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A Transdiagnostic Treatment for Comorbid Chronic Pain and Emotional Problems

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ClinicalTrials.gov Identifier: NCT02751749
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : September 27, 2016
Sponsor:
Collaborators:
Örebro County Council
Uppsala County Council, Sweden
Information provided by (Responsible Party):
Matilda Wurm, Örebro University, Sweden

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.

Condition or disease Intervention/treatment Phase
Chronic Pain and Comorbid Emotional Problems Behavioral: Unified Protocol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Unified Protocol

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).

Behavioral: Unified Protocol



Primary Outcome Measures :
  1. Overall Depression Severity and Impairment Scale (ODSIS) [ Time Frame: an average of 30 weeks ]
    measures general depression

  2. Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: an average of 30 weeks ]
    measures general anxiety

  3. The question: How intense has your pain been during the last week? [ Time Frame: an average of 30 weeks ]
    one item asking for pain during last week (1-10)


Secondary Outcome Measures :
  1. Mini International Neuropsychiatric Interview, MINI [ Time Frame: an average of 30 weeks ]
    diagnostic interview



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751749


Sponsors and Collaborators
Örebro University, Sweden
Örebro County Council
Uppsala County Council, Sweden
Investigators
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Principal Investigator: Matilda Wurm Örebro University

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Responsible Party: Matilda Wurm, PhD fellow, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02751749     History of Changes
Other Study ID Numbers: STARK
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms