Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain

Browse trials for

• Chronic Pain 2,920
• Opioid-Related Disorders 1,410

Study arms

• Experimental
  STOP Therapy Treatment group

  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.

  Other: STOP Therapy Treatment group

• Active comparator
  Treatment as usual (TAU) group

  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.

  Other: Treatment as usual (TAU) group

Interventions

• OtherSTOP Therapy Treatment group

  Testing of the STOP Therapy protocol

• OtherTreatment as usual (TAU) group

  Treatment as usual in the community through group therapy

Primary outcomes

1. 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

   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)

Secondary outcomes

1. Changes in Substance Use

   urinalysis toxicity screening

   Time frame: Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant)

Other outcomes

1. Substance Use, self-report

   Timeline Follow back self report (Report alcohol/drug that you may have used in the past two weeks)

   Time frame: Weekly through study completion, approximately 4-5 months for each participant

2. Pain assessment through Cold Pressor task

   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

3. 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.

   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

4. 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)

   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

5. Current pain levels

   0-100 Current pain rating scale (with 0 being no pain, 100 being extreme pain)

   Time frame: Weekly through study completion, approximately 4-5 months for each participant

6. Self-efficacy - Drug abstinence

   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

7. 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)

   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

8. Self-efficacy - Pain

   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

9. Craving - Brief Substance Craving Inventory

   Brief Substance Craving Inventory - self-report of drug cravings within the past 24 hours

   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

10. Craving - Current Craving levels

    Desire for Drug and current craving levels questionnaire - 14 items, 1-7 scale (1-not at all, 7- very much)

    Time frame: assessed weekly from 2nd week through 13th week for each participant

11. Distress Tolerance Scale

    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)

12. Coping

    Brief Cope Inventory - items rated from "never" to "always" on 28 items related to coping

    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

13. 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")

    Time frame: assessed weekly from 2nd week through 13th week for each participant

14. Addiction Severity Index

    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)

15. Hospital Anxiety and Depression scale

    HADS - asks participants to indicate how they generally feel on 14 items

    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

16. 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)

    Time frame: weekly through study completion, approximately 4-5 months for each participant

17. Weekly attendance data sheet

    table indicating which participants and the total number of participants that attend the therapy group each week

    Time frame: weekly through study completion, approximately 4-5 months for each participant

18. 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

    Time frame: assessed at initial session (week 1) for each participant

19. Demographics data sheet

    demographics information

    Time frame: assessed at initial session (week 1) for each participant

Publications

• 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. PubMed 35525964 ↗

Individual participant data

Plan to share: Undecided