Peer-delivered psychosocial support for patients with rare autoimmune liver diseases

Improving health-related quality of life in patients with rare autoimmune liver diseases by structured peer-delivered support: a transnational effectiveness-implementation hybrid trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15030282

Enrollment

472

Registered

2023-01-13

Start date

2023-01-31

Completion date

Unknown

Last updated

2025-01-28

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

Conditions

Rare autoimmune liver diseases, i.e. autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) Digestive System

Interventions

We will conduct a multicenter effectiveness-implementation hybrid trial type 1 (Curran et al., 2021, Med Care) with the primary aim of assessing the effectiveness of the peer-delivered psychosocial su

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Effectiveness focus: 1. Autoimmune rare liver disease (AIH, PSC, PBC) 2. Subjective psychosocial support need 3. =18 years 4. Written informed consent Implementation focus: Patients: see above Stakeholders: 1. Involvement in intervention delivery/implementation i.e. healthcare providers, patient representatives, health insurers 2. Written informed consent

Exclusion criteria

Exclusion criteria: Effectiveness focus: 1. Life-threatening health-status 2. Acute suicidality 3. Ongoing psychotherapy 4. Severe cognitive, auditory or visual impairment 5. Inability to complete assessments Implementation focus: 1. Involvement in outcome assessment or data analysis

Design outcomes

Primary

Measure	Time frame
1. Effectiveness outcomes will be assessed at baseline, after the program and at a 3-month follow-up. Our primary effectiveness outcome is the baseline-adjusted group difference in mental health-related quality of life directly after the intervention, measured with the Short Form Health Survey (SF-12). 2. Quantitative implementation outcomes will be assessed at post-assessment. Qualitative implementation outcomes after the follow-up assessment. Our primary implementation outcomes are acceptability and feasibility of the program, operationalized by completion rate and subjective rating of appropriateness, helpfulness, and feasibility on numeric rating scales from 0-10.	—

Measure

Time frame

1. Effectiveness outcomes will be assessed at baseline, after the program and at a 3-month follow-up. Our primary effectiveness outcome is the baseline-adjusted group difference in mental health-related quality of life directly after the intervention, measured with the Short Form Health Survey (SF-12). 2. Quantitative implementation outcomes will be assessed at post-assessment. Qualitative implementation outcomes after the follow-up assessment. Our primary implementation outcomes are acceptability and feasibility of the program, operationalized by completion rate and subjective rating of appropriateness, helpfulness, and feasibility on numeric rating scales from 0-10.

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Secondary

Measure	Time frame
All effectiveness outcomes will be assessed at baseline, after the program and at a 3-month follow-up. 1. Physical health-related quality of life (Short Form Health Survey (SF-12)) 2. Somatic symptom severity (Patient Health Questionnaire-15 (PHQ-15)) 3. Depression severity (Patient Health Questionnaire-9 (PHQ-9)) 4. Anxiety severity (Generalized Anxiety Disorder Scale-7 (GAD-7)) 5. Disease acceptance (Acceptance subscale of the Illness Cognition Questionnaire (ICQ)) 6. Helplessness (Helplessness subscale of the ICQ) 7. Social support (Social Support Questionnaire (F-SOZU)) 8. Self-management abilities (Appraisal of the Self-Care Agency Scale Revised (ASAS-R)) 10. Psychological burden related to somatic symptoms or associated health concerns is measured using the Somatic Symptom Disorder – B Criteria Scale (SSD-12) 11. General self-efficacy is measured using the Self-efficacy scale (SWE) 12. Illness perceptions are measured using the Brief Illness Perception Questionnaire (B-IPQ)	—

Measure

Time frame

All effectiveness outcomes will be assessed at baseline, after the program and at a 3-month follow-up. 1. Physical health-related quality of life (Short Form Health Survey (SF-12)) 2. Somatic symptom severity (Patient Health Questionnaire-15 (PHQ-15)) 3. Depression severity (Patient Health Questionnaire-9 (PHQ-9)) 4. Anxiety severity (Generalized Anxiety Disorder Scale-7 (GAD-7)) 5. Disease acceptance (Acceptance subscale of the Illness Cognition Questionnaire (ICQ)) 6. Helplessness (Helplessness subscale of the ICQ) 7. Social support (Social Support Questionnaire (F-SOZU)) 8. Self-management abilities (Appraisal of the Self-Care Agency Scale Revised (ASAS-R)) 10. Psychological burden related to somatic symptoms or associated health concerns is measured using the Somatic Symptom Disorder – B Criteria Scale (SSD-12) 11. General self-efficacy is measured using the Self-efficacy scale (SWE) 12. Illness perceptions are measured using the Brief Illness Perception Questionnaire (B-IPQ)

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Countries

Belgium, Canada, Germany, Hungary, Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026