Trial Outcomes & Findings for Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans (NCT NCT01893983)

Last Updated: 2019-09-27

Results Overview

Motivational Coaching (vs. Control) on MH treatment initiation. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates

Recruitment status

COMPLETED

Study phase

Target enrollment

418 participants

Primary outcome timeframe

26 months

Results posted on

2019-09-27

Participant Flow

(1) CBOC providers will refer veterans; (2) VA administrative data will be used to identify veterans; (3) veteran self-referral; (4) "snowball sampling"

Baseline assessment was used to determine mental health eligibility. Those who did not score high enough on mental health symptoms AND/OR had recently had recently had a mental health visit and/or a schedule mental health visit were excluded.

Participant milestones

Participant milestones
Measure	Motivational Coaching Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment	Referral Alone This is the current standard of care
Overall Study STARTED	140	140
Overall Study COMPLETED	130	134
Overall Study NOT COMPLETED	10	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant from the motivational coaching arm withdrew and requested their data not be used in data analysis.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 26 months

Population: Including 272 patients who provided primary outcome data (excluding those who withdrew).

Outcome measures

Outcome measures
Measure	Motivational Coaching n=137 Participants Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment	Referral Alone n=135 Participants This is the current standard of care
Mental Health (MH) Treatment Engagement	78 Participants	74 Participants

SECONDARY outcome

Timeframe: 26 months

Population: Including patients who provided primary outcome data.

Motivational Coaching (vs. Control) on MH treatment retention. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates

Outcome measures

Outcome measures
Measure	Motivational Coaching n=137 Participants Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment	Referral Alone n=135 Participants This is the current standard of care
Mental Health (MH) Treatment Retention	67 Participants	62 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 months

Population: Including patients who reported mental health symptoms, substance use, and quality of life.

Depression, anxiety, panic, PTSD, tobacco, alcohol, cannabis, cocaine, amphetamine, inhalants, sedatives, hallucinogen, opioid, and QOL domains: physical health, psychological health, social relationships, and environment. Ranges of scores: depression: 0-27, anxiety: 0-4, panic: 0-4, PTSD: PTSD: 0-80., tobacco: 0-31, alcohol: 0-39, cannabis use: 0-39, cocaine: 0-39, amphetamine: 0-39, inhalants: 0-39, sedatives: 0-39, hallucinogen: 0-39, opioid: 0-39, QOL physical health: 4-20, QOL psychological health: 4-20, QOL social relationships: 4-20, QOL environment: 4-20. Higher scores mean worse outcomes for mental health symptoms and substance use scores; higher scores mean worse outcomes for quality of life measures.

Outcome measures

Outcome measures
Measure	Motivational Coaching n=102 Participants Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment	Referral Alone n=118 Participants This is the current standard of care
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. anxiety	1.2 score on a scale Standard Deviation 0.9	1.3 score on a scale Standard Deviation 0.8
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. QOL physical health domain	12.6 score on a scale Standard Deviation 3.7	12.0 score on a scale Standard Deviation 3.1
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. QOL social relationships domain	13.3 score on a scale Standard Deviation 3.9	12.1 score on a scale Standard Deviation 3.8
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. QOL environment domain	14.4 score on a scale Standard Deviation 2.5	13.6 score on a scale Standard Deviation 2.6
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. depression	9.4 score on a scale Standard Deviation 6.2	11.1 score on a scale Standard Deviation 6.5
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. panic	0.6 score on a scale Standard Deviation 0.9	0.7 score on a scale Standard Deviation 0.9
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. PTSD	25.1 score on a scale Standard Deviation 18.4	29.7 score on a scale Standard Deviation 16.7
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. tobacco	8.8 score on a scale Standard Deviation 9.5	9.2 score on a scale Standard Deviation 10.0
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. alcohol	7.1 score on a scale Standard Deviation 7.7	7.7 score on a scale Standard Deviation 8.6
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. cannabis	3.1 score on a scale Standard Deviation 4.8	4.6 score on a scale Standard Deviation 6.7
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. cocaine	0.7 score on a scale Standard Deviation 2.9	0.9 score on a scale Standard Deviation 2.5
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. amphetamine	0.3 score on a scale Standard Deviation 1.6	0.7 score on a scale Standard Deviation 2.5
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. inhalants	0 score on a scale Standard Deviation 0	0.2 score on a scale Standard Deviation 1.4
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. sedatives	0.5 score on a scale Standard Deviation 2.9	0.8 score on a scale Standard Deviation 3.1
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. halluninogens	0.2 score on a scale Standard Deviation 1.1	0.2 score on a scale Standard Deviation 0.8
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. opioid	0.5 score on a scale Standard Deviation 2.7	0.9 score on a scale Standard Deviation 3.8
Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. QOL psychological health domain	13.4 score on a scale Standard Deviation 2.8	12.7 score on a scale Standard Deviation 2.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 months

Population: Including participants who responded to survey questions during follow-up.

Five types of self-care activities to relieve stress: internet or mobile applications, community groups (church groups, gun clubs), community classes (Yoga, cooking), alternative treatments (acupuncture, chiropractor, massage), and other self-care activities (meditation, fishing, walking).

Outcome measures

Outcome measures
Measure	Motivational Coaching n=115 Participants Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment	Referral Alone n=120 Participants This is the current standard of care
Self-care Activities Community classes	31 Participants	16 Participants
Self-care Activities Alternative treatments	40 Participants	38 Participants
Self-care Activities Internet or mobile applications	84 Participants	63 Participants
Self-care Activities Community groups	59 Participants	52 Participants
Self-care Activities Self-care activities	111 Participants	109 Participants

Adverse Events

Motivational Coaching

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Referral Alone

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Motivational Coaching n=140 participants at risk Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment	Referral Alone n=140 participants at risk This is the current standard of care
Injury, poisoning and procedural complications Hospitalization from Car Accident	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Gastrointestinal disorders Hospitalization from Stomach Flu	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Respiratory, thoracic and mediastinal disorders Hospitalization for Lung Transplant	0.71% 1/140 • Number of events 2 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Surgical and medical procedures Hospitalization for Abdominal Surgery	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Injury, poisoning and procedural complications Hospitalization due to injury	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.

Other adverse events

Other adverse events
Measure	Motivational Coaching n=140 participants at risk Telephone based Motivational Coaching sessions Motivational Coaching: Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment	Referral Alone n=140 participants at risk This is the current standard of care
Infections and infestations Recently illness	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Psychiatric disorders Adverse Events related to PTSD	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Injury, poisoning and procedural complications Broken Rib	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Psychiatric disorders Anxiety	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Respiratory, thoracic and mediastinal disorders Lung Cancer Diagnosis	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.
Injury, poisoning and procedural complications Hurt Shoulder	0.00% 0/140 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.	0.71% 1/140 • Number of events 1 • 2 years and 9 months Adverse events were collected during telephone interactions only if reported by the participant.

Additional Information

Dr. Karen Seal

San Francisco VA Healthcare System

Phone: 415-2214810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place