Trial document




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  DRKS00016714

Trial Description

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Title

Feasibility trial of an online intervention for symptoms of depression and anxiety in adolescents with chronic medical conditions (youthCOACH-CD)

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Trial Acronym

youthCOACH-CD

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URL of the Trial

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

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Brief Summary in Lay Language

Adolescents with chronic somatic conditions like type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis often suffer from a high amount of psychological strains and social distress as well as depression and anxiety. These influencing factors are associated with reduced quality of life, reduced treatment adherence and poorer long-term prognosis. Considering the limited access to evidence-based service supplies, the guided iCBT youthCOACH-CD, examined in this feasibility trial, may offer low-threshold access to address comorbid symptoms of depression and anxi-ety and improve psychological well-being. The aim of this feasibility trial is to firstly pilot the effectiveness of the intervention for adolescents with chronic somatic conditions (type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis). Secondly, the feasibility of the internet-based intervention will be scientifically tested. Par-ticipants can use the intervention independent of location and time in addition to all routine care services for somatic and mental health problems. This study is part of the project „Chronic Conditions in Adolescents: Implementation and Evaluation of Patient-centred Collaborative Healthcare (COACH)”, funded by the German Fed-eral Ministry of Education and Research.

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Brief Summary in Scientific Language

Introduction: Adolescents living with chronic somatic conditions like type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis are confronted with particularly significant challenges in daily life. Comorbid psychological strains and social distress as well as symptoms of depression and anxiety lead to reduced quality of life, reduced treatment adherence and poorer long-term prognosis for many adolescents. Combining possible advantages of an internet- and mobile-based intervention, the iCBT intervention youthCOACH-CD is thought to reduce symptoms of depression and anxiety in adolescents with chronic somatic conditions. The aim of this trial is to pilot the effectiveness and feasibility of the guided iCBT intervention, named youthCOACH-CD.

Method: This study is a randomized-controlled feasibility trial of a cognitive behavioural therapy-based internet intervention for children and adolescents with chronic somatic conditions like type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis. The recruitment of N=30 adolescents, between 12-21 years of age with different levels of anxiety and depression (ranging from asymptomatic to clinically relevant symptom severity), will start from February 2019. Participants will be randomly assigned to either the intervention group (n=15) or a waitlist control group (n=15). Based on cognitive behavioural therapy, the guided internet- and mobile-based intervention consists of an introduction plus seven weekly units. Each unit lasts between 50 and 70 minutes. The units include motivation and resources, behavioural activation, understanding and coping with anxiety and depression, emotion regulation, communication and social support as well as relapse prophylaxis. Guidance is given by an e-Coach, who reports semi-standardized feedback after each completed lesson via the intervention platform Minddistrict. Primary outcome will be effectiveness, assessed by symptom severity of anxiety and depression. Secondary outcome will be feasibility, evaluated by drop-out rate, acceptance and adverse events. Further secondary outcomes concerning for example the modification of psychological well-being will be assessed patient-reported. Additionally, the feasibility of a questionnaire battery, addressing aspects of health economics, will be determined.

Discussion: Results and findings gained through this feasibility trial will serve as basis for the subsequent main trial as well as further research, contributing to the advancement of paediatric internet interventions. 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

  •   DRKS00016714
  •   2019/03/25
  •   [---]*
  •   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
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Interventions/Observational Groups

  •   intervention group (includes the guided online intervention youthCOACH-CD with 7 lessons. Meanwhile, standard medical care (TAU) can continue to be used.)
  •   waitlist control group (WL+TAU): baseline interviews, after 3 and 6 months.
    Meanwhile, standard medical care (TAU) can continue to be used. The online intervention can be performed unguided after 3 months.
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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

Effectiveness: The Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS): combined depressive and anxiety symptom severity,
Measurement times: Baseline, after 3 and after 6 months

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Secondary Outcome

Feasibility: Drop-out, acceptance, adverse events, questionnaire battery
Demographic data
Beck´s Depression-Inventory Revision (BDI-II) Item 9
Coping with chronic health conditions (CODI)
Berlin Social Support Scale (BSSS)
General Self-Efficacy Scale (GSE)
Child and Adolescent Trauma Screen (CATS)
Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)
Behavioural Activation for Depression Scale (BADS)
Revised Questionnaire of positive and negative automatic thoughts (ATQ-R)
Questionnaire of stress-related personal growth (PRB)
Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I)
Working alliance questionnaire (WAI-SR)
Internet-Use Expectancies Scale (IUES)
Child and Adolescent Service Receipt Inventory – German Version (CAMSHRI-DE)
EQ-5D-Y
Questionnaire for the assessment of negative effects of psychotherapy (INEP-On)
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Mood and Feelings Questionnaire (MFQ)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/03/25
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Chronic disease (type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis)
internet access,
basic knowledge of the German language,
participants agreement or under the age of 15, agreement by a person with custody

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Exclusion Criteria

acute suicidal tendency: PHQ-9 Item 9 > 1

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Addresses

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    • Abteilung für Klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Mr.  Prof. Dr.  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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    • Abteilung für Klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Mr.  Prof. Dr.  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Abteilung für Klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Mr.  Dipl.-Psych.  Matthias  Domhardt 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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    • Abteilung für Klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Mr.  Dipl.-Psych.   Matthias  Domhardt 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • DLR Projektträger, Bereich Gesundheit
    • Heinrich-Konen-Straße 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

  •   Ethikvotum
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