Depression, UnipolarCAREDNCT06590038
Psychotherapy Feasibility Pilot of the Carolina Recovery From Depression Protocol
A study testing Single Session Psychotherapy Intervention in people with Depression, Unipolar, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answer are: Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Unipolar
- What is being tested?
- Single Session Psychotherapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 24 Apr 2025
- 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
- Age of 18 years or older
- Able to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Speak and understand English
- Diagnostic and Statistical Manual (DSM)-5 diagnosis of major depressive disorder (MDD) as confirmed by semi-structured clinical assessment
- Meet a cutoff of at least a moderate depression score on the Beck Depression Inventory (BDI-II) (≥ 20)
Who cannot join
- Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment
- Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
- Participants able to birth must not be pregnant or breastfeeding.
- Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
- Participants may not have undergone prior brain surgery
Show all 9Show fewer
- Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
- Participants may not have had brain injury or concussion within the last three months
- Participants may not have a history of brain injury requiring current treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, 27516
About this study
Official title: Psychotherapy Feasibility and Acceptability Pilot of the Carolina Recovery From Depression Protocol (CARED): A Novel Rapid Treatment Paradigm for Depression
The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answer are:
Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention feasible to implement in a single session? Is there evidence that the evidence-based intervention reduces psychological impairment in adults with moderate to severe depression?
Read more
Participants will complete:
- an in-depth diagnostic screening interview prior to enrollment
- a set of mental health questionnaires at baseline and two weeks post-intervention
- a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician
- Conditions
- Depression, Unipolar
- Being tested
- Single Session Psychotherapy Intervention
- Keywords
- Depression, Major Depressive Disorder, Psychotherapy, Single Session Intervention
- Medical subject headings
- Depressive Disorder, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Session Psychotherapy InterventionBehavioural
This is a single session intervention which incorporates elements from second- and third wave psychotherapies (Acceptance and Commitment Therapy and Behavioral Activation), as well as basic psychoeducation. Session will take approximately three hours in total, with the option for breaks between blocks of session.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy Arm | Experimental | Not described Receives: Behavioral: Single Session Psychotherapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
CARED Treatment Experience Survey
A brief survey which probes the qualitative experience of participants during the intervention (i.e., tolerability, their level of engagement, satisfaction with treatment). Participants respond to eight items, rated on a 4-point Likert scale (1 - Not at all to 4 - Completely) to indicate their level of agreement with each item. Higher scores on the measure indicate greater tolerability, satisfaction, and endorsement of treatment. Total possible scores range from 8 to 32.
Measured: Immediately post-intervention (same day)
Secondary outcomes (14)
Change from baseline on Behavioral Activation Scale at two weeks post-intervention
The Behavioral Activation Scale is a measure which assesses participant current levels of behavioral activation in the context of current depression. Participants respond to twenty-five items, rated on a 7-point Likert scale (0 - Not at all to 6 - Completely) to indicate their activation levels during the past week. Higher scores on the measure indicate greater activation (i.e., higher functioning) and lower scales indicate lower activation. Total possible scores range from 0 to 150.
Measured: Baseline and Two Weeks post-intervention
Change in baseline Repetitive Thinking Questionnaire - 10 item form to two weeks post-intervention
The Repetitive Thinking Questionnaire- 10 item form is a well-validated measure that assesses trait-like repetitive negative thinking (e.g., worry, cognitive rumination) during times of distress. Participants respond to ten items, rated on a 5-point Likert scale (1 - Not true at all to 5 - Very True) to indicate to what extent they agree with each statement. Higher scores on the measure indicate greater trait engagement in repetitive negative thinking. Total possible scores range from 10 to 50.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Snaith-Hamilton Pleasure Scale at two weeks post-intervention
The Snaith-Hamilton Pleasure Scale is a measure which assesses participant capacity to experience pleasure in the past few days. Participants respond to fourteen items, rated on a 4-point Likert scale (0 - Strongly disagree to 4 - Strongly agree) to indicate their hedonic capacity over the last few days. Higher scores on the measure indicate greater hedonic capacity, or capacity to experience pleasure. Total possible scores range from 0 to 56.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Inhibition Subscale at two weeks post-intervention
The Behavioral Inhibition and Behavioral Activation Scale- Inhibition subscale is a well-validated measure that assesses for trait-like behavioral inhibition, similar to overcontrol. Participants respond to seven items, rated on a 4-point Likert scale (1 - Very true for me to 4 - Very false for me) to indicate their general behavioral inhibition. Higher scores on the measure indicate higher inhibition. Total possible scores range from 7 to 28.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Drive Subscale at two weeks post-intervention
The Behavioral Inhibition and Behavioral Activation Scale- Activation Drive subscale is a well-validated measure that assesses for trait-like behavioral drive, similar to goal seeking activation. Participants respond to four items, rated on a 4-point Likert scale (1 - Very true for me to 4 - Very false for me) to indicate their general behavioral drive. Higher scores on the measure indicate higher drive/goal seeking. Total possible scores range from 4 to 16.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Fun Seeking Subscale at two weeks post-intervention
The Behavioral Inhibition and Behavioral Activation Scale- Activation Fun Seeking subscale is a well-validated measure that assesses for trait-like behavioral fun seeking, similar to excitement seeking and surgency on other measures of activation. Participants respond to four items, rated on a 4-point Likert scale (1 - Very true for me to 4 - Very false for me) to indicate their general levels of fun/excitement seeking. Higher scores on the measure indicate higher fun seeking. Total possible scores range from 4 to 16.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Reward Responsiveness Subscale at two weeks post-intervention
The Behavioral Inhibition and Behavioral Activation Scale- Activation Reward Responsiveness subscale is a well-validated measure that assesses for trait-like behavioral sensitivity to reward. Participants respond to five items, rated on a 4-point Likert scale (1 - Very true for me to 4 - Very false for me) to indicate their general levels of reward sensitivity. Higher scores on the measure indicate higher pleasure from reward and reward seeking. Total possible scores range from 5 to 20.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Quality of Life Enjoyment and Satisfaction Questionnaire at two weeks post-intervention
The Quality of Life Enjoyment and Satisfaction Questionnaire is a measure which assesses current levels participant satisfaction in many domains of their life (e.g., social and romantic relationships, work/school, health, overall wellbeing). Participants respond to sixteen items, rated on a 5-point Likert scale (1 - Very Poor to 6 - Very Good) to indicate their levels of quality of life and life satisfaction during the past week. Higher scores on the measure indicate greater satisfaction. Total possible scores range from 16 to 80.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Dimensional Anhedonia Rating Scale at two weeks post-intervention
The Dimensional Anhedonia Rating Scale is a measure which assesses participant current levels of hedonic capacity, or ability to feel pleasure. Participants fill in two experiences that they typically enjoy across four domains (favorite sensory experiences, favorite foods, favorite social activities, favorite pastimes/hobbies) and then rate how much they would enjoy, spend time on, desire for, and interest of each domain, rated on a 5-point Likert scale (1 - Not at All to 5 - Very Much). These ratings are summed to index overall desire for, satisfaction with, and likelihood of pursuing favorite activities at the trait-level (i.e., no specific timeframe). Higher scores indicate greater hedonic capacity. Total possible scores range from 16 to 80.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Intolerance of Uncertainty Scale at two weeks post-intervention
The Intolerance of Uncertainty Scale is a measure which assesses trait-like tolerance of uncertainty across numerous life domains. Participants respond to 27 items, rated on a 5-point Likert scale (0 - Not at all characteristic to 4 - Entirely characteristic) to indicate their general tolerance of uncertainty. Higher scores on the measure indicate greater intolerance of uncertainty. Total possible scores range from 0 to 108.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Flexibility Subscale at two weeks post-intervention
The Multidimensional Psychological Flexibility Inventory (short form)- Flexibility Subscale is a measure which assesses various aspects of psychological flexibility in line with the hexaflex model of psychological flexibility. Participants respond to twelve items, rated on a 6-point Likert scale (0 - Never true to 5 - Always true) to indicate their level of agreement with each statement regarding facets of flexibility over the past two weeks. Higher scores on the subscale indicate greater flexibility. Total possible scores range from 0 to 60.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Inflexibility Subscale at two weeks post-intervention
The Multidimensional Psychological Flexibility Inventory (short form)- Inflexibility Subscale is a measure which assesses various aspects of psychological inflexibility in line with the hexaflex model of psychological flexibility. Participants respond to twelve items, rated on a 6-point Likert scale (0 - Never true to 5 - Always true) to indicate their level of agreement with each statement regarding facets of inflexibility over the past two weeks. Higher scores on the subscale indicate greater inflexibility. Total possible scores range from 0 to 60.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Self-Compassion Scale Short Form at two weeks post-intervention
The Self-Compassion Scale Short Form is a measure which assesses an individual\'s general level of self-directed compassion when they are going through difficulties. Participants respond to twelve items, rated on a 5-point Likert scale (1 - Almost Never to 5 - Almost Always) to indicate their level of agreement with each statement regarding how self-compassionate they are with themselves. Higher scores on the scale indicate greater levels of self-compassion. Total possible scores range from 12 to 60.
Measured: Baseline and Two weeks post-intervention
Change from baseline on Becks Depression Inventory II at two weeks post-intervention
The Becks Depression Inventory II is a measure which assesses participant current levels of depression over the past two weeks. Participants respond to 21 items, rated on a 4-point Likert scale (0 - Not at all to 3 - Completely) to indicate how much they feel each symptom of depression. Higher scores on the measure indicate greater depression. Total possible scores range from 0 to 63.
Measured: Baseline and Two weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Mar 2025
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, Ph.D., Principal investigator, Univeristy of North Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590038
- Sponsor's protocol ID
- 23-1988
- Acronym
- CARED
- Status last verified
- May 2025
- First submitted
- 5 Sep 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy Feasibility and Acceptability Pilot of the Carolina Recovery From Depression Protocol (CARED): A Novel Rapid Treatment Paradigm for Depression
- ClinicalTrials.gov ID
- NCT06590038
- Acronym / sponsor ID
- CARED / 23-1988
- Conditions
- Depression, Unipolar
- Keywords
- Depression, Major Depressive Disorder, Psychotherapy, Single Session Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answer are:
Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention feasible to implement in a single session? Is there evidence that the evidence-based intervention reduces psychological impairment in adults with moderate to severe depression?
Participants will complete:
- an in-depth diagnostic screening interview prior to enrollment
- a set of mental health questionnaires at baseline and two weeks post-intervention
- a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy Arm | Experimental | Behavioral: Single Session Psychotherapy Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18 years or older
- Able to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Speak and understand English
- Diagnostic and Statistical Manual (DSM)-5 diagnosis of major depressive disorder (MDD) as confirmed by semi-structured clinical assessment
Key exclusion criteria (9 listed)
- Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment
- Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
- Participants able to birth must not be pregnant or breastfeeding.
- Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Session Psychotherapy InterventionThis is a single session intervention which incorporates elements from second- and third wave psychotherapies (Acceptance and Commitment Therapy and Behavioral Activation), as well as basic psychoeducation. Session will take approximately three hours in total, with the option for breaks between blocks of session. | Behavioural | Psychotherapy Arm |
Primary outcome
CARED Treatment Experience Survey
Time frame: Immediately post-intervention (same day)
A brief survey which probes the qualitative experience of participants during the intervention (i.e., tolerability, their level of engagement, satisfaction with treatment). Participants respond to eight items, rated on a 4-point Likert scale (1 - Not at all to 4 - Completely) to indicate their level of agreement with each item. Higher scores on the measure indicate greater tolerability, satisfaction, and endorsement of treatment. Total possible scores range from 8 to 32.
14 secondary outcomes
Change from baseline on Behavioral Activation Scale at two weeks post-intervention
Time frame: Baseline and Two Weeks post-intervention
Change in baseline Repetitive Thinking Questionnaire - 10 item form to two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Snaith-Hamilton Pleasure Scale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Inhibition Subscale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Drive Subscale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Fun Seeking Subscale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Reward Responsiveness Subscale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Quality of Life Enjoyment and Satisfaction Questionnaire at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Dimensional Anhedonia Rating Scale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Intolerance of Uncertainty Scale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Flexibility Subscale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Inflexibility Subscale at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Self-Compassion Scale Short Form at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Change from baseline on Becks Depression Inventory II at two weeks post-intervention
Time frame: Baseline and Two weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio Frohlich, Ph.D. principal investigator
Univeristy of North Carolina Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Session Psychotherapy Intervention in people with Depression, Unipolar, run by University of North Carolina, Chapel Hill 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 6 inclusion and 9 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 4 Jun 2025. 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. 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?
CARED Treatment Experience Survey (time frame: Immediately post-intervention (same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.