Last reviewed · How we verify
TelemEdiciNe-bAsed Cognitive TherapY for Migraines
NA trial testing TENACITY Telehealth Cognitive Behavioral Therapy for Migraine in Migraine Headache in 80 participants. Completed in 31 May 2023.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | health services research |
| Enrollment | 80 |
| Start date | 22 April 2021 |
| Primary completion | 29 April 2023 |
| Estimated completion | 31 May 2023 |
| Sites | 4 locations across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Migraine Headache. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Daily self-reported migraine headaches using a VA text message protocol
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 18.17 | ± 7.82 |
| Behavioral Usual Care | 19.19 | ± 8.54 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 16.47 | ± 10.17 |
| Behavioral Usual Care | 18.26 | ± 11.05 |
Costs associated with program implementation
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 12020.99 | |
| Behavioral Usual Care | 271.57 |
The MSQ is a 14-item measure of headache-related quality of life. Higher scores indicate a higher quality of life. Unscaled scores range from 0 to 70.
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 48.39 | ± 23.07 |
| Behavioral Usual Care | 57.06 | ± 19.36 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 48.79 | ± 24.29 |
| Behavioral Usual Care | 53.32 | ± 16.72 |
The MIDAS is a 5-item, self-report measure of disability related to headache based on number of missed or significantly limited activity days due to headache in school or paid work, household work, and family, social, or leisure activities. Responses are categorized as follows: little or no disability (0-5), mild disability (6-10), moderate disability (11-20), and severe disability (21+). Scale has a range from 0 to 270, with a higher score indicating a worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 83.09 | ± 68.72 |
| Behavioral Usual Care | 64.94 | ± 47.59 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 63.17 | ± 61.88 |
| Behavioral Usual Care | 68.68 | ± 61.40 |
The HPCS is a modified version of the validated Pain Catastrophizing Scale (substitutes "headache" for "pain" in the questions). The HPCS is a 13-item measure used to assess catastrophic thinking related to headache. Item responses range from 0 to 4 (0 = not at all, 4 = all the time). Total scores range from 0 to 52, with higher scores indicating higher levels of catastrophizing.
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 26.69 | ± 17.05 |
| Behavioral Usual Care | 20.88 | ± 9.69 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 23.55 | ± 18.57 |
| Behavioral Usual Care | 23.84 | ± 11.66 |
The HMSE is a 25-item measure used to assess a participant's perception of their ability to take actions to prevent and manage their headaches and headache-related disability. Item responses range from 1 to 7 (1 = strongly disagree, 7 = strongly agree). Total scores range from 25 to 175 with higher scores indicating higher levels of headache management self-efficacy.
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 101.09 | ± 26.16 |
| Behavioral Usual Care | 113.39 | ± 19.37 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 103.97 | ± 31.04 |
| Behavioral Usual Care | 111.00 | ± 23.15 |
The PCL is a validated 20-item, self-report measure of PTSD symptoms. Items are rated from 0 to 4 (0 = not at all, 4 = extremely). Total scores range from 0-80. Higher scores indicate higher post-traumatic stress symptoms.
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 33.29 | ± 17.62 |
| Behavioral Usual Care | 29.25 | ± 20.67 |
The PHQ-9 is a reliable and well-validated self-report measure of depressive symptom severity and suicide risk based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Items are rated from 0 to 3 (0 = not at all, 3 = nearly every day). Total scores range from 0 to 27. Totals are categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 9.27 | ± 6.28 |
| Behavioral Usual Care | 10.83 | ± 5.11 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 8.61 | ± 5.46 |
| Behavioral Usual Care | 7.88 | ± 4.88 |
The GAD-7 is a reliable and validated 7-item, self-report measure of anxiety. Items are rated from 0 to 3 (0 = not at all, 3 = nearly every day). Total scores range from 0 to 21 and are categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxious symptoms.
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 9.04 | ± 6.43 |
| Behavioral Usual Care | 6.78 | ± 4.17 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 8.30 | ± 6.28 |
| Behavioral Usual Care | 8.90 | ± 4.99 |
The VR-12 is a 12-item measure used to assess health related quality of life and to produce physical and mental health component scores. The 12 items are summed into a physical component score (PCS) and a mental component score (MCS). Both the PCS and MCS scores are transformed to a scale with a range of 1-100. A higher score indicates better health.
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 41.84 | ± 5.14 |
| Behavioral Usual Care | 41.94 | ± 4.15 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 39.93 | ± 5.90 |
| Behavioral Usual Care | 40.20 | ± 4.85 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 34.56 | ± 10.15 |
| Behavioral Usual Care | 34.81 | ± 5.95 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 35.02 | ± 7.78 |
| Behavioral Usual Care | 38.02 | ± 6.15 |
The ISI is a 7-item measure of the participant's perceptions of their insomnia, such as severity of sleep-onset and sleep maintenance difficulties. Items are rated from 0 to 4 (0 = not at all, 4 = very much). Total scores range from 0 to 28. Totals are categorized as follows: no clinically significant insomnia (0-7), subthreshold insomnia (8-14), clinical insomnia (moderately severe) (15-21), clinical insomnia (severe) (22-28).
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 16.35 | ± 7.44 |
| Behavioral Usual Care | 13.28 | ± 6.45 |
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 16.91 | ± 8.74 |
| Behavioral Usual Care | 14.86 | ± 5.48 |
Time associated with program implementation
| Group | Value | 95% CI |
|---|---|---|
| TENACITY Telehealth Cognitive Behavioral Therapy for Migraine | 201.1 | |
| Behavioral Usual Care | 4.0 |
Time frame: Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | TENACITY Telehealth Cognit… | Behavioral Usual Care |
|---|---|---|---|
| colitis | Gastrointestinal disorders | — | — |
| stomach pain | Gastrointestinal disorders | — | — |
| bowel obstruction | Gastrointestinal disorders | — | — |
| flu | Infections and infestations | — | — |
| Reaction | System | TENACITY Telehealth Cognit… | Behavioral Usual Care |
|---|---|---|---|
| COVID | Infections and infestations | — | — |
| depressive symptoms | Psychiatric disorders | — | — |
| fall | Injury, poisoning and procedural complications | — | — |
| flu | Infections and infestations | — | — |
| pain symptoms | Musculoskeletal and connective tissue disorders | — | — |
| allergic reaction | Immune system disorders | — | — |
| arm/leg pain | Musculoskeletal and connective tissue disorders | — | — |
| arthritis | Musculoskeletal and connective tissue disorders | — | — |
| asthma | Respiratory, thoracic and mediastinal disorders | — | — |
| back pain | Musculoskeletal and connective tissue disorders | — | — |
| chest pain | Cardiac disorders | — | — |
| GERD | Gastrointestinal disorders | — | — |
| dehydration | General disorders | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| fever | Infections and infestations | — | — |
| foot pain | Metabolism and nutrition disorders | — | — |
| hernia | Gastrointestinal disorders | — | — |
| hives | Immune system disorders | — | — |
| insomnia | General disorders | — | — |
| irregular heartbeat | Cardiac disorders | — | — |
| leg pain | Musculoskeletal and connective tissue disorders | — | — |
| migraine | General disorders | — | — |
| plantar wart | Skin and subcutaneous tissue disorders | — | — |
| PTSD | Psychiatric disorders | — | — |
| rash | Skin and subcutaneous tissue disorders | — | — |
| shoulder pain | Musculoskeletal and connective tissue disorders | — | — |
| sinus infection | Infections and infestations | — | — |
| stomach virus | Infections and infestations | — | — |
| superficial burn | Injury, poisoning and procedural complications | — | — |
Most-reported serious reactions: colitis, stomach pain, bowel obstruction, flu.
Data from ClinicalTrials.gov NCT04613362 adverse events section.
The goal of this pilot study is to evaluate a bundle of implementation strategies at three Veteran Affairs Medical Centers (VAMCs) to facilitate the referral and adoption of a telehealth based, cognitive behavioral therapy program delivered by Health Psychologists for Veterans with chronic migraine to inform a future fully-powered hybrid type 2 effectiveness-implementation design. Veteran patients will be randomized to either the telehealth delivered CBT or usual care. Headache symptoms and severity will be reported using a VA text messaging application.
2 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04613362.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing