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Pancreatitis, ChronicIMPACTNCT03322644

Internet-based Pain Self-management for Persons With Acute Recurrent and Chronic Pancreatitis Pain

A study testing Internet-based CBT intervention in people with Pancreatitis, Chronic and Pancreatitis, Acute Recurrent, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pain is the cardinal symptom of acute recurrent and chronic pancreatitis, and available medical treatments have limited efficacy. Pain self-management programs equip patients to minimize the impact of chronic painful conditions on activity, health, and psychosocial functioning. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Internet-based CBT intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
1 Feb 2018to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Able and willing to provide informed consent for participation in this study
  • Meet CPDPC criteria for diagnosis of either suspected CP (CPDPC "yellow zone") or definite CP (CPDPC "red zone")
  • Have personal internet access on any device (e.g., phone, tablet, computer)
  • Has experienced pain intensity rated as 4 or higher on a 0-10 scale in the last month

Who cannot join

  • Currently undergoing treatment for cancer
  • Inability to understand English well enough to complete questionnaires or to participate in treatment
  • Severe depression (i.e., indicated by a score > 22 on the Patient Health Questionnaire (PHQ-9)
  • Significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9)
  • Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months)
  • Currently receiving treatment with a psychologist

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Development and Feasibility Testing of an Internet-based Pain Self-management Program for Persons With Acute Recurrent and Chronic Pancreatitis Pain (The IMPACT Study)

Pain is the cardinal symptom of acute recurrent and chronic pancreatitis, and available medical treatments have limited efficacy. Pain self-management programs equip patients to minimize the impact of chronic painful conditions on activity, health, and psychosocial functioning. The purpose of the current study is to pilot the use of Internet-delivered pain self-management course in adults with chronic and acute recurrent pancreatitis to generate preliminary feasibility and acceptability data to inform design of a subsequent large randomized controlled trial.

Read the detailed description

Acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) are associated with high disease burden across the lifespan. Recurring abdominal pain is the most prevalent and distressing symptom. Pain severity reduces health-related quality of life for individuals with CP and is associated with increased fatigue, anxiety and depressive symptoms, lower general health status, and reduced physical and role functioning. Medical therapies for CP pain have limited efficacy. Cognitive-behavioral interventions (CBT) offer safe and effective alternatives to pharmacological treatments for pain management. In other chronic painful conditions including gastrointestinal disorders, CBT interventions have been effective for reducing pain and pain impact including disability and depressive symptoms. CBT is traditionally provided by trained psychologists working with individual patients one-on-one or in small groups. Access to CBT is limited by availability of providers, with long waiting lists at centers offering CBT. The Internet is an ideal medium to provide pain self-management interventions that are low-cost and sustainable, and internet-based CBT has shown efficacy in children and adults with chronic pain, allowing clinics to greatly extend their reach to patients. The purpose of this study is to test the acceptability, feasibility, and preliminary efficacy of an Internet-delivered CBT pain self-management course for adults with acute recurrent and chronic pancreatitis pain.

Being tested
Internet-based CBT intervention
Keywords
Pancreatitis, Pain, Internet Intervention, Behavioral Intervention
Medical subject headings
Pancreatitis, Chronic, Pancreatitis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based CBT interventionBehavioural

    The Internet-delivered Pancreatitis Pain Course consists of 5 lessons: 1) introduction, education, and symptom identification, 2) thought monitoring and challenging, 3) controlled breathing and pleasant activity scheduling, 4) activity pacing, and 5) relapse prevention and goal setting. Participants aim to complete one online lesson weekly for 5 weeks, and have up to 2 months to complete the course. Each lesson has a homework assignment to encourage participants to practice and apply skills. A coach who is part of the Seattle Children's Research Institute study team will make weekly contact with participants in the intervention arm through telephone or secure e-mail, for a period of between 10-15 minutes to encourage participants to work through the Course and apply the skills.

Study groups in NCT03322644
Study groupRoleWhat they receive
Internet-based CBT interventionExperimentalIn addition to standard medical care, participants in the Internet-based CBT group will receive access to the Pancreatitis Pain Course and will be asked to complete all online modules over 2 months using their own smartphone or computer. A coach will guide participants through the weekly lessons.
Receives: Behavioral: Internet-based CBT intervention
Wait list control groupNo interventionParticipants assigned to the Wait list control group will be asked to continue with any recommendations made by their clinic provider and will not be offered any internet-based content until after they complete the 5 month assessments (i.e. Months 5-7).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment acceptability

    Participants will complete a 12-item Treatment Evaluation Inventory questionnaire that assesses satisfaction and acceptability of the course of treatment and satisfaction with the outcome of the intervention. Items are rated on a 5-point Likert scale ranging from 1 = Strongly disagree, to 5 = Strongly agree.

    Measured: Immediately post-treatment

Secondary outcomes (8)

  1. Treatment feasibility

    Feasibility will be determined by calculating rates of accrual, drop out, compliance, and missing data. Criteria for feasibility success will be based on: accrual rates >70%, attrition rates <15%, minimal technical difficulties (i.e., reported by <10%), adherence rates >80%, and minimal missing data.

    Measured: Immediately post-treatment

  2. Change in pain intensity

    Participants will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain, and 10 = worst pain. Mean average intensity of the pain reported will serve as the pain measure.

    Measured: Baseline, 3-month follow-up

  3. Change in pain-related disability

    Participants will report their level of pain-related disability daily for 7 days at each assessment period. Questions of pain-related disability are taken from the Brief Pain Inventory and the Pain Disability Index. These measures assess the extent to which chronic pain disrupts aspects of daily life including social relations, work, mood, sleep, eating, and physical activity. All items are scored on a 0-10 NRS, with higher scores indicating greater disability.

    Measured: Baseline, 3-month follow-up

  4. Change in Disease specific and generic health related quality of life (HRQOL)

    Participants will complete the 18-item Pancreatitis Quality of Life Instrument to assess for disease-specific HRQOL difficulties. Items are scored on a 0-5 scale where 0 = Not applicable, 1 = Much less, and 5 = Much more. Participants will also complete the 12-item Short-Form Health Survey to assess for general HRQOL.

    Measured: Baseline, 3-month follow-up

  5. Change in Medication use

    Participants will record their medication use daily for 7 days at each assessment period

    Measured: Baseline, 3-month follow-up

  6. Change in Pain self-efficacy

    Participants will complete the 4-item Chronic Pain Self-Efficacy Scale. This scale assesses perceived self-efficacy over three factors: pain management, coping with symptoms, and physical function. All items are scored on a 7-point Likert scale where 0 = Not at all confident, and 6 = Completely confident

    Measured: Baseline, 3-month follow-up

  7. Change in Psychological distress

    Participants will complete the 4-item Anxiety and 4-item Depression subscales of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile to assess for levels of psychological distress over the past week. Items are scored on a 5-point Likert scale ranging from 1 = Never, to 5 = Always.

    Measured: Baseline, 3-month follow-up

  8. Change in Sleep and Fatigue

    Participants will complete the 4-item Sleep Disturbance and 4-item Fatigue subscales of the PROMIS-29 Profile to assess for problems with fatigue and sleep over the previous week. All items are scored on a 5-point Likert scale ranging 1 = Not at all, to 5 = Very much, except for one sleep item which is scored 1 = very poor, to 5 = Very good.

    Measured: Baseline, 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2017
  2. Study start1 Feb 2018
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03322644
Sponsor's protocol ID
Mayo IRB #17-007214
Other IDs
U01DK108334
Acronym
IMPACT
Status last verified
Sep 2021
First submitted
23 Oct 2017
Last updated
27 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Palermo TM, Law EF, Topazian MD, Slack K, Dear BF, Ko YJ, Vege SS, Fogel E, Trikudanathan G, Andersen DK, Conwell DL, Yadav D; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial. Clin Transl Gastroenterol. 2021 Jun 18;12(6):e00373. doi: 10.14309/ctg.0000000000000373.

    PubMed 34140460

  • Yadav D, Palermo TM, Phillips AE, Bellin MD, Conwell DL. Painful chronic pancreatitis - new approaches for evaluation and management. Curr Opin Gastroenterol. 2021 Sep 1;37(5):504-511. doi: 10.1097/MOG.0000000000000769.

    PubMed 34172622

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based CBT intervention in people with Pancreatitis, Chronic and Pancreatitis, Acute Recurrent, run by Seattle Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment acceptability (time frame: Immediately post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03322644, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.

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