Trial document




drksid header

  DRKS00012536

Trial Description

start of 1:1-Block title

Title

W-Decide: a guided internet- and mobile-based self-help intervention for cancer patients with depression – a randomized controlled pilot trial

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

W-Decide

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://geton-training.de/W-Decide.php

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Many cancer patients suffer from depression. The present study aims at evaluating the feasibility and potential effectiveness of an online training against depression in cancer patients. Participants will be randomly assigned to one of two groups and get access to the online training either immediately or after a waiting time. Different aspects of feasibility as well as changes in depression severity, anxiety severity, quality of life, fear of progression, and cancer-related fatigue will be investigated as outcomes.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Introduction: In addition to physical symptoms such as fatigue or pain, cancer patients are likely to experience psychological distress. Especially depressive symptoms are common in cancer populations and associated with worsened patient outcomes. Barriers to mental health care are still high for cancer patients, including stigmatization or limited mobility. Internet- and mobile-based interventions are an innovative and cost-effective approach to overcoming these barriers and serving the psychosocial needs of this population. The present trial therefore aims at evaluating the feasibility and potential effectiveness of “W-Decide”, a guided internet- and mobile-based self-help intervention for adult cancer patients with depressive symptoms.

Methods: A parallel group randomized controlled feasibility trial will be conducted. Recruitment of N=50 cancer patients with depressive symptoms (PHQ ≥ 5) will take place from June to July 2017. Participants will be randomly assigned to either the intervention group (n=25) or a wait-list control group (n=25). W-Decide is based on principles of cognitive behavioral therapy and consists of seven weekly minimally guided lessons, up to six out of nine integrated optional lessons and one booster lesson. The main components include psychoeducation, behavioral activation, problem solving and cognitive restructuring. Participants in the wait-list control group will receive standard medical care and get access to the unguided intervention after the final assessment. Feasibility of recruitment, intervention and safety procedures will be the primary outcome. Secondary outcomes will be assessed at baseline and post-intervention and include patient-reported depression severity, anxiety severity, quality of life, fear of progression and cancer-related fatigue. Potential intervention effects will be analysed based on an intention-to-treat approach.

Discussion: This study contributes to improving and facilitating mental health care for cancer patients by using an innovative e-health approach. Findings regarding feasibility and patient outcomes will inform decisions on the progression to a future definitive randomized controlled trial and guide future research on internet- and mobile-based interventions in cancer patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012536
  •   2017/06/23
  •   [---]*
  •   yes
  •   Approved
  •   47_17 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
  •   F30-F39 -  Mood [affective] disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   participants will receive standard care and immediately get access to a guided internet- and mobile-based self-help program against depression based on principles of cognitive-behavioural therapy; the program consists of 7 lessons, 6 out of 9 optional lessons and one booster session after four weeks; participants work on 1-2 lessons per week and will receive feedback after each lesson by e-coaches (trained psychologists); main components of the program include psychoeducation, behavioural activation, problem solving and cognitive restructuring
  •   waitlist control group: participants will receive standard care and get access to the same program as the intervention group after a waiting time (ca. 2 months); participants in the waitlist control group will work on the program without guidance
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Feasibility: recruitment strategies, recruitment numbers, acceptability, adverse events

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

symptom severity of depression (PHQ-9), symptom severity of anxiety (GAD-7), quality of life (AQoL-8D, EORTC QLQ-C30), fear of progression (PA-F), fatigue (11-item FQ)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • other 
  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2017/07/01
  •   50
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Cancer diagnosis;
PHQ-9 ≥ 5;
sufficient ability to read and write in the German language; access to the internet

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Acute suicidality; concurrent or life-time diagnosis of schizophrenia, psychosis or bipolar disorder; medical condition does not allow participation

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung für klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Mr.  Prof. Dr.l  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Lehrstuhl für Klinische Psychologie und Psychotherapie, Friedrich-Alexander-Universität Erlangen-Nürnberg
    • Mr.  Dr.  David Daniel  Ebert 
    • Nägelsbachstr. 25a
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Abteilung für klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Ms.  Natalie  Bauereiß 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Abteilung für klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Ms.  Natalie  Bauereiß 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Abteilung für klinische Psychologie und Psychotherapie, Institut für Psychologie und Pädagogik, Universität Ulm
    • Mr.  Prof. Dr.l  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • 89069  Ulm
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.