Musculoskeletal PainNCT03844880
Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain
A study testing Emotional Awareness and Expression Therapy and Cognitive Behavior Therapy in people with Musculoskeletal Pain, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Emotional Awareness and Expression Therapy and Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2017to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare Center
Los Angeles, California, 90073
About this study
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
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.
Read the 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Emotional Awareness and Expression Therapy, Cognitive Behavior Therapy
- Keywords
- Chronic Pain, Psychotherapy, Musculoskeletal Disease
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression TherapyBehavioural
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Cognitive Behavior TherapyBehavioural
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | 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. Receives: Behavioral: Emotional Awareness and Expression Therapy |
| Cognitive Behavior Therapy | Active comparator | 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. Receives: Behavioral: Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
Secondary outcomes (32)
Percent of Group Therapy Sessions Attended
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
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.
Measured: Change from baseline to 8 weeks
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.
Measured: Change from baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start19 Oct 2017
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844880
- Sponsor's protocol ID
- 0001
- Status last verified
- Sep 2020
- First submitted
- 19 Dec 2018
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03844880
- Acronym / sponsor ID
- 0001
- Conditions
- Musculoskeletal Pain
- Keywords
- Chronic Pain, Psychotherapy, Musculoskeletal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | Behavioral: Emotional Awareness and Expression TherapySeeks 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. |
| Cognitive Behavior Therapy | Active comparator | Behavioral: Cognitive Behavior TherapySeeks 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Awareness and Expression TherapyFocus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. | Behavioural | Emotional Awareness and Expression Therapy |
| Cognitive Behavior TherapyFocus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. | Behavioural | Cognitive Behavior Therapy |
Primary outcome
Mean Pain Severity
Time frame: Change from baseline to 8 weeks
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
Time frame: Change from baseline to 20 weeks
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.
32 secondary outcomes
Percent of Group Therapy Sessions Attended
Time frame: 8 weeks
Satisfaction with Therapy and Therapist Scale-Revised
Time frame: 8 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Behavior Short Form 7a v1.1
Time frame: Change from baseline to 8 weeks
PROMIS-Pain Behavior Short Form 7a v1.1
Time frame: Change from baseline to 20 weeks
PROMIS-Pain Interference Short Form 8a v1.0
Time frame: Change from baseline to 8 weeks
PROMIS-Pain Interference Short Form 8a v1.0
Time frame: Change from baseline to 20 weeks
PROMIS-Depression Short Form
Time frame: Change from baseline to 8 weeks
PROMIS-Depression Short Form
Time frame: Change from baseline to 20 weeks
PROMIS-Anxiety Short Form
Time frame: Change from baseline to 8 weeks
PROMIS-Anxiety Short Form
Time frame: Change from baseline to 20 weeks
PTSD Symptom Scale
Time frame: Change from baseline to 8 weeks
PTSD Symptom Scale
Time frame: Change from baseline to 20 weeks
NIH Toolbox-Positive Affect Short Form
Time frame: Change from baseline to 8 weeks
NIH Toolbox-Positive Affect Short Form
Time frame: Change from baseline to 20 weeks
NIH Toolbox-Purpose and Meaning Short Form
Time frame: Change from baseline to 8 weeks
NIH Toolbox-Purpose and Meaning Short Form
Time frame: Change from baseline to 20 weeks
NIH Toolbox-Life Satisfaction Short Form
Time frame: Change from baseline to 8 weeks
NIH Toolbox-Life Satisfaction Short Form
Time frame: Change from baseline to 20 weeks
PROMIS-Sleep Disturbance Short Form
Time frame: Change from baseline to 8 weeks
PROMIS-Sleep Disturbance Short Form
Time frame: Change from baseline to 20 weeks
PROMIS-Fatigue Short Form
Time frame: Change from baseline to 8 weeks
PROMIS-Fatigue Short Form
Time frame: Change from baseline to 20 weeks
Multidimensional Inventory of Subjective Cognitive Impairment
Time frame: Change from baseline to 8 weeks
Multidimensional Inventory of Subjective Cognitive Impairment
Time frame: Change from baseline to 20 weeks
Ambivalence over Emotional Expression Questionnaire
Time frame: Change from baseline to 8 weeks
Ambivalence over Emotional Expression Questionnaire
Time frame: Change from baseline to 20 weeks
Emotional Approach Coping Scales
Time frame: Change from baseline to 8 weeks
Emotional Approach Coping Scales
Time frame: Change from baseline to 20 weeks
Pain Catastrophizing Scale
Time frame: Change from baseline to 8 weeks
Pain Catastrophizing Scale
Time frame: Change from baseline to 20 weeks
Survey of Pain Attitudes
Time frame: Change from baseline to 8 weeks
Survey of Pain Attitudes
Time frame: Change from baseline to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Therapy and Cognitive Behavior Therapy in people with Musculoskeletal Pain, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pain Severity (time frame: Change from baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.