Trial Outcomes & Findings for Stepped-Care Telehealth for Distress in Cancer Survivors (NCT NCT03060096)

NCT ID: NCT03060096

Last Updated: 2024-02-28

Results Overview

Study retention will be estimated by the number of participants who complete the Week 7 and 13 visits

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

Randomization through completion of study at week 13

Results posted on

2024-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Moderate Anxiety/Depression: Low Intensity Stepped Care participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support. Moderate Anxiety/depression: Low Intensity Stepped care: The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.	Severe Anxiety/Depression: High Intensity Stepped Care Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally. Severe Anxiety/depression: High Intensity Stepped Care: The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.	Enhanced Usual Care Control (EUC) Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study. Enhanced Usual Care Control: Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.
Overall Study STARTED	19	15	34
Overall Study COMPLETED	16	12	32
Overall Study NOT COMPLETED	3	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stepped-Care Telehealth for Distress in Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate Anxiety/Depression: Low Intensity Stepped Care n=19 Participants participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support. Moderate Anxiety/depression: Low Intensity Stepped care: The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.	Severe Anxiety/Depression: High Intensity Stepped Care n=15 Participants Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally. Severe Anxiety/depression: High Intensity Stepped Care: The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.	Enhanced Usual Care Control (EUC) n=34 Participants Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study. Enhanced Usual Care Control: Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants	38 Participants n=4 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants	30 Participants n=4 Participants
Age, Continuous	65 years n=5 Participants	63 years n=7 Participants	62 years n=5 Participants	64 years n=4 Participants
Sex/Gender, Customized Female	18 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants	63 Participants n=4 Participants
Sex/Gender, Customized Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex/Gender, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants	60 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants	68 Participants n=4 Participants
Generalized Anxiety Disorder (GAD)-7 Score for Anxiety	8.5 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants	15.9 units on a scale STANDARD_DEVIATION 3.8 • n=7 Participants	11.4 units on a scale STANDARD_DEVIATION 5.1 • n=5 Participants	11.6 units on a scale STANDARD_DEVIATION 5.0 • n=4 Participants
Patient Health Questionnaire (PHQ)-9 Score for Depression	10.5 units on a scale STANDARD_DEVIATION 3.3 • n=5 Participants	17.4 units on a scale STANDARD_DEVIATION 3.2 • n=7 Participants	11.8 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	12.7 units on a scale STANDARD_DEVIATION 4.3 • n=4 Participants
Insomnia Severity Index (ISI)	14.0 units on a scale STANDARD_DEVIATION 4.5 • n=5 Participants	18.6 units on a scale STANDARD_DEVIATION 7.2 • n=7 Participants	13.8 units on a scale STANDARD_DEVIATION 6.3 • n=5 Participants	14.9 units on a scale STANDARD_DEVIATION 6.3 • n=4 Participants
PROMIS Fatigue t-Score	59.0 t-score STANDARD_DEVIATION 6.3 • n=5 Participants	64.8 t-score STANDARD_DEVIATION 7.9 • n=7 Participants	62.2 t-score STANDARD_DEVIATION 8.4 • n=5 Participants	61.9 t-score STANDARD_DEVIATION 7.9 • n=4 Participants
Fear of Recurrence Inventory Severity Subscale	21.4 units on a scale STANDARD_DEVIATION 8.8 • n=5 Participants	24.3 units on a scale STANDARD_DEVIATION 6.4 • n=7 Participants	22.8 units on a scale STANDARD_DEVIATION 7.9 • n=5 Participants	22.7 units on a scale STANDARD_DEVIATION 7.8 • n=4 Participants
Health Status Questionnaire (SF-36) Physical Health	40.9 units on a scale STANDARD_DEVIATION 10.5 • n=5 Participants	38.6 units on a scale STANDARD_DEVIATION 10.4 • n=7 Participants	39.1 units on a scale STANDARD_DEVIATION 10.1 • n=5 Participants	39.5 units on a scale STANDARD_DEVIATION 10.2 • n=4 Participants
Health Status Questionnaire (SF-36) Mental Health	37.4 units on a scale STANDARD_DEVIATION 10.4 • n=5 Participants	28.6 units on a scale STANDARD_DEVIATION 8.3 • n=7 Participants	36.1 units on a scale STANDARD_DEVIATION 11.3 • n=5 Participants	34.9 units on a scale STANDARD_DEVIATION 10.9 • n=4 Participants
Impact of Events Scale-Revised (IES-R) Total Score	4.0 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	5.4 units on a scale STANDARD_DEVIATION 2.6 • n=7 Participants	4.2 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants	4.4 units on a scale STANDARD_DEVIATION 2.4 • n=4 Participants

PRIMARY outcome

Timeframe: Randomization through completion of study at week 13

Study retention will be estimated by the number of participants who complete the Week 7 and 13 visits

Outcome measures

Outcome measures
Measure	Moderate Anxiety/Depression: Low Intensity Stepped Care n=19 Participants participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support. Moderate Anxiety/depression: Low Intensity Stepped care: The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.	Severe Anxiety/Depression: High Intensity Stepped Care n=15 Participants Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally. Severe Anxiety/depression: High Intensity Stepped Care: The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.	Enhanced Usual Care Control (EUC) n=34 Participants Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study. Enhanced Usual Care Control: Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.
Feasibility of Study Intervention Measured by Retention	16 Participants	12 Participants	32 Participants

PRIMARY outcome

Timeframe: Randomization through completion of study at week 13

Population: Adherence will be documented as the percentage of therapy sessions completed by each participant in the high intensity intervention group, or the percentage of check-in calls completed within the low intensity intervention group. Since the EUC involved no intervention, there was no data collected to assess adherence for this arm.

Intervention adherence will be estimated as the mean proportion of therapy (high-intensity intervention) or check-in (low-intensity intervention) sessions each participant completes.

Outcome measures

Outcome measures
Measure	Moderate Anxiety/Depression: Low Intensity Stepped Care n=19 Participants participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support. Moderate Anxiety/depression: Low Intensity Stepped care: The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.	Severe Anxiety/Depression: High Intensity Stepped Care n=15 Participants Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally. Severe Anxiety/depression: High Intensity Stepped Care: The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.	Enhanced Usual Care Control (EUC) Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study. Enhanced Usual Care Control: Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.
Feasibility of Study Intervention Measured by Adherence to Intervention	0.82 proportion of completed intervention Standard Deviation 0.34	0.78 proportion of completed intervention Standard Deviation 0.37	—

PRIMARY outcome

Timeframe: Screening through end of study at week 13

Population: All eligible people that were approached to enroll to this trial.

Recruitment rate will be determined by the number of eligible participants who met all eligibility criteria and percent who agreed to participate.

Outcome measures

Outcome measures
Measure	Moderate Anxiety/Depression: Low Intensity Stepped Care n=89 Participants participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support. Moderate Anxiety/depression: Low Intensity Stepped care: The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.	Severe Anxiety/Depression: High Intensity Stepped Care Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally. Severe Anxiety/depression: High Intensity Stepped Care: The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.	Enhanced Usual Care Control (EUC) Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study. Enhanced Usual Care Control: Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.
Feasibility of Study Intervention Measured by Recruitment Rate	68 Participants	—	—

PRIMARY outcome

Timeframe: Start of study screening time to end of study accrual

Population: All those enrolled.

The accrual rate is determined by dividing the overall number of participants recruited in each arm by the total span of 38 months between the start of the first screening for enrollment and the time the study closed to accrual.

Outcome measures

Outcome measures
Measure	Moderate Anxiety/Depression: Low Intensity Stepped Care n=19 Participants participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support. Moderate Anxiety/depression: Low Intensity Stepped care: The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.	Severe Anxiety/Depression: High Intensity Stepped Care n=15 Participants Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally. Severe Anxiety/depression: High Intensity Stepped Care: The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.	Enhanced Usual Care Control (EUC) n=34 Participants Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study. Enhanced Usual Care Control: Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.
Feasibility of Study Intervention Measured by Accrual Rate	0.5 participants per month	0.4 participants per month	0.9 participants per month

SECONDARY outcome

Timeframe: Screening or baseline (if >30 days since screening), Week 13

Population: Intent to treat analysis of all those participants that completed GAD-7 at baseline and at week 13.

The Generalized Anxiety Disorder (GAD) -7 is a self-report measure of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of Generalized Anxiety Disorder (GAD). Longitudinal changes in the GAD-7 will be measured in participants to evaluate the effectiveness of the intervention in reducing anxiety. Patients select 1 of 4 numbers with "0" indicating not all, to "3" indicating nearly everyday. The first 7 questions are summed to create a total score ranging from 0 to 21. Higher scores reflect greater anxiety severity. Scores above 10 are considered to be in the clinical range. GAD-7 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe anxiety, respectively.

Outcome measures

Outcome measures
Measure	Moderate Anxiety/Depression: Low Intensity Stepped Care n=16 Participants participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support. Moderate Anxiety/depression: Low Intensity Stepped care: The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.	Severe Anxiety/Depression: High Intensity Stepped Care n=12 Participants Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally. Severe Anxiety/depression: High Intensity Stepped Care: The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.	Enhanced Usual Care Control (EUC) n=34 Participants Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study. Enhanced Usual Care Control: Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.
Longitudinal Changes in the Generalized Anxiety Disorder (GAD)-7 Score for Anxiety From Baseline to 13 Weeks	-1.1 score on a scale Interval -3.8 to 1.5	-8.6 score on a scale Interval -11.4 to -5.7	-4.1 score on a scale Interval -6.3 to -1.8

SECONDARY outcome

Timeframe: Screening or baseline (if >30 days since screening), Week 13

Population: Intent to treat of all participants who have outcome at baseline and 13 weeks.

The PHQ-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder where participants rate how often they experienced 9 symptoms over past 2 weeks. Patients select 1 of 4 numbers with "0" indicating not all, to "3" indicating nearly everyday. Longitudinal changes in the PHQ-9 will be measured in participants to evaluate the effectiveness of the intervention in reducing depression. The possible range is 0-27. A larger score represents more severe depression level.

Outcome measures

Outcome measures
Measure	Moderate Anxiety/Depression: Low Intensity Stepped Care n=19 Participants participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support. Moderate Anxiety/depression: Low Intensity Stepped care: The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.	Severe Anxiety/Depression: High Intensity Stepped Care n=15 Participants Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally. Severe Anxiety/depression: High Intensity Stepped Care: The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.	Enhanced Usual Care Control (EUC) n=34 Participants Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study. Enhanced Usual Care Control: Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.
Longitudinal Changes in the Patient Health Questionnaire (PHQ-9) Score for Depression From Baseline to 13 Weeks	-2.0 score on a scale Interval -4.2 to 0.4	-8.8 score on a scale Interval -11.3 to -6.3	-3.2 score on a scale Interval -5.1 to -1.2

SECONDARY outcome

Timeframe: Week 13

Population: Intent to treat population of all those with data available at 13 weeks.

A combined variable will be created that indicates if a participant had moderate/severe depression or anxiety at mid- or post-intervention. This is defined as either PHQ-9 or GAD-7 greater than or equal to 15.