A Pilot Study of Positive Affect Training

January 16, 2018 updated by: Stefan G. Hofmann, Boston University Charles River Campus

Effect of a Novel Mindfulness Based Loving Kindness Meditation on Positive and Negative Affect

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Loving-kindness meditation (LKM) and mindfulness meditation, in which PAT is rooted, are derived from Buddhist practices that have been empirically shown to have applications in improving mental health. Throughout the 1990s and early 2000s, mindfulness based CBT was shown to decrease stress, negative affect, and chronic pain in both psychiatric and non-psychiatric subjects. Mindfulness-based therapy has since been shown to be effective for treating mood and anxiety disorders. Only recently has LKM been examined as an intervention for affective symptoms. This meditation practice seems to be particularly suited for reducing negative affect while also enhancing positive affect in individuals who show emotional dysregulation, such as people with dysthymic disorder. This notion is supported by experimental studies suggesting that LKM decreases anxiety and stress, positively influences emotional responses to neutral stimuli, and promotes positive emotions such as trust, love, hope, and compassion. Dr. Fredrickson, a prominent researcher and social psychologist who is the foremost expert in LKM will serve as an outside consultant for the development of the protocol. She is not listed as an official collaborator because she will not be in direct contact with the participant data that the investigators will collect.

The intervention the investigators plan to develop, Positive Affect Training (PAT), combines mindfulness and LKM, with a strong emphasis on the latter. The investigators will adopt strategies that have been described in a previous LKM protocol for trauma victims. The investigators contacted Dr. Kearney who shared his manual with us. Given the impressive effect LKM seems to have on generating positive, and attenuating negative affect in experimental studies, the investigators plan to test PAT as a method of improving positive affect. The current study aims to test the initial efficacy of PAT in individuals who report experiencing a low mood. The investigators hypothesize significant improvement in subjects' self-reported ratings of negative and positive affect as a result of the intervention.

Study Type

Interventional

Enrollment (Actual)

10

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Center for Anxiety and Related Disorders at Boston University

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positive Affect Training (PAT)
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Positive and Negative Affect Scale (PANAS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Self-Compassion Scale (SCS)
Time Frame: 12 weeks
12 weeks
Change from Baseline in Beck Anxiety and Depression Scale (BDI)
Time Frame: 12 weeks
12 weeks
Change from Baseline in Compassionate Love Scale
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Investigators

  • Principal Investigator: Stefan G. Hofmann, Ph.D., Boston University, Psychology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3151

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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