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临床试验/NCT03658226
NCT03658226已完成不适用

A Case Series Evaluation of Psychodynamic Interpersonal Therapy (PIT) in Chronic Low Back Pain (CLBP) Patients

Charlotte Morgan2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Objective measure of behaviour 1 - Number of sessions attended

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The PI/therapist will be blind to the outcome measures. All measures will be marked with a participant ID by an alternative researcher so that the therapist/PI will be unaware of individual participants' scores when analysing the data.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Therapy

Experimental

Psychodynamic Interpersonal Therapy (PIT)

干预措施: Psychodynamic Interpersonal Therapy (PIT) (Behavioral)

结局指标

主要结局

Objective measure of behaviour 1 - Number of sessions attended

时间窗: Measured at the end of therapy (at week 8).

Measuring feasibility/acceptability of therapy

Satisfaction questionnaire (PIT for CLBP)

时间窗: 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.

Measuring acceptability of therapy (face validity). A self-reported measure of satisfaction regarding the content of the therapy. A questionnaire has been devised based on the theoretical framework of acceptability in Sekon, Cartwright \& Francis (2017). There are two versions for post session one and post session eight with slightly different wording. This outcome measure will assess change.

Objective measure of behaviour 2 - Completion rate from therapy

时间窗: Measured at the end of therapy (at week 8).

Measuring feasibility/acceptability of therapy

Measure of adverse reactions

时间窗: 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.

A quantitative measure containing a list of anticipated/likely adverse reactions (e.g. exacerbation of pain, feeling more upset than usual, increased problems in relationships) and unanticipated/adverse reactions. It is expected that therapy may increase emotional symptoms in the short term as the participants make realisations within therapy. This is a tick box measure with a qualitative 'other' box for further input.This outcome measure will assess change.

次要结局

  • Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)(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.)
  • The Beck Depression Inventory (BDI)(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.)
  • Daily clinical measure (4 questions)(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.)
  • Pain Self Efficacy Questionnaire (PSEQ)(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.)
  • The Interpersonal Needs Questionnaire for Pain (INQ-P)(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.)

研究者

发起方
Charlotte Morgan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Charlotte Morgan

Trainee Clinical Psychologist

University of Manchester

研究点 (2)

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