Ignite Creation Date:
2024-05-06 @ 10:39 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03316846
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2017-09-01
Brief Title:
Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIPPS
Brief 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 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None