Pain Acceptance Training in Patients Experiencing Emotional Distress and Somatic Symptoms: Examination of Dialectical Thinking as a Mediating Factor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Chronic pain levels
研究概览
简要总结
Somatic symptoms, including physical pain, are highly prevalent among mental health patients. Current treatments have limited effectiveness for these symptoms, primarily because of patients' diminished introspective capacity and lack of emotional awareness. The current study proposes pain acceptance training as a new intervention. This intervention relies on the tenets of dialectical thinking, particularly on maintaining a dialectic perspective - at once acknowledging both the desire to end the pain and the ability to accept it as it is. We aim to examine the following: (1) the efficacy of pain acceptance training in the alleviation of somatic pain in patients with somatic symptoms; (2) the role of dialectical thinking as a mediator of pain acceptance training efficacy.
详细描述
Somatic symptom disorders are among the most common mental disorders, with an estimated prevalence of 5-7% in the general population1. Somatic disorders are characterized by persistent, unexplained physical symptoms, such as pain and gastrointestinal and cardiovascular symptoms, which cause significant impairments to regular functioning and high burden due to multiple medical consultations. A substantial proportion of patients also experience comorbid depression and anxiety.
Growing evidence indicates that specific maladaptive psychological factors (e.g., catastrophizing, emotion regulation problems, and negative physical self-concept) play a substantial role in causing and sustaining somatic symptoms. Therefore, psychological treatments such as cognitive behavioral therapy are the first line of treatment6. Still, individuals with somatic symptoms exhibit limited responsiveness to conventional psychotherapeutic approaches.
To remedy this, one possible approach is Dialectical Behavior Therapy (DBT), which aims to enhance dialectical thinking, a cognitive process that involves the ability to hold and reconcile opposing ideas or viewpoints and reflect on them curiously. Few studies have shown that increases in dialectical thinking during psychological treatment have positive effects on attention, coping flexibility, and self-processing.
A limited number of studies have examined the effects of DBT treatment among patients with somatic symptoms. One initial study exploring the effects of DBT in individuals suffering from somatic symptoms reported reduced somatization in patients diagnosed with borderline disorder, through an increase in emotional acceptance.
Though promising, DBT is a long-term, in-person intervention that must be carried out by trained professionals and is, therefore, resource-intensive and inaccessible to many people. Therefore, we propose an alternative related intervention for individuals experiencing somatic symptoms, namely Pain-Acceptance Training. Similar to DBT, the Pain-Acceptance Training targets core mechanisms related to pain processing and modulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women
- •Able to provide a signed informed consent
- •Experiencing significant pain symptoms that interfere with daily-life functioning
- •Experiencing significant emotional distress symptoms
排除标准
- •Patients under the age of 18 and/or diagnosed with one or more of the following diagnoses will be excluded from participation in the study:
- •Patients rating their average pain in the last week and in the last month as less than 3 in a 0-10 numerical rating scale (i.e. NPS)
- •Patients rating their emotional distress levels as less than 25 in a 10-50 numerical rating scale (i.e. Kessler Psychological Distress Scale [K10])
- •Patients diagnosed with psychotic disorders and/or suffering from psychotic symptoms.
- •Patients diagnosed with Autism Spectrum disorder.
- •Patients diagnosed with Intellectual disability.
- •Patients diagnosed with eating disorders.
- •Patients with Immediate suicidal risk.
- •Patients who initiated a new drug and/or psychotherapy treatment within the last month.
- •Pregnant women.
- •Patients currently serving in the IDF.
研究组 & 干预措施
Pain-acceptance intervention group
Patients in the pain-acceptance group will undergo a battery of baseline assessments in the first session, and receive a two-week intervention.
First, they receive an explanation of pain acceptance, and practice it with the experimenter through discussion and metaphors, and do two exercises: STOP and a cold-pressor task.
Next, they conduct two weeks of home practice. At home, they are asked to use the pain-acceptance strategy whenever they feel pain. After one week, the experimenter will conduct a short video call with the patient, to discuss the progress and the difficulties that arise in using the acceptance training.
The experimenter also supports them by phone and video call as needed. Further, they complete a brief survey on pain, disability, strategy use, and ease on a daily base.
After two weeks, they return for a follow-up assessment including questionnaires, cognitive tasks, and the cold-pressor test. Two weeks later they complete an online follow-up survey.
干预措施: Pain-acceptance intervention (Behavioral)
treatment-as-usual group
Patients in the treatment-as-usual group will first complete baseline assessments, including questionnaires, a cognitive task, and the Cold Pressor Task. Following this, they will engage in a brief structured conversation with the experimenter to provide an interaction comparable to that of the intervention group.
For the next two weeks, participants will complete daily online surveys delivered each evening via text message, assessing pain severity and functional disability experienced that day. At the end of the first week, they will also have a video call with the experimenter to discuss their feelings.
After two weeks, participants will return for a second assessment session, after which they will be offered the opportunity to receive the pain-acceptance intervention. Finally, two weeks after this session, they will complete the same battery of questionnaires online as administered previously.
结局指标
主要结局
Chronic pain levels
时间窗: Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.
Chronic pain levels will be measured by The BPI-SF is a validated and widely recommended tool for assessing pain severity and pain-related interference in chronic pain patients. It measures pain severity at its worst, least, average, and current level over the past week on a 0-10 scale, with 0 = no pain and 10 = worst pain imaginable. It also evaluates interference across seven domains (general activity, walking, work, mood, relations, sleep, and enjoyment of life), each scored 0-10, where 0 = no interference and 10 = complete interference. Scores can be averaged into the Pain Severity Index and Pain Interference Index. The BPI-SF is responsive to changes in pain over time.
Pain self-efficacy
时间窗: Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.
Measured by the Pain self-efficacy questionnaire (PSEQ). The PSEQ assesses the strength of a person's confidence in their ability to function, despite their pain. Patients are asked to rate how confident they are so that they can do each of the 10 activities or functions at present, despite their pain, by selecting a number on a seven-point scale, where zero equals 'not at all confident' and six equals 'completely confident'. Scores on the PSEQ may range from 0 to 60, with higher scores indicating stronger self-efficacy beliefs. Good reliability and validity of the PSEQ has been reported. The test-retest reliability and internal consistency of the PSEQ in two different studies with chronic pain patients were reported as 0.79 and 0.92, respectively.
次要结局
- Depression levels(Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.)
- Anxiety levels(Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.)
- Pain catastrophizing(Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.)
- Dialectical thinking(Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.)
- Dichotomous Thinking(Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.)
- Perceived improvement following the intervention(Measured at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.)
- Attention bias to pain-related images(Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.)
- Daily anxiety, distress and mood(Measured by evaluating daily pain ratings in the two weeks of the intervention period)
- Daily pain ratings and pain disruption(Measured by evaluating daily pain ratings in the two weeks of the intervention period)
- Experimental pain threshold and tolerance(Measured at the baseline assessment session, and at the evaluation session at the end of the two-weeks intervention.)