Trial Outcomes & Findings for Development of a Novel Transdiagnostic Intervention for Anhedonia - R33 Phase (NCT NCT04036136)
NCT ID: NCT04036136
Last Updated: 2024-06-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
Baseline, Post-treatment (between 8 to 15 weeks)
Results posted on
2024-06-21
Participant Flow
Participant milestones
| Measure |
Behavioral Activation
Treatment will consist of 8-15 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.
Behavioral Activation: Treatment will consist of 8-15 weekly 45-minute sessions.
|
Mindfulness Treatment
Behavioral Activation Therapy for Anhedonia (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. Treatment will be compromised of 8-15 weekly 45-minute sessions.
Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
55
|
|
Overall Study
COMPLETED
|
46
|
35
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Novel Transdiagnostic Intervention for Anhedonia - R33 Phase
Baseline characteristics by cohort
| Measure |
Behavioral Activation
n=61 Participants
Treatment will consist of 8-15 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.
Behavioral Activation: Treatment will consist of 8-15 weekly 45-minute sessions.
|
Mindfulness Treatment
n=55 Participants
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 8-15 weekly 45-minute sessions.
Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.26 years
STANDARD_DEVIATION 8.51 • n=93 Participants
|
30.20 years
STANDARD_DEVIATION 9.45 • n=4 Participants
|
29.18 years
STANDARD_DEVIATION 8.99 • n=27 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Behavioral Activation
n=61 Participants
Treatment will consist of 8-15 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.
Behavioral Activation: Treatment will consist of 8-15 weekly 45-minute sessions.
|
Mindfulness Treatment
n=55 Participants
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 8-15 weekly 45-minute sessions.
Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions.
|
|---|---|---|
|
Change in Snaith-Hamilton Pleasure Scale Score Over Time
Baseline
|
37.67 score on a scale
Standard Deviation 3.73
|
36.96 score on a scale
Standard Deviation 4.75
|
|
Change in Snaith-Hamilton Pleasure Scale Score Over Time
Last observation (up to Week 15)
|
29.62 score on a scale
Standard Deviation 5.15
|
29.76 score on a scale
Standard Deviation 6.90
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (between 8 to 15 weeks)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.
Outcome measures
| Measure |
Behavioral Activation
n=47 Participants
Treatment will consist of 8-15 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.
Behavioral Activation: Treatment will consist of 8-15 weekly 45-minute sessions.
|
Mindfulness Treatment
n=39 Participants
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 8-15 weekly 45-minute sessions.
Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions.
|
|---|---|---|
|
Change in Neural Activation During MID Task Anticipation Phase
Baseline
|
-0.030 percent signal change
Standard Deviation 0.172
|
0.052 percent signal change
Standard Deviation 0.162
|
|
Change in Neural Activation During MID Task Anticipation Phase
Last observation (up to Week 15)
|
-0.001 percent signal change
Standard Deviation 0.176
|
0.046 percent signal change
Standard Deviation 0.182
|
SECONDARY outcome
Timeframe: up to 15 weeksBrain 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.
Outcome measures
| Measure |
Behavioral Activation
n=47 Participants
Treatment will consist of 8-15 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.
Behavioral Activation: Treatment will consist of 8-15 weekly 45-minute sessions.
|
Mindfulness Treatment
n=39 Participants
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 8-15 weekly 45-minute sessions.
Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions.
|
|---|---|---|
|
Change in Neural Activation During MID Task Outcome Phase
Baseline
|
0.349 percent signal change
Standard Deviation 0.416
|
0.271 percent signal change
Standard Deviation 0.387
|
|
Change in Neural Activation During MID Task Outcome Phase
Last observation (up to Week 15)
|
0.114 percent signal change
Standard Deviation 0.374
|
0.263 percent signal change
Standard Deviation 0.371
|
Adverse Events
Behavioral Activation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Mindfulness Treatment
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Behavioral Activation
n=61 participants at risk
Treatment will consist of 8-15 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.
Behavioral Activation: Treatment will consist of 8-15 weekly 45-minute sessions.
|
Mindfulness Treatment
n=55 participants at risk
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 8-15 weekly 45-minute sessions.
Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
6.6%
4/61 • Number of events 4 • 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.
|
9.1%
5/55 • Number of events 5 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/61 • 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.
|
10.9%
6/55 • Number of events 6 • 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.
|
Additional Information
Gabriel Dichter, PhD
University of North Carollina at Chapel Hill
Phone: 919-364-4275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place