Trial Outcomes & Findings for Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study) (NCT NCT02774642)

Last Updated: 2024-10-08

Results Overview

PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5). Range (0 - 80). Lower scores equate to lower PTSD severity. Change in PTSD will be assessed longitudinally using linear mixed effects models of the CAPS-5 at each timepoint to estimate slope (change) over time.

Recruitment status

COMPLETED

Study phase

Target enrollment

94 participants

Primary outcome timeframe

Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

Results posted on

2024-10-08

Participant Flow

94 participants met inclusion criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	CBTI-PE Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
Overall Study STARTED	52	42
Overall Study COMPLETED	43	35
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	CBTI-PE Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
Overall Study Lost to Follow-up	9	7

Baseline Characteristics

Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBTI-PE n=52 Participants Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE n=42 Participants Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.	Total n=94 Participants Total of all reporting groups
Age, Continuous	39.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	41.2 years STANDARD_DEVIATION 12.4 • n=7 Participants	40.2 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	32 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	52 Participants n=5 Participants	42 Participants n=7 Participants	94 Participants n=5 Participants
Clinician Administered PTSD Scale (CAPS)	38.6 units on a scale STANDARD_DEVIATION 6.7 • n=5 Participants	37 units on a scale STANDARD_DEVIATION 9.5 • n=7 Participants	38 units on a scale STANDARD_DEVIATION 8.1 • n=5 Participants
Sleep Efficiency (SE)	70.94 Percentage of time asleep time in bed STANDARD_DEVIATION 14.46 • n=5 Participants	74.87 Percentage of time asleep time in bed STANDARD_DEVIATION 10.9 • n=7 Participants	72.45 Percentage of time asleep time in bed STANDARD_DEVIATION 13.28 • n=5 Participants
Insomnia Severity Index	21.26 units on a scale STANDARD_DEVIATION 4.7 • n=5 Participants	19.67 units on a scale STANDARD_DEVIATION 4.63 • n=7 Participants	20.53 units on a scale STANDARD_DEVIATION 4.73 • n=5 Participants
Quality of Life Physical Health	9.38 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants	11.34 units on a scale STANDARD_DEVIATION 2.09 • n=7 Participants	10.26 units on a scale STANDARD_DEVIATION 2.62 • n=5 Participants
Quality of Life Psychological	9.33 units on a scale STANDARD_DEVIATION 3.28 • n=5 Participants	11.19 units on a scale STANDARD_DEVIATION 2.73 • n=7 Participants	10.16 units on a scale STANDARD_DEVIATION 3.16 • n=5 Participants
Quality of Life Social relationships	9.51 units on a scale STANDARD_DEVIATION 4.04 • n=5 Participants	11.19 units on a scale STANDARD_DEVIATION 3.78 • n=7 Participants	10.26 units on a scale STANDARD_DEVIATION 4 • n=5 Participants
Quality of Life Environment	12.20 units on a scale STANDARD_DEVIATION 3.27 • n=5 Participants	13.64 units on a scale STANDARD_DEVIATION 2.67 • n=7 Participants	12.85 units on a scale STANDARD_DEVIATION 3.09 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

Population: Individuals who gave at least 2 time points are included in ITT analyses in the estimation models. Observed means at each timepoint are presented below.

Outcome measures

Outcome measures
Measure	CBTI-PE n=43 Participants Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE n=35 Participants Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
Change in PTSD Symptoms Post-Treatment	25.74 score on a scale Standard Error 12.34	28.18 score on a scale Standard Error 11.62
Change in PTSD Symptoms 3 Month Follow-up	28.59 score on a scale Standard Error 12.68	24.93 score on a scale Standard Error 12.61

PRIMARY outcome

Timeframe: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

Population: Individuals who gave at least 2 time points are included in ITT analyses in the estimation models. Observed means at each timepoint are presented below.

Change in sleep efficiency. Sleep efficiency is calculated from two variables acquired from daily sleep logs filled out by patient: a) time spend in bed and b) time spent asleep. Sleep efficiency = time spent asleep / time spent in bed. Range (0 -100%). Higher sleep efficiency is better. Change in Sleep Efficiency will be assessed longitudinally using linear mixed effects models of measure at each timepoint to estimate slope (change) over time.

Outcome measures

Outcome measures
Measure	CBTI-PE n=25 Participants Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE n=21 Participants Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
Change in Sleep Efficiency Post-Treatment	88.71 Percentage of time asleep time in bed Standard Deviation 6.46	78.44 Percentage of time asleep time in bed Standard Deviation 9.71
Change in Sleep Efficiency 3 Month Follow-Up	86.46 Percentage of time asleep time in bed Standard Deviation 7.67	78.23 Percentage of time asleep time in bed Standard Deviation 10.86

SECONDARY outcome

Timeframe: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

Population: Participants analyzed are the observed means. Different from the Intent to treat number of participants reported.

Change in Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. All subscores, higher scores equate to better quality of life. Physical Health Range (7-35); Psychological Range (6-30); Social Relationships (3-15); Environment (8-40).

Outcome measures

Outcome measures
Measure	CBTI-PE n=39 Participants Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE n=30 Participants Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
Change in Quality of Life Psychological - 3m	9.31 score on a scale Standard Deviation 5.77	11.64 score on a scale Standard Deviation 4.99
Change in Quality of Life Social relationships - post-TX	10.63 score on a scale Standard Deviation 5.05	9.49 score on a scale Standard Deviation 5.98
Change in Quality of Life Environment - post-tx	12.13 score on a scale Standard Deviation 5.22	11.08 score on a scale Standard Deviation 6.34
Change in Quality of Life Environment - 3m	11.15 score on a scale Standard Deviation 6.56	12.94 score on a scale Standard Deviation 5.31
Change in Quality of Life Physical Health - Post TX	11.6 score on a scale Standard Deviation 5.32	10.53 score on a scale Standard Deviation 6.44
Change in Quality of Life Physical Health - 3m	10.12 score on a scale Standard Deviation 6.14	12.11 score on a scale Standard Deviation 7.56
Change in Quality of Life Psychological - post treatment	10.46 score on a scale Standard Deviation 4.81	10.26 score on a scale Standard Deviation 6.13
Change in Quality of Life Social relationships - 3m	9.61 score on a scale Standard Deviation 6.46	11.24 score on a scale Standard Deviation 4.99

SECONDARY outcome

Timeframe: Baseline, week 5, Post Treatment (14-weeks), Follow-up (26-weeks)

Population: Individuals who gave at least 2 time points are included in ITT analyses in the estimation models. Observed means at each timepoint are presented below.

Insomnia Severity will be assessed using the Insomnia Severity Index (ISI). Range (0 - 28). Lower scores equate to lower insomnia severity. Change in ISI will be assessed longitudinally using linear mixed effects models of the ISI scores at each timepoint to estimate slope (change) over time.

Outcome measures

Outcome measures
Measure	CBTI-PE n=45 Participants Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE n=36 Participants Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
Change in Insomnia Severity Week 5	15.13 score on a scale Standard Error 6.50	17.69 score on a scale Standard Error 4.76
Change in Insomnia Severity Post-Treatment	9.46 score on a scale Standard Error 6.98	12.93 score on a scale Standard Error 6.58
Change in Insomnia Severity 3 Month Follow-up	11.76 score on a scale Standard Error 6.70	12.37 score on a scale Standard Error 7.57

OTHER_PRE_SPECIFIED outcome

Timeframe: Post Treatment ( up to 14-weeks)

CSQ assesses client satisfaction for therapy session. Range (8-32) with higher scores equating to higher satisfaction.

Outcome measures

Outcome measures
Measure	CBTI-PE n=41 Participants Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE n=33 Participants Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
The Client Satisfaction Questionnaire (CSQ)	29.41 score on a scale Standard Deviation 3.11	29.56 score on a scale Standard Deviation 2.97

OTHER_PRE_SPECIFIED outcome

Timeframe: post treatment, and 3-month follow-ups presented.

Population: N is for observed means only, not Intent to Treatment repeated measures analysis.

Brief Pain Inventory ranges from 0 - 40, with higher score indicating worse pain.

Outcome measures

Outcome measures
Measure	CBTI-PE n=29 Participants Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE n=26 Participants Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
Brief Pain Inventory Post-Treatment	18.69 score on a scale Standard Deviation 9.14	15.63 score on a scale Standard Deviation 10.12
Brief Pain Inventory 3 Month Follow-up	18.41 score on a scale Standard Deviation 7.81	16.08 score on a scale Standard Deviation 9.94

Adverse Events

CBTI-PE

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Hygiene-PE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CBTI-PE n=43 participants at risk Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. CBTI-PE: Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence	Hygiene-PE n=35 participants at risk Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. Hygiene-PE: The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
General disorders Suicidal ideation	2.3% 1/43 • Number of events 1 • Adverse events were tracked for the duration of our study ( from baseline until3-month follow-up assessment date, up to 26 weeks).	0.00% 0/35 • Adverse events were tracked for the duration of our study ( from baseline until3-month follow-up assessment date, up to 26 weeks).

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Colvonen

San Diego VA Healthcare System

Phone: 858-552-8585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place