Chronic Pain Clinical Trial
Official title:
How do Self-compassion and Psychological Flexibility Mediate Change in a Compassion-Focused Therapy Group for Chronic Pain?
This research aims to study how Compassion-Focused Therapy (CFT) might work for people with
chronic pain. People with chronic pain may feel shameful about their condition and this type
of therapy aims to help people to view themselves and their difficulties in a kinder, less
critical way (i.e. self-compassion). Currently, no research is available on the effectiveness
of CFT in helping people with chronic pain.
Participants attending a CFT-incorporated Pain Management Programme will complete a battery
of questionnaires at the start of the group (week 1), in the middle of the group (week 5) and
at the end of the group (week 11).
Pain Management Programmes help people to manage their pain and improve quality of life, and
this research will look into the processes by which this happens. This study will look at two
psychological concepts: 'self-compassion' (kindness to self) and 'psychological flexibility'
(willingness to tolerate difficult experiences in order to meet meaningful goals). These
concepts help in understanding how people think about themselves in the context of pain.
Principle Research Question: Do self-compassion and psychological flexibility mediate change
(anxiety/depression/well-being) in a Compassion-Focused Therapy group for adults with chronic
pain?
Primary Outcome Measure: Strength of mediation effects
Sample Size:
[Reference 1] propose guidelines for recommended sample sizes in order to detect mediation
effects with .8 power. These guidelines are informed by existing literature in the field.
There is less robust research on self-compassion and chronic pain, therefore, this
calculation is based on research in psychological flexibility and chronic pain.
[Reference 2] conducted correlational analyses on the processes of psychological flexibility
following a group intervention based on ACT. These processes included acceptance of pain,
mindfulness, psychological acceptance and values-based action (r values between 0.33 and
0.55). These positive correlations indicate that the group intervention was related to higher
levels of psychological flexibility.
[Reference 3]'s review identified several studies that reported correlational effect sizes
between acceptance, and depression/anxiety/daily functioning related to chronic pain (r =
-0.58/-0.66/0.47 respectively). These negative correlations illustrate that higher levels of
psychological flexibility were related to better outcomes.
Based on these correlational effect sizes, guidelines in [Reference 1] suggest that a sample
size of 53-71 is required.
Analysis:
The analysis will focus on the proposed mediating factors (self-compassion and psychological
flexibility) and how they explain the outcome of the CFT-incorporated group intervention. In
order to study the processes of change, this study will measure change in mediators and
outcomes over the course of the group.
In a mediation model, the effect of the independent variable (IV; CFT group) on a dependent
variable (DV; outcome/change in symptoms) is conveyed through a third mediating variable. In
order to be a mediator, a variable must change during the intervention, be associated with
the intervention, and have an impact on the outcome.
In this study, it is hypothesised that self-compassion and/or psychological flexibility are
the mediating variables that explain the influence of the group intervention on eventual
outcome, i.e. the overall change in symptoms at the end of the group. Linear regression and
nonparametric bias-corrected bootstrap, which corrects for skew in the data, will be applied
to the data using SPSS, using the PROCESS macro. An effect of mediation will be indicated if
the confidence interval does not contain zero.
Missing data will be handled using either the maximum likelihood or multiple imputation
method, as recommended in literature.
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