Feasibility and initial signals of efficacy of ReMind, an ESM-based Monitoring, Feedback and Ecological Momentary Intervention for Refocusing of Attention on Positive Events in Patients with Chronic Pain and Psychological Distress

Feasibility and initial signals of efficacy of ReMind, an ESM-based Monitoring, Feedback and Ecological Momentary Intervention for Refocusing of Attention on Positive Events in Patients with Chronic Pain and Psychological Distress - ReMind

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037510

Enrollment

Registered

2025-08-28

Start date

2025-09-17

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent musculoskeletal pain

Interventions

Group 1: Patients in the experimental condition will receive the 8-week ReMind intervention delivered via an app (investigational device), which will be offered in addition to treatment-as-usual (TAU)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 18 years, 2. Able to give informed consent, 3. Willing to use the app on their personal smartphone or a study smartphone, 4. Psychological distress assessed by the CORE-10 (Barkham et al., 2013, Couns. Psychother. Res.) above the cut-off value of = 6, and 5. Meet diagnostic criteria for a chronic pain condition, including, but not limited to: a) persistent musculoskeletal pain b) peripheral and central neuropathic pain c) phantom limb pain d) chronic inflammatory conditions causing pain e) Individuals recovering from surgical procedures with ongoing pain f) chronic pain syndromes g) chronic pain treated with Spinal Cord Stimulation

Exclusion criteria

Exclusion criteria: 1. Acute pain conditions requiring immediate medical attention 2. Pain conditions related to migraine 3. Pain arising from underlying organic diseases that require specific medical treatment 4. Severe cognitive impairments that hinder app usability 5. Mental or physical impairment that prevents patient from using a smartphone 6. Severe psychological distress assessed by the CORE-10 above the cut-off value of = 25 7. Concurrent participation in another clinical trial (AMG/CTR) during and 4 weeks prior to inclusion.

Design outcomes

Primary

Measure	Time frame
Clinical feasibility of trial methodology (based on successful recruitment, assessment of inclusion criteria, randomization, retention in the assessment of outcomes), determined using a priori defined criteria according to three categories (in line with a traffic light system): (1) feasibility fully established (green), (2) feasibility established, but study procedures need to be modified (yellow), and (3) feasibility not established (red).	—

Measure

Time frame

Clinical feasibility of trial methodology (based on successful recruitment, assessment of inclusion criteria, randomization, retention in the assessment of outcomes), determined using a priori defined criteria according to three categories (in line with a traffic light system): (1) feasibility fully established (green), (2) feasibility established, but study procedures need to be modified (yellow), and (3) feasibility not established (red).

—

Secondary

Measure	Time frame
We will assess feasibility of delivering the intervention (based on acceptability, intervention adherence, and intervention fidelity) using a priori defined criteria grouped according to three categories in line with a traffic light system.	—

Countries

Germany

Contacts

Public ContactLeonie Ader

Uniklinikum Heidelberg

leonie.ader@med.uni-heidelberg.de+496221567543

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026