AzTrials
AzTrials

Chronic PainTIPPSNCT03316846

Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress

A study testing Internet-Delivered Cognitive Behavioral Therapy in people with Chronic Pain and Depressive Symptoms, run by Uppsala University at 1 site in Sweden.

Completed

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

Official record
Search all trials

Trial summary

This study is a randomized controlled trial studying the efficacy of an iCBT treatment for patients with chronic pain and comorbid psychiatric distress. Half the participants will receive treatment at first, while the other half serve as a control group. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Chronic Pain, Depressive Symptoms, Anxiety
What is being tested?
Internet-Delivered Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
1 siteSweden
Study dates
13 Sep 2016to Dec 2018
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 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Experienced pain for at least the three previous months
  • Medically evaluated regarding the pain condition
  • Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
  • Access to, and ability to use, a personal computer with internet access
  • Mastery of the swedish language

Who cannot join

  • Currently undergoing or planning to undergo CBT-treatment during the course of the study
  • Currently undergoing or planning to undergo major changes in pharmacotherapy during the course of the study, or have made such changes in the last 2 months
  • Have planned surgical intervention during the course of the study
  • Currently experiencing symptoms of severe depression (scores >16 on suicidality on M.I.N.I.)
  • Currently experiencing significant symptoms of psychosis (fulfills M.I.N.I criteria for psychotic syndrome, current)
  • Currently experiencing significant symptoms of alcohol or substance abuse (fulfills M.I.N.I criteria for alcohol- or substance use disorder)

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Department of Psychology, Uppsala University

    Uppsala, Uppland, 75236

Other trials in Sweden

About this study

Official title: Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress

This study is a randomized controlled trial studying the efficacy of an iCBT treatment for patients with chronic pain and comorbid psychiatric distress. Half the participants will receive treatment at first, while the other half serve as a control group. After the first group has received treatment, the same program will be offered to participants in the control group. Treatment will be tailored on the level of individual participants, enabling individuals suffering a wide range of problems to be recruited. The treatment will consist of a 10-week guided self-help program, followed by a booster program and follow-up one year later. During the curse of the treatment the participants will be guided via text communication by a licensed psychologist or a candidate psychologist on their last year of studies.

The primary hypothesis is that an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric distress. The investigators expect that patients in the treatment group will show reduced levels of disability, depression and anxiety, while improving on scales measuring coping and quality of life.

Read the detailed description

Patients suffering from chronic pain often experience comorbid psychiatric distress. Cognitive behavioral therapy (CBT) has been shown to be effective in treating both these problems. However delivering relevant treatment can be difficult due to logistics, cost and lack of personnel with required competence. Delivering CBT though the internet (iCBT) is a novel approach, sidestepping logistical issues while lowering costs. This however, is an area were research is lacking, and though there are several studies showing iCBT to be efficacious in treating both pain and psychiatric conditions, research on a combined approach is scarce.

This study will primarily investigate whether an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric conditions. The project will also clarify whether a following booster-program, also administered tough the internet, is helpful in maintaining and increasing effects of the initial treatment. Lastly, analysis of possible mediating variables will be able to give insight into the internal workings of the treatment itself, further elucidating efficacy of specific interventions, data which will be useful in future developments of treatment design.

The treatment will be based on a previously developed program, devised to target depression and anxiety in patients with chronic pain. The treatment will consist of a 10-week period where participants would get access to a series of treatment modules, each addressing a separate problem area using CBT techniques. The treatment includes modules addressing depression, anxiety, panic, worry, insomnia, stress, trauma, communication skills, and relaxation. The booster program will be based on the initial treatment, but will shorter, focusing on repetition, strategies for maintenance, and coping with setbacks. The platform used is an existing platform employed by Smärtcentrum at Uppsala university hospital for delivering internet based treatments.

The study will be conducted using a randomized controlled trial with a between-group design. Participants will be randomized to two groups, were one group will gain access to iCBT treatment while the second group will be a wait-list control, and will gain access to the program once treatment of the active group is finished. Participants will assessed by a licensed psychologist, and treatment modules assigned based on their individual needs. In addition to online CBT modules, consisting of information, exercises and homework assignments, all participants will have regular contact by secure email-channel with a licensed psychologist or last-year psychology student under supervision. This contact will guide treatment, providing support, feedback on homework, and if necessary clarify treatment content and help with IT-related problems interfering with treatment adherence. After a year, participants will be invited to take part in a follow-up module, consisting of limited treatment recapitulation and evaluation.

Being tested
Internet-Delivered Cognitive Behavioral Therapy
Keywords
Chronic Pain, Depression, Anxiety, Stress, iCBT, Cognitive behavioral therapy, Internet delivered, Tailored treatment
Medical subject headings
Chronic Pain, Depression, Anxiety Disorders, Stress, Psychological

What participants receive

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

  • Internet-Delivered Cognitive Behavioral TherapyBehavioural

Study groups in NCT03316846
Study groupRoleWhat they receive
Internet-delivered therapyExperimental10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
Receives: Behavioral: Internet-Delivered Cognitive Behavioral Therapy
Wait list control groupNo interventionWait list control group, receives treatment at later point.

What is being measured

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

  1. Change from baseline in depressive symptoms

    Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items

    Measured: at 10 weeks

  2. Change from baseline in depressive symptoms

    Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items

    Measured: at one-year

  3. Change from baseline in psychosocial consequences of pain

    Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items

    Measured: at 10 weeks

  4. Change from baseline in psychosocial consequences of pain

    Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items

    Measured: at one-year

Secondary outcomes (30)
  1. Change from baseline in anxiety sensitivity

    Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items

    Measured: at 10 weeks

  2. Change from baseline in anxiety sensitivity

    Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items

    Measured: at one-year

  3. Change from baseline in symptoms of depression and anxiety

    Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items

    Measured: at 10 weeks

  4. Change from baseline in symptoms of depression and anxiety

    Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items

    Measured: at one-year

  5. Change from baseline in pain disability

    Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items

    Measured: at 10 weeks

  6. Change from baseline in pain disability

    Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items

    Measured: at one-year

  7. Change from baseline in quality of life

    Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items

    Measured: at 10 weeks

  8. Change from baseline in quality of life

    Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items

    Measured: at one-year

  9. Fear of pain due to movement

    Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items

    Measured: Baseline only

  10. Change from baseline in insomnia symptoms

    Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version

    Measured: at 10 weeks

  11. Change from baseline in insomnia symptoms

    Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version

    Measured: at one-year

  12. Change from baseline in PTSD symptoms

    Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version

    Measured: at 10 weeks

  13. Change from baseline in PTSD symptoms

    Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version

    Measured: at one-year

  14. Change from baseline in stress

    Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version

    Measured: at 10 weeks

  15. Change from baseline in stress

    Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version

    Measured: at one-year

  16. Change from baseline in GAD-symptoms

    Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version

    Measured: at 10 weeks

  17. Change from baseline in GAD-symptoms

    Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version

    Measured: at one-year

  18. Change from baseline in pain catastrophizing

    Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version

    Measured: at 5 weeks

  19. Change from baseline in pain catastrophizing

    Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version

    Measured: at 10 weeks

  20. Change from baseline in pain catastrophizing

    Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version

    Measured: at one-year

  21. Change from baseline in coping strategies

    Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version

    Measured: at one-year

  22. Change from baseline in coping strategies

    Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version

    Measured: at 5 weeks

  23. Change from baseline in coping strategies

    Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version

    Measured: at 10 weeks

  24. Change from baseline in pain acceptance

    Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version

    Measured: at 5 weeks

  25. Change from baseline in pain acceptance

    Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version

    Measured: at 10 weeks

  26. Change from baseline in pain acceptance

    Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version

    Measured: at one-year

  27. Change from baseline in self efficacy

    Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version

    Measured: at 5 weeks

  28. Change from baseline in self efficacy

    Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version

    Measured: at 10 weeks

  29. Change from baseline in self efficacy

    Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version

    Measured: at one-year

  30. Treatment credibility rating

    Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version

    Measured: Baseline only

Timeline

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

  1. First posted20 Oct 2017
  2. Study start13 Sep 2016
  3. Primary completionMay 2017
  4. Study completionDec 2018

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
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03316846
Sponsor's protocol ID
140371
Acronym
TIPPS
Status last verified
May 2020
First submitted
1 Sep 2017
Last updated
27 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Internet-Delivered Cognitive Behavioral Therapy in people with Chronic Pain and Depressive Symptoms, run by Uppsala University at 1 site in Sweden.

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 May 2020. 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 Sweden. 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?

Change from baseline in depressive symptoms (time frame: at 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 May 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in