Trial Outcomes & Findings for Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD (NCT NCT02139137)

Results Overview

Model estimations of the means and standard deviation of posttreatment score at the mean level of baseline severity reported below. Scale range: 0-40, higher values indicate greater symptom severity

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2017-11-06

Participant Flow

47 individuals consented to participate in the study. Of those, 42 started the study and were randomized. The remaining 5 were not assigned to either condition. Intent to treat analyses are presented using last observation carried forward for all continuous measures.

Participant milestones

Participant milestones
Measure	High Interference Control Condition Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task	Low Interference Control Condition Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition
Overall Study STARTED	22	20
Overall Study COMPLETED	15	10
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Interference Control Condition n=22 Participants Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task	Low Interference Control Condition n=20 Participants Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Model estimations of the means and standard deviation of posttreatment score at the mean level of baseline severity reported below. Scale range: 0-40, higher values indicate greater symptom severity

Outcome measures

Outcome measures
Measure	High Interference Control Condition n=22 Participants Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task	Low Interference Control Condition n=20 Participants Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition
Change in Clinician Administered PTSD Scale; Re-experiencing	11.78 units on a scale Standard Error 1.14	15.69 units on a scale Standard Error 1.20

SECONDARY outcome

Timeframe: Week 4

Population: Number of participants analyzed is based on the number of participants who completed the post-treatment CAPS interview.

Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score

Outcome measures

Outcome measures
Measure	High Interference Control Condition n=13 Participants Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task	Low Interference Control Condition n=8 Participants Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition
Clinician Administered PTSD Scale Total Score - Responder Status	11 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Scale Range: 0-63; higher scores indicate greater symptom severity

Outcome measures

Outcome measures
Measure	High Interference Control Condition n=22 Participants Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task	Low Interference Control Condition n=20 Participants Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition
Change in Depression: Beck Depression Inventory	6.8 units on a scale Standard Deviation 8.9	4.6 units on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: Baseline, Week 4

Range: 20-80; higher scores indicate greater symptom severity

Outcome measures

Outcome measures
Measure	High Interference Control Condition n=22 Participants Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task	Low Interference Control Condition n=20 Participants Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition
Change in General Anxiety: Spielberger State-Trait Anxiety Inventory	6.1 units on a scale Standard Deviation 8.6	3.0 units on a scale Standard Deviation 9.3

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Data at one time point for one participant in the LIC condition are not available.

Range: 0-30; greater values indicate greater disability severity ratings

Outcome measures

Outcome measures
Measure	High Interference Control Condition n=22 Participants Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task	Low Interference Control Condition n=19 Participants Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition
Change in Functional Impairment; Sheehan Disability Scale	3.2 units on a scale Standard Deviation 7.2	1.7 units on a scale Standard Deviation 6.3

Adverse Events

High Interference Control Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Interference Control Condition

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

Jessica Bomyea

SDSU/UCSD Joint Doctoral Program in Clinical Psychology

Phone: 8585528585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place