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Completed

NCT Number: NCT03916276

Living in Full Even With Pain Study

This project will increase our understanding of the mechanisms underlying changes in opioid medication use associated with three psychosocial chronic pain (CP) treatments. These treatments are: (1) Cognitive Therapy (CT), (2) Mindfulness Meditation (MM), and (3) Behavioral Activation (BA). The sample will be adults with CP who are at risk of opioid misuse. The purpose of this study is to understand the specific ways these treatments work for reducing opioid use. In addition, the investigators are interested in examining moderators of treatment response. The findings will potentially inform the future streamlining of psychosocial treatments, as well as the development of algorithms for matching individuals with CP who are at risk for opioid misuse to the specific treatment most likely to efficiently optimize benefit.

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Key information

Conditions

Musculoskeletal Pain Chemically-Induced Disorders Chronic Pain Mental Disorders Muscular Diseases Musculoskeletal Diseases Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington, Ninth and Jefferson Building

Seattle, Washington, 98104, United States

About this study

This study involves participating in eight videoconference group treatment sessions and telephone interviews over the course of approximately eight to nine months. All study procedures will take place over videoconferencing computer software, online, or by telephone. There are no in-person visits for the study. Participants wear an activity monitor for about two and a half months starting two weeks before treatment begins. They will also complete brief online surveys twice a day, once in the morning and once in the evening, for about two and a half months starting two weeks before treatment begins. These surveys will be completed on a computer, tablet, or smartphone.

Extended Assessments

During the study, participants would also complete four extended assessments with a research staff member. The first interview is completed before treatment begins, the second is completed after treatment ends, the third is completed three months after treatment ends, and the fourth and final is completed six months after treatment ends. The first two extended assessments (Pre- and Post-Treatment) are completed with a research staff member verbally over the telephone. The final two extended assessments (3-month and 6-month Follow-up) may be completed either with a research staff member verbally over the telephone or independently online.

Online Surveys

About two weeks before treatment starts, participants begin doing brief (~2-5 minutes) online surveys twice a day. The online surveys can be completed on a smartphone, tablet, laptop, or desktop computer. Automated notifications in the morning and in the evening remind the participant to complete the brief survey twice a day.

Activity Monitor

Participants wear an activity monitor 24 hours a day for the 2.5-month Monitoring Period (which spans two weeks before treatment to one month after treatment). The activity monitor is worn on the non-dominant wrist, like a wristwatch.

Weekly Interviews

Beginning two weeks prior to treatment, participants will be contacted weekly by a staff member to complete a telephone survey. Participants complete 10 total surveys over the course of 10 weeks, concluding about one month after treatment ends. Each survey takes approximately 10-15 minutes.

Treatment

Participants are randomly assigned to one of the three treatment groups. Treatment consists of eight group treatment sessions completed remotely over a videoconferencing platform. There will be, on average, two sessions per week, and each session will take up to 90 minutes. Each treatment session will take place over the internet on a computer, tablet, or smartphone using the videoconference application. Each session will be led by the same study clinician, who is a trained clinical psychologist. Participants will be required to use a video camera and audio through either a microphone or phone for each group treatment session.

All three treatment interventions will involve educating participants about pain, discussing the impact of pain, and discussing different ways to manage it in hopes of decreasing pain and its impact. The three treatments are: (1) Mindfulness Meditation, (2) Cognitive Therapy, and (3) Behavioral Activation (BA).

Each treatment intervention will have home practice activities to complete between sessions. Home practice activities may include, but are not limited to, creating thought records, listening to pre-recorded guided practices, and keeping track of activities and goals. Participants also receive a treatment workbook with materials to refer to and discuss during the group sessions as well as additional materials to read between sessions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years;
  • Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months);
  • Use of opioid medication in the past week;
  • Daily average opioid analgesic medication use in the past week of ≥20 MMEs;
  • Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months;
  • Able to read, speak, and understand English; and
  • Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access.

Exclusion criteria

  • Primary pain condition is headache;
  • Severe cognitive impairment;
  • Current alcohol or substance dependence;
  • Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus);
  • Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention;
  • Significant pain from a recent surgery or injury;
  • Pain condition for which surgery has been recommended and is planned;
  • Any planned surgery, procedure, hospitalization, treatment, or event that may conflict with or otherwise influence participation in the study;
  • Currently receiving or had received other psychosocial treatments for any pain condition;
  • Current or past participation in a research study with treatment components that may overlap, conflict, or affect those in the current study;
  • Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
  • Psychiatric hospitalization within the past 6 months;
  • Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months;
  • Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate participant may be inappropriate in a group setting; and
  • Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal or homicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking.

Treatment and study plan

Cognitive Therapy (CT)

Behavioral

The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.

Mindfulness Meditation (MM)

Behavioral

Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.

Behavioral Activation (BA)

Behavioral

Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.

Primary outcomes

  1. Change in Morphine Milligram Equivalent (MME) Average Daily Dose

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change).

Secondary outcomes

  1. Change in Pain Interference (Micro-level)

    Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

    Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

  2. Change in Affect (Micro-level)

    Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

    Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

  3. Change in Physical Function

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A. Responses are summed and the raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

  4. Change in Sleep Quality

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A. Responses from each item will be summed. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

  5. Change in Pain Interference (Macro-level)

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

  6. Change in Affect (Macro-level)

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed via phone, responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25. When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Other outcomes

  1. Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism)

    Time frame: ActiGraph worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported

    Primary Mechanism Variable

    Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level. In this study, we used the vector magnitude average counts variable, which is the average of all activity counts recorded per minute that the device was worn (i.e., it removes non-wear time from the analysis). Higher activity counts indicate higher intensity activities that day; the minimum possible score theoretically is zero, with no theoretical maximum score. Slopes were calculated by computing the linear regression slopes for the Actigraph collected activity counts.

  2. Change in Non-Judgment (Cognitive Process Mechanism, Micro-level)

    Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

    Primary Mechanism Variable

    Change in non-judgment will be measured with 4 items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

  3. Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level)

    Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

    Primary Mechanism Variable

    Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

  4. Change in Pain Intensity (Mechanism, Micro-level)

    Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

    Primary Mechanism Variable

    Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

  5. Change in Depression and Anxiety Severity (Mechanism, Macro-level)

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Change in depression and anxiety will be measured with the respective Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms. Responses were summed for a total raw score for depression and anxiety. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of depression and anxiety. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

  6. Change in Activity Level (Self-report Mechanism, EMA)

    Time frame: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported

    Secondary Mechanism Variable

    Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). The daily EMA items asked how many times that day did the participant engage in >15mins of strenuous exercise, >15mins of moderate exercise and >15mins of mild exercise. The total frequencies for each category for a week were summed, and this scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.

  7. Change in Activity Level (Self-report Mechanism, Telephone Assessed)

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Secondary Mechanism Variable

    Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants were asked how many times in the past 7-days did they engage in >15mins of strenuous exercise, >15mins of moderate exercise and >15mins of mild exercise. This scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

  8. Change in Non-Judgment (Cognitive Process Mechanism, Macro-level)

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Primary Mechanism Variable

    Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. The full 6-item scale will be used. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

  9. Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level)

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Primary Mechanism Variable

    Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

  10. Change in Pain Intensity (Mechanism, Macro-level)

    Time frame: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)

    Primary Mechanism Variable

    Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Medical University of South Carolina
  • National Center for Complementary and Integrative Health (NCCIH)
  • Rush University
  • The University of Queensland

Registry information

Official study title

Mechanisms of Psychosocial Treatments on Opioid Use in Chronic Pain

Acronym: LIFE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2019
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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