NCT01853098

Brief Summary

The primary objective of this study is a proof-of-concept study to test whether a novel mindfulness based intervention, Positive Affect Training (PAT), can enhance positive affect and compassion, and decrease negative affect and feelings of depression. PAT involves a combination of practicing mindfulness meditation and loving-kindness meditation in groups. The goal of the research is to test the initial feasibility and efficacy in increasing positive affect and decreasing negative affect in individuals recruited from the general community who experience negative affect. If the training proves to be successful, we will test the intervention, in additional studies, on individuals with dysthymic disorder and other clinical disorders. PAT is a cost-effective, non-invasive intervention. Therefore if effective, it could be an alternative or supplemental intervention option to existing psychotherapy for dysthymic disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

May 10, 2013

Last Update Submit

January 16, 2018

Conditions

Affect (Mental Function)Compassion

Keywords

loving-kindness meditationmindfulness meditationcompassion

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Positive and Negative Affect Scale (PANAS)

    12 weeks

Secondary Outcomes (3)

  • Change from Baseline in Self-Compassion Scale (SCS)

    12 weeks

  • Change from Baseline in Beck Anxiety and Depression Scale (BDI)

    12 weeks

  • Change from Baseline in Compassionate Love Scale

    12 weeks

Study Arms (1)

Positive Affect Training (PAT)

EXPERIMENTAL

The intervention will be conducted in groups with 6-8 participants and 2 facilitators/therapists per group. The groups will meet once a week for 12 successive weeks and each session will be approximately 60 minutes long.

Behavioral: Positive Affect Training (PAT)

Interventions

Positive Affect Training (PAT)BEHAVIORAL

During the PAT sessions, the participants will be taught the basics of mindfulness and how to concentrate their thoughts and feelings on the present moment in a non-judgmental fashion. As the therapy sessions continue, participants will be introduced to basic loving-kindness meditation (LKM). They will be taught to identify and focus the positive feelings they have when they are around someone or something they care about, and transfer these feelings first to themselves, then to a close friend, to a neutral individual, to people whom they dislike, and finally to all living beings.

Positive Affect Training (PAT)

Eligibility Criteria

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

You may qualify if:

  • Must be at least 18 years of age
  • Responds positively to the question on the recruitment material (flyer and posting): "Have you been feeling depressed or in a low mood for most of the day, more days than not, nearly every day for 1 year or longer?"
  • Must have a negative affect scale score of the PANAS of at least 21.6 (1 SD above the mean of normative sample)

You may not qualify if:

  • Participants with a BDI score of 30 or higher (more than moderate depression) will be excluded.
  • Participants who are at risk of harming themselves will be excluded from participating in the study. Suicidality will be assessed after obtaining consent during the screening visit. In addition, the Beck Depression Inventory will be examined for self-reported suidicality. If a participant is found to have suicidal ideation, the PI will be contacted immediately and appropriate follow-up care will be provided by referring the participant to the ER.
  • Participants will be assessed through a phone screen using questions from the Anxiety Disorders Interview Schedule (ADIS) for disorders that could impose a safety risk for the participants or others (e.g., bipolar disorder, schizophrenia, etc). Subjects who endorse "yes" responses to phone screen items will be excluded.
  • Participants who are receiving any psychiatric or psychological treatment for a mood or anxiety disorder at the time of the assessment will be excluded from the study. Participants who initiate such treatments while being enrolled in the study will be closely monitored. These participants will be allowed to remain in the study, but will later be excluded from the data analyses. They are allowed to remain in the study for ethical reasons and because the present trial is a proof-of-concept study and not a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (7)

  • Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

    PMID: 20350028BACKGROUND

  • Hofmann SG, Sawyer AT, Fang A, Asnaani A. Emotion dysregulation model of mood and anxiety disorders. Depress Anxiety. 2012 May;29(5):409-16. doi: 10.1002/da.21888. Epub 2012 Mar 16.

    PMID: 22430982BACKGROUND

  • Hofmann SG, Grossman P, Hinton DE. Loving-kindness and compassion meditation: potential for psychological interventions. Clin Psychol Rev. 2011 Nov;31(7):1126-32. doi: 10.1016/j.cpr.2011.07.003. Epub 2011 Jul 26.

    PMID: 21840289BACKGROUND

  • Carson JW, Keefe FJ, Lynch TR, Carson KM, Goli V, Fras AM, Thorp SR. Loving-kindness meditation for chronic low back pain: results from a pilot trial. J Holist Nurs. 2005 Sep;23(3):287-304. doi: 10.1177/0898010105277651.

    PMID: 16049118BACKGROUND

  • Hutcherson CA, Seppala EM, Gross JJ. Loving-kindness meditation increases social connectedness. Emotion. 2008 Oct;8(5):720-4. doi: 10.1037/a0013237.

    PMID: 18837623BACKGROUND

  • Fredrickson BL, Cohn MA, Coffey KA, Pek J, Finkel SM. Open hearts build lives: positive emotions, induced through loving-kindness meditation, build consequential personal resources. J Pers Soc Psychol. 2008 Nov;95(5):1045-1062. doi: 10.1037/a0013262.

    PMID: 18954193BACKGROUND

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PMID: 3397865BACKGROUND

Study Officials

  • Stefan G. Hofmann, Ph.D.

    Boston University, Psychology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 14, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(1)