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Major Depressive DisorderHOPENCT02004145

Trial of a Positive Psychology Intervention in Major Depressive Disorder

A study testing Positive Psychology in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Positive Psychology
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteUnited States
Study dates
Oct 2013to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Major Depression

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.

Read more

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.

Read the detailed description

Participants will be randomized to receive the intervention or recollection (control) arm. They will be randomized by a random-number generator and will be assigned a condition after receiving baseline questionnaires. The RA/blinded assessor will be blind to the study condition. The interventionist and subjects will not be blind to the study condition.

Baseline assessments: After consent and eligibility rule outs, subjects will receive baseline questionnaires to assess hopelessness (BHS46), suicidality (CHRT47), depression (QIDS-SR48), and positive states (LOT-R,43 GQ-6,44 PANAS45). Then, subjects will be randomized via random number generator to receive the control or intervention condition.

After completing baseline questionnaires and receiving randomization, subjects in both groups will have a 20 minute initial in-hospital session ("week #1"), within a week of anticipated discharge, in which the interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the exercise. The next day, the exercise will be reviewed and an exercise assigned for the next week. Immediately after completing the exercise, subjects will rate (on a Likert scale of 1-5) ease of exercise completion, overall utility, and initial impact on hopelessness/optimism, to assess immediate effects.

After discharge from the hospital, subjects will have five 20 minute weekly phone sessions ("weeks #2-6") with a different exercise used each week (assigned in the same order to all subjects). The phone sessions will include: (a) review of the prior week's exercise (including subject ratings of ease and impact as in week #1), (b) discussion of the rationale and assignment of the next week's exercise via a guided review of the study manual, and (c) completion of the Clinical Status questions and the Clinical Global Improvement scale (CGI) to monitor symptoms and improvement. Sessions will be audiotaped and random sessions reviewed by our PP consultant to ensure fidelity to the intervention (and that other techniques, e.g., Cognitive Behavioral Therapy, are not used).

Positive psychology (intervention condition)

Exercises. These were selected based on their superior performance in our pre-pilot study and others' work:

  • Gratitude for positive events: Subjects recall three events, small or large, in the preceding week that were associated with satisfaction, happiness, pride, or other positive states.
  • Gratitude letter: Subjects write a letter of gratitude thanking a person for an act of kindness; subject may, at their discretion, share the letter with the other person.
  • Performing acts of kindness: Subjects are instructed to complete three acts of kindness in one day. The acts can be small or large, planned or spontaneous, but must be expressly completed to be kind to another.
  • Using personal strengths: Subjects undergo a brief assessment of personal strengths, then find a new way to use that strength in the next 24 hours.
  • Enjoyable and meaningful activities: Subjects complete a series of self-selected activities that vary between those that bring immediate boosts in mood and those that are more deeply meaningful.
  • Repetition of an exercise previously done.

Recollection (control condition) The recollection condition was selected because it has been used in a prior study by our team of a phone-based positive psychology intervention and it was found to be feasible and well-accepted. Each week, subjects will record recent life events in a manual without describing emotions associated with the events. The nature, setting, or type of events to be recorded will differ each week to provide variety and maintain subjects' interest. This will be described as an intervention that may assist with organization and hone recall of important life events. Also, as an attentional control, it has a parallel structure to the experimental arm with a treatment manual, weekly exercises, and weekly calls to review exercises.

Follow-up 6 and 12 week phone call. After completion of the intervention (6 weeks), and then at 12 weeks, a blinded study research assistant (RA) will call subjects at 6 and 12 weeks to repeat measures of hopelessness (BHS), suicidality (CHRT), depression (QIDS-SR) and positive states (e.g., GQ-6, PANAS, LOT-R). Subjects will also be asked to rate their overall satisfaction with the treatment they received for their cardiac condition (outside of this study) over the last 6 and 12 weeks on a scale of 1 (excellent) to 5 (poor). We will record specific times that subjects would prefer to be called (and not to be called) for future follow-ups, to reduce intrusion on subjects' lives. We will also send a postcard to subjects reminding them of their upcoming study phone call. The blinded assessor will make 2 follow-up phone calls (at 6 and 12 weeks) to gather information about outcomes. If subjects would rather complete the questions in written form rather than over the phone, we will send them a written packet at the time of each follow-up.

Being tested
Positive Psychology, Control Condition
Keywords
MDD, Positive Psychology, Suicidality
Medical subject headings
Depressive Disorder, Major, Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive PsychologyBehavioural

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

  • Control ConditionBehavioural

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

Study groups in NCT02004145
Study groupRoleWhat they receive
Positive PsychologyExperimentalThe 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.
Receives: Behavioral: Positive Psychology
Organizational SkillsSham comparatorThe 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.
Receives: Behavioral: Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 6 weeks, and 12 weeks

Secondary outcomes (2)
  1. Change in CHRT Scores

    The Concise Health Risk Tracking scale (CHRT) is a brief, twelve item, self-report and clinician rating of suicidal risk.

    Measured: Baseline, 6 weeks, and 12 weeks

  2. Change in QIDS-SR Scores

    The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) is a sixteen item, self-report measure of depressive symptom severity derived from the 30-item Inventory of Depressive Symptomatology (IDS).

    Measured: Baseline, 6 weeks, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02004145
Sponsor's protocol ID
2013P001234
Other IDs
SRG-2-019-12
Acronym
HOPE
Status last verified
Apr 2016
First submitted
3 Dec 2013
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33884617

Questions about this trial

What is this clinical trial studying?

A study testing Positive Psychology in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BHS Scores (time frame: Baseline, 6 weeks, and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02004145, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.

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