BalanceUP – Chatbot coaching to support a balanced lifestyle in people suffering from headache

BalanceUP – Chatbot coaching to support a balanced lifestyle in people suffering from headache - BalanceUP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017422

Enrollment

150

Registered

2022-02-14

Start date

2022-04-08

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Headache

Interventions

Group 1: Arm 1: Participants receive 4 to 8 weeks of digital coaching with a fully automated conversational agent to deliver stress management and relaxation exercises to improve general well-being. G

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants must be at least 18 years old, have internet access with their own smartphone, be German-speaking, have suffered from regular headaches for at least 3 months and suffer from headaches on at least 4 days per month.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
The time span of the coaching varies with a minimum of (28 days) and maximum (59 days). Assessment for both intervention and control group takes place before coaching (T0; baseline). For the intervention group, primary endpoint will be post-coaching (between day 28 and 59), after completion of all relevant modules (T1). For the control group, primary endpoint will be the mean of the coaching duration (day 44). Follow-up will be measured 6 months post-randomization. Primary outcome will be the general well-being (PHQ-ADS).	—

Measure

Time frame

The time span of the coaching varies with a minimum of (28 days) and maximum (59 days). Assessment for both intervention and control group takes place before coaching (T0; baseline). For the intervention group, primary endpoint will be post-coaching (between day 28 and 59), after completion of all relevant modules (T1). For the control group, primary endpoint will be the mean of the coaching duration (day 44). Follow-up will be measured 6 months post-randomization. Primary outcome will be the general well-being (PHQ-ADS).

—

Secondary

Measure	Time frame
Secondary endpoint is pain management (FESV), presenteeism and absenteeism based on MIDAS, headache management self-efficacy (HMSE), stage of change (HAPA), and perceived stress (PSS). Between-module interim assessments are conducted for the intervention group with a subset of outcomes (session alliance SAI, trigger evaluation HTSAQ-F-SF, session engagement and session evaluation (GTS-P), patient global impression of change (PGIC), and technology acceptance (uMARS). Follow-up will be for the coaching group 6 months after randomization, including pain management (FESV), presentism and absenteeism (MIDAS), headache management self-efficacy (HMSE), stage of change (HAPA), and perceived stress (PSS). All data are collected via the online survey platform Limesurvey and within the app, according to the company.	—

Measure

Time frame

Secondary endpoint is pain management (FESV), presenteeism and absenteeism based on MIDAS, headache management self-efficacy (HMSE), stage of change (HAPA), and perceived stress (PSS). Between-module interim assessments are conducted for the intervention group with a subset of outcomes (session alliance SAI, trigger evaluation HTSAQ-F-SF, session engagement and session evaluation (GTS-P), patient global impression of change (PGIC), and technology acceptance (uMARS). Follow-up will be for the coaching group 6 months after randomization, including pain management (FESV), presentism and absenteeism (MIDAS), headache management self-efficacy (HMSE), stage of change (HAPA), and perceived stress (PSS). All data are collected via the online survey platform Limesurvey and within the app, according to the company.

—

Countries

Austria, Germany, Switzerland

Contacts

Public ContactSandra Ulrich

ZHAW Departement P, Psychologisches Institut, Fachgruppe Diagnostik und Beratung

balanceup.pi@zhaw.ch+41796537152

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026