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Development of a Novel Transdiagnostic Intervention for Anhedonia - R61 Phase

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ClinicalTrials.gov Identifier: NCT02874534
Recruitment Status : Completed
First Posted : August 22, 2016
Results First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
Duke University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Anhedonia
Interventions Behavioral: Behavioral Activation
Behavioral: Mindfulness Treatment
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Behavioral Activation Mindfulness Treatment
Hide Arm/Group Description

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.

Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions.

Behavioral Activation Treatment 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. 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.

Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions.

Period Title: Overall Study
Started 31 26
Completed 23 15
Not Completed 8 11
Reason Not Completed
Withdrawal by Subject             5             8
Lost to Follow-up             2             2
Ongoing in study             1             1
Arm/Group Title Behavioral Activation Mindfulness Treatment Total
Hide Arm/Group Description

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.

Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions.

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.

Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions.

Total of all reporting groups
Overall Number of Baseline Participants 31 26 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 26 participants 57 participants
27.61  (8.47) 33.35  (9.25) 30.23  (9.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 26 participants 57 participants
Female
23
  74.2%
19
  73.1%
42
  73.7%
Male
8
  25.8%
7
  26.9%
15
  26.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 26 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
  22.6%
3
  11.5%
10
  17.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  12.9%
5
  19.2%
9
  15.8%
White
18
  58.1%
16
  61.5%
34
  59.6%
More than one race
2
   6.5%
1
   3.8%
3
   5.3%
Unknown or Not Reported
0
   0.0%
1
   3.8%
1
   1.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 31 participants 26 participants 57 participants
31
 100.0%
26
 100.0%
57
 100.0%
SHAPS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants 26 participants 57 participants
37.61  (4.38) 38.00  (5.25) 37.79  (4.76)
[1]
Measure Description: The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item self-report scale that measures the ability to experience pleasure. The SHAPS scale has a range from 14-56. Higher scores on the SHAPS scale indicate less ability to experience pleasure.
1.Primary Outcome
Title Change From Baseline to Week 15 in Neural Activation
Hide Description Change due to BATA, relative to MBCT, from baseline in right caudate nucleus activation during the anticipation phase of the Monetary Incentive Delay (MID) task assessed by Functional Magnetic Resonance Imaging (fMRI). The BOLD (Blood Oxygen Level-Dependent signal change is expressed as a z-score that represents the magnitude of change relative to baseline. A score of 0 would correspond to no change, and a score of 1 would represent 1 standard deviation of change. The difference in z-scores between the BATA and the MBCT groups reflects the difference in change in fMRI responses between the two treated groups. Thus even a score of 0 in the BATA group may reflect greater change than observed in the MBCT group if change in the MBCT group is negative.
Time Frame Baseline, 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The fMRI data quality for one participant was inadequate and was excluded from the analysis.
Arm/Group Title Behavioral Activation Mindfulness Treatment
Hide Arm/Group Description:

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.

Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions.

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.

Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions.

Overall Number of Participants Analyzed 22 15
Mean (Standard Deviation)
Unit of Measure: Z-score
0.0075  (0.23) -0.1059  (0.21)
2.Secondary Outcome
Title Change From Baseline to Week 15 in Snaith-Hamilton Pleasure Scale Score
Hide Description The Snaith-Hamilton Pleasure Scale (SHAPS), used to assess hedonic capacity. The sum of the 14 items scores ranges from 0 to 56. A higher score represents more anhedonic symptoms. The below means represent change in units on the Snaith-Hamilton Pleasure Scale.
Time Frame Baseline, 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The fMRI data quality for one participant was inadequate and was excluded from the analysis.
Arm/Group Title Behavioral Activation Mindfulness Treatment
Hide Arm/Group Description:

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.

Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions.

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.

Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions.

Overall Number of Participants Analyzed 22 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.0  (4.87) 9.3  (7.6)
Time Frame From initial assessment through post treatment scan, a total of approximately 3 to 5 months.
Adverse Event Reporting Description Study team members (e.g., study coordinator, study therapists) asked participants at each visit following the initial appointment if any adverse events or changes in health were experienced since the last visit. Adverse Events were assessed by a trained study coordinator, study therapist, or other approved study team member, and discussed at the weekly research staff meetings.
 
Arm/Group Title Behavioral Activation Mindfulness Treatment
Hide Arm/Group Description

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.

Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions.

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.

Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions.

All-Cause Mortality
Behavioral Activation Mindfulness Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)      0/26 (0.00%)    
Hide Serious Adverse Events
Behavioral Activation Mindfulness Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/26 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavioral Activation Mindfulness Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/31 (32.26%)      12/26 (46.15%)    
Cardiac disorders     
Hypertension   1/31 (3.23%)  1 1/26 (3.85%)  1
Presyncopal Episode   0/31 (0.00%)  0 1/26 (3.85%)  1
Endocrine disorders     
Elevated TSH   0/31 (0.00%)  0 1/26 (3.85%)  1
Eye disorders     
Intermittent eye twitching  [1]  1/31 (3.23%)  1 0/26 (0.00%)  0
Infections and infestations     
Cold Symptoms   2/31 (6.45%)  2 1/26 (3.85%)  1
Flu   0/31 (0.00%)  0 1/26 (3.85%)  1
Pneumonia   0/31 (0.00%)  0 1/26 (3.85%)  1
Sinus Infection   2/31 (6.45%)  2 1/26 (3.85%)  1
Upper respiratory infection   1/31 (3.23%)  1 0/26 (0.00%)  0
Streptococcal pharyngitis   0/31 (0.00%)  0 1/26 (3.85%)  1
Metabolism and nutrition disorders     
Decreased appetite   1/31 (3.23%)  1 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain   2/31 (6.45%)  3 1/26 (3.85%)  1
Hip Pain   1/31 (3.23%)  1 0/26 (0.00%)  0
Broken Collar Bone   0/31 (0.00%)  0 1/26 (3.85%)  1
Worsening arthritis  [2]  0/31 (0.00%)  0 1/26 (3.85%)  1
Psychiatric disorders     
Suicidal Ideation  [3]  1/31 (3.23%)  1 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
Burns on right forearm   1/31 (3.23%)  1 0/26 (0.00%)  0
Scalp Acne   0/31 (0.00%)  0 1/26 (3.85%)  1
Telogen Effluvium   0/31 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
[1]
Intermittent eye twitching after mri scan
[2]
worsening arthritis pain (back & neck) secondary to MRI
[3]
Suicidal Ideation secondary to motor vehicle accident
These results represent the complete therapeutic target results for this trial's R61 phase that may be combined with the results of the ongoing clinical endpoint R33 phase study whose final results will be reported in NCT04036136.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gabriel S. Dichter, PhD
Organization: University of North Carolina at Chapel Hill
Phone: 9194450132
EMail: dichter@med.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02874534    
Other Study ID Numbers: 16-2268a
R61MH110027-01A1 ( U.S. NIH Grant/Contract )
First Submitted: August 17, 2016
First Posted: August 22, 2016
Results First Submitted: February 20, 2020
Results First Posted: April 24, 2020
Last Update Posted: April 24, 2020