Trial of a Positive Psychology Intervention in Major Depressive Disorder

NCT02004145 | Completed

• 2 other identifiers: 2013P001234SRG-2-019-12
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Keywords

MDD; Positive Psychology; Suicidality

Outcome Measures

Primary Outcomes (1)

• Change in BHS Scores

  The Beck Hopelessness Scale (BHS) is a validated, twenty item, self-report measure that assesses three major aspects of hopelessness: feelings about the future, loss of motivation, and expectations.

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (2)

• Change in CHRT Scores

  Baseline, 6 weeks, and 12 weeks

• Change in QIDS-SR Scores

  Baseline, 6 weeks, and 12 weeks

Other Outcomes (7)

• Change in LOT-R Scores

  Baseline, 6 weeks, and 12 weeks

• Change in GQ-6 Scores

  Baseline, 6 weeks, and 12 weeks

• Change in PANAS Scores

  Baseline, 6 weeks, and 12 weeks

Study Arms (2)

Positive Psychology

EXPERIMENTAL

The Positive Psychology intervention consists of 6 exercises that will be completed by the participant with the guidance of a trainer. Exercises: Gratitude for positive events Gratitude letter Performing acts of kindness Using personal strengths Enjoyable and meaningful activities: Repeating one of the previous exercises.

Behavioral: Positive Psychology

Organizational Skills

SHAM COMPARATOR

The Control Condition consists of 6 exercises that will be completed by the participant with the guidance of a trainer. Exercises: Daily Events Health Events Morning and Evening Events Interactions with Others Leisure Time Activities Repeating one of the previous exercises.

Behavioral: Control Condition

Interventions

Positive Psychology BEHAVIORAL

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

Positive Psychology

Control Condition BEHAVIORAL

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

Organizational Skills

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient admitted to Massachusetts General Hospital inpatient psychiatric unit
• Age 18 and older
• Able to read/write in English
• SI documented on admission OR admission due to a suicide attempt
• Admission diagnosis of MDD (and current major depressive episode), confirmed using the Mini International Neuropsychiatric Interview (MINI) and inpatient chart review

You may not qualify if:

• Psychotic symptoms, as assessed using the MINI and inpatient chart review
• Cognitive disorder, assessed using a six-item cognitive screen developed for research
• Primary admission diagnosis of substance use disorder

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation

Interventions

Psychology, Positive

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Blake 11

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 6, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

US (1)