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Trial of a Positive Psychology Intervention in Major Depressive Disorder

NCT02004145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2016-04-19

No results posted yet for this study

Summary

In this study, the investigators will perform an exploratory randomized trial of Positive Psychology (PP). The trial will consist of 50 participants and will compare the impact of a phone-based PP intervention vs. an attentional control condition, in Major Depressive Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is a 12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and 12 weeks.

Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP intervention in this high-risk population.

Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP and with follow-up data from at least 80% of subjects). The ratings of ease and subjective helpfulness of the exercise and other mental states as measured before and after each PP exercise will be more than 6 out of 10 and higher than the same ratings obtained from subjects in the control condition.

Specific Aim #2: To examine the impact of the six-session PP intervention on positive psychological well-being.

Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores on scales of optimism (measured via the Life Orientation Test-Revised \[LOT-R\]), gratitude (Gratitude Questionnaire-6 \[GQ-6\]), and positive affect (Positive Affect Negative Affect Schedule \[PANAS\]) at 6 and 12 weeks.

Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide risk factors.

Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck Hopelessness Scale \[BHS\]; primary study outcome measure), suicidal ideation (SI) (Concise Health Risk Tracking scale \[CHRT\]), and depression (Quick Inventory of Depressive Symptomatology-Self Report \[QIDS-SR\]) at 6 and 12 weeks.

We will also measure impact on readmission and suicide attempts to assess these key outcomes.

Conditions

Interventions

BEHAVIORAL

Positive Psychology

The Positive Psychology intervention consists of 6 exercises that will be completed by the participant with the guidance of a trainer.

BEHAVIORAL

Control Condition

The Control Condition consists of 6 exercises that will be completed by the participant with the guidance of a trainer.

Sponsors & Collaborators

  • American Foundation for Suicide Prevention

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jeff C Huffman, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004145 on ClinicalTrials.gov