An Intervention to Correct Dualistic Reasoning About the Effectiveness of Psychotherapy for Biologically Caused Mental Disorders
Exemption: Perception of Mental Disorders
2 other identifiers
interventional
1,243
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2022
CompletedFirst Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedMay 6, 2023
May 1, 2023
1.5 years
March 22, 2023
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
EXPERIMENTALParticipants 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.
Mind-level condition
ACTIVE COMPARATORParticipants 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.
Control condition
NO INTERVENTIONParticipants assigned to this condition received no additional materials.
Interventions
Participants will receive a brief reading passage about the neurobiological effects of psychotherapy.
Participants will receive an active control consisting of a brief reading passage about the effectiveness of psychotherapy.
Eligibility Criteria
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
- Yale Universitylead
Study Sites (1)
Yale University
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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