Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00019095

Trial Description

start of 1:1-Block title

Title

Enhancing the quality of life of tumor patients through hypnosystemic resource activation - a hypnotherapeutic short-term program to strengthen their own resources ("HypRa")

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

Trial Acronym

HypRa

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

In order to improve the quality of life of tumor patients and to strengthen individual coping skills, a psycho-oncological short-term program for support during outpatient therapy has been developed, which is currently being evaluated in a randomised-controlled trial.

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

Brief Summary in Scientific Language

Oncological patients (N = 60) were randomly assigned to one of two treatment arms (HT) vs (CBT) with three individual sessions each, or to a waiting group. Participants in both intervention groups were asked to reflect on their own resources by keeping a diary. In addition, participants in the HT group (Hypnosystemic Therapy) became acquainted with the use of individual internal mental images for self-hypnosis, while participants in the CBT group (Cognitive Behavioral Therapy) learned supportive methods (psychoeducation for mindfulness and self-care). During the waiting period, patients in the waiting group received care as usual (CAU). Changes in coping with distress and anxiety have been evaluated by standardized questionnaires at three measuring points of time. The extent of psychosocial stress and stress management skills were examined using multilevel mixed-effects linear regression models adjusted for diagnosis and duration of disease since first diagnosis.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

Supporting information will be made available (study protocol, statistical analysis plan, results). Corresponding procedure (timeframe, platform) TBD.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00019095
  •   2020/01/27
  •   [---]*
  •   yes
  •   Approved
  •   431/16, Ethik-Kommission der Universität Ulm
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

  •   F43 -  Reaction to severe stress, and adjustment disorders
  •   Coping with oncological disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients of the first intervention group (Hypnosystemic Therapy = HT) learned in three individual sessions the application of individual internal mental images for resource activation via self-hypnosis. They were also asked to reflect on their own resources in a diary. Changes in coping with stress and anxiety were evaluated by standardized questionnaires at three measuring points of time.
  •   Patients in the second intervention group (CBT = Cognitive Behavioural Therapy) learned supportive methods of mindfulness and self-care in three individual sessions, which are based on an established standard of psychoeducation. They were also asked to reflect on their own resources in a diary. Changes in coping with stress and anxiety were evaluated by standardized questionnaires at three measuring points of time.
  •   During the waiting period, patients in the waiting group received care as usual (CAU).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Changes in stress management and resource activation capabilities, measured by a standardized questionnaire survey at three measurement points of time.

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

Secondary Outcome

Extent and coping with anxiety - in particular with the fear of progression of the disease (progredience anxiety) - and depressiveness, measured by a standardized questionnaire survey at three measuring points as well as via the evaluation of diary entries regarding individual resource activation.

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

Countries of Recruitment

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

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/05/02
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Oncological patients with chemo- or immunotherapy

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

Exclusion Criteria

Cognitive or language limitations, severe psychiatric or neurological disorders

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

Addresses

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
    • Deutsche Gesellschaft für Hypnose und Hypnotherapie e.V.
    • Ms.  Dipl.-Psych. Dr.  Helga  Hüsken-Janßen 
    • Daruper Str. 14
    • 48653  Coesfeld
    • 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 complete, follow-up continuing
  •   [---]*
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.