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

NCT ID: NCT07067619

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

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.

CURRENT INTERVENTION

Pain-acceptance training is based on dialectical thinking, particularly in maintaining a dialectic perspective, on the suffering caused by the pain - simultaneously wishing it to end and accepting it. Acceptance-based pain interventions attempt to teach patients to experience their emotions, pains, and bodily sensations more fully and without avoidance, and to notice fully the presence of thoughts without following, resisting, believing, or disbelieving them. Accepting thoughts and feelings impedes the control these exert over behavioral tendencies and limits their impact on pursuing personal goals. Thus, even though acceptance-based strategies do not aim at pain reduction, various studies have shown that these strategies can alter the pain experience and therefore may be considered regulation strategies. This training method is also easily implemented, and can be imparted to participants both online and in person. Research shows that short trainings in pain acceptance regulation strategies increase pain tolerance, enhance recovery from pain, lower pain anxiety, distress ratings, and negative emotions related to pain, and facilitate better overall functioning despite the pain.

Prior Clinical Experience

In our recent randomized controlled single-session trial of pain-acceptance training that was conducted at the University of Haifa, healthy individuals showed reduced sensitivity to suprathreshold pain and reported an increase in pain threshold. This increase correlated with an increase in the vagal tone reactivity to pain, suggesting that the training modulates pain via the antinociceptive effect of the vagus nerve. Crucially and even more importantly, the reduction in pain sensitivity and increase in pain threshold were maintained for a month following the training, thus showing long long-lasting impact on pain perception. Furthermore, this training resulted in a decrease in pain catastrophizing levels one month later, suggesting that participants had better emotional capacities for dealing with pain.

RESEARCH OBJECTIVES & SIGNIFICANCE

As demonstrated, pain acceptance training showed promising results in altering the pain perception of healthy participants. The current study aims at translating these outcomes to a clinical setting; to examine a novel form of acceptance-training for pain relief in psychiatric patients suffering from somatic symptoms. We hypothesize that pain intensity, functional disability, and negative affect will decrease as a result of acceptance training, and that these changes will be mediated by an increase in patients' dialectical thinking abilities.

STUDY ENDPOINTS / OUTCOMES

To the best of our knowledge, this is the first study to examine pain acceptance training in psychiatric patients with somatic symptoms. To determine the efficacy of the training, we will utilize different pain outcome measures, and assess emotional and cognitive correlates of the change. As such, we believe this study will provide preliminary data that will serve as a basis for further randomized control trials examining the clinical implications of acceptance based training compared to other standard pain-treatment methods, and exploring the mechanisms underlying pain acceptance training for somatic symptoms relief.

Our primary training outcome measures will be pain-related, and will be conducted in three phases: Baseline, End of Intervention Assessments, and Follow-up Assessments. We expect that following two-week of acceptance training, patients will feel lower pain intensity and will show better abilities to cope with their pain. These improvements are expected to be maintained over time, and we will observe this in the follow up assessments.

These measures include pain intensity assessment, assessment of the degree of widespread body pain, pain catastrophizing levels and pain self-efficacy believes, as well as actual pain coping measurement of cold pain threshold, and cold pain tolerance.

The secondary training measures will include emotional state measures, dialectical thinking measures, and attention bias for pain. Demographic and medical records variables will serve as covariates for evaluating individual factors affecting training efficacy.

Conditions

Chronic Pain; Somatic Pain; Comorbid Pain and Emotional Difficulties

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pain-acceptance intervention

Intervention Type: 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.

treatment-as-usual group

Patients in the 'treatment as usual' will undergo a battery of baseline assessments in the first session, including questionnaires, cognitive task and Cold pressure task.

Afterwards, they complete the daily online evaluations during two weeks. During this period, a brief online survey is sent to the participants daily in the evening via text massage. The survey include questions about pain severity and functional disability felt today. Additionally, at the end of the first week, they will have a video call with the experimenter , to discuses their feelings.

At the end of the two-week pain evaluation, they will arrive for the end of intervention session of the assessments, and at the end of this session will be offered to receive the pain-acceptance intervention.

Two weeks after the end of intervention assessment session, patients will receive a link to complete online the same battery of questionnaires as administered in the previous session.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pain-acceptance intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Men and Women

2. Aged 18-70

3. Able to provide a signed informed consent

4. Experiencing significant pain symptoms that interfere with daily-life functioning

5. Experiencing significant emotional distress symptoms

Exclusion Criteria

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:

1. 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)

2. Patients rating their emotional distress levels as less than 25 in a 10-50 numerical rating scale (i.e. Kessler Psychological Distress Scale [K10])

3. Patients diagnosed with psychotic disorders and/or suffering from psychotic symptoms.

4. Patients diagnosed with Autism Spectrum disorder.

5. Patients diagnosed with Intellectual disability.

6. Patients diagnosed with eating disorders.

7. Patients with Immediate suicidal risk.

8. Patients who initiated a new drug and/or psychotherapy treatment within the last month.

9. Pregnant women.

10. Patients currently serving in the IDF.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Hospital, Haifa, Israel

UNKNOWN

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Psychiatric Division, Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

University of Haifa

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sulamit Grinapol

Role: CONTACT

s_grinapol@rambam.health.gov.il

+972 047771718

Einav Gozansky

Role: CONTACT

einavgoz@gmail.com

Facility Contacts

Shulamit Grinapol, Ph.D.

Role: primary

s_grinapol@rambam.health.gov.il

04-7771718

Hadas Okon-Singer

Role: primary

hadasos@psy.haifa.ac.il

+972-4-8249671

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0062-24

Identifier Type: -

Identifier Source: org_study_id