About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and Women
Aged 18-70
Able to provide a signed informed consent
Experiencing significant pain symptoms that interfere with daily-life functioning
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Pain-acceptance intervention
BehavioralThe intervention start with a conversation and inquiry about the participant's pain while continuously validating his experience and creating a shared understanding of their struggles and difficulties due to the pain. Next, the experimenter explain the relations between distress, pain and suffering, emphasizing that in many cases trying to control our pain, emotions and thoughts leads us to undesirable results through emotional avoidance, anger and escape. This explanation will be accompanied with commonly used metaphors to enhance participants' understanding. Afterwards, participants are familiarized with the strategy of "emotional acceptance of pain". The strategy will be comprehensively explained and participants will practice it with the experimenter twice: Firstly, by practicing with the mental exercise of "STOP" (i.e. Stop, Take a step back, Observe, Procced Mindfully); Secondly by practicing the pain acceptance strategy while feeling moderate pain, and discuss their experience.
Treatment groups
Trial outcomes
Primary outcomes
Chronic pain levels
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
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.
Secondary outcomes
Depression levels
Measured by using the Patient Health Questionnaire-9 (PHQ-9). A self-report questionnaire for adults, the purpose of which is to examine the presence and severity of clinical depression23. The questionnaire includes 9 items that are a list of major depressive symptoms, according to the DSM. For each item, the examinee is asked to estimate how often he was bothered by the statement described in the item during the last two weeks, on a 4-point Likert scale of 3 (0 - not at all, 3 - almost every day). In addition, the examinee was asked how much the problems he reported made it difficult for him to do his job, take care of things at home or get along with others. This last item is important and significant to assess the degree of distress caused to a person by his symptoms, and the score in it is closely related to the degree of the person's quality of life.
Anxiety levels
Measured by using the Generalized Anxiety Disorder 7-Item Scale (GAD-7). A self-report questionnaire with 7 items describing anxiety symptoms. In this questionnaire, the participant is asked to describe how well each statement describes his situation in the past two weeks, on a 4-point Likert scale (0 - not at all, 3 - almost every day). The questionnaire is acceptable for use for research and clinical purposes to detect anxiety symptoms in general, and general anxiety symptoms in particular, both in the general population and in clinical populations. The questionnaire has good psychometric properties including high internal reliability (Cronbach's alpha index = 0.89), and high validity indices.
Dichotomous Thinking
Measured by using the Dichotomous Thinking Inventory (DTI), a self-report measure used to assess a black-and-white cognitive thinking style or worldview. The questionnaire assesses an individual's dichotomous thinking style in a general setting by measuring the degree of positive view of dichotomy, such as dichotomous thinking being better than other thinking styles and dichotomy being consequent, deserved, and worthy. The DTI has 15 items scored on a 6-point scale ranging from 1 = disagree strongly to 6 = agree strongly. The DTI has 3 components: preference for dichotomy, dichotomous beliefs, and profit-and-loss thinking.
Daily pain ratings and pain disruption
Measured by evaluating daily pain ratings in the two weeks during the intervention period, via online questionnaire, on a scale ranging from 0 -not pain at all, to 100 - maximum pain they can imagine. Further, evaluating who much the pain interfered with daily activities, on a scale ranging from 0 - not at all, to 100 - interfered with all daily tasks.
Other outcomes
Usage and ease of usage in the pain-acceptance strategy
Evaluating how much participants used the pain-acceptance strategy daily (ranging from 0 - never, to 100 - for all pain sensations), how easy was it for participants to use the strategy (ranging from 0 - not easy at all to use, to 100 - very easy to use), how much they perceive the strategy relief the pain (ranging from 0 - no relief at all, to 100 -maximum relief), and how much they perceive the strategy usage help them cope with the pain and the suffering (ranging from 0 - did not assist me coping with my pain, to 100 - assisted me greatly coping with my pain).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Haifa
Lead sponsor
Rambam Health Care Campus
Collaborator