NCT03332381

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started May 2015

Typical duration for not_applicable anxiety

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

May 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

October 30, 2017

Last Update Submit

November 1, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Changes in self-compassion as assessed by the Self-Compassion Scale Short Form

    Baseline, immediately after last session, 6 months after intervention

  • Changes in the attention flexibility subscale of the Detached Mindfulness Questionnaire

    Baseline, immediately after last session, 6 months after intervention

  • Changes in mindfulness as assessed with The Five Facet Mindfulness Questionnaire

    Baseline, immediately after last session, 6 months after intervention

Study Arms (2)

Attention training technique

ACTIVE COMPARATOR
Behavioral: Attention training technique

Mindful self-compassion

ACTIVE COMPARATOR
Behavioral: Mindful self-compassion

Interventions

Attention training involves modifying metacognitive control and enhancing attention flexibility so that people can refrain from responding to intrusions with extended processing.

Also known as: ATT
Attention training technique

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.

Also known as: MSC
Mindful self-compassion

Eligibility Criteria

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

You may qualify if:

  • self reported symptoms of stress/anxiety/depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykologisk Institutt, Dragvoll

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionStress, Psychological

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Magne Flaten, phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations