Comparing Single-Session Therapies for Chronic Pain

ConditionChronic Musculoskeletal Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMark A. Lumley

About this trial

Many people in the US suffer from chronic pain. Often times, individuals who have chronic pain also feel depressed, anxious, or hopeless, which can worsen pain. Psychologists, therefore, have developed several treatments to help people with chronic pain. These psychological treatments differ. The most common treatment is Cognitive Behavioral Therapy (CBT) for chronic pain, which helps patients better manage pain through changing thoughts and behaviors. Two newer, less common psychological therapies are Pain Reprocessing Therapy (PRT) and Emotion Awareness and Expression Therapy (EAET). These therapies emphasize that chronic pain is mainly due to plastic processes of over-sensitization in the brain and nervous system, and that psychotherapies can significantly reduce or eliminate pain. Although similar, PRT and EAET stress different aspects of treatment. PRT emphasizes that one's fear of pain and bodily injury maintains the brain's sense of threat, thereby also maintaining the pain response; EAET emphasizes that one's conditioned psychological state of stress and tension maintains a sense of threat, thereby maintaining the pain response. These three treatments have yet to be compared; it is unclear which psychological processes are most important to treating chronic pain.

There is growing interest in single-session psychotherapy interventions. Studies have shown that just a single session of CBT or EAET can help individuals reduce their pain. PRT has yet to be condensed to a single-session intervention.

This study will compare a single session of CBT, PRT, and EAET with a no-treatment control group to test whether 1) one treatment outperforms the others, and 2) different mechanisms/ approaches matter to chronic pain treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pain for at least 3 months and experienced 4 or more days/week for the past 6 months

Pain intensity last week is >= 3 (0 to 10 rating scale)

Pain interference last week is >= 3 (0 to 10 rating scale)

At least age 18

Disqualifiers

Complex regional pain syndrome

Epilepsy/seizure disorder

Autoimmune disease

Liver disease

Trial design

Design model

Parallel

Treatments tested in this trial

Cognitive Behavioral Therapy
Behavioral
CBT endorses a pain management model and teaches people skills to cope with chronic pain through reframing thoughts and encouraging behavioral change.
Pain Reprocessing Therapy
Behavioral
PRT advocates a pain treatment model in which pain can be substantially reduced by helping people learn that their pain is brain-based and can be substantially reduced or eliminated by decreasing fear of pain and bodily injury and providing education on the neuroscience of pain.
Emotion Awareness and Expression Therapy
Behavioral
EAET advocates a pain treatment model in which pain can be substantially reduced by helping people learn that their pain is brain-based and can be substantially reduced or eliminated by decreasing fear of pain and of various emotional/interpersonal problems.

Treatment groups

160 Participants

are divided into 4 treatment groups

Group A: Cognitive Behavioral TherapyExperimental treatment 1 intervention

Group B: Pain Reprocessing TherapyExperimental treatment 1 intervention

Group C: Emotion Awareness and Expression TherapyExperimental treatment 1 intervention

Group D: Treatment As Usual (TAU)No intervention 0 interventions

Trial outcomes

Primary outcomes

Brief Pain Inventory (BPI) - Pain Severity

4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up

Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a

8-item measure of pain interference over past week (range1 to 5; higher scores = more pain interference)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up

Pain Rating Question

1-item pain rating developed by research team asking "Please rate your pain by circling the one number that tells how much pain you have right now". (0 = No pain, 10 = Pain as bad as you can imagine; higher = more pain)

Time frame

Immediately pre and immediately post-treatment

Symptom Rating Question

1 -item symptom rating developed by research team asking "Please rate your physical symptoms by circling the one number that tells how much physical symptoms you have right now". (0 = no symptoms; 10 = symptoms as bad as you can imagine; higher = more symptoms).

Time frame

Immediately pre and immediately post-treatment

Secondary outcomes

Mood Rating Question

7-item measure to assess current mood developed by research team asking "For each of the items below, use the 1 to 7 scale and circle a number that indicates how you feel right now". Current mood symptoms assess are: calm, sad, proud, afraid, alert, happy, angry, guilty, nervous on a seven-point scale (1 = not at all, 7 = a great deal; higher = more of that mood)

Time frame

Immediately pre and immediately post-treatment

Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a

4-item measure of current physical function (range 1 to 5; higher scores = poorer physical function)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up

Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form

4-item measure of anxiety symptoms in the past week (range 1 to 5; higher scores = more anxiety symptoms)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up

Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form

4-item measure of depression symptoms in the past week (range 1 to 5; higher scores = more depression symptoms)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up

Other outcomes

Pain Catastrophizing Scale (PCS)-short form

Potential Mediator; 6-item measure of pain catastrophizing (range 0 to 4; higher scores = higher pain catastrophizing)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up

Pain Self-Efficacy Questionnaire (PSEQ) - Short Form

Potential Mediator; 4-item measure of current pain self-efficacy (range 0 to 6; higher scores = higher pain self-efficacy)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up.

Survey of Pain Attitudes (SOPA): Pain Control, Disability, Harm, Emotion subscales

Potential Mediator; 4, 2-item measures of current pain attitudes (range 0 to 4; higher scores = more of that construct)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up

Behavioral Activation for Depression (BADS) - Short Form

Potential Mediator; 9-item measure of behavioral activation for depression in the past week (range 0 to 6; higher scores = higher behavioral activation)

Time frame

Baseline to 1-week post-treatment and 1-month follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mark A. Lumley

Lead sponsor

Wayne State University

Sponsor institution

Source ClinicalTrials.gov

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