Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy (NCT NCT05427201)

Last Updated: 2026-07-17

Results Overview

The PROMIS Pain Interference questionnaire consists of 8-items that assess the degree to which pain interferes with various aspects of life, including mobility, social activity, and mood. Items are scored on a 1 ("Not at all") to 5 ("Very much") scale with a range of 8 - 40. These scores are subsequently transcribed to a T-score. PROMIS measures are reported as standardized T-scores with a population mean of 50 and standard deviation of 10. Higher scores indicate greater pain interference. A 10-point difference represents one standard deviation from the reference population mean.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Baseline, weekly during ACT intervention, 9 weeks (post-treatment) for total of 10 timepoints

Results posted on

2026-07-17

Participant Flow

Enrollment began in May 2023 and concluded in February 2025. Participants were recruited via study flyer and referral from the Neuromodulation Program, Mental Health, Behavioral Medicine, and Primary Care clinics at VA San Diego Healthcare System.

Of the 31 participants that met initial screening criteria and completed informed consent procedures, 5 were excluded following the psychiatric diagnostic interview, 3 declined to participate, and 4 were lost to follow-up. This left a total of 19 participants that were randomized to treatment.

Participant milestones

Participant milestones
Measure	DLPFC-TMS + ACT Randomized to receive 24 TMS treatments over the left dorsolateral prefrontal cortex (DLPFC) and 8 ACT sessions	Sham-TMS + ACT Randomized to receive 24 sham TMS sessions and 8 ACT sessions
Overall Study STARTED	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DLPFC-rTMS + ACT n=10 Participants Active DLPFC-rTMS with ACT treatment	Sham-rTMS + ACT n=9 Participants Sham delivered rTMS with ACT treatment	Total n=19 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=20 Participants	9 Participants n=20 Participants	17 Participants n=40 Participants
Age, Continuous	43.90 Years of age STANDARD_DEVIATION 10.75 • n=20 Participants	42.00 Years of age STANDARD_DEVIATION 13.07 • n=20 Participants	43.00 Years of age STANDARD_DEVIATION 11.61 • n=40 Participants
Sex: Female, Male Female	4 Participants n=20 Participants	3 Participants n=20 Participants	7 Participants n=40 Participants
Sex: Female, Male Male	6 Participants n=20 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) White	8 Participants n=20 Participants	4 Participants n=20 Participants	12 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=20 Participants	0 Participants n=20 Participants	2 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline, weekly during ACT intervention, 9 weeks (post-treatment) for total of 10 timepoints

Outcome measures

Outcome measures
Measure	DLPFC-rTMS + ACT n=10 Participants Active DLPFC-rTMS with ACT treatment	Sham-rTMS + ACT n=9 Participants Sham delivered rTMS with ACT treatment
PROMIS Pain Interference Change Baseline	68.54 T-score Standard Deviation 6.89	66.30 T-score Standard Deviation 6.85
PROMIS Pain Interference Change Week 1	66.51 T-score Standard Deviation 4.50	59.67 T-score Standard Deviation 8.76
PROMIS Pain Interference Change Week 2	65.00 T-score Standard Deviation 5.22	60.62 T-score Standard Deviation 5.36
PROMIS Pain Interference Change Week 3	66.20 T-score Standard Deviation 5.71	60.50 T-score Standard Deviation 7.10
PROMIS Pain Interference Change Week 4	66.18 T-score Standard Deviation 6.96	58.59 T-score Standard Deviation 8.46
PROMIS Pain Interference Change Week 5	63.85 T-score Standard Deviation 6.03	58.33 T-score Standard Deviation 6.30
PROMIS Pain Interference Change Week 6	63.32 T-score Standard Deviation 6.31	57.81 T-score Standard Deviation 7.51
PROMIS Pain Interference Change Week 7	62.36 T-score Standard Deviation 7.14	56.33 T-score Standard Deviation 7.34
PROMIS Pain Interference Change Week 8	63.23 T-score Standard Deviation 7.34	56.07 T-score Standard Deviation 7.35
PROMIS Pain Interference Change Week 9, Post-treatment	65.57 T-score Standard Deviation 7.85	57.13 T-score Standard Deviation 8.07

SECONDARY outcome

Timeframe: Baseline, weekly during ACT intervention, 9 weeks (post-treatment) for total of 10 timepoints

The PHQ-9 is a widely used measure of depressive symptoms. Items are scored on a 0 ("not at all") to 3 ("Nearly every day") scale with a range of 0 - 27. Higher scores indicate greater depression severity.

Outcome measures

Outcome measures
Measure	DLPFC-rTMS + ACT n=10 Participants Active DLPFC-rTMS with ACT treatment	Sham-rTMS + ACT n=9 Participants Sham delivered rTMS with ACT treatment
Patient Health Questionnaire-9 Change Week 5	13.30 units on a scale Standard Deviation 5.50	9.89 units on a scale Standard Deviation 3.76
Patient Health Questionnaire-9 Change Week 6	12.67 units on a scale Standard Deviation 6.42	8.78 units on a scale Standard Deviation 5.19
Patient Health Questionnaire-9 Change Week 9, post-treatment	12.20 units on a scale Standard Deviation 6.13	8.00 units on a scale Standard Deviation 3.71
Patient Health Questionnaire-9 Change Baseline	16.80 units on a scale Standard Deviation 5.05	13.44 units on a scale Standard Deviation 4.93
Patient Health Questionnaire-9 Change Week 1	15.00 units on a scale Standard Deviation 5.12	10.89 units on a scale Standard Deviation 5.01
Patient Health Questionnaire-9 Change Week 2	15.10 units on a scale Standard Deviation 5.57	9.78 units on a scale Standard Deviation 4.02
Patient Health Questionnaire-9 Change Week 3	13.20 units on a scale Standard Deviation 5.53	12.00 units on a scale Standard Deviation 5.94
Patient Health Questionnaire-9 Change Week 4	15.60 units on a scale Standard Deviation 5.17	11.11 units on a scale Standard Deviation 4.51
Patient Health Questionnaire-9 Change Week 7	11.63 units on a scale Standard Deviation 6.95	9.50 units on a scale Standard Deviation 3.57
Patient Health Questionnaire-9 Change Week 8	11.56 units on a scale Standard Deviation 6.23	7.67 units on a scale Standard Deviation 3.97

SECONDARY outcome

Timeframe: Baseline, weekly during ACT intervention, 9 weeks (post-treatment) for total of 10 timepoints

The PROMIS Pain Intensity questionnaire consists of 3 items assessing worst and average pain over the past week, as well as current pain. Items are scored on a 1 ("No pain") to 5 ("Very severe") scale with a range of 3 - 15. Total scores are subsequently converted to T-scores. PROMIS measures are reported as standardized T-scores with a population mean of 50 and standard deviation of 10. Higher scores indicate greater pain intensity. A 10-point difference represents one standard deviation from the reference population mean.

Outcome measures

Outcome measures
Measure	DLPFC-rTMS + ACT n=10 Participants Active DLPFC-rTMS with ACT treatment	Sham-rTMS + ACT n=9 Participants Sham delivered rTMS with ACT treatment
PROMIS Pain Intensity Change Week 4	56.43 T-score Standard Deviation 6.85	48.96 T-score Standard Deviation 6.67
PROMIS Pain Intensity Change Baseline	56.20 T-score Standard Deviation 5.01	55.33 T-score Standard Deviation 3.33
PROMIS Pain Intensity Change Week 1	56.19 T-score Standard Deviation 6.81	54.17 T-score Standard Deviation 4.10
PROMIS Pain Intensity Change Week 2	53.23 T-score Standard Deviation 7.17	51.60 T-score Standard Deviation 4.46
PROMIS Pain Intensity Change Week 3	55.15 T-score Standard Deviation 5.51	50.24 T-score Standard Deviation 6.74
PROMIS Pain Intensity Change Week 5	56.06 T-score Standard Deviation 5.25	49.76 T-score Standard Deviation 6.08
PROMIS Pain Intensity Change Week 6	55.06 T-score Standard Deviation 4.55	48.41 T-score Standard Deviation 5.76
PROMIS Pain Intensity Change Week 7	54.99 T-score Standard Deviation 6.14	49.44 T-score Standard Deviation 5.43
PROMIS Pain Intensity Change Week 8	54.82 T-score Standard Deviation 7.48	48.78 T-score Standard Deviation 6.28
PROMIS Pain Intensity Change Week 9, post-treatment	56.02 T-score Standard Deviation 8.86	48.46 T-score Standard Deviation 6.73

Adverse Events

DLPFC-rTMS + ACT

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham-rTMS + ACT

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DLPFC-rTMS + ACT n=10 participants at risk Active DLPFC-rTMS with ACT treatment	Sham-rTMS + ACT n=9 participants at risk Sham delivered rTMS with ACT treatment
General disorders Headache	50.0% 5/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	44.4% 4/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
Musculoskeletal and connective tissue disorders Muscle Soreness	20.0% 2/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	11.1% 1/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
General disorders Fatigue	30.0% 3/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	11.1% 1/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
General disorders Tingling around TMS stimulation site	10.0% 1/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	22.2% 2/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
General disorders Eye twitch	20.0% 2/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	0.00% 0/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
General disorders Ear ache	10.0% 1/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	0.00% 0/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
General disorders Dizziness	10.0% 1/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	0.00% 0/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
General disorders Nausea	0.00% 0/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	22.2% 2/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
General disorders Ringing in ears	0.00% 0/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	11.1% 1/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
Psychiatric disorders Depression	0.00% 0/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	11.1% 1/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
Psychiatric disorders Anxiety	10.0% 1/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	0.00% 0/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
Gastrointestinal disorders Diarrhea	0.00% 0/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	11.1% 1/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.
General disorders Toothache	0.00% 0/10 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.	11.1% 1/9 • Adverse events were assessed at each rTMS session, up to 9 weeks Adverse events were assessed prior to each of the 24 rTMS sessions. Specifically, participants were asked if they experienced any side-effects or adverse events since the previous rTMS session.

Additional Information

Matthew Herbert

VA San Diego Healthcare System

Phone: 8586421411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place