Trial Outcomes & Findings for Cognitive-Behavior Therapy for Posttraumatic Headache (NCT NCT02419131)
NCT ID: NCT02419131
Last Updated: 2024-08-13
Results Overview
Baseline headache-related disability will be assessed over time based on headache-related disability scores on the HIT-6 obtained at multiple time points: at the end of 6 weeks of treatment, and at 3 and 6 months post-treatment. The Headache Impact Test (HIT-6) is a questionnaire for measuring the impact of headache. A total of six questions are completed by the patient. They focus on daily activities such as work, education, home situation and leisure time. The HIT-6 gives a general overview of the impact of headache, including pain intensity, impairment and other items. Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
193 participants
Primary outcome timeframe
Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
Results posted on
2024-08-13
Participant Flow
Subjects who were consented and randomized, but did not continue to therapy
Participant milestones
| Measure |
Behavioral Headache Therapy
A standard, manualized behavioral intervention for primary headache disorders
Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders
|
Cognitive Processing Therapy
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
|
Treatment as Usual
Treatment as usual, receiving standard care for PTHA
Treatment as Usual: Treatment as usual, receiving standard care for PTHA
|
|---|---|---|---|
|
Consent and Randomization
STARTED
|
65
|
64
|
64
|
|
Consent and Randomization
COMPLETED
|
55
|
48
|
57
|
|
Consent and Randomization
NOT COMPLETED
|
10
|
16
|
7
|
|
Randomization and Treatment
STARTED
|
55
|
48
|
57
|
|
Randomization and Treatment
Completed 3-month Follow-up
|
31
|
21
|
40
|
|
Randomization and Treatment
Completed 6-month Follow-up
|
32
|
23
|
40
|
|
Randomization and Treatment
Completed Post-Treatment Follow-up
|
33
|
23
|
48
|
|
Randomization and Treatment
Completed All Follow-up
|
23
|
21
|
36
|
|
Randomization and Treatment
Included in Analysis
|
65
|
64
|
64
|
|
Randomization and Treatment
COMPLETED
|
33
|
23
|
48
|
|
Randomization and Treatment
NOT COMPLETED
|
22
|
25
|
9
|
Reasons for withdrawal
| Measure |
Behavioral Headache Therapy
A standard, manualized behavioral intervention for primary headache disorders
Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders
|
Cognitive Processing Therapy
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
|
Treatment as Usual
Treatment as usual, receiving standard care for PTHA
Treatment as Usual: Treatment as usual, receiving standard care for PTHA
|
|---|---|---|---|
|
Consent and Randomization
Did not receive treatment after randomization
|
10
|
16
|
7
|
|
Randomization and Treatment
Withdrawn or lost to follow-up
|
22
|
25
|
9
|
Baseline Characteristics
1 individual did not report gender
Baseline characteristics by cohort
| Measure |
Behavioral Headache Therapy
n=65 Participants
A standard, manualized behavioral intervention for primary headache disorders
Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders
|
Cognitive Processing Therapy
n=64 Participants
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy
|
Treatment as Usual
n=64 Participants
Treatment as usual, receiving standard care for PTHA
Treatment as Usual: Treatment as usual, receiving standard care for PTHA
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 8.4 • n=65 Participants
|
39.7 years
STANDARD_DEVIATION 8.4 • n=64 Participants
|
39.7 years
STANDARD_DEVIATION 8.4 • n=64 Participants
|
39.7 years
STANDARD_DEVIATION 8.4 • n=193 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=65 Participants • 1 individual did not report gender
|
6 Participants
n=64 Participants • 1 individual did not report gender
|
10 Participants
n=63 Participants • 1 individual did not report gender
|
25 Participants
n=192 Participants • 1 individual did not report gender
|
|
Sex: Female, Male
Male
|
56 Participants
n=65 Participants • 1 individual did not report gender
|
58 Participants
n=64 Participants • 1 individual did not report gender
|
53 Participants
n=63 Participants • 1 individual did not report gender
|
167 Participants
n=192 Participants • 1 individual did not report gender
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
27 Participants
n=64 Participants • 2 individuals did not report ethnicity
|
28 Participants
n=64 Participants • 2 individuals did not report ethnicity
|
26 Participants
n=63 Participants • 2 individuals did not report ethnicity
|
81 Participants
n=191 Participants • 2 individuals did not report ethnicity
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
37 Participants
n=64 Participants • 2 individuals did not report ethnicity
|
36 Participants
n=64 Participants • 2 individuals did not report ethnicity
|
37 Participants
n=63 Participants • 2 individuals did not report ethnicity
|
110 Participants
n=191 Participants • 2 individuals did not report ethnicity
|
|
Race
American Indian
|
0 Participants
n=65 Participants • 2 individuals did not report race
|
1 Participants
n=63 Participants • 2 individuals did not report race
|
4 Participants
n=63 Participants • 2 individuals did not report race
|
5 Participants
n=191 Participants • 2 individuals did not report race
|
|
Race
Asian
|
2 Participants
n=65 Participants • 2 individuals did not report race
|
1 Participants
n=63 Participants • 2 individuals did not report race
|
4 Participants
n=63 Participants • 2 individuals did not report race
|
7 Participants
n=191 Participants • 2 individuals did not report race
|
|
Race
Black/African American
|
7 Participants
n=65 Participants • 2 individuals did not report race
|
14 Participants
n=63 Participants • 2 individuals did not report race
|
13 Participants
n=63 Participants • 2 individuals did not report race
|
34 Participants
n=191 Participants • 2 individuals did not report race
|
|
Race
Native Hawaiian
|
2 Participants
n=65 Participants • 2 individuals did not report race
|
2 Participants
n=63 Participants • 2 individuals did not report race
|
2 Participants
n=63 Participants • 2 individuals did not report race
|
6 Participants
n=191 Participants • 2 individuals did not report race
|
|
Race
White
|
43 Participants
n=65 Participants • 2 individuals did not report race
|
34 Participants
n=63 Participants • 2 individuals did not report race
|
33 Participants
n=63 Participants • 2 individuals did not report race
|
110 Participants
n=191 Participants • 2 individuals did not report race
|
|
Race
Other
|
11 Participants
n=65 Participants • 2 individuals did not report race
|
11 Participants
n=63 Participants • 2 individuals did not report race
|
7 Participants
n=63 Participants • 2 individuals did not report race
|
29 Participants
n=191 Participants • 2 individuals did not report race
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatmentPopulation: Intent-to-treat
Baseline headache-related disability will be assessed over time based on headache-related disability scores on the HIT-6 obtained at multiple time points: at the end of 6 weeks of treatment, and at 3 and 6 months post-treatment. The Headache Impact Test (HIT-6) is a questionnaire for measuring the impact of headache. A total of six questions are completed by the patient. They focus on daily activities such as work, education, home situation and leisure time. The HIT-6 gives a general overview of the impact of headache, including pain intensity, impairment and other items. Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
Outcome measures
| Measure |
Behavioral Headache Therapy
n=65 Participants
A standard, manualized behavioral intervention for primary headache disorders
Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders
41 - contributed \>= 1 HIT-6 outcome 40 - contributed \>= 1 PCL-5 outcomes 65 - included in multiple imputation
|
Cognitive Processing Therapy
n=64 Participants
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy
|
Treatment as Usual
n=64 Participants
Treatment as usual, receiving standard care for PTHA
Treatment as Usual: Treatment as usual, receiving standard care for PTHA
|
|---|---|---|---|
|
Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6)
Baseline
|
66.1 score on a scale
Standard Deviation 5.4
|
66.1 score on a scale
Standard Deviation 5.1
|
65.2 score on a scale
Standard Deviation 6.4
|
|
Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6)
Post-treatment
|
61.9 score on a scale
Standard Deviation 6.3
|
63.3 score on a scale
Standard Deviation 6.9
|
64.2 score on a scale
Standard Deviation 6.6
|
|
Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6)
3-Month Follow-up
|
61.3 score on a scale
Standard Deviation 8.0
|
64.8 score on a scale
Standard Deviation 7.2
|
64.1 score on a scale
Standard Deviation 7.1
|
|
Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6)
6-Month Follow-up
|
60.9 score on a scale
Standard Deviation 8.8
|
63.3 score on a scale
Standard Deviation 7.1
|
64.1 score on a scale
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatmentPost-traumatic stress scores will be assessed over time. The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point. Likert scale ranging from 0-4. Items are summed to provide a total severity score (range = 0-80). A higher score indicates more PTSD. 0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely
Outcome measures
| Measure |
Behavioral Headache Therapy
n=65 Participants
A standard, manualized behavioral intervention for primary headache disorders
Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders
41 - contributed \>= 1 HIT-6 outcome 40 - contributed \>= 1 PCL-5 outcomes 65 - included in multiple imputation
|
Cognitive Processing Therapy
n=64 Participants
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy
|
Treatment as Usual
n=64 Participants
Treatment as usual, receiving standard care for PTHA
Treatment as Usual: Treatment as usual, receiving standard care for PTHA
|
|---|---|---|---|
|
Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5)
Baseline
|
47.7 score on a scale
Standard Deviation 14.7
|
48.6 score on a scale
Standard Deviation 14.6
|
49.0 score on a scale
Standard Deviation 13.3
|
|
Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5)
Post-Treatment
|
36.5 score on a scale
Standard Deviation 19.7
|
30.0 score on a scale
Standard Deviation 20.9
|
41.6 score on a scale
Standard Deviation 17.1
|
|
Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5)
3-Month Follow-up
|
30.2 score on a scale
Standard Deviation 18.2
|
29.9 score on a scale
Standard Deviation 20.0
|
43.0 score on a scale
Standard Deviation 16.5
|
|
Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5)
6-Month Follow-up
|
30.3 score on a scale
Standard Deviation 20.0
|
32.9 score on a scale
Standard Deviation 21.0
|
41.0 score on a scale
Standard Deviation 16.1
|
Adverse Events
Behavioral Headache Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Processing Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Behavioral Headache Therapy
n=65 participants at risk
A standard, manualized behavioral intervention for primary headache disorders
Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders
|
Cognitive Processing Therapy
n=64 participants at risk
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy
|
Treatment as Usual
n=64 participants at risk
Treatment as usual, receiving standard care for PTHA
Treatment as Usual: Treatment as usual, receiving standard care for PTHA
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/65 • Baseline to 6-month post-treatment follow-up for a total of approximately 7 months (+/- 2 weeks).
Adverse events were gathered at all study visits (i.e., treatment and assessment visits) and TAU participants were contacted twice during the treatment phase to assess for adverse events.
|
0.00%
0/64 • Baseline to 6-month post-treatment follow-up for a total of approximately 7 months (+/- 2 weeks).
Adverse events were gathered at all study visits (i.e., treatment and assessment visits) and TAU participants were contacted twice during the treatment phase to assess for adverse events.
|
0.00%
0/64 • Baseline to 6-month post-treatment follow-up for a total of approximately 7 months (+/- 2 weeks).
Adverse events were gathered at all study visits (i.e., treatment and assessment visits) and TAU participants were contacted twice during the treatment phase to assess for adverse events.
|
Other adverse events
| Measure |
Behavioral Headache Therapy
n=65 participants at risk
A standard, manualized behavioral intervention for primary headache disorders
Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders
|
Cognitive Processing Therapy
n=64 participants at risk
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy
|
Treatment as Usual
n=64 participants at risk
Treatment as usual, receiving standard care for PTHA
Treatment as Usual: Treatment as usual, receiving standard care for PTHA
|
|---|---|---|---|
|
Psychiatric disorders
Worsening PTSD symptoms
|
0.00%
0/65 • Baseline to 6-month post-treatment follow-up for a total of approximately 7 months (+/- 2 weeks).
Adverse events were gathered at all study visits (i.e., treatment and assessment visits) and TAU participants were contacted twice during the treatment phase to assess for adverse events.
|
3.1%
2/64 • Number of events 2 • Baseline to 6-month post-treatment follow-up for a total of approximately 7 months (+/- 2 weeks).
Adverse events were gathered at all study visits (i.e., treatment and assessment visits) and TAU participants were contacted twice during the treatment phase to assess for adverse events.
|
0.00%
0/64 • Baseline to 6-month post-treatment follow-up for a total of approximately 7 months (+/- 2 weeks).
Adverse events were gathered at all study visits (i.e., treatment and assessment visits) and TAU participants were contacted twice during the treatment phase to assess for adverse events.
|
Additional Information
Dr. Tim Houle
Massachusetts General Hospital, Harvard Medical School
Phone: 617-724-2111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place