=93 Participants	58 Participants n=4 Participants	118 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	32 Participants n=93 Participants	37 Participants n=4 Participants	69 Participants n=27 Participants
Race (NIH/OMB) White	22 Participants n=93 Participants	17 Participants n=4 Participants	39 Participants n=27 Participants
Race (NIH/OMB) More than one race	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Marital status Married or partnered	23 Participants n=93 Participants	19 Participants n=4 Participants	42 Participants n=27 Participants
Marital status Divorced or separated	25 Participants n=93 Participants	25 Participants n=4 Participants	50 Participants n=27 Participants
Marital status Never married or other	18 Participants n=93 Participants	16 Participants n=4 Participants	34 Participants n=27 Participants
Education level High school or less	10 Participants n=93 Participants	14 Participants n=4 Participants	24 Participants n=27 Participants
Education level Some college	36 Participants n=93 Participants	26 Participants n=4 Participants	62 Participants n=27 Participants
Education level College graduate or more	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Pain duration	22.5 years STANDARD_DEVIATION 18.2 • n=93 Participants	24.4 years STANDARD_DEVIATION 17.3 • n=4 Participants	23.3 years STANDARD_DEVIATION 17.7 • n=27 Participants
No. prescribed opioids at baseline Opioids	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
No. prescribed opioids at baseline No opioids	58 Participants n=93 Participants	54 Participants n=4 Participants	112 Participants n=27 Participants
Any psychiatric diagnosis Psychiatric diagnosis (e.g., depression, anxiety, PTSD)	44 Participants n=93 Participants	43 Participants n=4 Participants	87 Participants n=27 Participants
Any psychiatric diagnosis No psychiatric diagnosis	22 Participants n=93 Participants	17 Participants n=4 Participants	39 Participants n=27 Participants
VA service-connected for PTSD VA service-connected for PTSD	25 Participants n=93 Participants	22 Participants n=4 Participants	47 Participants n=27 Participants
VA service-connected for PTSD Not VA service-connected for PTSD	41 Participants n=93 Participants	38 Participants n=4 Participants	79 Participants n=27 Participants
No. non-pain chronic medical conditions	5.0 conditions STANDARD_DEVIATION 2.2 • n=93 Participants	4.9 conditions STANDARD_DEVIATION 2.7 • n=4 Participants	5.0 conditions STANDARD_DEVIATION 2.4 • n=27 Participants
No. prescription medications	9.9 medications STANDARD_DEVIATION 5.2 • n=93 Participants	9.4 medications STANDARD_DEVIATION 4.3 • n=4 Participants	9.6 medications STANDARD_DEVIATION 4.8 • n=27 Participants
Mini-Mental State Examination Scores	28.9 units on a scale STANDARD_DEVIATION 1.1 • n=93 Participants	28.4 units on a scale STANDARD_DEVIATION 1.6 • n=4 Participants	28.6 units on a scale STANDARD_DEVIATION 1.4 • n=27 Participants
Back pain Back pain	63 Participants n=93 Participants	58 Participants n=4 Participants	121 Participants n=27 Participants
Back pain No back pain	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants

PRIMARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Pain Severity	-2.18 score on a scale Interval -3.0 to -1.37	-0.60 score on a scale Interval -1.13 to -0.06

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Pain Severity	-1.26 score on a scale Interval -1.83 to -0.68	-0.25 score on a scale Interval -0.72 to 0.23

SECONDARY outcome

Timeframe: 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Overall satisfaction is a single item on the Satisfaction with Therapy and Therapist Scale-Revised scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction) with higher scores indicating a better outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction)	4.30 score on a scale Interval 4.05 to 4.54	4.01 score on a scale Interval 3.83 to 4.19

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Sum of eight self-report items assessing interference of pain with daily activities over the past 7 days. Items range from 1-5 (1 = no interference; 5 = maximum interference), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Pain Interference Short Form 8a v1.0	-5.41 score on a scale Interval -7.33 to -3.48	-3.99 score on a scale Interval -6.41 to -1.56

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Pain Interference Short Form 8a v1.0	-2.87 score on a scale Interval -4.96 to -0.78	-3.08 score on a scale Interval -4.59 to -1.57

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Sum of eight self-report items assessing depression and emotional distress over the past 7 days. Items range from 1-5 (1 = never feeling a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Depression Short Form	-5.12 score on a scale Interval -6.62 to -3.62	-2.06 score on a scale Interval -4.31 to 0.2

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Depression Short Form	-3.48 score on a scale Interval -4.94 to -2.03	-1.09 score on a scale Interval -2.97 to 0.78

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Sum of seven self-report items assessing anxiety over the past 7 days. Items range from 1-5 (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 7 and 35 with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Anxiety Short Form	-3.13 score on a scale Interval -4.56 to -1.7	-0.64 score on a scale Interval -2.18 to 0.89

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Anxiety Short Form	-3.17 score on a scale Interval -4.58 to -1.76	-1.22 score on a scale Interval -2.53 to 0.09

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy when PTSD symptoms were assessed; groups 3-10)

Sum of twenty self-report items assessing PTSD according to the frequency in which symptoms are experienced over the past month. Items range from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely), yielding a total score between 0 and 80 with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=52 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=47 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PTSD Checklist for DSM-5	-4.45 score on a scale Interval -7.55 to -1.34	-0.06 score on a scale Interval -3.55 to 3.44

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy when PTSD symptoms were assessed; groups 3-10)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=52 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=47 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PTSD Checklist for DSM-5	-4.07 score on a scale Interval -6.26 to -1.88	-0.31 score on a scale Interval -5.28 to 4.66

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Sum of five self-report items assessing general life satisfaction. Items range from 1-5 (1 = no satisfaction; 5 = maximum satisfaction), yielding a total score between 5 and 25 with higher scores indicating a better outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
NIH Toolbox-Life Satisfaction Short Form	1.68 score on a scale Interval 1.02 to 2.34	0.45 score on a scale Interval -0.15 to 1.05

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
NIH Toolbox-Life Satisfaction Short Form	1.15 score on a scale Interval 0.82 to 1.48	0.21 score on a scale Interval -0.94 to 1.35

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Sum of eight self-report items assessing sleep disturbance over the past 7 days. Items range from 1-5 (1 = no sleep disturbance; 5 = maximum sleep disturbance), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Sleep Disturbance Short Form	-2.69 score on a scale Interval -4.39 to -0.98	-0.84 score on a scale Interval -2.61 to 0.94

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Sleep Disturbance Short Form	-2.73 score on a scale Interval -4.21 to -1.24	-0.16 score on a scale Interval -2.21 to 1.89

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Sum of seven self-report items assessing fatigue over the past 7 days. Items range from 1-5 (1 = no fatigue; 5 = maximum fatigue), yielding a total score between 7 and 35 with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Fatigue Short Form	-1.97 score on a scale Interval -3.0 to -0.93	-1.19 score on a scale Interval -2.44 to 0.06

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
PROMIS-Fatigue Short Form	-1.47 score on a scale Interval -2.53 to -0.4	-1.17 score on a scale Interval -2.49 to 0.15

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference) with higher scores indicating a better outcome.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Patient's Global Impression of Change Scale	4.67 score on a scale Interval 4.17 to 5.16	3.20 score on a scale Interval 2.79 to 3.61

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Patient's Global Impression of Change Scale	4.01 score on a scale Interval 3.61 to 4.41	2.77 score on a scale Interval 2.34 to 3.21

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 . Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is 30% lower than at baseline.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Percentage of Participants With at Least 30% Improvement in Pain Severity	63.5 percentage of participants Interval 50.6 to 76.4	17.1 percentage of participants Interval 6.8 to 27.5

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 30% lower than at baseline.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Percentage of Participants With at Least 30% Improvement in Pain Severity	40.3 percentage of participants Interval 26.8 to 53.8	14.2 percentage of participants Interval 4.3 to 24.0

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is at least 50% lower than at baseline.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Percentage of Participants With at Least 50% Improvement in Pain Severity	35.7 percentage of participants Interval 21.5 to 49.8	7.4 percentage of participants Interval 0.0 to 14.7

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 50% lower than at baseline.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Percentage of Participants With at Least 50% Improvement in Pain Severity	16.6 percentage of participants Interval 5.8 to 27.4	3.9 percentage of participants Interval 0.0 to 9.4

SECONDARY outcome

Timeframe: Change from baseline to 10 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is at least 70% lower than at baseline.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Percentage of Participants With at Least 70% Improvement in Pain Severity	12.8 percentage of participants Interval 2.7 to 22.8	1.9 percentage of participants Interval 0.0 to 5.8

SECONDARY outcome

Timeframe: Change from baseline to 20 weeks

Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)

Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 70% lower than at baseline.

Outcome measures

Outcome measures
Measure	Emotional Awareness and Expression Therapy n=66 Participants Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 Participants Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Percentage of Participants With at Least 70% Improvement in Pain Severity	7.5 percentage of participants Interval 0.0 to 15.3	2.1 percentage of participants Interval 0.0 to 6.1

Adverse Events

Emotional Awareness and Expression Therapy

Serious events: 2 serious events

Other events: 10 other events

Deaths: 1 deaths

Cognitive Behavior Therapy

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Emotional Awareness and Expression Therapy n=66 participants at risk Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 participants at risk Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Cardiac disorders Acute decompensated heart failure	0.00% 0/66 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	1.7% 1/60 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Musculoskeletal and connective tissue disorders Hospitalized for worsening chronic rib pain	1.5% 1/66 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	0.00% 0/60 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Gastrointestinal disorders Urgent cholecystectomy	1.5% 1/66 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	0.00% 0/60 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB

Other adverse events

Other adverse events
Measure	Emotional Awareness and Expression Therapy n=66 participants at risk Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.	Cognitive Behavior Therapy n=60 participants at risk Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Musculoskeletal and connective tissue disorders Temporary worsening of pain	3.0% 2/66 • Number of events 2 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	5.0% 3/60 • Number of events 3 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Psychiatric disorders Temporary worsening of depression	0.00% 0/66 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	1.7% 1/60 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Renal and urinary disorders Hematuria	0.00% 0/66 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	1.7% 1/60 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Skin and subcutaneous tissue disorders Rash	3.0% 2/66 • Number of events 2 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	0.00% 0/60 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Cardiac disorders Palpitations	1.5% 1/66 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	0.00% 0/60 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Gastrointestinal disorders Abdominal pain	1.5% 1/66 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	0.00% 0/60 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Respiratory, thoracic and mediastinal disorders COVID-19	1.5% 1/66 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	0.00% 0/60 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Musculoskeletal and connective tissue disorders Fall	3.0% 2/66 • Number of events 2 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	0.00% 0/60 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
Eye disorders Retinal detachment	1.5% 1/66 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB	0.00% 0/60 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months. Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB

Additional Information

Brandon C. Yarns

VA Greater Los Angeles Healthcare System

Phone: 310-478-3711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place