Trial document




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  DRKS00017161

Trial Description

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Title

Effectiveness and cost-effectiveness of guided internet-and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHcd): a multicentre randomized controlled trial with a 12-month follow-up

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Trial Acronym

youthCOACHcd

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URL of the Trial

https://www.coach.klips-ulm.de

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Brief Summary in Lay Language

Adolescents and young adults (AYA) with chronic somatic conditions often suffer from psychological strains as well as social distress and have an increased risk for comorbid depression and anxiety symptoms. These comorbidities can have a negative impact on quality of life, compliance with therapy, long-term prognosis as well as psychological well-being of the adolescents concerned. At present, AYA with chronic somatic conditions and comorbid symptoms of depression and anxiety have only limited access to evidence-based mental health services. Internet- and mobile-based cognitive behavioural therapy (iCBT) might be a possibility to offer low-threshold access to address comorbid psychological symptoms. The aim of this randomised controlled trial (RCT) is to examine the effectiveness and cost-effectiveness of the guided iCBT youthCOACHcd for AYA (aged 12-21) with chronic somatic conditions (type 1 diabetes, cystic fibrosis, juvenile idiopathic arthritis) and comorbid symptoms of depression and/ or anxiety. Participants can use youthCOACHcd independent of time and space in addition to all routine care services for somatic and mental health problems. This study is part of the multicentre project COACH „Chronic Conditions in Adolescents: Implementation and Evaluation of Patient-centred Collaborative Healthcare”, funded by the German Federal Ministry of Education and Research.

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Brief Summary in Scientific Language

Introduction: Adolescents and young adults (AYA) with chronic somatic conditions such as type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis show an increased risk for comorbid depression and anxiety symptoms. However, access to evidence-based treatment services is limited. Internet-and mobile-based cognitive behavioural therapy (iCBT) might be a possibility to reduce this gap. This trial aims to evaluate the (cost-) effectiveness of guided iCBT youthCOACHcd additional to treatment as usual (TAU) compared to enhanced treatment as usual (TAU+), which is essential for its implementation in routine care.

Method: This study is a multicentre two-armed randomized controlled trial (RCT) evaluating the (cost-) effectiveness of guided iCBT (youthCOACHcd) compared to enhanced treatment as usual (TAU+) in AYA aged 12-21 years with one of three chronic somatic conditions (type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis). AYA with one of the chronic somatic conditions and elevated symptoms of anxiety and/or depression (PHQ-9 and/or GAD-7 ≥ 7) will be eligible for inclusion. Recruitment will take place in routine care through three German patient registries. Primary outcome is the effectiveness of youthCOACHcd, measured by the combined severity of the anxiety and depression symptoms at baseline and 3 months after randomisation. Secondary outcomes include health-related quality of life, coping strategies, self-efficacy, post-traumatic growth, social support, behavioural activation, adjustment and trauma related symptoms, automatic thoughts, working alliance, and internet usage. The cost-effectiveness will be determined and potential moderators and mediators of intervention effects will be explored.

Discussion: Results and findings gained through this trial will provide important insights in paediatric e-health, psychological care for AYA with a chronic somatic condition, and how iCBT could be implemented into existing health care. This study is part of the project „Chronic Conditions in Adolescents: Implementation and Evaluation of Patient-centred Collaborative Healthcare (COACH)”, funded by the German Federal Ministry of Education and Research.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017161
  •   2019/09/17
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  •   yes
  •   Approved
  •   292/18, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   E10 -  Type 1 diabetes mellitus
  •   E84 -  Cystic fibrosis
  •   M08 -  Juvenile arthritis
  •   F41 -  Other anxiety disorders
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34 -  Persistent mood [affective] disorders
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Interventions/Observational Groups

  •   intervention group: guided internet and mobile-based intervention youthCOACHcd with 7 modules; meanwhile, standard medical care (treatment as usual = TAU) can (continue to) be used.
  •   control group: standard medical care (treatment as usual = TAU) can (continue to) be used (TAU) and additional material about psychological care is provided (TAU enhanced=TAU +).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is the combined depressive and anxiety symptom severity at t2 (3 months post-randomisation), assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS).

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Secondary Outcome

All primary and secondary outcome measurement instruments are online provided questionnaires (self-report or caregiver report). There are five assessment points: baseline (t0), 6 weeks (t1), 3 months (t2), 6 months (t3) and 12 months (t4) post-randomisation. Additionally, medical variables will be measured in clinical routine.

Self-report:
Sociodemographic variables (date of birth, gender, relationship status, type of school, grade of school or vocational training, and occupation)

Depression and anxiety symptom severity (PHQ-ADS) (t1, t3, t4)

Coping (CODI) (t0, t1, t2, t3, t4)

Social Support (BSSS) (t0, t2, t4)

Stress-related growth (SRGS) (t0, t1, t2, t3, t4)

Self-Efficacy (GSE) (t0, t1, t2, t4)

Traumatic Experiences (CATS, items 7-17) (t0, t1, t2, t3, t4)

Behavioural Activation (BADS) (t0, t1, t2, t3)

Automatic thoughts (ATQ-R) (t0, t1, t2, t3)

Quality of life (EQ-5D-Y) (t0, t3, t4)



Recorded in intervention group only:
Intervention Satisfaction (CSQ-I) (t1, t2)

Therapeutic alliance (WAI-SR) (t1, t2, t3)



Caregiver Report:
Anxiety symptom severity (SCARED) (t0, t1, t2, t3, t4)

Depression symptom severity (MFQ) (t0, t1, t2, t3, t4)

Social Support (BSSS) (t0, t2, t4)

Traumatic experience (CATS-C-D, items 7-17) (t0, t1, t2, t3, t4)



Side effects:
Internet usage behaviour (IUES) (t0, t2, t3)

Suicidal ideations (PHQ-9 Item 9 > 1, Beck Depressions-Inventar Revision (BDI-II) Item 9) (t0, t1, t2, t3, t4)

Symptom Deterioration (PHQ-ADS) (t0, t1, t2, t3, t4)



Recorded in intervention group only:
Subjective side effects (INEP-On) (t2, t3, t4)



Health economics:
Quality of life (EQ-5D-Y) (t0, t3, t4)

Child and Adolescent Service Receipt (CAMSHRI-DE) (t0, t3, t4)



Medical variables:
Type 1 Diabetes
HbA1c, number of severe hypoglycaemias (with and without coma), DKA, CSII/ICT, insulin dose per day, SMBG, CGM/FGM, training and celiac disease diabetes education and presence of celiac disease

Cystic fibrosis
FEV 1, diabetes, pancreatic status, liver cirrhosis, pseudomonas infection, number of exacerbations, number of antibiotic therapies, ABPA

Juvenile idiopathic arthritis
Physician Global Assessment of Disease Activity (Numeric rating scale [NRS] 0-10), active joint count, patient/parent global assessment of overall- wellbeing (NRS), the clinical juvenile arthritis disease activity score-10 = composite index, functional status (assessed by the Childhood Health Assessment Questionnaire), CrP, JIA category (systemic arthritis, persistent olioarthritis, extended olioarthritis, rheumatoid factor-negative polyarthritis, rheumatoid factor-positive polyarthritis, enthesitis-associated related arthritis, psoriatic arthritis, other arthritis)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/11/25
  •   212
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   21   Years
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Additional Inclusion Criteria

Symptoms of depression and/ or anxiety (PHQ-9 and/or GAD-7 >=7); Chronic disease (type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis);
internet access;
basic knowledge of the German language;
participants informed consent (participants younger than 16 years require also the informed consent of parents/ person with custody)

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Exclusion Criteria

Possible acute suicidality as indicated with PHQ-9 Item 9 > 1 at screening in clinical centres or medical practices

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Addresses

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    • Universität Ulm, Fakultät Ingenieurwissenschaften, Informatik und Psychologie, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Mr.  Prof. Dr.  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • 89081  Ulm
    • Germany
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    • Universität Ulm, Fakultät Ingenieurwissenschaften, Informatik und Psychologie, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Mr.  Prof. Dr.  Harald   Baumeister 
    • Albert-Einstein-Allee 47
    • 89081  Ulm
    • Germany
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    • Universität Ulm, Fakultät Ingenieurwissenschaften, Informatik und Psychologie, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Mr.  Dipl.-Psych.  Matthias  Domhardt 
    • Albert-Einstein-Allee 47
    • 89081  Ulm
    • Germany
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    • Universität Ulm, Fakultät Ingenieurwissenschaften, Informatik und Psychologie, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Ms.  M.Sc. Psych.  Agnes  Geirhos 
    • Albert-Einstein-Allee 47
    • 89081  Ulm
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Universität Ulm, Fakultät Ingenieurwissenschaften, Informatik und Psychologie, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Ms.  M.Sc. Psych.  Frederike  Lunkenheimer 
    • Albert-Einstein-Allee 47
    • 89081  Ulm
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie II der Universität Ulm am Bezirkskrankenhaus Günzburg,Sektion: Gesundheitsökonomie und Versorgungsforschung
    • Ms.  Dr.  Annabel Sandra  Mueller-Stierlin 
    • Ludwig-Heilmeyer-Straße 2
    • 89312  Günzburg
    • Germany
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    • Universität UlmFakultät Ingenieurwissenschaften, Informatik und PsychologieInstitut für Psychologie und PädagogikAbteilung für Klinische Psychologie und Psychotherapie
    • Ms.  M.Sc. Psych.  Agnes  Geirhos 
    • Albert-Einstein-Allee 47
    • 89081  Ulm
    • Germany
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  • start of 1:1-Block address public-contact
    • Universität Ulm, Fakultät Ingenieurwissenschaften, Informatik und Psychologie, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Ms.  M.Sc. Psych.  Frederike  Lunkenheimer 
    • Albert-Einstein-Allee 47
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF), Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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