A Transdiagnostic Treatment for Comorbid Chronic Pain and Emotional Problems

NCT02751749 | Completed

• 1 other identifier: STARK
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain and Comorbid Emotional Problems

Outcome Measures

Primary Outcomes (3)

• Overall Depression Severity and Impairment Scale (ODSIS)

  measures general depression

  an average of 30 weeks

• Overall Anxiety Severity and Impairment Scale (OASIS)

  measures general anxiety

  an average of 30 weeks

• The question: How intense has your pain been during the last week?

  one item asking for pain during last week (1-10)

  an average of 30 weeks

Secondary Outcomes (1)

• Mini International Neuropsychiatric Interview, MINI

  an average of 30 weeks

Study Arms (1)

Unified Protocol

EXPERIMENTAL

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

Interventions

Unified Protocol BEHAVIORAL

Unified Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Örebro County Council: collaborator
• Uppsala County Council, Sweden: collaborator

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matilda Wurm

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 26, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09