Trial document




drksid header

  DRKS00010800

Trial Description

start of 1:1-Block title

Title

Efficacy of a nature- and animal-assisted mindfulness program for unstable or partially remitted depressive high risk patients

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

Trial Acronym

[---]*

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

The current study investigates the effectiveness of a nature- and animal-assisted mindfulness training. The program is offered to patients, who are unstable or partially recovered from a depression. There is evidence, that mindfulness trainings can reduce the relapse rate in patients with recurrent depressive episodes. Especially for patients with rest symptoms or early traumatic experiences it is difficult to learn and persevere the traditional meditative mindfulness practice of sitting. For this reason, the training will take place within nature, including the use of animals (sheep), as an alternative to a closed and clinical therapy room.
A total of 64 patients will be included in the study. Patients will participate in an eight-week nature- and animal-assisted mindfulness program with a total of eight 2.5-hour appointments in the group (each 5-8 participants; mindfulness group). After 6 months, one booster session is scheduled. The participants of the waiting group have the opportunity to participate in the mindfulness program after the study period. Other forms of treatment (e.g. medication, psychotherapy) can be maintained. Before and after the treatment as well as after a 12-month follow-up period diagnostic interviews will take place.
It is assumed that participants in the mindfulness group - compared to participants in the waiting group - will show lower depression scores, fewer and shorter relapses and benefits in other parameters (e.g. rumination, quality of life) throughout the study period.

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

Brief Summary in Scientific Language

The current study investigates the effectiveness of a nature- and animal-assisted mindfulness training. The program is offered to patients, who are unstable or partially recovered from a depression. There is evidence, that mindfulness trainings can reduce the relapse rate in patients with recurrent depressive episodes. Especially for patients with rest symptoms or early traumatic experiences it is difficult to learn and persevere the traditional meditative mindfulness practice of sitting. For this reason, the training will take place within nature, including the use of animals (sheep), as an alternative to a closed and clinical therapy room.
A total of 64 patients will be included in the study. Patients will participate in an eight-week nature- and animal-assisted mindfulness program with a total of eight 2.5-hour appointments in the group (each 5-8 participants; mindfulness group). After 6 months, one booster session is scheduled. The participants of the waiting group have the opportunity to participate in the mindfulness program after the study period. Other forms of treatment (e.g. medication, psychotherapy) can be maintained. Before and after the treatment as well as after a 12-month follow-up period diagnostic interviews will take place.
It is assumed that participants in the mindfulness group - compared to participants in the waiting group - will show lower depression scores, fewer and shorter relapses and benefits in other parameters (e.g. rumination, quality of life) throughout the study period.

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

Organizational Data

  •   DRKS00010800
  •   2016/07/18
  •   [---]*
  •   yes
  •   Approved
  •   436/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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

  •   ICD-10-CM (F33.41) Recurrent depression in partial remission
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Mindfulness group: 8-week nature- and animal- assisted mindfulness training in the group (8 sessions à 150 min), 1 booster session after 6 months. Additionally, continuation of previous treatments.
  •   Waiting group: continuation of previous treatments
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   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

Relapse/recurrence of a major depressive episode during the study course, measured with SKID-I-Interview at T0 (baseline), T1 (post) and T2 (12 month follow up) measurement times, and in between, if relevant.

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

Secondary Outcome

Measurement of changes in the course of the study in:
- depression scores (HRSD-17, BDI)
- rumination (RSQ-D)
- mindfulness skills (Skills, FFA)
- quality of life (WHOQoL)

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

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

Recruitment

  •   Actual
  •   2016/07/25
  •   64
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

- age 18-70 years
- partly or instable remission of a major depressive episode (recurring episode in incomplete remission 296.35 / F33.41)
- at least 3 major depressive episodes in the past (one in the last 2 years)
- early traumatisation before the age of 18 (measured with CTQ)
- in medical treatment during the complete duration of the study
- signature of informed consent
- good German language skills

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

Exclusion Criteria

- current depressive episode (SKID-I)
- acute suicidality
- schizophrenia, schizoaffective disorder, bipolar disorder, substance abuse, organic psychiatric disorder
- other current axis-I-disorder as primary diagnose
- antisocial, schizotypic or borderline personality disorder
- severe physical impairment

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Elisabeth  Schramm 
    • Hauptstr. 5
    • 79104  Freiburg
    • 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 scientific-contact
    • Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Elisabeth  Schramm 
    • Hauptstr. 5
    • 79104  Freiburg
    • 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
    • Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Elisabeth  Schramm 
    • Hauptstr. 5
    • 79104  Freiburg
    • 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
    • Stiftung zur Förderung der Erforschung von Zivilisationskrankheiten
    • 76530  Baden-Baden
    • 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.