Trial Outcomes & Findings for A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes (NCT NCT02469233)
NCT ID: NCT02469233
Last Updated: 2025-08-12
Results Overview
Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment.
COMPLETED
NA
121 participants
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
2025-08-12
Participant Flow
Participant milestones
| Measure |
TranS-C
The 'Transdiagnostic' Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
UC-DT
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
Received Allocated Intervention
|
59
|
60
|
|
Overall Study
Completed Post-assessment
|
49
|
58
|
|
Overall Study
Completed Follow-up
|
53
|
57
|
|
Overall Study
Analyzed
|
61
|
60
|
|
Overall Study
COMPLETED
|
53
|
57
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
TranS-C
The 'Transdiagnostic' Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
UC-DT
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to post or 6 month follow up
|
7
|
2
|
Baseline Characteristics
A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
Baseline characteristics by cohort
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (UC-DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.45 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
47.97 years
STANDARD_DEVIATION 11.51 • n=7 Participants
|
46.72 years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Civil status
Single
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Civil status
Married/common law partner
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Civil status
Separated/divorced/widowed
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Education
High school or below
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Education
Vocational school
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
Some college or completed college
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Education
Graduate school
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Employment
Full-time
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Employment
Part-time
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Employment
Unemployed
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Employment
Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Employment
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Living arrangement
Alone
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Living arrangement
With family (spouse or children)
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Living arrangement
With friend or roommate or pet
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Living arrangement
Supported housing
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Living arrangement
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
MINI Diagnosis at pre-treatment (current or past)
Schizophrenia spectrum disorder
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
MINI Diagnosis at pre-treatment (current or past)
Bipolar disorder
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
MINI Diagnosis at pre-treatment (current or past)
Major depressive disorder
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
MINI Diagnosis at pre-treatment (current or past)
Any anxiety disorder
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
MINI Diagnosis at pre-treatment (current or past)
Obsessive compulsive disorder
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
MINI Diagnosis at pre-treatment (current or past)
Post-traumatic stress disorder
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
MINI Diagnosis at pre-treatment (current or past)
Substance use disorder
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
MINI Diagnosis at pre-treatment (current or past)
Psychotic symptoms/features
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
DUKE diagnoses at pre-treatment (current)
Insomnia disorder
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
DUKE diagnoses at pre-treatment (current)
Hypersomnolence disorder
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
DUKE diagnoses at pre-treatment (current)
Circadian Rhythm Disorder: Delayed sleep phase type
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
DUKE diagnoses at pre-treatment (current)
Circadian Rhythm Disorder: Advanced sleep phase type
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
DUKE diagnoses at pre-treatment (current)
Circadian Rhythm Disorder: Irregular sleep-wake type
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
DUKE diagnoses at pre-treatment (current)
Circadian Rhythm Disorder: Restless leg syndrome
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
DUKE diagnoses at pre-treatment (current)
Circadian Rhythm Disorder: Periodic limb movement disorder
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education (in years)
|
13.38 Years
STANDARD_DEVIATION 3.89 • n=5 Participants
|
13.80 Years
STANDARD_DEVIATION 3.05 • n=7 Participants
|
13.59 Years
STANDARD_DEVIATION 3.48 • n=5 Participants
|
|
Annual personal income
|
12,429 Dollars ($)
STANDARD_DEVIATION 15,317 • n=5 Participants
|
12,636 Dollars ($)
STANDARD_DEVIATION 9,850 • n=7 Participants
|
12,531 Dollars ($)
STANDARD_DEVIATION 12,838 • n=5 Participants
|
|
Annual household income
|
24,091 Dollars ($)
STANDARD_DEVIATION 27,507 • n=5 Participants
|
26,537 Dollars ($)
STANDARD_DEVIATION 23,576 • n=7 Participants
|
25,216 Dollars ($)
STANDARD_DEVIATION 25,546 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Impairment (Sheehan Disability Scale)
Pre treatment
|
14.30 score on a scale
Standard Deviation 8.51
|
12.03 score on a scale
Standard Deviation 6.20
|
|
Impairment (Sheehan Disability Scale)
Post treatment
|
11.76 score on a scale
Standard Deviation 7.57
|
6.57 score on a scale
Standard Deviation 7.07
|
|
Impairment (Sheehan Disability Scale)
6-month follow-up
|
10.51 score on a scale
Standard Deviation 8.36
|
7.00 score on a scale
Standard Deviation 6.41
|
PRIMARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
DSM-5 Cross Cutting Measure. 23-items. Individuals report how much each domain has bothered them in the last 2 weeks on a 0-4 scale (not at all to nearly every day). The total score is calculated by summing the highest score in each of the 13 domains (depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use). Total scores can range from 0 to 52, with higher scores indicating greater severity of impairment. is rated on a 5-point scale, with higher scores indicating more severe impairment.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Disorder-Focused Composite Score (DSM-5)
Pre treatment
|
25.57 score on a scale
Standard Deviation 10.72
|
25.05 score on a scale
Standard Deviation 9.75
|
|
Disorder-Focused Composite Score (DSM-5)
Post treatment
|
23.53 score on a scale
Standard Deviation 10.59
|
17.00 score on a scale
Standard Deviation 11.23
|
|
Disorder-Focused Composite Score (DSM-5)
6-month follow-up
|
23.07 score on a scale
Standard Deviation 9.78
|
18.67 score on a scale
Standard Deviation 11.38
|
PRIMARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System). The 8-item short version assesses sleep disturbance over the past 7 days, including restlessness, sleep quality, ability to fall and stay asleep, and refreshment following sleep using a 1-5 scale (not at all or never to very much or always). Scores range from 8 to 40, with higher scores indicating increased disturbance.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Sleep and Circadian Function: PROMIS-Sleep Disturbance
PROMIS-Sleep Disturbance (Pre)
|
29.02 score on a scale
Standard Deviation 6.57
|
28.26 score on a scale
Standard Deviation 6.06
|
|
Sleep and Circadian Function: PROMIS-Sleep Disturbance
PROMIS-Sleep Disturbance (Post)
|
27.33 score on a scale
Standard Deviation 7.22
|
20.88 score on a scale
Standard Deviation 8.91
|
|
Sleep and Circadian Function: PROMIS-Sleep Disturbance
PROMIS-Sleep Disturbance (6-month follow-up)
|
26.40 score on a scale
Standard Deviation 8.00
|
20.87 score on a scale
Standard Deviation 8.50
|
PRIMARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System). 16-item. Scores range from 16 to 80, with higher scores indicating increased disturbance.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Sleep and Circadian Function: PROMIS-Sleep-Related Impairment
PROMIS-Sleep-Related Impairment (Pre)
|
51.02 score on a scale
Standard Deviation 14.09
|
47.93 score on a scale
Standard Deviation 11.80
|
|
Sleep and Circadian Function: PROMIS-Sleep-Related Impairment
PROMIS-Sleep-Related Impairment (Post)
|
47.22 score on a scale
Standard Deviation 14.14
|
35.16 score on a scale
Standard Deviation 14.01
|
|
Sleep and Circadian Function: PROMIS-Sleep-Related Impairment
PROMIS-Sleep-Related Impairment (6-month follow-up)
|
44.30 score on a scale
Standard Deviation 15.22
|
35.65 score on a scale
Standard Deviation 13.83
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
QIDS (Quick Inventory of Depressive Symptoms). 16-item instrument assessing depressive symptoms. Each item is rated on a 4-point scale (0-3), with higher scores indicating greater symptom severity. Scoring involves summing the highest score from each of the 9 DSM-IV Major Depressive Disorder symptom domains (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Total scores range from 0 (Normal/No Depression) to 27 (Very Severe Depression). Higher scores indicate greater severity of depressive symptoms.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Depression (QIDS)
Post-treatment
|
10.55 score on a scale
Standard Deviation 5.54
|
8.88 score on a scale
Standard Deviation 5.70
|
|
Depression (QIDS)
6-month follow-up
|
10.67 score on a scale
Standard Deviation 4.58
|
8.46 score on a scale
Standard Deviation 5.03
|
|
Depression (QIDS)
Pre-treatment
|
12.50 score on a scale
Standard Deviation 4.71
|
12.03 score on a scale
Standard Deviation 5.15
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
ASSIST (Alcohol, Smoking and Substance Involvement Screening Test). Frequency of use, substance dependence, and related health, social, legal, financial, and employment problems in the past 3 months are rated on a 5-point scale (never to daily of almost daily). Problems with family and friends caused by substance use and failed attempts to cut down or quit substance use are measured on a 3-point scale (no, never, yes, in the past 3 months, yes, but not in the past 3 months). The total risk score is calculated by summing scores across all drug categories, with total scores ranging from 0 to 414. Higher scores indicate greater substance-related risks and problems.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Substance Use (ASSIST )
Pre-treatment
|
33.68 score on a scale
Standard Deviation 25.87
|
39.70 score on a scale
Standard Deviation 26.68
|
|
Substance Use (ASSIST )
Post-treatment
|
14.62 score on a scale
Standard Deviation 17.15
|
15.35 score on a scale
Standard Deviation 17.13
|
|
Substance Use (ASSIST )
6-month follow-up
|
32.58 score on a scale
Standard Deviation 25.25
|
34.60 score on a scale
Standard Deviation 24.10
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
PSYRATS (Psychotic Symptom Rating Scales). Each of the 17 items is rated on a 5-point scale from 0 (absent) to 4 (severe). Scores are summed for auditory hallucinations (sum of 11 items) and delusions (sum of 6 items). Total scores range from 0 to 68, with higher scores indicating greater severity of psychotic symptoms.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Psychotic Symptoms (PSYRATS )
Pre-treatment
|
36.60 score on a scale
Standard Deviation 5.13
|
39.60 score on a scale
Standard Deviation 14.29
|
|
Psychotic Symptoms (PSYRATS )
Post-treatment
|
41.73 score on a scale
Standard Deviation 11.39
|
36.00 score on a scale
Standard Deviation 14.82
|
|
Psychotic Symptoms (PSYRATS )
6-month follow-up
|
42.58 score on a scale
Standard Deviation 9.44
|
25.80 score on a scale
Standard Deviation 11.23
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Sleep efficiency (SE), calculated as total sleep time divided by time in bed, multiplied by 100, was recorded via sleep diary over 7 consecutive days. For each participant, the mean and within-person standard deviation (SD) of SE were calculated across the days to reflect an average and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Means and Variability of Sleep Efficiency (Daily Sleep Diary)
SE mean at Pre-treatment
|
77.61 percentage of sleep efficiency
Standard Deviation 11.89
|
77.39 percentage of sleep efficiency
Standard Deviation 13.52
|
|
Means and Variability of Sleep Efficiency (Daily Sleep Diary)
SE variability at Pre-treatment
|
12.52 percentage of sleep efficiency
Standard Deviation 7.63
|
11.92 percentage of sleep efficiency
Standard Deviation 6.71
|
|
Means and Variability of Sleep Efficiency (Daily Sleep Diary)
SE mean at Post-treatment
|
78.93 percentage of sleep efficiency
Standard Deviation 14.50
|
84.31 percentage of sleep efficiency
Standard Deviation 10.07
|
|
Means and Variability of Sleep Efficiency (Daily Sleep Diary)
SE variability at Post-treatment
|
11.86 percentage of sleep efficiency
Standard Deviation 8.49
|
10.01 percentage of sleep efficiency
Standard Deviation 7.95
|
|
Means and Variability of Sleep Efficiency (Daily Sleep Diary)
SE mean at 6-month follow-up
|
79.54 percentage of sleep efficiency
Standard Deviation 12.88
|
84.78 percentage of sleep efficiency
Standard Deviation 10.86
|
|
Means and Variability of Sleep Efficiency (Daily Sleep Diary)
SE variability at 6-month follow-up
|
11.25 percentage of sleep efficiency
Standard Deviation 6.71
|
9.24 percentage of sleep efficiency
Standard Deviation 7.87
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Actigraphy-derived total sleep time (TST) is the total amount of sleep obtained by the participant per 24 hrs, which was recorded daily over a 1-week period per timepoint. For each participant, the mean and standard deviation (SD) of TST were calculated across the days. Group-level outcomes reflect the average of these participant-level means and SDs.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Actigraphy Measured Sleep (TST)
TST mean at Pre-treatment
|
421.35 Minutes
Standard Deviation 126.92
|
453.65 Minutes
Standard Deviation 147.28
|
|
Actigraphy Measured Sleep (TST)
TST variability at Pre-treatment
|
132.08 Minutes
Standard Deviation 75.83
|
132.34 Minutes
Standard Deviation 79.71
|
|
Actigraphy Measured Sleep (TST)
TST mean at Post-treatment
|
411.82 Minutes
Standard Deviation 108.28
|
427.23 Minutes
Standard Deviation 135.85
|
|
Actigraphy Measured Sleep (TST)
TST variability at Post-treatment
|
135.38 Minutes
Standard Deviation 75.05
|
140.06 Minutes
Standard Deviation 95.02
|
|
Actigraphy Measured Sleep (TST)
TST mean at 6-month follow-up
|
443.24 Minutes
Standard Deviation 119.47
|
437.69 Minutes
Standard Deviation 137.88
|
|
Actigraphy Measured Sleep (TST)
TST variability at 6-month follow-up
|
144.86 Minutes
Standard Deviation 88.72
|
134.43 Minutes
Standard Deviation 96.75
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Daytime activity was measured via actigraphy over 7 consecutive days per timepoint. For each participant, their daily waking activity counts were extracted, and the mean and within-person standard deviation (SD) of these counts were calculated across 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Daytime Activity (Actigraphy)
Count Mean at Pre-treatment
|
1309.74 Activity counts
Standard Deviation 532.79
|
1280.09 Activity counts
Standard Deviation 607.46
|
|
Daytime Activity (Actigraphy)
Count Variability at Pre-treatment
|
379.69 Activity counts
Standard Deviation 211.65
|
394.04 Activity counts
Standard Deviation 256.07
|
|
Daytime Activity (Actigraphy)
Count Mean at Post-treatment
|
1361.19 Activity counts
Standard Deviation 532.36
|
1257.82 Activity counts
Standard Deviation 680.06
|
|
Daytime Activity (Actigraphy)
Count Variability at Post-treatment
|
393.58 Activity counts
Standard Deviation 223.01
|
371.08 Activity counts
Standard Deviation 310.24
|
|
Daytime Activity (Actigraphy)
Count Mean at 6-month follow-up
|
1362.37 Activity counts
Standard Deviation 598.01
|
1281.35 Activity counts
Standard Deviation 667.83
|
|
Daytime Activity (Actigraphy)
Count Variability at 6-month follow-up
|
447.2 Activity counts
Standard Deviation 257.81
|
354.96 Activity counts
Standard Deviation 212.71
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2.0). 36-item measure that assesses disability in adults ages 18 years and older. It assesses disability across six domains on a scale from 1-5 (none to extreme or cannot do). Each item on the self-administered version of the WHODAS-2.0 asks the individual to rate how much difficulty he or she has had in specific areas of functioning during the past 30 days. Scores are summed across the six domains (cognition, mobility, self-care, getting along, life activities, and participation). Total scores range from 36 to 180, with higher scores indicating greater levels of disability.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Impairment (World Health Organization Disability Assessment Schedule 2.0)
Pre-treatment
|
81.53 score on a scale
Standard Deviation 25.56
|
76.48 score on a scale
Standard Deviation 21.38
|
|
Impairment (World Health Organization Disability Assessment Schedule 2.0)
Post-treatment
|
81.48 score on a scale
Standard Deviation 26.80
|
68.93 score on a scale
Standard Deviation 25.53
|
|
Impairment (World Health Organization Disability Assessment Schedule 2.0)
6-month follow-up
|
73.45 score on a scale
Standard Deviation 26.14
|
66.63 score on a scale
Standard Deviation 23.17
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Four question 'healthy days' core module developed by the Centers for Disease Control and Prevention. A summary measure combines physically and mentally unhealthy days. An "unhealthy days" summary measure based on the second and third questions and estimates the overall number of recent days (in the past 30 days) when physical or mental health was not good.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Overall Health ('Healthy Days' Core Module)
Pre-treatment
|
3.57 Days
Standard Deviation 1.17
|
3.44 Days
Standard Deviation 1.03
|
|
Overall Health ('Healthy Days' Core Module)
Post-treatment
|
3.40 Days
Standard Deviation 1.26
|
3.37 Days
Standard Deviation 1.27
|
|
Overall Health ('Healthy Days' Core Module)
6-month follow-up
|
3.40 Days
Standard Deviation 1.26
|
3.37 Days
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Composite Sleep Health Score is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint sleep fluctuation across a 7-day sleep diary \< 1 hour), Satisfaction (Sleep quality question on PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System)), Alertness (Daytime sleepiness question on PROMIS-Sleep Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)), Timing (Mean midpoint sleep across the 7 day sleep diary between 2 and 4 AM), Efficiency (Average sleep efficiency based on the 7 day sleep diary ≥ 85%), and Duration (Total Sleep Time average based on 7 day sleep diary between 7 and 9 hours). Each dimension was dichotomized such that 1 = good /yes; 0 = poor/no). Total composite sleep health score ranges from 0 to 6, with larger values indicating better sleep health.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Composite Sleep Health Score
Pre-treatment
|
2.28 Score on a scale
Standard Deviation 1.29
|
2.54 Score on a scale
Standard Deviation 1.60
|
|
Composite Sleep Health Score
Post-treatment
|
2.34 Score on a scale
Standard Deviation 1.33
|
3.45 Score on a scale
Standard Deviation 1.39
|
|
Composite Sleep Health Score
6-month follow-up
|
2.53 Score on a scale
Standard Deviation 1.39
|
3.38 Score on a scale
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Total sleep time (TST), measured as the total amount of sleep obtained by the participant, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of TST were calculated to assess typical sleep duration and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Means and Variability of Total Sleep Time (Daily Sleep Diary)
TST mean at Pre-treatment
|
452.42 Minutes
Standard Deviation 101.37
|
431.06 Minutes
Standard Deviation 111.47
|
|
Means and Variability of Total Sleep Time (Daily Sleep Diary)
TST variability at Pre-treatment
|
109.59 Minutes
Standard Deviation 55.14
|
103.96 Minutes
Standard Deviation 46.37
|
|
Means and Variability of Total Sleep Time (Daily Sleep Diary)
TST mean at Post-treatment
|
459.09 Minutes
Standard Deviation 100.16
|
450.71 Minutes
Standard Deviation 92.77
|
|
Means and Variability of Total Sleep Time (Daily Sleep Diary)
TST variability at Post-treatment
|
123.59 Minutes
Standard Deviation 79.11
|
96.50 Minutes
Standard Deviation 97.84
|
|
Means and Variability of Total Sleep Time (Daily Sleep Diary)
TST mean at 6-month follow-up
|
465.23 Minutes
Standard Deviation 115.13
|
464.90 Minutes
Standard Deviation 106.54
|
|
Means and Variability of Total Sleep Time (Daily Sleep Diary)
TST variability at 6-month follow-up
|
99.30 Minutes
Standard Deviation 52.38
|
90.87 Minutes
Standard Deviation 58.77
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Total wake time (TWT), measured as minutes of wakefulness within a sleep period, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of their TWT were calculated across days to assess means and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Means and Variability of Total Wake Time (Daily Sleep Diary)
TWT mean at Pre-treatment
|
131.89 Minutes
Standard Deviation 80.47
|
124.84 Minutes
Standard Deviation 75.03
|
|
Means and Variability of Total Wake Time (Daily Sleep Diary)
TWT variability at Pre-treatment
|
77.85 Minutes
Standard Deviation 54.92
|
74.04 Minutes
Standard Deviation 46.48
|
|
Means and Variability of Total Wake Time (Daily Sleep Diary)
TWT mean at Post-treatment
|
131.29 Minutes
Standard Deviation 116.57
|
84.37 Minutes
Standard Deviation 49.45
|
|
Means and Variability of Total Wake Time (Daily Sleep Diary)
(TWT variability at Post-treatment
|
82.07 Minutes
Standard Deviation 77.64
|
61.33 Minutes
Standard Deviation 62.27
|
|
Means and Variability of Total Wake Time (Daily Sleep Diary)
TWT mean at 6-month follow-up
|
118.92 Minutes
Standard Deviation 77.55
|
83.55 Minutes
Standard Deviation 65.53
|
|
Means and Variability of Total Wake Time (Daily Sleep Diary)
TWT variability at 6-month follow-up
|
73.27 Minutes
Standard Deviation 47.70
|
52.69 Minutes
Standard Deviation 52.56
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Bedtime was reported via a 7-day daily sleep diary using a 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). Each participant's mean and within-person SD of bedtime across 7 days were computed to capture average bedtime and variability. Group-level outcomes reflect the average of these participant-level means and SDs.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Means and Variability of Bedtime (Daily Sleep Diary)
Bedtime mean at Pre-treatment
|
22.20 hours
Standard Deviation 1.95
|
22.17 hours
Standard Deviation 2.36
|
|
Means and Variability of Bedtime (Daily Sleep Diary)
Bedtime variability at Pre-treatment
|
1.39 hours
Standard Deviation 1.06
|
1.28 hours
Standard Deviation 0.79
|
|
Means and Variability of Bedtime (Daily Sleep Diary)
(Bedtime mean at Post-treatment
|
22.39 hours
Standard Deviation 1.56
|
22.00 hours
Standard Deviation 1.65
|
|
Means and Variability of Bedtime (Daily Sleep Diary)
Bedtime variability at Post-treatment
|
1.41 hours
Standard Deviation 1.07
|
1.01 hours
Standard Deviation 0.93
|
|
Means and Variability of Bedtime (Daily Sleep Diary)
Bedtime mean at 6-month follow-up
|
22.41 hours
Standard Deviation 1.88
|
21.96 hours
Standard Deviation 2.13
|
|
Means and Variability of Bedtime (Daily Sleep Diary)
Bedtime variability at 6-month follow-up
|
1.55 hours
Standard Deviation 1.32
|
1.00 hours
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Wake times, using a 24-hour decimal format, were reported daily across 7 days. The mean and within-person SD were calculated for each participant's wake time across days. Group-level outcomes reflect the average of these participant-level means and SDs.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
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TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Means and Variability of Wake Time (Daily Sleep Diary)
Wake time variability at Post-treatment
|
1.61 hours
Standard Deviation 1.11
|
1.10 hours
Standard Deviation 1.08
|
|
Means and Variability of Wake Time (Daily Sleep Diary)
Wake time mean at Pre-treatment
|
7.90 hours
Standard Deviation 1.83
|
7.31 hours
Standard Deviation 2.02
|
|
Means and Variability of Wake Time (Daily Sleep Diary)
Wake time variability at Pre-treatment
|
1.42 hours
Standard Deviation 0.88
|
1.34 hours
Standard Deviation 1.00
|
|
Means and Variability of Wake Time (Daily Sleep Diary)
Wake time mean at Post-treatment
|
8.26 hours
Standard Deviation 2.25
|
7.31 hours
Standard Deviation 1.82
|
|
Means and Variability of Wake Time (Daily Sleep Diary)
Wake time mean at 6-month follow-up
|
7.95 hours
Standard Deviation 1.83
|
7.33 hours
Standard Deviation 1.74
|
|
Means and Variability of Wake Time (Daily Sleep Diary)
Wake time variability at 6-month follow-up
|
1.22 hours
Standard Deviation 0.69
|
1.26 hours
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupPopulation: Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
Actigraphy-derived total wake time (TWT), measured as minutes of wakefulness within a sleep period, was collected daily over a 1-week period. Each participant's mean and within-person SD were calculated across the 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.
Outcome measures
| Measure |
UC-DT
n=60 Participants
Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
TranS-C
n=61 Participants
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
|
|---|---|---|
|
Actigraphy Measured Sleep (TWT)
TWT variability at 6-month follow-up
|
56.22 Minutes
Standard Deviation 48.70
|
41.41 Minutes
Standard Deviation 30.65
|
|
Actigraphy Measured Sleep (TWT)
TWT mean at Pre-treatment
|
91.06 Minutes
Standard Deviation 41.52
|
94.95 Minutes
Standard Deviation 55.18
|
|
Actigraphy Measured Sleep (TWT)
TWT variability at Pre-treatment
|
55.65 Minutes
Standard Deviation 51.16
|
54.46 Minutes
Standard Deviation 48.26
|
|
Actigraphy Measured Sleep (TWT)
TWT mean at Post-treatment
|
91.39 Minutes
Standard Deviation 48.65
|
90.80 Minutes
Standard Deviation 44.85
|
|
Actigraphy Measured Sleep (TWT)
TWT variability at Post-treatment
|
60.36 Minutes
Standard Deviation 68.61
|
51.72 Minutes
Standard Deviation 41.86
|
|
Actigraphy Measured Sleep (TWT)
TWT mean at 6-month follow-up
|
92.73 Minutes
Standard Deviation 41.87
|
84.51 Minutes
Standard Deviation 45.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predictedOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered at the end of Session 2 of treatmentCredibility Expectancy Questionnaire
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followupOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline OnlySnoring, tiredness/sleepiness, observed apneas, hypertension, BMI \> 35 kg/m2, age \> 50 years, neck circumference \> 40 cm, and male gender (STOP-BANG) Questionnaire. 8-item screen for obstructive sleep apnea.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-upCurrent symptoms of chronic pain
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: One time at the convenience of clinic staffExplore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: One time following the completion of the first post-treatment assessmentExploration of barriers and facilitators to behavior change
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-upMeasure of cytokines present in saliva (e.g., Interleukin (IL) -1 beta, IL-6, IL-8, Tumor necrosis factor (TNF) alpha, and/or C-reactive protein (CRP)) to assess immune function
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.Client evaluation of treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-upParticipant recall of sleep coaching treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-upClient feedback and application of treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-upMeasure of sleep coaching elements used/useful to clients
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After each treatment session filled out by therapist (8 times)Therapist evaluation of client adherence to treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-upTo calculate BMI
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatmentTo calculate BMI
Outcome measures
Outcome data not reported
Adverse Events
TranS-C
UC-DT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor of Clinical Psychology
Department of Psychology, University of California, Berkeley
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place