Randomized Controlled Trial to Test the Efficacy of a Digital Cognitive Behavioral Therapy for Functional Somatic Symptoms

Randomized Controlled Trial to Test the Efficacy of a Digital Cognitive Behavioral Therapy for Functional Somatic Symptoms - IMPACT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036893

Enrollment

102

Registered

2025-05-20

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

F45.0 F45.1 F45.2 F45.3 F45.4 F45.41

Interventions

Group 1: Intervention group: digital cognitive behavioral therapy for functional somatic symptoms (kaarlo

kaarlo health GmbH) + access to care as usual (CAU) for a period of 12 weeks. Group 2: Control group: access to care as usual (CAU) for a period of 12 weeks.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed F45 diagnosis according to ICD-10-GM Reaching the cut-off score of at least 23 points on the primary outcome measure SSD-12 Provision of informed consent Confident use of a smartphone Stable internet access throughout the intervention period

Exclusion criteria

Exclusion criteria: Acute substance dependence or withdrawal syndrome: F1*.2; F1*.3 Presence of a bipolar or psychotic disorder (e.g., schizophrenia): F2*; F31; F32.3; F33.3 or a severe depressive episode: F32.2; F32.3 Acute suicidality Pregnancy or breastfeeding Insufficient German language skills Ongoing or recently completed (within the last 6 months) psychotherapy or comparable digital intervention focused on managing somatic symptoms Exclusively acute pain or tumor-related pain

Design outcomes

Primary

Measure	Time frame
Somatic symptom burden at post-treatment (measured at baseline, 6- and 12-weeks post-randomization) using the Somatic Symptom Disorder – B Criteria Scale (SSD-12)	—

Secondary

Measure	Time frame
Severity of Somatic Symptoms (PHQ-15; baseline, 6 and 12 weeks post-randomization) Health-Related Quality of Life (SF-36; baseline, 6 and 12 weeks post-randomization) Depressive Symptoms (PHQ-9; baseline, 6 and 12 weeks post-randomization) Anxiety Symptoms (GAD-7; baseline, 6 and 12 weeks post-randomization) Pain-Related Distress (MPI interference scale; baseline, 6 and 12 weeks post-randomization) Additional analyses: Side effects of the intervention (Negative Effect Questionnaire; NEQ) Satisfaction with the application Adherence Reasons for dropout	—

Measure

Time frame

Severity of Somatic Symptoms (PHQ-15; baseline, 6 and 12 weeks post-randomization) Health-Related Quality of Life (SF-36; baseline, 6 and 12 weeks post-randomization) Depressive Symptoms (PHQ-9; baseline, 6 and 12 weeks post-randomization) Anxiety Symptoms (GAD-7; baseline, 6 and 12 weeks post-randomization) Pain-Related Distress (MPI interference scale; baseline, 6 and 12 weeks post-randomization) Additional analyses: Side effects of the intervention (Negative Effect Questionnaire; NEQ) Satisfaction with the application Adherence Reasons for dropout

—

Countries

Germany

Contacts

Public ContactSusanne Becker

Heinrich-Heine-Universität Düsseldorf

sbecker@uni-duesseldorf.de0211 81-14722

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026