Trial Outcomes & Findings for Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest (NCT NCT04596891)

NCT ID: NCT04596891

Last Updated: 2025-04-08

Results Overview

Reduction in symptoms as measured by the Clinician Administered PTSD Scale (Caps-5: ranging from 0-80 ) from pre- to post-treatment. Lower scores mean better outcome (reduction of symptom severity).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake
• Results posted on: 2025-04-08

Participant Flow

Participant milestones

Measure	Intervention Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest

Baseline characteristics by cohort

Measure	Intervention n=11 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Age, Continuous	51.55 years STANDARD_DEVIATION 9.1 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Diagnosis at Baseline: Posttraumatic Stress Disorder (PTSD)	11 Participants n=93 Participants
Diagnosis at Baseline: Depression	9 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake

Population: Baseline, midpoint, and post-treatment analysis of symptom scores for participants who completed the study protocol.

Reduction in symptoms as measured by the Clinician Administered PTSD Scale (Caps-5: ranging from 0-80 ) from pre- to post-treatment. Lower scores mean better outcome (reduction of symptom severity).

Outcome measures

Measure	Intervention n=10 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Change in PTSD Symptoms Over Time Baseline	37.00 score on a scale Standard Deviation 7.05
Change in PTSD Symptoms Over Time Midpoint (4 weeks)	25.90 score on a scale Standard Deviation 9.15
Change in PTSD Symptoms Over Time Posttreatment	16.20 score on a scale Standard Deviation 10.84

PRIMARY outcome

Timeframe: End of treatment: approximately 3 months from intake

Population: baseline conducted on all enrolled participants, posttreatment data available for 9 patients

Participants' cardiac medication adherence is measured by self-report using the Morisky Medication Adherence Scale (MMAS). Scores can range from 0-8. If a patient scores higher on the scale, they are evaluated as more adherent.

Outcome measures

Measure	Intervention n=11 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Change in Medication Adherence Over Time Baseline	3.18 score on a scale Standard Deviation 1.83
Change in Medication Adherence Over Time Posttreatment	2.38 score on a scale Standard Deviation 1.41

PRIMARY outcome

Timeframe: End of treatment: approximately 3 months from intake

Participants level of physical activity is measured objectively by a wrist worn Fitbit device.

Outcome measures

Measure	Intervention n=11 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Change in Physical Activity Over Time Baseline	7109.83 daily steps Standard Deviation 5377.75
Change in Physical Activity Over Time Posttreatment	9296.83 daily steps Standard Deviation 5600.44

SECONDARY outcome

Timeframe: End of treatment: approximately 3 months from intake

Population: Data is available for participants who attended post-treatment assessment.

Treatment satisfaction will be measured by the Client Satisfaction Questionnaire (CSQ-3). Scores range from 0-12 with higher scores indication more satisfaction with treatment.

Outcome measures

Measure	Intervention n=10 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Participant Satisfaction With Treatment	10.9 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: End of treatment: approximately 3 months from intake

Preliminary tolerability of the protocol will assessed by the number of enrolled participants who comply with all study procedures

Outcome measures

Measure	Intervention n=11 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Proportion of Participants Who Complete the Study Protocol	10 Participants

SECONDARY outcome

Timeframe: At Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake

Population: Treatment completers.

Change in symptoms as measured by the Hamilton Depression Rating Scale (HDRS-17; range 0-52) from pre- to post-treatment. Lower scores indicate better outcomes (reduction in symptoms).

Outcome measures

Measure	Intervention n=10 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Change in Depressive Symptoms Over Time Baseline	17.27 score on a scale Standard Deviation 6.36
Change in Depressive Symptoms Over Time Midpoint (4 weeks)	13.50 score on a scale Standard Deviation 4.50
Change in Depressive Symptoms Over Time Posttreatment	10.10 score on a scale Standard Deviation 7.23

SECONDARY outcome

Timeframe: Baseline, Post-treatment: approximately 3 months from intake

Population: Treatment completers

Changes in hypervigilance driven interoceptive attention and acceptance/mindfulness-based attention will be measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA). The scale consists of 8 scales (addressing 5 dimensions of body awareness)The MAIA consists of 8 scales (addressing 5 dimensions of body awareness): Noticing (0-20); Not-Distracting (0-30); Not-Worrying (0-25); Attention Regulation (0-35); Emotional Awareness (0-25); Self-Regulation (0-20); Body Listening (0-15); Trust (0-15). A total scale score is not relevant. Higher scores indicate better outcomes (increased adaptive interoceptive attention).

Outcome measures

Measure	Intervention n=10 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Change in Interoceptive Attention Style Over Time Baseline: Noticing Subscale	10.73 score on a scale Standard Deviation 3.13
Change in Interoceptive Attention Style Over Time Posttreatment: Noticing Subscale	11.56 score on a scale Standard Deviation 3.57
Change in Interoceptive Attention Style Over Time Baseline: Not Distracting Subscale	12.63 score on a scale Standard Deviation 5.30
Change in Interoceptive Attention Style Over Time Posttreatment: Not Distracting Subscale	10.22 score on a scale Standard Deviation 4.29
Change in Interoceptive Attention Style Over Time Baseline: Not Worrying Subscale	9.81 score on a scale Standard Deviation 2.18
Change in Interoceptive Attention Style Over Time Posttreatment: Not Worrying Subscale	8.56 score on a scale Standard Deviation 2.79
Change in Interoceptive Attention Style Over Time Baseline: Attention Regulation Subscale	15.73 score on a scale Standard Deviation 4.88
Change in Interoceptive Attention Style Over Time Posttreatment: Attention Regulation Subscale	15.67 score on a scale Standard Deviation 4.15
Change in Interoceptive Attention Style Over Time Baseline: Emotional Awareness Subscale	13.73 score on a scale Standard Deviation 3.64
Change in Interoceptive Attention Style Over Time Posttreatment: Emotional Awareness Subscale	14.44 score on a scale Standard Deviation 4.07
Change in Interoceptive Attention Style Over Time Baseline: Self-Regulation Subscale	7.00 score on a scale Standard Deviation 2.61
Change in Interoceptive Attention Style Over Time Posttreatment: Self-Regulation Subscale	8.56 score on a scale Standard Deviation 2.65
Change in Interoceptive Attention Style Over Time Baseline: Body Listening Subscale	5.00 score on a scale Standard Deviation 2.61
Change in Interoceptive Attention Style Over Time Posttreatment: Body Listening Subscale	6.78 score on a scale Standard Deviation 2.17
Change in Interoceptive Attention Style Over Time Baseline: Trust Subscale	5.18 score on a scale Standard Deviation 2.40
Change in Interoceptive Attention Style Over Time Posttreatment: Trust Subscale	6.11 score on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: Baseline, Post-treatment: approximately 3 months from intake

Population: treatment completers

Change in cardiac anxiety from pre- to post-treatment assessment will be assessed using the Cardiac Anxiety Questionnaire (CAQ: score range: 0-72). Low scores mean better outcome (reduction in cardiac anxiety).

Outcome measures

Measure	Intervention n=10 Participants Remotely delivered psychotherapy combining exposure therapy with mindfulness Psychotherapy: Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Change in Cardiac Anxiety Baseline	36.67 score on a scale Standard Deviation 9.67
Change in Cardiac Anxiety Posttreatment	35.00 score on a scale Standard Deviation 10.39

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yuval Neria

New York State Psychiatric Institute

Phone: 646-774-8092

Email: ny126@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place