Back to resultsAttention Training Technique and Mindful Self-Compassion
Primary Purpose
Anxiety, Depression, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Attention training technique
Mindful self-compassion
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- self reported symptoms of stress/anxiety/depression
Exclusion Criteria:
-
Sites / Locations
- Psykologisk Institutt, Dragvoll
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Attention training technique
Mindful self-compassion
Arm Description
Outcomes
Primary Outcome Measures
Change in symptoms of depression as assessed with the Patient Health Questionnaire-9
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.
Change in symptoms of anxiety as assessed with the Generalized Anxiety Disorder-7 scale
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.
Secondary Outcome Measures
Changes in self-compassion as assessed by the Self-Compassion Scale Short Form
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.
Changes in the attention flexibility subscale of the Detached Mindfulness Questionnaire
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.
Changes in mindfulness as assessed with The Five Facet Mindfulness Questionnaire
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.
Full Information
NCT ID
NCT03332381
First Posted
October 30, 2017
Last Updated
November 1, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03332381
Brief Title
Attention Training Technique and Mindful Self-Compassion
Official Title
A Randomized Controlled Trial Comparing the Attention Training Technique and Mindful Self-Compassion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Stress, Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attention training technique
Arm Type
Active Comparator
Arm Title
Mindful self-compassion
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Attention training technique
Other Intervention Name(s)
ATT
Intervention Description
Attention training involves modifying metacognitive control and enhancing attention flexibility so that people can refrain from responding to intrusions with extended processing.
Intervention Type
Behavioral
Intervention Name(s)
Mindful self-compassion
Other Intervention Name(s)
MSC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in symptoms of depression as assessed with the Patient Health Questionnaire-9
Description
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.
Time Frame
Baseline, immediately after last session, 6 months after intervention
Title
Change in symptoms of anxiety as assessed with the Generalized Anxiety Disorder-7 scale
Description
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.
Time Frame
Baseline, immediately after last session, 6 months after intervention
Secondary Outcome Measure Information:
Title
Changes in self-compassion as assessed by the Self-Compassion Scale Short Form
Description
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.
Time Frame
Baseline, immediately after last session, 6 months after intervention
Title
Changes in the attention flexibility subscale of the Detached Mindfulness Questionnaire
Description
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.
Time Frame
Baseline, immediately after last session, 6 months after intervention
Title
Changes in mindfulness as assessed with The Five Facet Mindfulness Questionnaire
Description
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.
Time Frame
Baseline, immediately after last session, 6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
self reported symptoms of stress/anxiety/depression
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magne Flaten, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Psykologisk Institutt, Dragvoll
City
Trondheim
ZIP/Postal Code
7491
Country
Norway
12. IPD Sharing Statement
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Attention Training Technique and Mindful Self-Compassion
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