An N-of-1 Trial of an Internet-delivered CBT Program Based on the Psychological Flexibility Model of Chronic Pain for Cancer-related Difficulties

NCT06749964 | Recruiting

• 1 other identifier: 2024-04724-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a commonly occurring complication of cancer and can have negatively impact day-to-day functioning and well-being. The recommended treatment for all forms of chronic pain is cognitive behavioral therapy (CBT). However, access to this treatment in primary and specialist care is limited, including access to specialist pain clinics that do not routinely accept people with cancer-related pain. In addition, we know from clinical trials of pain-focused CBT that the symptom presentation of patients can vary greatly and may require interventions that are more tailored to their specific needs. The primary objective of the research is to test the feasibility, acceptability and preliminary efficacy of an internet-delivered, therapist-assisted, intervention for chronic pain with adults suffering from chronic cancer-related pain. The intervention is a form of CBT called Acceptance Commitment Therapy (ACT) and is based on the psychological flexibility model of pain. Psychological flexibility refers to an overall pattern of persistent behaviors characterized by a present-moment focus, acceptance rather than avoidance of distressing symptoms, and engagement with one's core values and goals. The intervention aims to improve overall functioning and well-being by helping participants to develop persistent patterns of behavior that align with with their core values and goals (e.g., personal, family, social, health, occupational) despite the presence of pain and other distressing symptoms. To achieve this aim, an existing pain-focused, internet-delivered, psychological flexibility based intervention was modified specifically for cancer-related pain with input from cancer patients and survivors. The 8-session, online intervention involves a mixture of written, audio, and videotaped materials, and instructions for experiential exercises, all of which are designed to reduce unhelpful coping behaviors and to increase psychological flexibility. Participants receive written support (and ask questions) from a therapist via the online platform where the intervention is hosted. Where necessary, participants may also access a limited number of face-to-face meetings (online) with their therapist. During the treatment phase, information from daily diary recordings (via smartphone) are used to provide individualized support to participants in the form of text messages from a therapist via the online platform. Where necessary, a limited number of face-to-face sessions (online) with a therapist are scheduled.

Conditions

Chronic Cancer-related Pain

Keywords

chronic cancer-related pain; psychological flexibility; internet delivered cognitive behavioral therapy; n-of-1 design; mediation

Outcome Measures

Primary Outcomes (1)

• Pain interference

  The Brief Pain Inventory (BPI) scale was developed to assess the severity of pain and its impact on functioning. For the current study, the six questions assessing pain interference with daily activities will be used. Items will range from 0 to 100, with higher scores indicating worst outcomes. Only one of the items will be administered daily via a smart phone application.

  From enrollment to the end of treatment at 6-8 weeks, and at month 5.

Secondary Outcomes (10)

• Pain severity

  From enrollment to the end of treatment at 6-8 weeks, and at month 5.

• Fatigue severity and interference

  From enrollment to the end of treatment at 6-8 weeks, and at month 5.

• Fear of cancer recurrence

  From enrollment to the end of treatment at 6-8 weeks, and at month 5.

• Depression

  At enrollment, at month 2 and at month 5.

• Anxiety

  At enrollment, at month 2 and at month 5.

Study Arms (1)

Pain focused CBT for chronic pain

EXPERIMENTAL

Baseline consists of a random assigned period between 7 and 21 days with measurements and no intervention. Intervention consists of 8 sessions of psychological flexibility training over 5 weeks.

Behavioral: Internet-delivered, therapist-assisted, pain-focused CBT based on the psychological flexibility model for chronic pain

Interventions

Internet-delivered, therapist-assisted, pain-focused CBT based on the psychological flexibility model for chronic pain BEHAVIORAL

8-session intervention, twice weekly for the first 3 weeks and once weekly for the final 2 weeks (45-60 min each session) aimed at promoting psychological flexibility. Treatment involves a mixture of video and audiotaped presentations and homework activities for the participant.

Pain focused CBT for chronic pain

Eligibility Criteria

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

You may qualify if:

• Current or previous former cancer diagnosis;
• Recurring cancer-related pain;
• Aged 18 years or older;
• Living in Sweden;
• Fluent in Swedish;
• Possession of a smartphone where they can download the application necessary for the daily diary recordings;
• Access to a device with internet access to receive the intervention;
• Not receiving another psychological treatment.

Sponsors & Collaborators

• Lund University: lead
• Swedish Cancer Foundation: collaborator

Study Sites (1)

Lund University

Lund, Sweden

RECRUITING

MeSH Terms

Conditions

Negotiating

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Sean Perrin, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Perrin, PhD

CONTACT

+46(0)723-709-827; sean.perrin@psy.lu.se

Frida Björkstrand, MS

CONTACT

+46 (0)704-566-728; frida.bjorkstrand@psy.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study applies a nonconcurrent, randomised baseline length, single case experimental design (SCED) where each participant serves as their own control. Participants are randomized to a 7 - 21 days long Baseline Phase wherein they receive no intervention, immediately followed by the 5-week Treatment Phase, and then a 3-month Follow-Up Phase.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 27, 2024
• Study Start: March 5, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)