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The public health relevance of this proposed project is substantial given the current opioid abuse epidemic as identified by the Centers for Disease Control (CDC). This study finalizes and tests a new psychotherapy treatment that is designed to treat chronic pain and opioid addiction at the same time in a format that could be easily used in a community addiction treatment setting. Final products of the study will yield an integrated STOP (Self-regulation/Cognitive-behavioral therapy (CBT) Therapy for Opioid addiction and Pain) manual guided protocol, patient workbook, and therapist training protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STOP Therapy Treatment group | Experimental | Self-regulation Treatment for Opioid addiction and Pain (STOP) is a 12-week, rolling entry group therapy protocol that underwent initial development in a previous K23 study. Treatment consists of weekly 90-minute CBT+SR (Self Regulation) treatment with skill building exercises for co-morbid opioid addiction and pain. STOP will be provided in lieu of TAU (Treatment as Usual) group therapy. |
|
| Treatment as usual (TAU) group | Active Comparator | Psychotherapy for Addiction in conjunction with medication assisted treatment. Standard community treatment for opioid addiction consists of 90-minute weekly rolling entry addiction treatment for 12 weeks to allow for the learning and rehearsal of skills designed to reduce relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STOP Therapy Treatment group | Other | Testing of the STOP Therapy protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Daily Functioning - Pain | Multi-dimensional pain inventory - 60 items (participant ratings 0 to 6 on various measures, from none to extreme or from never to very often, related to their pain and functioning); subscales (ratings in each subscale are averaged to form subscale scores): Interference, Support, Pain Severity, Life-Control, Affective Distress, Negative Responses, Solicitous Responses, Distracting Responses, Household Chores, Outdoor Work, Activities Away from Home, Social Activities, General Activity | Baseline (week 1) to post-treatment assessment time-point (week 14) and to a 1-month post-treatment follow-up assessment for each participant (approximately 4-5 month total time frame per participant) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Substance Use | urinalysis toxicity screening | Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant) |
| Measure | Description | Time Frame |
|---|---|---|
| Substance Use, self-report | Timeline Follow back self report (Report alcohol/drug that you may have used in the past two weeks) | Weekly through study completion, approximately 4-5 months for each participant |
| Pain assessment through Cold Pressor task |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy B Wachholtz, PhD, MDiv, MS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Denver | Colorado | 80204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35525964 | Derived | Wachholtz A, Robinson D, Epstein E. Developing a novel treatment for patients with chronic pain and Opioid User Disorder. Subst Abuse Treat Prev Policy. 2022 May 7;17(1):35. doi: 10.1186/s13011-022-00464-4. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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1 Treatment group with STOP therapy; 1 Treatment as usual group
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| Treatment as usual (TAU) group |
| Other |
Treatment as usual in the community through group therapy |
|
Cold pressor task assessment measures: 0-100 acute pain levels after task (0 being no pain, 100 being extreme pain), pain sensitivity (duration in water until reported feeling pain), pain tolerance (length of time hand is kept in cold water), physiological response to cold water
| Assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Daily Functioning - Timed up and go | Timed up and go test - measure of function with correlates to balance and fall risk; participant is timed while getting up from a chair, walking, and returning to a seated position; scores of greater than or equal to 14 seconds indicate higher fall risk. | Assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Daily functioning - physical performance | Modified Physical performance test - 9 items in which participant performs basic physical activities: Standing Static Balance, Chair rise, Lift book, Put on jacket, Pick up penny, turn 360 degrees, 50 ft walk test, climb one flight of stairs, climb stairs (max. 4 flights); items are scored 0 to 4 based on time to complete task (with 0 being unable to complete task, 1 being longest timeframe to complete task and 4 being shortest timeframe) | Assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Current pain levels | 0-100 Current pain rating scale (with 0 being no pain, 100 being extreme pain) | Weekly through study completion, approximately 4-5 months for each participant |
| Self-efficacy - Drug abstinence | Drug abstinence self-efficacy scale - 12 items, 1-5 scale (1 being not at all confident, 5 being extremely confident) | Assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Pain Catastrophizing | Pain Catastrophizing scale - assesses 13 items on a 0-4 scale (0-not at all, 1-to a slight degree, 2-to a moderate degree, 3-to a great degree, or 4-all the time) | Assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Self-efficacy - Pain | Pain self-efficacy questionnaire - 10 items, 0-6 scale (0 - not at all confident, 6 - extremely confident) | Assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Craving - Brief Substance Craving Inventory | Brief Substance Craving Inventory - self-report of drug cravings within the past 24 hours | assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Craving - Current Craving levels | Desire for Drug and current craving levels questionnaire - 14 items, 1-7 scale (1-not at all, 7- very much) | assessed weekly from 2nd week through 13th week for each participant |
| Distress Tolerance Scale | Distress tolerance scale - 15 items, rate from "strong agree" to "strong disagree" | assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) |
| Coping | Brief Cope Inventory - items rated from "never" to "always" on 28 items related to coping | assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Positive and Negative Affect Scale | PANAS - ratings for how a participant has felt in the past two weeks, from 1 ("very slightly or not at all") to 5 ("extremely") | assessed weekly from 2nd week through 13th week for each participant |
| Addiction Severity Index | ASI - survey on participant's baseline addiction severity; 5 parts (Background, Basic Health, Relationships, Alcohol and Drug Use, Legal situation) | assessed at initial session (week 1) |
| Hospital Anxiety and Depression scale | HADS - asks participants to indicate how they generally feel on 14 items | assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant |
| Session feedback | 12 items, 1 for each weekly therapy topic, participants rate from 1 (very useful and will definitely use the strategies discussed) to 4 (not very useful and may not use the strategies discussed) | weekly through study completion, approximately 4-5 months for each participant |
| Weekly attendance data sheet | table indicating which participants and the total number of participants that attend the therapy group each week | weekly through study completion, approximately 4-5 months for each participant |
| Eligibility phone screening | 6 yes or no items for inclusion/exclusion criteria, 1 open-ended item to provide medication and dosage frequency, 1 item to provide typical pain level on 0-10 scale | assessed at initial session (week 1) for each participant |
| Demographics data sheet | demographics information | assessed at initial session (week 1) for each participant |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |