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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLund University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Current or previous former cancer diagnosis;

Recurring cancer-related pain;

Aged 18 years or older;

Living in Sweden;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Pain focused CBT for chronic painExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Pain severity

The Brief Pain Inventory (BPI) scale was developed to assess the severity of pain and its impact on functioning. For the current study, only 3 items will be used measuring pain severity at current, usual, and worst levels . 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.

Time frame
From enrollment to the end of treatment at 6-8 weeks, and at month 5.
2

Fatigue severity and interference

The Brief Fatigue Inventory (BFI) is a 9-item rating scale developed to assess subjective fatigue. The first three questions measure fatigue severity at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities. Items will range from 0 to 100, with higher scores indicating worst outcomes. Only two of the items will be administered daily via a smart phone application.

Time frame
From enrollment to the end of treatment at 6-8 weeks, and at month 5.
3

Fear of cancer recurrence

The severity subscale of the Fear of Cancer Recurrence Inventory (FCRI) is used to assess fear of cancer recurrence. This 9-item subscale evaluates the presence and severity of intrusive thoughts associated with FCR. Each item is rated on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal' or "all the time"), with higher scores indicating a worst outcome. Only two items will be administered daily via a smart phone application. These items will range from 0 to 100.

Time frame
From enrollment to the end of treatment at 6-8 weeks, and at month 5.
4

Depression

The Patient Health Questionnaire (PHQ-9) is composed of 9 items that assess the frequency of depressive symptoms (feelings thoughts, states), from 0 ("Not at all) to 3 ("Nearly every day"), with higher scores indicating a worst outcome.

Time frame
At enrollment, at month 2 and at month 5.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lund University

Lead sponsor

Swedish Cancer Foundation

Collaborator