Trial Outcomes & Findings for Suicide Prevention for Patients With Chronic Pain (NCT NCT04490265)

NCT ID: NCT04490265

Last Updated: 2025-07-24

Results Overview

The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score. Scores range from 0-100 with higher scores equaling better problem-solving.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Change from Baseline to 12 weeks
• Results posted on: 2025-07-24

Participant Flow

Enrolled = Participants who enrolled into the study (n=60) Baseline = Participants who consented into the study and were randomized (n=44)

Participant milestones

Measure	Problem-Solving Treatment Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Overall Study STARTED	22	22
Overall Study COMPLETED	19	16
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suicide Prevention for Patients With Chronic Pain

Baseline characteristics by cohort

Measure	Problem-Solving Treatment n=20 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=21 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions	Total n=41 Participants Total of all reporting groups
Age, Continuous	48.2 years n=5 Participants	52.5 years n=7 Participants	50.4 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Social Problem-Solving	82.16 units on a scale STANDARD_DEVIATION 18.20 • n=5 Participants	88.81 units on a scale STANDARD_DEVIATION 22.33 • n=7 Participants	85.65 units on a scale STANDARD_DEVIATION 20.37 • n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 12 weeks

Population: Only individuals who provided data were analyzed.

The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score. Scores range from 0-100 with higher scores equaling better problem-solving.

Outcome measures

Measure	Problem-Solving Treatment n=17 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=14 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Social Problem-solving Inventory - Patient Report	8.12 score on a scale Interval 0.0 to 16.24	3.64 score on a scale Interval -1.99 to 9.28

PRIMARY outcome

Timeframe: Change from Baseline to 6 months

Population: Only individuals who provided data were analyzed.

The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score.Scores range from 0-100 with higher scores equaling better problem-solving.

Outcome measures

Measure	Problem-Solving Treatment n=13 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=17 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Social Problem-solving Inventory - Patient Report	8.31 score on a scale Interval 0.91 to 15.7	-.24 score on a scale Interval -5.33 to 4.86

PRIMARY outcome

Timeframe: Change from Baseline to 12 weeks

Population: Only individuals who provided data were analyzed.

Emotional Go No Go measures attention and impulse inhibition. Inhibiting impulses is a key component of preventing impulsive behavior that can lead to suicide. Reported is the hit rate with scores from 0-1.0. Higher scores are better.

Outcome measures

Measure	Problem-Solving Treatment n=12 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=7 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Emotional Go No Go	-.01 score on a scale Interval -0.09 to 0.08	.06 score on a scale Interval -0.03 to 0.15

PRIMARY outcome

Timeframe: Change from Baseline to 12 weeks

Population: Only individuals who provided data were analyzed.

The Means End Problem-Solving Task consists of a series of scenarios, with each one identifying the beginning and end of a story. The subject's task is to come up with the middle of the story. Stories are scored according to how many steps to reaching the end the patient identifies. An increase in effective means generated is expected to drive reduction in suicide ideation. We report the total score, the range was 2-19. Scores higher=better problem-solving.

Outcome measures

Measure	Problem-Solving Treatment n=14 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=17 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Means End Problem-Solving Task	-1.36 score on a scale Interval -4.66 to 1.95	0.29 score on a scale Interval -1.99 to 2.58

PRIMARY outcome

Timeframe: Change from Baseline to 12-weeks

Population: Only individuals who provided data were analyzed.

The Iowa gambling task is a neuropsychological task of problem-solving. The participgoal of the task is to make money. Participants are presented four decks of cards and have to choose the best deck to make money. The Iowa gambling task has been shown to change after problem-solving therapy. Scores range from -100 to 100 with higher equaling better problem-solving.

Outcome measures

Measure	Problem-Solving Treatment n=12 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=7 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Iowa Gambling Task	23.33 score on a scale Interval -3.77 to 50.44	26.14 score on a scale Interval -27.73 to 80.01

PRIMARY outcome

Timeframe: Change from Baseline to 12 weeks

Population: Only individuals who provided data were analyzed.

The emotional Stroop is a test of response inhibition. There are four category conditions: aggression, color, negative, and positive. Scores were derived based on the difference between the median latency of neutral condition subtracted from median latency of category conditions (unit=miliseconds) with higher scores equaling better problem-solving. Score range did not exceed -500 to 500.

Outcome measures

Measure	Problem-Solving Treatment n=12 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=7 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Emotional Stroop Aggression	59.21 score on a scale Interval -24.19 to 142.6	13.50 score on a scale Interval -52.15 to 79.15
Emotional Stroop Color	123.00 score on a scale Interval 33.49 to 212.51	59.49 score on a scale Interval -123.77 to 242.74
Emotional Stroop Negative	55.50 score on a scale Interval -77.95 to 188.95	72.71 score on a scale Interval -101.21 to 246.64
Emotional Stroop Positive	97.67 score on a scale Interval 22.15 to 173.18	71.14 score on a scale Interval -80.86 to 223.15

SECONDARY outcome

Timeframe: Change from Baseline to 12 weeks, Baseline to 6 months

Population: Only individuals who provided data were analyzed.

Feelings of burdensomeness and belongingness will be measured by the Interpersonal Needs Questionnaire (INQ). This measure is 18-item self-report questionnaire. The belonging subscale is 6 items and scores range from 6-42 with higher scores indicating less belonging, the burdensomeness subscale is 9 items and scores range from 9-63 with higher scores indicating greater burdensomeness.

Outcome measures

Measure	Problem-Solving Treatment n=19 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=18 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Interpersonal Needs Questionnaire Belonging - follow-up	-2.37 score on a scale Interval -8.05 to 3.31	-.81 score on a scale Interval -6.54 to 4.91
Interpersonal Needs Questionnaire Burden-follow-up	-4.37 score on a scale Interval -7.44 to -1.29	-.5 score on a scale Interval -3.96 to 2.96
Interpersonal Needs Questionnaire Belonging-6 months	-.4 score on a scale Interval -5.26 to 4.46	-.79 score on a scale Interval -3.72 to 2.14
Interpersonal Needs Questionnaire Burden - 6 months	-3.2 score on a scale Interval -6.37 to -0.03	.11 score on a scale Interval -4.22 to 4.43

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 12 weeks and Baseline to 6 months

Population: Only individuals who provided data were analyzed.

Columbia-Suicide Severity Rating Scale (C-SSRS) is the gold standard for suicide assessment and measures level and intensity of suicidal ideation, planning and preparation for suicidal behavior, and method and lethality of recent (past week) and past lifetime suicidal behavior. The intensity of ideation subscale (the summed score from five separate items on Part II; subscale range = 2-25) will be the primary dependent variable for the fully powered clinical trial. The intensity of ideation asks about the intensity of ideation in the past 6 months (e.g., the frequency, duration controllability). Higher scores are equal to greater ideation.

Outcome measures

Measure	Problem-Solving Treatment n=11 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=14 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Columbia-Suicide Severity Rating Scale (C-SSRS) follow-up	-.82 score on a scale Interval -3.38 to 1.75	-1.14 score on a scale Interval -4.08 to 1.79
Columbia-Suicide Severity Rating Scale (C-SSRS) 6-months	-1.23 score on a scale Interval -5.01 to 2.54	-.5 score on a scale Interval -3.43 to 2.43

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 12 weeks

Population: Only individuals who provided data were analyzed.

Suicide Ideation Questionnaire (SIQ) is a 30-item self-report instrument designed to assess thoughts about suicide experienced during the prior month. This measure has strong internal consistency and construct validity. This measure will allow for supplementary investigation of ideation. Scores range from 7-210 with higher equaling worse ideation.

Outcome measures

Measure	Problem-Solving Treatment n=18 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=16 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Suicide Ideation Questionnaire (SIQ).	-19.28 score on a scale Interval -33.09 to -5.47	-2.88 score on a scale Interval -17.29 to 11.54

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 6 months

Population: Only individuals who provided data were analyzed.

Suicide Ideation Questionnaire (SIQ) is a 30-item self-report instrument designed to assess thoughts about suicide experienced during the prior month. This measure has strong internal consistency and construct validity. This measure will allow for supplementary investigation of ideation. Scores range from 7-210 with higher equaling worse ideation.

Outcome measures

Measure	Problem-Solving Treatment n=14 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=18 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Suicide Ideation Questionnaire (SIQ).	-21.71 score on a scale Interval -39.95 to -3.48	-7.0 score on a scale Interval -19.51 to 5.51

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 12 weeks

Population: Only individuals who provided data were analyzed.

The Suicide-Related Coping Scale captures an individual's perceived ability to use internal and external coping to problem-solve suicidal thoughts and urges. This measure was validated in a Veteran sample. The items in this measure capture the types of skills we expect Veterans to be able to use after learning problem-solving (i.e., "I recognize the circumstances that make me suicidal"). Scores range from 0-68 with higher scores indicating better coping.

Outcome measures

Measure	Problem-Solving Treatment n=17 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=16 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Suicide-Related Coping Scale	1.94 score on a scale Interval -2.76 to 6.64	4.06 score on a scale Interval -1.63 to 9.75

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 6 months

Population: Only individuals who provided data were analyzed.

The Suicide-Related Coping Scale captures an individual's perceived ability to use internal and external coping to problem-solve suicidal thoughts and urges. This measure was validated in a Veteran sample. The items in this measure capture the types of skills we expect Veterans to be able to use after learning problem-solving (i.e., "I recognize the circumstances that make me suicidal"). Scores range from 0-68 with higher scores indicating better coping.

Outcome measures

Measure	Problem-Solving Treatment n=15 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=18 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Suicide-Related Coping Scale	1.53 score on a scale Interval -3.09 to 6.16	3.33 score on a scale Interval -1.51 to 8.18

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 12 weeks

Population: Only individuals who provided data were analyzed.

Pain Disability Index (PDI) is a 7 item measure of the impact of pain on daily activities and social relationships. It will be used to assess disability from pain. The PDI ranges from 0-70 with higher scores indicating worse disability from pain.

Outcome measures

Measure	Problem-Solving Treatment n=16 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=16 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Pain Disability Index (PDI)	-4.88 score on a scale Interval -9.88 to 0.13	2.13 score on a scale Interval -4.13 to 8.38

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 6 months

Population: Only individuals who provided data were analyzed.

Pain Disability Index (PDI) is a 7 item measure of the impact of pain on daily activities and social relationships. It will be used to assess disability from pain.The PDI ranges from 0-70 with higher scores indicating worse disability from pain.

Outcome measures

Measure	Problem-Solving Treatment n=14 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=18 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Pain Disability Index (PDI)	-2.79 score on a scale Interval -8.26 to 2.69	1.06 score on a scale Interval -4.29 to 6.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 12 weeks

Population: Only individuals who provided data were analyzed.

Brief Pain Inventory (BPI) measure of pain severity and interference. The total severity composite score ranges from 0-10 with higher scores indicating worse pain. The total pain interference score ranges from 0-10 with higher scores indicating more interference.

Outcome measures

Measure	Problem-Solving Treatment n=19 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=13 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Brief Pain Inventory (BPI) Composition	.33 score on a scale Interval -0.18 to 0.84	-.13 score on a scale Interval -0.67 to 0.4
Brief Pain Inventory (BPI) Interference	-.2 score on a scale Interval -1.37 to 0.96	.77 score on a scale Interval -0.13 to 1.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to 6 months

Population: Only individuals who provided data were analyzed.

Brief Pain Inventory (BPI) measure of pain severity and interference. The total severity composite score ranges from 0-10 with higher scores indicating worse pain. The total pain interference score ranges from 0-10 with higher scores indicating more interference.

Outcome measures

Measure	Problem-Solving Treatment n=15 Participants Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=18 Participants Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Brief Pain Inventory (BPI) Composite Score	.82 score on a scale Interval -0.04 to 1.68	-.18 score on a scale Interval -0.95 to 0.59
Brief Pain Inventory (BPI) Interference	.58 score on a scale Interval -0.81 to 1.97	-.29 score on a scale Interval -1.34 to 0.75

Adverse Events

Problem-Solving Treatment

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Supportive Psychotherapy

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Problem-Solving Treatment n=22 participants at risk Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=22 participants at risk Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Psychiatric disorders Increase in psychiatric symptoms	13.6% 3/22 • Number of events 3 • 6-months Adverse events were counts tabulated medical vs. psychiatric.	9.1% 2/22 • Number of events 2 • 6-months Adverse events were counts tabulated medical vs. psychiatric.
Cardiac disorders Suspected transient ischemic attack	4.5% 1/22 • Number of events 1 • 6-months Adverse events were counts tabulated medical vs. psychiatric.	0.00% 0/22 • 6-months Adverse events were counts tabulated medical vs. psychiatric.
Gastrointestinal disorders Increase in GI symptoms	4.5% 1/22 • Number of events 2 • 6-months Adverse events were counts tabulated medical vs. psychiatric.	4.5% 1/22 • Number of events 1 • 6-months Adverse events were counts tabulated medical vs. psychiatric.
Endocrine disorders High blood sugar	4.5% 1/22 • Number of events 1 • 6-months Adverse events were counts tabulated medical vs. psychiatric.	0.00% 0/22 • 6-months Adverse events were counts tabulated medical vs. psychiatric.

Other adverse events

Measure	Problem-Solving Treatment n=22 participants at risk Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring. Problem-solving treatment: included in arm descriptions	Supportive Psychotherapy n=22 participants at risk Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video. Supportive Psychotherapy: included in arm descriptions
Psychiatric disorders Psychiatric adverse event	13.6% 3/22 • Number of events 4 • 6-months Adverse events were counts tabulated medical vs. psychiatric.	9.1% 2/22 • Number of events 2 • 6-months Adverse events were counts tabulated medical vs. psychiatric.
Investigations Medical adverse event	86.4% 19/22 • Number of events 29 • 6-months Adverse events were counts tabulated medical vs. psychiatric.	63.6% 14/22 • Number of events 37 • 6-months Adverse events were counts tabulated medical vs. psychiatric.

Additional Information

Lisa McAndrew

US Department of Veterans Affairs

Phone: 862-400-3317

Email: lisa.mcandrew@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place