Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).

Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.

Telephone interview

Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.

Cognitive Behavioral Therapy

Suzanne C Danhauer, Ph.D

The purpose of this research is to assess the feasibility of administering a telephone-based intervention to treat depression and anxiety in Hispanic cancer survivors.

Primary Objectives

* To assess the feasibility (participation, accrual, retention, adherence) of administering the intervention in Hispanic cancer survivors.
* To culturally adapt an existing behavioral intervention for cancer survivors based on stakeholder feedback.

Exploratory Objectives

* To summarize emotional distress (anxiety, depressive symptoms) and fear of recurrence in these post-treatment Hispanic cancer survivors.
* To describe the therapy process in terms of satisfaction with treatment and the therapist-participant relationship.

Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors

To determine participation rate, investigators will track the total number of individuals approached, the number of individuals who met all eligibility criteria and percent who agree to participate.

Accrual rates will be calculated by calculating the mean number of participants recruited per month.

Study retention will be estimated by the proportion of participants who complete the Week 13 visit. Drop-out is defined as 100% minus the dropout %

Intervention adherence will be estimated as the mean percentage of therapy or check-in sessions each participant completes. Participants must complete at least 9 of the 12 sessions (75%) to be considered adherent.

The General Anxiety Disorder (GAD)-7 is a self-report measure of DSM-IV symptoms of general anxiety disorder. Participants rate 7 questions on a scale of 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day); one additional question assesses the interference of these symptoms with functioning. The first 7 questions are summed to create a total score. Scoring range is 0-21 with the higher score indicating a higher level of anxiety (scores 0 to less than or equal to 9 = no/mild anxiety; scores greater than or equal to 10 to less than or equal to 14 = moderate anxiety; scores greater than or equal to 15 to 21 = severe anxiety).

The Patient Health Questionnaire (PHQ)-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder. Participants rate how often they have experienced nine symptoms over the past 2 weeks on a scale of 0 (not at all); 1 (several days), 2 (more than half the days) and 3 (nearly every day). Responses are summed, with higher scores indicating greater depressive symptomatology. Scoring scale = 0-27 (scores 0 to less than or equal to 7 = no/mild depressive symptoms; scores greater than or equal to 8 to less than or equal to 14 = moderate depressive symptoms; scores greater than or equal to 15 to 27 = severe depressive symptoms)

The Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence. This 9-item subscale measures the presence and severity of the intrusive thoughts or images associated with the fear of recurrence. Scoring scale ranges from 0 (not at all or never) to 4 (a great deal or all of the time). Score ranges from 0-36. The higher the score, the greater the participants' fear of recurrence.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).

Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.

Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.

Spots Global Cancer Trial Database for Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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