NCT05800119

Brief Summary

The goal of this clinical trial is to test in three samples, including sample 1: lay people without reported depression symptoms, sample 2: lay people with reported depression symptoms and sample 3: mental health clinicians. The main questions it aims to answer are: 1) do each of these populations show a bias against psychotherapy wherein they judge psychotherapy to be less effective, relative to baseline ratings, when a mental illness (i.e., depression) is attributed to biological factors, 2) whether an intervention emphasizing the neurobiological effects of psychotherapy can remove this bias against psychotherapy for biologically-caused mental disorders, and 3) whether this intervention is more effective compared to an active control intervention that emphasizes the effectiveness of psychotherapy, but not its neurobiological effects. Participants will

  • rate the effectiveness of psychotherapy for depression before and after learning about the biological causes of depression
  • be assigned to one of three conditions: 1) an intervention condition where participants will receive a brief reading passage (approximately 126 words in length) providing psychoeducation about how psychotherapy changes the brain of an individual with depression, or 2) an active control condition where participants will receive a reading passage (approximately 115 words) emphasizing the effectiveness of psychotherapy, or 3) a control condition where they will receive no additional materials
  • as a secondary outcome, participants will also rate the effectiveness of medication for depression, before and after learning about the biological causes of depression

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,243

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2020

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

Study Start

First participant enrolled

September 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

March 22, 2023

Last Update Submit

May 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in beliefs about the effectiveness of psychotherapy from baseline to after learning about the biological causes of depression, as measured by two survey questions taken at pretest and at post-test

    This outcome is measured with two questions, both on a 1-7 rating scale. The questions measure participants' beliefs about the effectiveness of psychotherapy. These two questions were asked on an online survey where participants completed the questions at pretest (before participants learned about the biological causes of depression, and were assigned to one of the three conditions) and at post-test. The questions were as follows: 1) "how effective would psychotherapy treatment be at addressing what might be the causes of depression? From 1 "not at all effective" to 7 "extremely effective" and 2) "how likely is it that symptoms will improve with psychotherapy treatment? From 1 "no improvement" to 7 "full recovery with no remaining symptoms." These questions were averaged to create a composite pretest and post-test psychotherapy effectiveness score. The change in mean scores from pretest to post-test will be the outcome of interest.

    Pretest and post-test, both measures completed during an approximately 10-minute survey

Secondary Outcomes (1)

  • Change in beliefs about the effectiveness of medication from baseline to after learning about the biological causes of depression, as measured by two survey questions taken at pretest and at post-test

    Pretest and post-test, both measures completed during an approximately 10-minute survey

Study Arms (3)

Brain-level condition

EXPERIMENTAL

Participants assigned to this condition received a brief reading passage (126 words) that provided psychoeducation about how psychotherapy can change the brain of those with depression, and specifically how psychotherapy can change the functioning of the prefrontal cortex and the amygdala, and affect neurotransmitters.

Behavioral: Brain-level condition

Mind-level condition

ACTIVE COMPARATOR

Participants assigned to this condition received a brief reading passage (115 words) that provided psychoeducation about the effectiveness of psychotherapy for depression, and specifically how psychotherapy can improve maladaptive thought processes and teach people with depression how to regulate negative emotions.

Other: Mind-level condition

Control condition

NO INTERVENTION

Participants assigned to this condition received no additional materials.

Interventions

Participants will receive a brief reading passage about the neurobiological effects of psychotherapy.

Brain-level condition

Participants will receive an active control consisting of a brief reading passage about the effectiveness of psychotherapy.

Mind-level condition

Eligibility Criteria

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

You may qualify if:

  • Participation was open to individuals in the US
  • For sample 2, lay people with reported depression symptoms, participants were included if they indicated via Amazon Mechanical Turk Toolkit that they experienced symptoms of depression
  • For sample 3, mental health clinicians, participants were included if they indicated that they were a practicing mental health clinician in the United States

You may not qualify if:

  • For lay people with reported depression symptoms, participants were excluded if they scored \< 14 on the Beck Depression Inventory-II (BDI-II), indicating no depression symptoms
  • For mental health clinicians, participants were excluded if they indicated that they were not currently licensed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not made aware of the condition they were assigned to.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 5, 2023

Study Start

September 18, 2020

Primary Completion

April 2, 2022

Study Completion

April 2, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations