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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
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain and Comorbid Emotional Problems

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 11, 2016
    Last Updated
    September 26, 2016
    Sponsor
    Örebro University, Sweden
    Collaborators
    Örebro County Council, Uppsala County Council, Sweden
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    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

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    A Transdiagnostic Treatment for Comorbid Chronic Pain and Emotional Problems

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