NCT02920320

Brief Summary

In this study, people who suffer from strong self-critical tendencies will be randomized to two study conditions. The first group receives an account to an internet-based self-help intervention. The second group is a waiting control group. In both conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of an internet-based self-help intervention on depressive, anxiety and stress symptoms compared to a waiting list. Assessments are at baseline, 8-week and 6-months post-randomization. After 8 weeks, participants in the waiting control group get also access to the intervention and fill out questionnaires after 8 weeks again.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

September 27, 2016

Last Update Submit

October 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Depression anxiety stress scale (DASS)

    8-week

Secondary Outcomes (11)

  • Self-Compassion Scale

    Baseline, 8-week, 6-month

  • Mini International Neuropsychiatric Interview

    Baseline, 8-week

  • Forms of Self-Criticism and Self-Reassurance Scale

    Baseline, 8-week, 6-month

  • Comprehensive Inventory of Mindfulness Experiences

    Baseline, 8-week, 6-month

  • Positive and Negative Affective Schedule

    Baseline, 8-week, 6-month

  • +6 more secondary outcomes

Study Arms (2)

Internet-based self-help

EXPERIMENTAL

Internet-based self-help on the basis of the program "Mindfulness-Based Compassionate Living" (van den Brink \& Koster, 2015). The self-help program consists of seven text-based sessions, various exercises (z.B. breathing meditations, diaries,) and tasks. Participants have the possibility for guidance to the program on request.

Other: Internet-based self-help program

Waiting control group

NO INTERVENTION

Interventions

Internet-based self-help

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Increased levels of self-criticism
  • years or older
  • Internet account
  • Sufficient German language skills
  • Written informed consent

You may not qualify if:

  • Substance dependence, psychotic disorder, bipolar disorder
  • Acute suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, 3012, Switzerland

Location

Study Officials

  • Tobias Krieger, PhD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 30, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations