A Transdiagnostic Treatment for Comorbid Chronic Pain and Emotional Problems
Primary Purpose
Chronic Pain and Comorbid Emotional Problems
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unified Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain and Comorbid Emotional Problems
Eligibility Criteria
Inclusion Criteria:
- Chronic pain problems (duration > 3 months)
- Depressive symptoms and/or anxiety symptoms (> 15 points on the Swedish Montgomery Åsberg Depression Schedule (MDRS-S) and/or > 7 points on the Overall Anxiety Symptoms and Impairment Scale, (OASIS))
- MMR within the last three years
- > 18 years
- Fluent in reading and writing Swedish, and
- Internet access.
Exclusion Criteria:
- Ongoing or planned psychological treatment delivered by a psychologist or a psychotherapist
- Planned surgery
- Suicidality
- Severe depression
- Ongoing alcohol or substance abuse, and
- Ongoing psychosis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Unified Protocol
Arm Description
CBT based Internet delivered treatment targeting transdiagnostic vulnerability and maintaining factors for chronic pain and emotional problems. Since this is a new target Group, a replicated single case design was used and participants are their own Control Group (no other treatment arms).
Outcomes
Primary Outcome Measures
Overall Depression Severity and Impairment Scale (ODSIS)
measures general depression
Overall Anxiety Severity and Impairment Scale (OASIS)
measures general anxiety
The question: How intense has your pain been during the last week?
one item asking for pain during last week (1-10)
Secondary Outcome Measures
Mini International Neuropsychiatric Interview, MINI
diagnostic interview
Full Information
NCT ID
NCT02751749
First Posted
April 11, 2016
Last Updated
September 26, 2016
Sponsor
Örebro University, Sweden
Collaborators
Örebro County Council, Uppsala County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02751749
Brief Title
A Transdiagnostic Treatment for Comorbid Chronic Pain and Emotional Problems
Official Title
Chronic Pain and Emotional Problems: a Single Case Study of an Internet Based Self-help Treatment Based on CBT Principles and the Unified Protocol for Transdiagnostic Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden
Collaborators
Örebro County Council, Uppsala County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study uses a replicated randomized single case design. Participants were 12 individuals with chronic pain problems and residual problems after undergoing a multimodal pain rehabilitation. They also had comorbid emotional problems. Treatment consisted of 10 weeks of Internet delivered, therapist guided CBT based self-help treatment based on the Unified Protocol.
Detailed Description
The study uses a replicated randomized single case design. Twelve participants were recruited from three pain clinics and five primary care centers in different municipalities in central Sweden. The clinics and care centers provided addresses and sent a total of 600 letters with information regarding the study to patients who had completed a multimodal pain rehabilitation (MMR) at their facility within the last three years. Participants were also recruited via the Internet through an advertisement on Google Ads that was visible for two months. No reward was offered for taking part in the study. Potential participants were screened and provided demographic information on a secure internet based platform. Afterwards all screened individuals received a telephone call. Excluded individuals were informed about the reason for exclusion and given recommendations regarding alternative treatment options when indicated. Eligible participants were screened further using selected parts of the Mini International Neuropsychiatric Interview. They were also given more information about the study and invited to ask questions. Individuals who met selection criteria were randomized in blocks of four using randomizer.org and half participated in an initial pilot study while half participated in the treatment study reported here. Participants for the treatment study were thereafter randomized to either a short (five week) or a long (10 week) baseline as well as separately randomized to one of five therapists. Therapists were two clinical psychology students in their last year of training, one graduated clinical psychologist, one postgraduate clinical psychology fellow and one certified clinical psychologist. Participants gave written informed consent by sending in a form included in the initial information letter.
Participants were 12 individuals with chronic pain problems. The sample consisted of 9 females (75 %) and 3 males (25 %). Participants' age ranged from 30 to 60 (M= 47, sd= 9). See table 1 for further description of the participants. All participants had completed MMR within the past three years.
Participants for the treatment study filled in baseline measurements at between 3 and 10 time points. Baseline measurements were separated by at least five days. In connection with the last baseline measurement, participants filled out pretreatment measurements and started treatment, consisting of 10 weekly modules. Process measurements were filled out once every module, as well as longer measurements at mid- and post treatment. A follow-up was done via the platform after 3 months. Treatment consisted of 10 weeks of internet delivered, therapist guided CBT based self-help treatment based on the Unified Protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain and Comorbid Emotional Problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unified Protocol
Arm Type
Experimental
Arm Description
CBT based Internet delivered treatment targeting transdiagnostic vulnerability and maintaining factors for chronic pain and emotional problems.
Since this is a new target Group, a replicated single case design was used and participants are their own Control Group (no other treatment arms).
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol
Primary Outcome Measure Information:
Title
Overall Depression Severity and Impairment Scale (ODSIS)
Description
measures general depression
Time Frame
an average of 30 weeks
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
measures general anxiety
Time Frame
an average of 30 weeks
Title
The question: How intense has your pain been during the last week?
Description
one item asking for pain during last week (1-10)
Time Frame
an average of 30 weeks
Secondary Outcome Measure Information:
Title
Mini International Neuropsychiatric Interview, MINI
Description
diagnostic interview
Time Frame
an average of 30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic pain problems (duration > 3 months)
Depressive symptoms and/or anxiety symptoms (> 15 points on the Swedish Montgomery Åsberg Depression Schedule (MDRS-S) and/or > 7 points on the Overall Anxiety Symptoms and Impairment Scale, (OASIS))
MMR within the last three years
> 18 years
Fluent in reading and writing Swedish, and
Internet access.
Exclusion Criteria:
Ongoing or planned psychological treatment delivered by a psychologist or a psychotherapist
Planned surgery
Suicidality
Severe depression
Ongoing alcohol or substance abuse, and
Ongoing psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matilda Wurm
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Transdiagnostic Treatment for Comorbid Chronic Pain and Emotional Problems
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