AnhedoniaNCT04036136

Development of a Novel Transdiagnostic Intervention for Anhedonia - R33 Phase

A study testing Behavioral Activation and Mindfulness Treatment in people with Anhedonia, run by University of North Carolina, Chapel Hill 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

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Anhedonia
What is being tested?: Behavioral Activation and Mindfulness Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2019to 31 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

18-50 years old and treatment seeking;
SHAPS scores ≥ 20, corresponding to clinically significant anhedonia;
Clinician's Global Impression Scale-Severity score (CGI-S) > 3 to assure a clinically impaired sample;
Seeking treatment for anhedonia (i.e., referred from an outpatient clinic or responded to an advertisement for anhedonia treatment; endorses desire for treatment during screening).

Who cannot join

Those for whom medication management is the primary gold-standard treatment, including those with bipolar disorder/mania, schizophrenia spectrum, and other psychotic disorders;
Prior treatment with behavioral activation therapy for depression or mindfulness-based treatments (those with exposure to other forms of psychotherapy, e.g., supportive therapy, will be eligible);
Those who may have difficulty understanding the cognitive components of BATA, including those with intellectual disability, neurocognitive disorders, and dissociative disorders;
Feeding and eating disorders which may have confounding effects on the fMRI signal;
Substance Use Disorders given confounding effects of substances of abuse on the fMRI signal;
Suicidal intent and plan;

Show all 10Show fewer

Psychotropic medication use in the past 4 weeks (8 weeks for fluoxetine) and/or current psychotherapy. Participants must be medication-free at study entry; study personnel will not supervise medication taper for the purpose of the study, but those who taper under the supervision of their regular provider will be eligible;
Currently pregnant, as measured by urine pregnancy screen immediately before MRI scans;
Positive urinalysis screen for cocaine, marijuana, opiates, methadone, amphetamines, and benzodiazepines (conducted on-site via Biosite Triage Meter Plus) at study entry.
No neurological conditions (e.g., history of stroke, seizure, or TBI); Contraindications for fMRI imaging: Metal in the body, dental work that is not fillings or gold, any tattoos, any metal in the body, any metal injury - especially those to the eyes, any other type of implant unless they are 100% plastic.

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC-Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599-7255

Other trials in United States

About this study

The overall goal of this project is to develop a novel transdiagnostic treatment for anhedonia, called Behavioral Activation Treatment for Anhedonia (BATA), using ultra-high field functional neuroimaging. There is a critical need for a validated treatment that specifically targets anhedonia, and this project will evaluate the effects of this new treatment on anhedonia and will establish how this treatment impacts brain systems that mediate reward processing, clinical symptoms of anhedonia, functional outcomes, and behavioral indices of reward processing. This work will also identify brain targets by which future novel anhedonia treatment may be evaluated.

Read the detailed description

Deficits in motivation and pleasure, together referred to as anhedonia, are implicated in a number of psychiatric illnesses, including mood and anxiety disorders, substance-use disorders, schizophrenia, and attention-deficit/hyperactivity disorder. As a result, constructs related to anhedonia are central to the NIMH Research Domain Criteria (RDoC) project. Anhedonia is often one of the most difficult psychiatric symptoms to treat and thus represents a critical endophenotype and vulnerability factor for a range of psychiatric disorders. Given the centrality of anhedonia to a large number of psychiatric disorders, improved interventions to treat motivation and pleasure are critical for these disorders. The overall goal of this R61/R33 project is to develop a novel transdiagnostic treatment for anhedonia, called Behavioral Activation Treatment for Anhedonia (BATA). This new intervention is designed to treat anhedonia by emphasizing supported engagement with personally relevant goals and reducing avoidance behaviors. Consistent with the objectives and milestones outlined in RFA-MH-16-406 ("Exploratory Clinical Trials of Novel Interventions for Mental Disorders"), in the R61 phase of this trial that lasted from June 22, 2017-July 31, 2019, the investigators proposed to use an experimental therapeutics approach to first evaluate mesocorticolimbic target engagement by this treatment in a transdiagnostic sample characterized by clinically impairing anhedonia (Aim 1). Specifically, the investigators examined the effects of this treatment, relative to an active comparison treatment, on caudate nucleus activation during reward anticipation and rostral anterior cingulate cortex activation during reward outcomes using ultra-high field (7T) functional magnetic resonance imaging. The investigators also used fMRI to determine the optimal dose of the intervention (Aim 2).

In the current R33 phase of the study, which begins recruitment 8/1/2019, the investigators plan to evaluate the effects of the optimal dose of this new treatment, versus an active comparison treatment, on anhedonic symptoms and functional outcomes (Aim 3), behavioral indicators of reward sensitivity (Aim 4), and neural indicators of reward processing (Aim 5).

Conditions: Anhedonia
Being tested: Behavioral Activation, Mindfulness Treatment
Medical subject headings: Anhedonia

What participants receive

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

Behavioral ActivationBehavioural
Treatment will consist of 15 weekly 45-minute sessions.
Mindfulness TreatmentBehavioural
Treatment will consist of 15 weekly 45-minute sessions.

Study groups in NCT04036136
Study group	Role	What they receive
Behavioral Activation	Experimental	Treatment will consist of 15 weekly 45-minute sessions. Session 1 provides orientation and psychoeducation on anhedonia, and activity monitoring is introduced. Sessions 2-3 include structured values assessments of 10 life areas to enhance motivation for sustained behavior change and to clarify goals. Following goals clarification, an activity hierarchy is developed, establishing a set of idiographic behavioral targets across life areas prioritized by ease of implementation to scaffold task engagement during the course of treatment. Receives: Behavioral: Behavioral Activation
Mindfulness Treatment	Active comparator	BATA will be compared to mindfulness based cognitive therapy (MBCT), chosen because its mechanisms of action are hypothesized to impact different brain mechanisms than BATA. Mindfulness is nonjudgmentally bringing awareness and acceptance to one's present-moment experience. MBCT will be administered in an individual format. The MBCT protocol will be modeled on the session outlines presented in Wahbeh et al., 2014. Treatment will be compromised of 15 weekly 45-minute sessions. Receives: Behavioral: Mindfulness Treatment

What is being measured

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

Change in Snaith-Hamilton Pleasure Scale Score Over Time
The Snaith-Hamilton Pleasure Scale (SHAPS), a well-validated 14-item questionnaire will be used to assess hedonic capacity. The sum of the 14 items scores ranges from 0 to 56. A higher score represents more anhedonic symptoms. Treatment duration varied across participants. Participants participated in as few as 8 weekly sessions or in as many as 15 weekly sessions of psychotherapy, based on therapist judgement. Thus the outcome measure timeframe varied between 8 and 15 weeks.
Measured: Baseline, Post-treatment (between 8 to 15 weeks)

Secondary outcomes (2)

Change in Neural Activation During MID Task Anticipation Phase
Neural activation assessed by Functional Magnetic Resonance Imaging (fMRI) during Monetary Incentive Delay (MID) task. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. MID task reward anticipation is defined by the contrast in fMRI signal between reward and neutral trials during the presentation of cues and the fixation cross. Because this subtraction method is used to define the fMRI signal, it is possible for this value to be negative. Treatment duration varied across participants. Participants participated in as few as 8 weekly sessions or in as many as 15 weekly sessions of psychotherapy, based on therapist judgement. Thus the outcome measure timeframe varied between 8 and 15 weeks.
Measured: Baseline, Post-treatment (between 8 to 15 weeks)
Change in Neural Activation During MID Task Outcome Phase
Brain activation assessed by Functional Magnetic Resonance Imaging (fMRI) during Monetary Incentive Delay (MID) task. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. MID task reward outcome is defined by the contrast in fMRI signal between successful and unsuccessful reward trials during the presentation of feedback. Because this subtraction method is used to define the fMRI signal, it is possible for this value to be negative.
Measured: up to 15 weeks

Timeline

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

1 Aug 201931 Jul 2023

First posted29 Jul 2019
Study start1 Aug 2019
Primary completion31 Jul 2023
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for AnhedoniaStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04036136
Sponsor's protocol ID: 16-2268b
Other IDs: R61MH110027
Status last verified: Oct 2023
First submitted: 25 Jul 2019
Last updated: 21 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Will share de-identified data through the National Database for Clinical Trials Related to Mental Illness (NDCT)

Publications

Cernasov PM, Walsh EC, Nagy GA, Kinard JL, Kelley L, Phillips RD, Pisoni A, Diehl J, Haworth K, West J, Freeman L, Pfister C, Scott M, Daughters SB, Gaylord S, Dichter GS, Smoski MJ. A parallel-arm, randomized trial of Behavioral Activation Therapy for anhedonia versus mindfulness-based cognitive therapy for adults with anhedonia. Behav Res Ther. 2024 Nov;182:104620. doi: 10.1016/j.brat.2024.104620. Epub 2024 Aug 23.
PubMed 39213738
Gibson K, Cernasov P, Styner M, Walsh EC, Kinard JL, Kelley L, Bizzell J, Phillips R, Pfister C, Scott M, Freeman L, Pisoni A, Nagy GA, Oliver JA, Smoski MJ, Dichter GS. The effects of psychotherapy for anhedonia on subcortical brain volumes measured with ultra-high field MRI. J Affect Disord. 2024 Sep 15;361:128-138. doi: 10.1016/j.jad.2024.05.140. Epub 2024 May 28.
PubMed 38815760
Cernasov PM, Kinard JL, Walsh E, Kelley L, Phillips R, Pisoni A, Arnold M, Lowery SC, Ammirato M, Nagy GA, Oliver JA, Haworth K, Daughters SB, Dichter GS, Smoski M. Parsing within & between-person dynamics of therapy homework completion and clinical symptoms in two cognitive behavioral treatments for adults with anhedonia. Behav Res Ther. 2023 Jul;166:104322. doi: 10.1016/j.brat.2023.104322. Epub 2023 Apr 26.
PubMed 37148652
Phillips R, Walsh E, Jensen T, Nagy G, Kinard J, Cernasov P, Smoski M, Dichter G. Longitudinal associations between perceived stress and anhedonia during psychotherapy. J Affect Disord. 2023 Jun 1;330:206-213. doi: 10.1016/j.jad.2023.03.011. Epub 2023 Mar 11.
PubMed 36907457

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anhedonia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a Novel Transdiagnostic Intervention for Anhedonia - R33 Phase
ClinicalTrials.gov ID: NCT04036136
Acronym / sponsor ID: 16-2268b
Conditions: Anhedonia
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Duke University, National Institute of Mental Health (NIMH)
Study start: 1 Aug 2019 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 29 Jul 2019 (actual)
Results: Posted 21 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Behavioral Activation	Experimental	Behavioral: Behavioral ActivationTreatment will consist of 15 weekly 45-minute sessions. Session 1 provides orientation and psychoeducation on anhedonia, and activity monitoring is introduced. Sessions 2-3 include structured values assessments of 10 life areas to enhance motivation for sustained behavior change and to clarify goals. Following goals clarification, an activity hierarchy is developed, establishing a set of idiographic behavioral targets across life areas prioritized by ease of implementation to scaffold task engagement during the course of treatment.
Mindfulness Treatment	Active comparator	Behavioral: Mindfulness TreatmentBATA will be compared to mindfulness based cognitive therapy (MBCT), chosen because its mechanisms of action are hypothesized to impact different brain mechanisms than BATA. Mindfulness is nonjudgmentally bringing awareness and acceptance to one's present-moment experience. MBCT will be administered in an individual format. The MBCT protocol will be modeled on the session outlines presented in Wahbeh et al., 2014. Treatment will be compromised of 15 weekly 45-minute sessions.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

18-50 years old and treatment seeking;
SHAPS scores ≥ 20, corresponding to clinically significant anhedonia;
Clinician's Global Impression Scale-Severity score (CGI-S) > 3 to assure a clinically impaired sample;
Seeking treatment for anhedonia (i.e., referred from an outpatient clinic or responded to an advertisement for anhedonia treatment; endorses desire for treatment during screening).

Key exclusion criteria (10 listed)

Those for whom medication management is the primary gold-standard treatment, including those with bipolar disorder/mania, schizophrenia spectrum, and other psychotic disorders;
Prior treatment with behavioral activation therapy for depression or mindfulness-based treatments (those with exposure to other forms of psychotherapy, e.g., supportive therapy, will be eligible);
Those who may have difficulty understanding the cognitive components of BATA, including those with intellectual disability, neurocognitive disorders, and dissociative disorders;
Feeding and eating disorders which may have confounding effects on the fMRI signal;
Substance Use Disorders given confounding effects of substances of abuse on the fMRI signal;

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
Behavioral ActivationTreatment will consist of 15 weekly 45-minute sessions.	Behavioural	Behavioral Activation
Mindfulness TreatmentTreatment will consist of 15 weekly 45-minute sessions.	Behavioural	Mindfulness Treatment

Primary outcome

Change in Snaith-Hamilton Pleasure Scale Score Over Time
Time frame: Baseline, Post-treatment (between 8 to 15 weeks)
The Snaith-Hamilton Pleasure Scale (SHAPS), a well-validated 14-item questionnaire will be used to assess hedonic capacity. The sum of the 14 items scores ranges from 0 to 56. A higher score represents more anhedonic symptoms. Treatment duration varied across participants. Participants participated in as few as 8 weekly sessions or in as many as 15 weekly sessions of psychotherapy, based on therapist judgement. Thus the outcome measure timeframe varied between 8 and 15 weeks.

2 secondary outcomes

Change in Neural Activation During MID Task Anticipation Phase
Time frame: Baseline, Post-treatment (between 8 to 15 weeks)
Change in Neural Activation During MID Task Outcome Phase
Time frame: up to 15 weeks

Results and safety

Results posted to the registry on 21 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Behavioral Activation	61	46
Mindfulness Treatment	55	35

Primary outcome: Change in Snaith-Hamilton Pleasure Scale Score Over Time

Time frame: Baseline, Post-treatment (between 8 to 15 weeks). Mean (Standard Deviation). Unit: score on a scale

Measure	Behavioral Activation n = 61	Mindfulness Treatment n = 55
Baseline	37.67 (3.73)	36.96 (4.75)
Last observation (up to Week 15)	29.62 (5.15)	29.76 (6.90)

Behavioral Activation vs Mindfulness Treatment: Mean Difference (Final Values): -0.36 (95% CI -2.41 to 1.68), p = 0.724, ANCOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the time of signing informed consent through final MRI sessions. Due to the design of the trial, each participant was in the trial for between 8-15 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Behavioral Activation	0 of 61 (0%)	4 of 61 (6.6%)	0 of 61
Mindfulness Treatment	0 of 55 (0%)	11 of 55 (20%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39213738Cernasov PM, Walsh EC, Nagy GA, Kinard JL, Kelley L, Phillips RD, Pisoni A, Diehl J, Haworth K, West J, Freeman L, Pfister C, Scott M, Daughters SB, Gaylord S, Dichter GS, Smoski MJ. A parallel-arm, randomized trial of Behavioral Activation Therapy for anhedonia versus mindfulness-based cognitive therapy for adults with anhedonia. Behav Res Ther. 2024 Nov;182:104620. doi: 10.1016/j.brat.2024.104620. Epub 2024 Aug 23.
Derived from this study: PubMed 38815760Gibson K, Cernasov P, Styner M, Walsh EC, Kinard JL, Kelley L, Bizzell J, Phillips R, Pfister C, Scott M, Freeman L, Pisoni A, Nagy GA, Oliver JA, Smoski MJ, Dichter GS. The effects of psychotherapy for anhedonia on subcortical brain volumes measured with ultra-high field MRI. J Affect Disord. 2024 Sep 15;361:128-138. doi: 10.1016/j.jad.2024.05.140. Epub 2024 May 28.
Derived from this study: PubMed 37148652Cernasov PM, Kinard JL, Walsh E, Kelley L, Phillips R, Pisoni A, Arnold M, Lowery SC, Ammirato M, Nagy GA, Oliver JA, Haworth K, Daughters SB, Dichter GS, Smoski M. Parsing within & between-person dynamics of therapy homework completion and clinical symptoms in two cognitive behavioral treatments for adults with anhedonia. Behav Res Ther. 2023 Jul;166:104322. doi: 10.1016/j.brat.2023.104322. Epub 2023 Apr 26.
Derived from this study: PubMed 36907457Phillips R, Walsh E, Jensen T, Nagy G, Kinard J, Cernasov P, Smoski M, Dichter G. Longitudinal associations between perceived stress and anhedonia during psychotherapy. J Affect Disord. 2023 Jun 1;330:206-213. doi: 10.1016/j.jad.2023.03.011. Epub 2023 Mar 11.
Individual participant dataSharing planned: Yes. Will share de-identified data through the National Database for Clinical Trials Related to Mental Illness (NDCT)

Related trials for Anhedonia

Active, not recruitingPhase 4
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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.

Gabriel S Dichter, PhD principal investigator

UNC-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 Behavioral Activation and Mindfulness Treatment in people with Anhedonia, 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 4 inclusion and 10 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 21 Jun 2024. 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?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Snaith-Hamilton Pleasure Scale Score Over Time (time frame: Baseline, Post-treatment (between 8 to 15 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 NCT04036136, which also lists 4 linked publications.

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 21 Jun 2024.