- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03332381
Attention Training Technique and Mindful Self-Compassion
November 1, 2017 updated by: Norwegian University of Science and Technology
A Randomized Controlled Trial Comparing the Attention Training Technique and Mindful Self-Compassion
The design of the study is a randomized controlled trial.
A total of 80 students with self-reported symptoms of stress/anxiety/depression will be invited to take part in a 3-session course consisting of either attention training or self-compassion/mindfulness based meditation.
Attention training involves modifying metacognitive control and enhancing attention flexibility so that people can refrain from responding to intrusions with extended processing.
Self-compassion involves not avoiding painful or distressing feelings.
Instead these experiences are held in awareness with kindness, understanding, and a sense of shared humanity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway, 7491
- Psykologisk Institutt, Dragvoll
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- self reported symptoms of stress/anxiety/depression
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Attention training technique
|
Attention training involves modifying metacognitive control and enhancing attention flexibility so that people can refrain from responding to intrusions with extended processing.
Other Names:
|
ACTIVE_COMPARATOR: Mindful self-compassion
|
Self-compassion involves not avoiding painful or distressing feelings.
Instead these experiences are held in awareness with kindness, understanding, and a sense of shared humanity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in symptoms of depression as assessed with the Patient Health Questionnaire-9
Time Frame: Baseline, immediately after last session, 6 months after intervention
|
Assesses symptoms of depression.
Total score range from 0 (no depression) to 27 (very depressed).
Lower values represent better outcome.
Subscale scores are not used.
|
Baseline, immediately after last session, 6 months after intervention
|
Change in symptoms of anxiety as assessed with the Generalized Anxiety Disorder-7 scale
Time Frame: Baseline, immediately after last session, 6 months after intervention
|
Assesses symptoms of anxiety.
Total score range from 0 (no depression) to 21 (very depressed).
Lower values represent better outcome.
Subscale scores are not used.
|
Baseline, immediately after last session, 6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in self-compassion as assessed by the Self-Compassion Scale Short Form
Time Frame: Baseline, immediately after last session, 6 months after intervention
|
Assessment of self-compassion.
Total score range from 12 (no self-compassion) to 60 (high on self-compassion).
Higher values represent better outcome.
Subscale scores are not used.
|
Baseline, immediately after last session, 6 months after intervention
|
Changes in the attention flexibility subscale of the Detached Mindfulness Questionnaire
Time Frame: Baseline, immediately after last session, 6 months after intervention
|
Assessment of attention flexibility.
Total score for attention flexibility range from 5 (no flexibility) to 25 (very flexible).
Higher values represent better outcome.
No other subscales are used.
|
Baseline, immediately after last session, 6 months after intervention
|
Changes in mindfulness as assessed with The Five Facet Mindfulness Questionnaire
Time Frame: Baseline, immediately after last session, 6 months after intervention
|
Assessment of mindfulness.
Total score range from 20 (not mindful at all) to 100(very mindful).
Higher values represent better outcome.
Subscale scores are not analyzed.
|
Baseline, immediately after last session, 6 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Magne Flaten, phd, Norwegian University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2015
Primary Completion (ACTUAL)
May 1, 2017
Study Completion (ACTUAL)
September 1, 2017
Study Registration Dates
First Submitted
October 30, 2017
First Submitted That Met QC Criteria
November 1, 2017
First Posted (ACTUAL)
November 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 6, 2017
Last Update Submitted That Met QC Criteria
November 1, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/470-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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