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Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Awareness and Expression Therapy
Cognitive Behavior Therapy
Sponsored by
VA Greater Los Angeles Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Chronic Pain, Psychotherapy, Musculoskeletal Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veteran;
  • Age 50 years and older;
  • 3 months of musculoskeletal pain including low back pain and other regional pain syndromes (e.g. neck, leg, pelvic pain and temporomandibular joint disorders), whiplash, widespread pain (e.g. fibromyalgia), or tension headaches.

Exclusion Criteria:

  • Leg pain greater than back pain (to exclude radiculopathy in isolation);
  • Electromyography (EMG)-confirmed "tunnel" syndromes (e.g. carpal or tarsal tunnel syndrome) without any other pain complaints;
  • Autoimmune disease that typically generates pain (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis);
  • Confirmed hip or knee osteoarthritis without any other pain complaints;
  • Cancer pain, sickle cell disease, neuralgias (e.g. trigeminal neuralgia), burn pain, infection associated with pain (e.g. vertebral infection), cauda equina syndrome, gout as the only pain complaint, migraine or cluster headaches only;
  • Uncontrolled severe psychiatric disorder including current psychotic disorder (e.g. schizophrenia or bipolar I disorder not controlled with medications), dissociative identity disorder, or active suicide/violence risk in the past 6 months;
  • Moderate to severe cognitive impairment or dementia (Mini-Mental State Exam score ≤ 25);
  • Active severe alcohol or substance use disorder that inhibits the participant's ability to attend sessions or participate in homework;
  • Currently with pain-related litigation or applying for compensation or compensation increase (e.g. applying for VA service connection or applying for VA service connection increase for pain);
  • Unable to fluently read/converse in English;
  • Planning to move from the area in the next 6 months.

Sites / Locations

  • VA Greater Los Angeles Healthcare Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Emotional Awareness and Expression Therapy

Cognitive Behavior Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean Pain Severity
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
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.

Secondary Outcome Measures

Percent of Group Therapy Sessions Attended
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
Satisfaction with Therapy and Therapist Scale-Revised
Satisfaction with therapy subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Satisfaction with therapist subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Overall satisfaction is an additional single item scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction). The two subscales and the overall satisfaction item are each reported separately.
Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Behavior Short Form 7a v1.1
Sum of seven self-report items assessing behaviors associated with pain over the past 7 days. Items range from 1-6 (1 = had no pain; 6 = always), yielding a total score between 7 and 42.
PROMIS-Pain Behavior Short Form 7a v1.1
Sum of seven self-report items assessing behaviors associated with pain over the past 7 days. Items range from 1-6 (1 = had no pain; 6 = always), yielding a total score between 7 and 42.
PROMIS-Pain Interference Short Form 8a v1.0
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.
PROMIS-Pain Interference Short Form 8a v1.0
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.
PROMIS-Depression Short Form
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.
PROMIS-Depression Short Form
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.
PROMIS-Anxiety Short Form
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.
PROMIS-Anxiety Short Form
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.
PTSD Symptom Scale
Sum of seventeen self-report items assessing PTSD according to the frequency in which symptoms are experienced over the last two weeks. Items range from 0-3 (0 = not experiencing a symptom; 1 = once per week or less / a little bit / once in a while; 2 = 2 to 4 times per week / somewhat / half the time; 3 = 3 to 5 or more times per week / very much / almost always), yielding a total score between 0 and 51.
PTSD Symptom Scale
Sum of seventeen self-report items assessing PTSD according to the frequency in which symptoms are experienced over the last two weeks. Items range from 0-3 (0 = not experiencing a symptom; 1 = once per week or less / a little bit / once in a while; 2 = 2 to 4 times per week / somewhat / half the time; 3 = 3 to 5 or more times per week / very much / almost always), yielding a total score between 0 and 51.
NIH Toolbox-Positive Affect Short Form
Sum of fifteen self-report items assessing positive affect over the past 7 days. Items range from 1-5 (1 = not at all experiencing a type of positive emotion; 5 = very much feeling that emotion), yielding a total score between 15 and 75.
NIH Toolbox-Positive Affect Short Form
Sum of fifteen self-report items assessing positive affect over the past 7 days. Items range from 1-5 (1 = not at all experiencing a type of positive emotion; 5 = very much feeling that emotion), yielding a total score between 15 and 75.
NIH Toolbox-Purpose and Meaning Short Form
Sum of seven self-report items assessing general feelings of meaning and purpose. Items range from 1-5 (1 = no purpose and meaning; 5 = maximum purpose and meaning), yielding a total score between 7 and 35.
NIH Toolbox-Purpose and Meaning Short Form
Sum of seven self-report items assessing general feelings of meaning and purpose. Items range from 1-5 (1 = no purpose and meaning; 5 = maximum purpose and meaning), yielding a total score between 7 and 35.
NIH Toolbox-Life Satisfaction Short Form
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.
NIH Toolbox-Life Satisfaction Short Form
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.
PROMIS-Sleep Disturbance Short Form
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.
PROMIS-Sleep Disturbance Short Form
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.
PROMIS-Fatigue Short Form
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.
PROMIS-Fatigue Short Form
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.
Multidimensional Inventory of Subjective Cognitive Impairment
Sum of ten self-report items assessing subjective cognitive impairment over the past 7 days. Items range from 1-5 (1 = no impairment; 5 = maximum impairment), yielding a total score between 10 and 50.
Multidimensional Inventory of Subjective Cognitive Impairment
Sum of ten self-report items assessing subjective cognitive impairment over the past 7 days. Items range from 1-5 (1 = no impairment; 5 = maximum impairment), yielding a total score between 10 and 50.
Ambivalence over Emotional Expression Questionnaire
Sum of fourteen self-report items assessing ambivalence of emotional expression. Items range from 1-5 (1 = no ambivalence; 5 = maximum ambivalence), yielding a total score between 14 and 70.
Ambivalence over Emotional Expression Questionnaire
Sum of fourteen self-report items assessing ambivalence of emotional expression. Items range from 1-5 (1 = no ambivalence; 5 = maximum ambivalence), yielding a total score between 14 and 70.
Emotional Approach Coping Scales
Sum of eight self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 8 and 32.
Emotional Approach Coping Scales
Sum of eight self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 8 and 32.
Pain Catastrophizing Scale
Sum of thirteen self-report items assessing the types of thoughts and feelings experienced with pain. Items range from 0-4 (0 = not experiencing a type of thought / feeling; 5 = experiencing that thought / feeling all the time), yielding a total score between 0 and 52. Higher scores indicate the subject experiences thoughts and emotions that typically catastrophizes their pain.
Pain Catastrophizing Scale
Sum of thirteen self-report items assessing the types of thoughts and feelings experienced with pain. Items range from 0-4 (0 = not experiencing a type of thought / feeling; 5 = experiencing that thought / feeling all the time), yielding a total score between 0 and 52. Higher scores indicate the subject experiences thoughts and emotions that typically catastrophizes their pain.
Survey of Pain Attitudes
Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.
Survey of Pain Attitudes
Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4, yielding a total score between 0 and 56.

Full Information

First Posted
December 19, 2018
Last Updated
September 2, 2020
Sponsor
VA Greater Los Angeles Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT03844880
Brief Title
Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain
Official Title
Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for the Treatment of Chronic Musculoskeletal Pain in Older Veterans: A Pilot Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Greater Los Angeles Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized clinical trial for Veterans age 50 years and older with chronic musculoskeletal pain in which Emotional Awareness and Expression Therapy (EAET) is compared against Cognitive Behavior Therapy (CBT) to evaluate acceptability, feasibility, and efficacy of the two treatments on pain and other outcomes, as well as potential mediators of treatment response.
Detailed Description
Outpatient Veterans age 50 years and older at the West Los Angeles VA Medical Center who have chronic musculoskeletal pain complete baseline questionnaires and are randomized into one of two forms of psychotherapy: Emotional Awareness and Expression Therapy (EAET), which helps patients make connections between avoided or conflicted emotions and pain, or Cognitive Behavior Therapy (CBT), which teaches pain coping skills. Each treatment is delivered by an experienced therapist and includes one 90-minute individual session and eight 90-minute group sessions (in small groups of 8 Veterans). Patients in both conditions complete post-treatment and 3-month follow-up questionnaires. Outcomes of each type of psychotherapy are compared and mediators of treatment response are evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
Chronic Pain, Psychotherapy, Musculoskeletal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotional Awareness and Expression Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavior Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Awareness and Expression Therapy
Intervention Description
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Primary Outcome Measure Information:
Title
Mean Pain Severity
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
Mean Pain Severity
Description
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.
Time Frame
Change from baseline to 20 weeks
Secondary Outcome Measure Information:
Title
Percent of Group Therapy Sessions Attended
Description
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
Time Frame
8 weeks
Title
Satisfaction with Therapy and Therapist Scale-Revised
Description
Satisfaction with therapy subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Satisfaction with therapist subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Overall satisfaction is an additional single item scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction). The two subscales and the overall satisfaction item are each reported separately.
Time Frame
8 weeks
Title
Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Behavior Short Form 7a v1.1
Description
Sum of seven self-report items assessing behaviors associated with pain over the past 7 days. Items range from 1-6 (1 = had no pain; 6 = always), yielding a total score between 7 and 42.
Time Frame
Change from baseline to 8 weeks
Title
PROMIS-Pain Behavior Short Form 7a v1.1
Description
Sum of seven self-report items assessing behaviors associated with pain over the past 7 days. Items range from 1-6 (1 = had no pain; 6 = always), yielding a total score between 7 and 42.
Time Frame
Change from baseline to 20 weeks
Title
PROMIS-Pain Interference Short Form 8a v1.0
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
PROMIS-Pain Interference Short Form 8a v1.0
Description
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.
Time Frame
Change from baseline to 20 weeks
Title
PROMIS-Depression Short Form
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
PROMIS-Depression Short Form
Description
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.
Time Frame
Change from baseline to 20 weeks
Title
PROMIS-Anxiety Short Form
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
PROMIS-Anxiety Short Form
Description
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.
Time Frame
Change from baseline to 20 weeks
Title
PTSD Symptom Scale
Description
Sum of seventeen self-report items assessing PTSD according to the frequency in which symptoms are experienced over the last two weeks. Items range from 0-3 (0 = not experiencing a symptom; 1 = once per week or less / a little bit / once in a while; 2 = 2 to 4 times per week / somewhat / half the time; 3 = 3 to 5 or more times per week / very much / almost always), yielding a total score between 0 and 51.
Time Frame
Change from baseline to 8 weeks
Title
PTSD Symptom Scale
Description
Sum of seventeen self-report items assessing PTSD according to the frequency in which symptoms are experienced over the last two weeks. Items range from 0-3 (0 = not experiencing a symptom; 1 = once per week or less / a little bit / once in a while; 2 = 2 to 4 times per week / somewhat / half the time; 3 = 3 to 5 or more times per week / very much / almost always), yielding a total score between 0 and 51.
Time Frame
Change from baseline to 20 weeks
Title
NIH Toolbox-Positive Affect Short Form
Description
Sum of fifteen self-report items assessing positive affect over the past 7 days. Items range from 1-5 (1 = not at all experiencing a type of positive emotion; 5 = very much feeling that emotion), yielding a total score between 15 and 75.
Time Frame
Change from baseline to 8 weeks
Title
NIH Toolbox-Positive Affect Short Form
Description
Sum of fifteen self-report items assessing positive affect over the past 7 days. Items range from 1-5 (1 = not at all experiencing a type of positive emotion; 5 = very much feeling that emotion), yielding a total score between 15 and 75.
Time Frame
Change from baseline to 20 weeks
Title
NIH Toolbox-Purpose and Meaning Short Form
Description
Sum of seven self-report items assessing general feelings of meaning and purpose. Items range from 1-5 (1 = no purpose and meaning; 5 = maximum purpose and meaning), yielding a total score between 7 and 35.
Time Frame
Change from baseline to 8 weeks
Title
NIH Toolbox-Purpose and Meaning Short Form
Description
Sum of seven self-report items assessing general feelings of meaning and purpose. Items range from 1-5 (1 = no purpose and meaning; 5 = maximum purpose and meaning), yielding a total score between 7 and 35.
Time Frame
Change from baseline to 20 weeks
Title
NIH Toolbox-Life Satisfaction Short Form
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
NIH Toolbox-Life Satisfaction Short Form
Description
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.
Time Frame
Change from baseline to 20 weeks
Title
PROMIS-Sleep Disturbance Short Form
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
PROMIS-Sleep Disturbance Short Form
Description
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.
Time Frame
Change from baseline to 20 weeks
Title
PROMIS-Fatigue Short Form
Description
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.
Time Frame
Change from baseline to 8 weeks
Title
PROMIS-Fatigue Short Form
Description
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.
Time Frame
Change from baseline to 20 weeks
Title
Multidimensional Inventory of Subjective Cognitive Impairment
Description
Sum of ten self-report items assessing subjective cognitive impairment over the past 7 days. Items range from 1-5 (1 = no impairment; 5 = maximum impairment), yielding a total score between 10 and 50.
Time Frame
Change from baseline to 8 weeks
Title
Multidimensional Inventory of Subjective Cognitive Impairment
Description
Sum of ten self-report items assessing subjective cognitive impairment over the past 7 days. Items range from 1-5 (1 = no impairment; 5 = maximum impairment), yielding a total score between 10 and 50.
Time Frame
Change from baseline to 20 weeks
Title
Ambivalence over Emotional Expression Questionnaire
Description
Sum of fourteen self-report items assessing ambivalence of emotional expression. Items range from 1-5 (1 = no ambivalence; 5 = maximum ambivalence), yielding a total score between 14 and 70.
Time Frame
Change from baseline to 8 weeks
Title
Ambivalence over Emotional Expression Questionnaire
Description
Sum of fourteen self-report items assessing ambivalence of emotional expression. Items range from 1-5 (1 = no ambivalence; 5 = maximum ambivalence), yielding a total score between 14 and 70.
Time Frame
Change from baseline to 20 weeks
Title
Emotional Approach Coping Scales
Description
Sum of eight self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 8 and 32.
Time Frame
Change from baseline to 8 weeks
Title
Emotional Approach Coping Scales
Description
Sum of eight self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 8 and 32.
Time Frame
Change from baseline to 20 weeks
Title
Pain Catastrophizing Scale
Description
Sum of thirteen self-report items assessing the types of thoughts and feelings experienced with pain. Items range from 0-4 (0 = not experiencing a type of thought / feeling; 5 = experiencing that thought / feeling all the time), yielding a total score between 0 and 52. Higher scores indicate the subject experiences thoughts and emotions that typically catastrophizes their pain.
Time Frame
Change from baseline to 8 weeks
Title
Pain Catastrophizing Scale
Description
Sum of thirteen self-report items assessing the types of thoughts and feelings experienced with pain. Items range from 0-4 (0 = not experiencing a type of thought / feeling; 5 = experiencing that thought / feeling all the time), yielding a total score between 0 and 52. Higher scores indicate the subject experiences thoughts and emotions that typically catastrophizes their pain.
Time Frame
Change from baseline to 20 weeks
Title
Survey of Pain Attitudes
Description
Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.
Time Frame
Change from baseline to 8 weeks
Title
Survey of Pain Attitudes
Description
Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4, yielding a total score between 0 and 56.
Time Frame
Change from baseline to 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veteran; Age 50 years and older; 3 months of musculoskeletal pain including low back pain and other regional pain syndromes (e.g. neck, leg, pelvic pain and temporomandibular joint disorders), whiplash, widespread pain (e.g. fibromyalgia), or tension headaches. Exclusion Criteria: Leg pain greater than back pain (to exclude radiculopathy in isolation); Electromyography (EMG)-confirmed "tunnel" syndromes (e.g. carpal or tarsal tunnel syndrome) without any other pain complaints; Autoimmune disease that typically generates pain (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis); Confirmed hip or knee osteoarthritis without any other pain complaints; Cancer pain, sickle cell disease, neuralgias (e.g. trigeminal neuralgia), burn pain, infection associated with pain (e.g. vertebral infection), cauda equina syndrome, gout as the only pain complaint, migraine or cluster headaches only; Uncontrolled severe psychiatric disorder including current psychotic disorder (e.g. schizophrenia or bipolar I disorder not controlled with medications), dissociative identity disorder, or active suicide/violence risk in the past 6 months; Moderate to severe cognitive impairment or dementia (Mini-Mental State Exam score ≤ 25); Active severe alcohol or substance use disorder that inhibits the participant's ability to attend sessions or participate in homework; Currently with pain-related litigation or applying for compensation or compensation increase (e.g. applying for VA service connection or applying for VA service connection increase for pain); Unable to fluently read/converse in English; Planning to move from the area in the next 6 months.
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain

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