Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy

NCT06171230 | Recruiting

• 1 other identifier: DOC 090
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy in reducing pain intensity in individuals with chronic painful diabetic neuropathy (PDN). The main questions it aims to answer are:

1. 1.Does EMDR therapy significantly reduce pain intensity in individuals with chronic PDN?
2. 2.What is the impact of EMDR therapy on secondary outcomes, specifically anxiety, sleep disturbances, and personalized pain-related limitations? Additionally, the study will explore the correlation between pain scores and symptoms of post-traumatic stress disorder (PTSD) in individuals with chronic PDN.

Conditions

Neuropathic Pain; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured with the Numeric Rating Scale (NRS)

  The NRS is an 11-point numeric scale form 0 (no pain ) to 10 (worst pain)

  Pain intensity is assessed once daily in the evening for a maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)

Secondary Outcomes (3)

• Anxiety

  The anxiety level is assessed once daily in the evening for maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)

• Quality of your sleep

  Sleep problems are assessed once daily in the evening for a maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)

• Pain Disability Index (PDI) Limitations in daily activities

  The selected questions from the PDI are assessed once daily in the evening for a maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)

Study Arms (1)

Eye Movement Desensitization and Reprocessing

EXPERIMENTAL

Participants will undergo six 90-minute EMDR sessions. The EMDR treatment concludes when the selected target images attain a Subjective Units of Disturbance (SUD) score of 0 or when three consecutive sessions show no further decrease in the SUD. Between the baseline phase (phase A) and the intervention phase (phase C), an attention control phase is introduced (phase B). This phase controls for the non-specific effects of the intervention, such as attention, treatment contact, and social support.

Other: Eye Movement Desensitization and Reprocessing; Other: Attention control phase

Interventions

Eye Movement Desensitization and Reprocessing OTHER

Using the LEC and PCL-5, emotionally charged images are selected at the onset of the EMDR intervention. Initially, events meeting the criteria for PTSD (A-criterion worthy events) are processed. Subsequently, pain-related experiences, including any distressing images, are addressed. If the emotional charge of the events diminishes (SUD=0) before the completion of the six EMDR sessions, the participant is categorized as an 'early completer,' and the post-assessment is conducted immediately. The duration of each EMDR session is 90 minutes.

Eye Movement Desensitization and Reprocessing

Attention control phase OTHER

Prior to EMDR, there is a two-week attention control phase. During this phase, the participant is asked to daily record their activities, emotions, and thoughts when experiencing pain. This information is further explored and evaluated in two sessions lasting 45 minutes each, involving in-depth discussions with the participant.

Eye Movement Desensitization and Reprocessing

Eligibility Criteria

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

You may qualify if:

• Age: ≥ 18 years.
• Diagnosis of Diabetes Mellitus.
• Severity of pain in the past month, NRS-pain score ≥ 6.
• Ability to communicate in both written and spoken Dutch.
• Willingness to participate in the study (signed informed consent (IC)).

You may not qualify if:

• Severe psychiatric disorders requiring immediate treatment.
• IQ \< 80.
• Initiation of medication within 3 months before the start of the study (medication in use for more than 3 months can be maintained; discontinuation of medication during the study is possible but not desirable).
• Concurrent psychotherapeutic treatment targeting neuropathic pain during the study.
• Substance abuse and/or dependence, unless medically prescribed.
• Inability to complete the questionnaires.
• Co-morbid conditions affecting the lower extremities, such as peripheral arterial disease, severe rheumatoid arthritis, osteoarthritis. Other conditions causing pain in the feet and/or damage to the peripheral nervous system, for example, ulcers.
• Co-morbid chronic pain syndromes.

Sponsors & Collaborators

• Dijklander Ziekenhuis: lead

Study Sites (1)

Dijklander Ziekenhuis

Hoorn, 1624 NP, Netherlands

RECRUITING

MeSH Terms

Conditions

Neuralgia; Diabetes Mellitus

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Suzan Zyto, Drs

  Dijklander Ziekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick vd Molen, Drs

CONTACT

0031643120551; p.r.vandermolen@dijklander.nl

Suzan Zyto, Drs

CONTACT

s.zyto@dijklander.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: In psychological research, it is not feasible to employ a 'blind' approach for both participants and EMDR therapists regarding the intervention. An independent research assistant, not otherwise involved in the study, oversees the completion of daily measurements and questionnaires. This ensures that EMDR therapists remain blind to the obtained data. An exception to this is the utilization of the results from the LEC and PCL-5, which are employed for case conceptualization. There will be no randomization of baseline length or initiation of the intervention, as seen in multiple baseline designs.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-case experimental design, replicated nine times (N-of-1 study).

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 14, 2023
• Study Start: March 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)