A Transdiagnostic Treatment for Comorbid Chronic Pain and Emotional Problems

Chronic Pain and Comorbid Emotional Problems Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751749
• Other study ID #: STARK
• Status: Completed
• Phase: N/A
• First received: April 11, 2016
• Last updated: September 26, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain and Comorbid Emotional Problems

Intervention

Behavioral:
• Unified Protocol

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Örebro University, Sweden	Örebro County Council, Uppsala County Council, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Depression Severity and Impairment Scale (ODSIS)	measures general depression	an average of 30 weeks	No
Primary	Overall Anxiety Severity and Impairment Scale (OASIS)	measures general anxiety	an average of 30 weeks	No
Primary	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	No
Secondary	Mini International Neuropsychiatric Interview, MINI	diagnostic interview	an average of 30 weeks	No