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