University of Colorado Denver
Denver, Colorado, 80204, United States
NCT Number: NCT03363243
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Denver, Colorado, 80204, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Testing of the STOP Therapy protocol
Treatment as usual in the community through group therapy
Time frame: 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)
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
Time frame: Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant)
urinalysis toxicity screening
Time frame: Weekly through study completion, approximately 4-5 months for each participant
Timeline Follow back self report (Report alcohol/drug that you may have used in the past two weeks)
Time frame: 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
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
Time frame: 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
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.
Time frame: 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
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)
Time frame: Weekly through study completion, approximately 4-5 months for each participant
0-100 Current pain rating scale (with 0 being no pain, 100 being extreme pain)
Time frame: 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
Drug abstinence self-efficacy scale - 12 items, 1-5 scale (1 being not at all confident, 5 being extremely confident)
Time frame: 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 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)
Time frame: 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 self-efficacy questionnaire - 10 items, 0-6 scale (0 - not at all confident, 6 - extremely confident)
Time frame: 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
Brief Substance Craving Inventory - self-report of drug cravings within the past 24 hours
Time frame: assessed weekly from 2nd week through 13th week for each participant
Desire for Drug and current craving levels questionnaire - 14 items, 1-7 scale (1-not at all, 7- very much)
Time frame: 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)
Distress tolerance scale - 15 items, rate from "strong agree" to "strong disagree"
Time frame: 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
Brief Cope Inventory - items rated from "never" to "always" on 28 items related to coping
Time frame: assessed weekly from 2nd week through 13th week for each participant
PANAS - ratings for how a participant has felt in the past two weeks, from 1 ("very slightly or not at all") to 5 ("extremely")
Time frame: assessed at initial session (week 1)
ASI - survey on participant's baseline addiction severity; 5 parts (Background, Basic Health, Relationships, Alcohol and Drug Use, Legal situation)
Time frame: 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
HADS - asks participants to indicate how they generally feel on 14 items
Time frame: weekly through study completion, approximately 4-5 months for each participant
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)
Time frame: weekly through study completion, approximately 4-5 months for each participant
table indicating which participants and the total number of participants that attend the therapy group each week
Time frame: assessed at initial session (week 1) for each participant
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
Time frame: assessed at initial session (week 1) for each participant
demographics information
University of Colorado, Denver
Other
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