Pain Acceptance Training in Patients Experiencing Emotional Distress and Somatic Symptoms: Examination of Dialectical Thinking as a Mediating Factor

NCT07067619 | Recruiting

• 1 other identifier: 0062-24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain; Somatic Pain; Comorbid Pain and Emotional Difficulties

Keywords

Chronic pain; Somatic pain; Pain Acceptance; Intervention; Training; Experimental pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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 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.

  Measured at the baseline assessment session, at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.

Secondary Outcomes (10)

• 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.

• 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.

• Daily pain ratings and pain disruption

  Measured by evaluating daily pain ratings in the two weeks of the intervention period

• Perceived improvement following the intervention

  Measured at the evaluation session at the end of the two-weeks intervention, and after two weeks follow-up.

Other Outcomes (1)

• Usage and ease of usage in the pain-acceptance strategy

  Measured by evaluating daily pain ratings in the two weeks of the intervention period

Study Arms (2)

Pain-acceptance intervention group

EXPERIMENTAL

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.

Behavioral: Pain-acceptance intervention

treatment-as-usual group

NO INTERVENTION

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.

Interventions

Pain-acceptance intervention BEHAVIORAL

The 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.

Pain-acceptance intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women
• Aged 18-70
• Able to provide a signed informed consent
• Experiencing significant pain symptoms that interfere with daily-life functioning
• Experiencing significant emotional distress symptoms

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: collaborator
• University of Haifa: lead

Study Sites (2)

Psychiatric Division, Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

University of Haifa

Haifa, 3498838, Israel

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sulamit Grinapol

CONTACT

+972 047771718; s_grinapol@rambam.health.gov.il

Einav Gozansky

CONTACT

einavgoz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (RCT).

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 16, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)