Clinical trial NCT03658226: Case Series Evaluation of Psychodynamic Interpersonal Therapy in Chronic Low Back Pain
Official title: A Case Series Evaluation of Psychodynamic Interpersonal Therapy (PIT) in Chronic Low Back Pain (CLBP) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Case Series
Acceptability
Feasibility
Psychodynamic Interpersonal Therapy
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A series of experimental single case studies comparing individual CLBP participants' clinical outcomes during a baseline phase (receive no treatment) with those during a treatment phase (receive 8 sessions of PIT). Clinical outcomes will be the impact of treatment on pain distress/intensity, self-efficacy, mood and interpersonal functioning. There will be repeated measurement (daily/weekly) of the outcomes during baseline and intervention phases, to assess real-time change in these variables on a case-by-case basis. We will vary the length of the baseline phase randomly across participants, who will commence treatment following 3, 4, 5 or 6 weeks. This "multiple baselines" design will allow us to establish whether any improvement in clinical outcomes is caused by the intervention rather than natural change over time. We will assess feasibility/acceptability of the intervention by recording adverse reactions, side effects, adherence and participants' views about the intervention.
Primary purpose: TREATMENT

Brief summary: Many people in the world have chronic pain; this is pain which lasts more than twelve weeks. Pain can cause people to feel low in mood and change how they feel about themselves and others around them. Therapy for chronic pain does not always work and often people do not have lasting effects from treatment. This study hopes to see if a different therapy, called Psychodynamic Interpersonal Therapy (PIT), can help people with chronic pain. This therapy looks at how we see ourselves and our relationships with others; it aims to help people address personal problems that make it difficult for them to manage their pain.

The study aims to show that PIT is a suitable treatment for chronic low back pain and that people will have fewer problems with their mood, how they feel about themselves and their relationships. This study will give people with chronic low back pain eight sessions of PIT and during therapy they will fill in forms about their pain, mood, relationship problems and how they feel about themselves. We will also look at practical things to do with the therapy (e.g. how many sessions people came to, reasons for stopping therapy etc.) and ask people about how they felt about the therapy they had. Three months after the study has finished, people will be asked to fill in the forms again to see if the effects have lasted.

This research could help to give people with chronic pain a new and different treatment option which has good and lasting effects.

Detailed description: Chronic pain is continuous, long-term pain of more than 12 weeks. Patients with chronic pain are a heterogeneous group with varied pathologies (e.g. osteoarthritis; fibromyalgia) and pain sites (e.g., chronic low back pain, CLBP; chronic widespread pain). Chronic pain affects more than two fifths of the UK population, that is, around 28 million adults. Currently, the biopsychosocial model of pain is the most widely used heuristic approach to understanding chronic pain. The biopsychosocial perspective recognises that pain emerges from a dynamic interplay of a patient's physiological state, thoughts, emotions, behaviours, and sociocultural influences. This acknowledges that pain is a subjective experience and treatment approaches are aimed at management, rather than cure, of chronic pain.

Chronic pain affects social, psychological and emotional wellbeing. Current psychological treatments (e.g. CBT and ACT) aim to support patients to cope with the impact of chronic pain and improve their quality of life. However, some critical questions remain regarding the effectiveness of these interventions. Research indicates that substantial numbers of patients do not benefit greatly from these approaches and often effects are not maintained across time. Audit data from a local Pain Management Programme (PMP) indicates that many patients remain distressed by pain after treatment, with approximately 80% scoring 5 or more out of 10 on a pain distress scale six months later. Thus, it appears that current psychological therapies are not targeting all relevant issues.

Evidence indicates that psychodynamic therapies show some efficacy in the treatment of chronic pain, demonstrating patterns of change in interpersonal problems, pain intensity and depression-anxiety. Interpersonal literature states that aspects of relating are implicated in chronic pain; for example, perceived burdensomeness (feeling a burden on others) and thwarted belongingness (loneliness and feeling alienated from others) are significantly associated with pain intensity, self-efficacy and functional limitations.

Psychodynamic Interpersonal Therapy affirms that our sense of self and ability to relate to others are important determinants of how able we are to regulate emotion, manage adversity and access social support. As such, they are likely to play a fundamental role in how we cope with chronic pain. Studies have found an association between insecure attachment and related interpersonal difficulties with poor pain self-efficacy, anxiety and poor coping. Therefore, a psychological therapy such as PIT which focuses on addressing negative relationship patterns and strengthening sense of self may be of value in the treatment of chronic pain.

Psychological interventions such as PMPs seek to address the role of relationships and social networks in self-management of pain but do not target the psychological issues underlying interpersonal problems. Where individuals report high levels of interpersonal difficulties, a more in-depth focus on these issues may be required. As PIT seeks to understand how problematic patterns of relating are contributing to a person's distress and maladaptive coping, it may be a helpful approach. A clinical example of this is a person whose pain is exacerbated by overactivity related to their inability to say no to other's demands (e.g. for fear of upsetting them or eliciting conflict and rejection). Additionally, PIT has many strengths as an approach; it is a short, manualised and evidence-based treatment which has previously demonstrated promising results in the treatment of other conditions characterised by disabling chronic pain such as multisomatoform functional syndromes disorder and irritable bowel syndrome.

Presently, the efficacy of PIT in chronic pain is unknown. With that in mind, the proposed study seeks to conduct an evaluation of the acceptability, feasibility and efficacy of PIT in a chronic pain population; treatment resistant CLBP. The outcome of this study has the potential to inform future therapeutic options for those with chronic pain. The results may support the use of an alternative 1:1 therapy for those with interpersonal difficulties as it follows that they would require a treatment for chronic pain which has an interpersonal focus.

The primary aim of this study is to conduct a preliminary evaluation of whether PIT is an acceptable and feasible therapy for patients with treatment resistant CLBP (where patients are still experiencing clinically significant pain following previous treatment) and interpersonal difficulties. This will be measured using adherence to therapy and patient satisfaction and acceptability measures.

The secondary aim is to conduct an initial evaluation of the efficacy of PIT in people with treatment resistant CLBP and interpersonal problems, including its impact on pain distress, self -efficacy, and interpersonal functioning.

Eligibility criteria: Inclusion Criteria:

* Previously attended the Walton Centre pain management programme (PMP).
* Treatment resistant; six months after PMP treatment still experiencing clinically significant pain measured as 5+ on the pain distress rating scale. IMMPACT recommendations advise the use of numerical rating scales (NRS) in clinical trials of chronic pain treatments (Dworkin et al., 2005).
* Classified as "interpersonally distressed" on the West Haven Yale Multidimensional Pain Inventory (WHYMPI).
* Able to converse in English proficiently which is a requirement given the conversational nature of therapy.
* Able to commit to treatment and willing to be randomly allocated to baseline.

Exclusion Criteria:

* Other comorbid degenerative conditions and cancers.
* Psychosis
* History of prior suicide attempts.
* Active plans of self-harm and/or suicide.

Primary outcomes:
measure: Objective measure of behaviour 1 - Number of sessions attended
timeFrame: Measured at the end of therapy (at week 8).
measure: Satisfaction questionnaire (PIT for CLBP)
timeFrame: Administered twice in the 8 weeks of therapy after session 1 (week 1) and Session 8 (week 8); the first and last sessions of therapy.
measure: Measure of adverse reactions
timeFrame: Participants will complete this before each therapy session weekly and it will be discussed with the therapist/PI in session. As therapy is for 8 weeks, participants will complete this once weekly for eight weeks.
measure: Objective measure of behaviour 2 - Completion rate from therapy
timeFrame: Measured at the end of therapy (at week 8).
Secondary outcomes:
measure: Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
timeFrame: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
measure: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
measure: The Interpersonal Needs Questionnaire for Pain (INQ-P)
timeFrame: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
measure: The Beck Depression Inventory (BDI)
timeFrame: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
measure: Daily clinical measure (4 questions)
timeFrame: During baseline (no therapy) answered daily for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will answer them daily during therapy for 8 weeks.
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Charlotte Morgan
role: PRINCIPAL_INVESTIGATOR
References: