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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03332381
Other study ID # 2015/470-1
Secondary ID
Status Completed
Phase N/A
First received October 30, 2017
Last updated November 1, 2017
Start date May 1, 2015
Est. completion date September 1, 2017

Study information

Verified date November 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date September 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- self reported symptoms of stress/anxiety/depression

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
Norway Psykologisk Institutt, Dragvoll Trondheim

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, immediately after last session, 6 months after intervention
Primary 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. Baseline, immediately after last session, 6 months after intervention
Secondary 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. Baseline, immediately after last session, 6 months after intervention
Secondary 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. Baseline, immediately after last session, 6 months after intervention
Secondary 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. Baseline, immediately after last session, 6 months after intervention
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