Protocol Overview

May 12, 2010

The Expert Review Panel has not reviewed this measure yet.

This protocol is divided into two separate parts. The first part contains the subsections of the Composite International Diagnostic Interview - Short Form (CIDI-SF) that screen for the presence or absence of generalized anxiety disorder, specific phobia, social phobia, agoraphobia and panic attack. The second part contains specific questions from the Symptom Check List 90 (SCL-90) that provide a more quantitative measure of anxiety symptom severity.

The Psychiatric Working Group has recommended that the portions of the Composite International Diagnostic Interview - Short Form (CIDI-SF) be used separately to screen for specific disorders in the PhenX Toolkit. Specifically, the entire instrument is included as the PhenX Measure General Psychiatric Assessment, section A is included as a protocol for the PhenX Measure of Depression, section I is included as a protocol for the PhenX Measure of Obsessive Compulsive Disorders, and sections B, C, D, E and F are included as a protocol Anxiety Disorders. Therefore, selecting the General Psychiatric Assessment measure in combination with Depression, Obsessive Compulsive Disorder and / or Anxiety Disorders will result in selecting the same protocol multiple times.

The Symptom Checklist 90 (SCL-90) is a proprietary, fee-based instrument that is available from Pearson Education, Inc.

Part I: Anxiety Screener from the Composite International Diagnostic Interview - Short Form

Editor’s Note: Question numbers have been altered to be consistent within the PhenX Toolkit. Original question numbers are found in parentheses at the end of each question.

Generalized Anxiety Disorder Section

1. Have you ever had a period lasting one month or longer when most of the time you felt worried, tense, or anxious? (B1)

1a. People differ a lot in how much they worry about things. Did you ever have a time when you worried a lot more than most people would in your situation? (B1a)

[if 1a=1]

2. What is the longest period of time that this kind of worrying has ever continued? (B2)

__________ years and __________ months

or __________ all of my life/as long as I can remember

[if 2 is less than 6 months, go to Specific Phobia]

Please think of the period in your life when you have felt worried, tense, anxious, or more worried than most people would in your situation. This could be in the past, or it could be continuing now.

3. During that period, was your worry stronger than in other people? (B4)

4. Did you worry most days? (B5)

5. Did you usually worry about one particular thing, such as your job security or the failing health of a loved one, or more than one thing? (B6)

6. Did you find it difficult to stop worrying? (B7)

7. Did you ever have different worries on your mind at the same time? (B8)

8. How often was your worry so strong that you couldn’t put it out of your mind no matter how hard you tried? (B9)

9. How often did you find it difficult to control your worry? (B10)

10. When you were worried or anxious, were you also: (B12)

11. Did you ever tell a professional about these problems (medical doctor, psychologist, social worker, counselor, nurse, clergy, or other helping professional)? (B14)

12. Did you take medication or use drugs or alcohol more than once for the worry or the problems it was causing? (B15)

13. How much did the worry or anxiety interfere with your life or activities? (B16)

Specific Phobia Section

14. The next questions are about things that make some people so afraid that they avoid them, even when there is no real danger. (C1)

Do you have an unreasonably strong fear or avoid any of the following things:

[If 0 Yes responses to 14 series, go to Social Phobia Section]

[repeat the following statement for the rest of Specific Phobia Section]

Please think of the situations that you fear such as:

15. How often do you get upset when you are in that situation? (C2)

16. How long have you had any of these fears? (C4)

17. How much have any of these fears ever interfered with your life or activities? (C5)

18. Have you ever been very upset with yourself for having any of these fears? (C6)

19. Is your fear unreasonable - that is, much stronger than it should be? (C7)

20. Is your fear much stronger than in other people? (C8)

Social Phobia Section

21. Here’s another list of situations that can cause unreasonably strong fears. They involve doing things in front of other people or being the center of attention. Do you have an unreasonably strong fear or avoid any of the following situations: (D1)

[if 0 Yes responses to 21 series, go to Agoraphobia Section]

[repeat the following statement for the rest of Social Section]

Please think only of the situation(s) that cause you unreasonably strong fears such as:

22. How often do you get very upset when you are in this situation? (D2)

23. How long have you had any of these fears? (D3)

24. How much have any of these fears ever interfered with your life or activities? (D4)

25. Have you ever been very upset with yourself for having any of these fears? (D5)

26. Is your fear unreasonable - that is, much stronger than it should be? (D6)

27. Is your fear much stronger than in other people? (D7)

Agoraphobia Section

28. Here’s a final list of situations that can cause unreasonably strong fears. Do you have an unreasonably strong fear for or avoid any of the following: (E1)

[if 0 Yes responses to 28 series, go to Panic Attack Section]

[repeat the following statement between 29-34]

Please think only of the situation(s) that cause you to have unreasonably strong fears, such as:

29. How often do you get very upset in the situation? (E2)

30. How long have you had any of these fears? (E4)

31. Were you ever afraid that you might faint, lose control, or embarrass yourself in other ways? (E5)

32. Do you worry that you might be trapped without any way to escape? (E6)

33. Do you worry that help might not be available if you needed it? (E7)

34. How much did any of these fears ever interfere with your life or activities? (E8)

Panic Attack Section

35. Did you ever have a spell or an attack when all of a sudden you felt frightened, anxious, or very uneasy? (F1)

35a. Did any of these attacks occur when you were in a life-threatening situation? (F1a)

[if skip, go to 35b]

35b. Did any of these attacks occur when you were not in a life-threatening situation? (F1b)

36. About how many attacks have you had in your life? (F2)

Please enter the number of attacks you have had in your life in the box below.

__________

37. How long ago did you have the most recent attack? (F3)

__________ months ago (enter 0 if you had one in the past month)

38. Did some of your attacks happen in a situation when you were not in danger or not the center of attention? (F4)

39. We already asked about specific situations that cause unreasonably strong fears (heights, elevators, snakes, etc.).

When you have sudden anxiety attacks, do they usually occur in specific situations that cause you unreasonably strong fear? (F5)

39a. Did you ever have an attack when you were not in a situation that usually causes you to have unreasonably strong fears? (F5a)

40. When you have attacks: (F6)

Scoring Instructions

Detailed scoring information can be found in the following pdf: Please see scoring information in the following pdf: CIDI_SF_scoring.pdf

Part II: Symptom Assessment from the Symptom Check List 90

The Psychiatric Working Group recommends that investigators ask respondents questions 2, 11, 17, 23, 24, 33, 39, 57, 63, 67, 72, 74, 78, 80, 81, 86 from the Symptom Checklist 90. In the Symptom Checklist 90, the respondent rates symptoms that include nervousness, irritation, outbursts, and restlessness on a scale of 0 to 4 (with 0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit and 4 = extremely) which best describes how much that problem has bothered them in the last 4 weeks.

Symptom Checklist-90-Revised (SCL-90-R). Copyright © 1975, 2004 Leonard R. Derogatis, Ph.D. Published and distributed exclusively by NCS Pearson, Inc. All rights reserved.

"SCL-90-R" is a trademark of Leonard R. Derogatis, Ph.D.

Export Variables

Variable Name	Variable ID	Variable Description	Version	Mapping
PX120202_GAD_Worried_Two_Weeks	PX120202010000	Have you ever had a period lasting one month or longer when most of the time you felt worried, tense, or anxious?	4	N/A
PX120202_GAD_Worried_More_Than_Others	PX120202010100	People differ a lot in how much they worry about things. Did you ever have a time when you worried a lot more than most people would in your situation?	4	N/A
PX120202_GAD_Longest_Time_Worried_Years	PX120202020100	What is the longest period of time that this kind of worrying has ever continued? (Years)	4	N/A
PX120202_GAD_Longest_Time_Worried_Months	PX120202020200	What is the longest period of time that this kind of worrying has ever continued? (Months)	4	N/A
PX120202_GAD_Longest_Time_Worried_Always	PX120202020300	What is the longest period of time that this kind of worrying has ever continued?	4	N/A
PX120202_GAD_Longest_Period_Stronger_Worry	PX120202030000	During that period, was your worry stronger than in other people?	4	N/A
PX120202_GAD_Worry_Most_Days	PX120202040000	Did you worry most days?	4	N/A
PX120202_GAD_Worry_One_Particular_Thing	PX120202050000	Did you usually worry about one particular thing, such as your job security or the failing health of a loved one, or more than one thing?	4	N/A
PX120202_GAD_Difficult_Stop_Worry	PX120202060000	Did you find it difficult to stop worrying?	4	N/A
PX120202_GAD_Different_Worries_Same_Time	PX120202070000	Did you ever have different worries on your mind at the same time?	4	N/A
PX120202_GAD_Worry_Constantly_On_Mind	PX120202080000	How often was your worry so strong that you couldn't put it out of your mind no matter how hard you tried?	4	N/A
PX120202_GAD_Difficult_Control_Worry	PX120202090000	How often did you find it difficult to control your worry?	4	N/A
PX120202_GAD_Also_Restless	PX120202100100	When you were worried or anxious, were you also: Restless?	4	N/A
PX120202_GAD_Also_On_Edge	PX120202100200	When you were worried or anxious, were you also: Keyed up or on edge?	4	N/A
PX120202_GAD_Also_Easily_Tired	PX120202100300	When you were worried or anxious, were you also: Easily tired?	4	N/A
PX120202_GAD_Also_Difficulty_Concentrating	PX120202100400	When you were worried or anxious, were you also: Having difficulty keeping your mind on what you were doing?	4	N/A
PX120202_GAD_Also_Irritable	PX120202100500	When you were worried or anxious, were you also: More irritable than usual?	4	N/A
PX120202_GAD_Also_Tense	PX120202100600	When you were worried or anxious, were you also: Having tense, sore, or aching muscles?	4	N/A
PX120202_GAD_Also_Trouble_Sleeping	PX120202100700	When you were worried or anxious, were you also: Often having trouble falling or staying asleep?	4	N/A
PX120202_GAD_Tell_Professional	PX120202110000	Did you ever tell a professional about these problems (medical doctor, psychologist, social worker, counselor, nurse, clergy, or other helping professional)?	4	N/A
PX120202_GAD_Take_Medication	PX120202120000	Did you take medication or use drugs or alcohol more than once for the worry or the problems it was causing?	4	N/A
PX120202_GAD_Interfere_Activities	PX120202130000	How much did the worry or anxiety interfere with your life or activities?	4	N/A
PX120202_Specific_Water	PX120202140100	Do you have an unreasonably strong fear or avoid any of the following things: Heights, storms, thunder, lightning, or being in still water, like a swimming pool or lakes?	4	N/A
PX120202_Specific_Enclosed_Space	PX120202140200	Do you have an unreasonably strong fear or avoid any of the following things: Being in a closed space like a cave, tunnel, elevator, or airplane?	4	N/A
PX120202_Specific_Animals	PX120202140300	Do you have an unreasonably strong fear or avoid any of the following things: Snakes, birds, rats, bugs, or other animals?	4	N/A
PX120202_Specific_Blood	PX120202140400	Do you have an unreasonably strong fear or avoid any of the following things: Seeing blood, getting a shot or injection, seeing a dentist, or going to a hospital?	4	N/A
PX120202_Specific_How_Often_Upset	PX120202150100	Please think of the situations that you fear such as [Insert situations respondent feared from Section 14]. How often do you get upset when you are in that situation?	4	N/A
PX120202_Specific_How_Long_Had_Fears	PX120202160100	Please think of the situations that you fear such as [Insert situations respondent feared from Section 14]. How long have you had any of these fears?	4	N/A
PX120202_Specific_How_Long_Had_Fears_SpecifyMonths	PX120202160101	Please think of the situations that you fear such as [Insert situations respondent feared from Section 14]. How long have you had any of these fears?	4	N/A
PX120202_Specific_Interfere_Activities	PX120202170100	Please think of the situations that you fear such as [Insert situations respondent feared from Section 14]. How much have any of these fears ever interfered with your life or activities?	4	N/A
PX120202_Specific_Upset_With_Self	PX120202180100	Please think of the situations that you fear such as [Insert situations respondent feared from Section 14]. Have you ever been very upset with yourself for having any of these fears?	4	N/A
PX120202_Specific_Fear_Unreasonable	PX120202190100	Please think of the situations that you fear such as [Insert situations respondent feared from Section 14]. Is your fear unreasonable - that is, much stronger than it should be?	4	N/A
PX120202_Specific_Fear_Stronger_Than_Others	PX120202200100	Please think of the situations that you fear such as [Insert situations respondent feared from Section 14]. Is your fear much stronger than in other people?	4	N/A
PX120202_Social_Speech	PX120202210100	Do you have an unreasonably strong fear or avoid any of the following situations: Giving a speech or speaking in public?	4	N/A
PX120202_Social_Public_Drinking	PX120202210200	Do you have an unreasonably strong fear or avoid any of the following situations: Eating or drinking where someone could watch you?	4	N/A
PX120202_Social_Sound_Foolish	PX120202210300	Do you have an unreasonably strong fear or avoid any of the following situations: Talking to people because you might have nothing to say or might sound foolish?	4	N/A
PX120202_Social_Writing	PX120202210400	Do you have an unreasonably strong fear or avoid any of the following situations: Writing while someone watches?	4	N/A
PX120202_Social_Speaking_Class_Meeting	PX120202210500	Do you have an unreasonably strong fear or avoid any of the following situations: Taking part or speaking in a meeting or class?	4	N/A
PX120202_Social_Party	PX120202210600	Do you have an unreasonably strong fear or avoid any of the following situations: Going to a party or other social outing?	4	N/A
PX120202_Social_How_Often_Upset	PX120202220100	Please think only of the situation(s) that cause you unreasonably strong fears such as [Insert situations respondent feared from Section 21]. How often do you get very upset when you are in this situation?	4	N/A
PX120202_Social_How_Long_Had_Fears	PX120202230100	Please think only of the situation(s) that cause you unreasonably strong fears such as [Insert situations respondent feared from Section 21]. How long have you had any of these fears?	4	N/A
PX120202_Social_How_Long_HadFears_Months	PX120202230101	Please think only of the situation(s) that cause you unreasonably strong fears such as [Insert situations respondent feared from Section 21]. How long have you had any of these fears?	4	N/A
PX120202_Social_Fears_Interfere_Activities	PX120202240100	Please think only of the situation(s) that cause you unreasonably strong fears such as [Insert situations respondent feared from Section 21]. How much have any of these fears ever interfered with your life or activities?	4	N/A
PX120202_Social_Upset_With_Self	PX120202250100	Please think only of the situation(s) that cause you unreasonably strong fears such as [Insert situations respondent feared from Section 21]. Have you ever been very upset with yourself for having any of these fears?	4	N/A
PX120202_Social_Unreasonable	PX120202260100	Please think only of the situation(s) that cause you unreasonably strong fears such as [Insert situations respondent feared from Section 21]. Is your fear unreasonable - that is, much stronger than it should be?	4	N/A
PX120202_Social_Fear_Stronger_Than_Others	PX120202270100	Please think only of the situation(s) that cause you unreasonably strong fears such as [Insert situations respondent feared from Section 21]. Is your fear much stronger than in other people?	4	N/A
PX120202_Agoraphobia_Crowd	PX120202280100	Do you have an unreasonably strong fear for or avoid any of the following: Being in a crowd or standing in line?	4	N/A
PX120202_Agoraphobia_Away_From_Home	PX120202280200	Do you have an unreasonably strong fear for or avoid any of the following: Being away from home alone?	4	N/A
PX120202_Agoraphobia_Travelling_Alone	PX120202280300	Do you have an unreasonably strong fear for or avoid any of the following: Traveling alone?	4	N/A
PX120202_Agoraphobia_Bus_Car_Train	PX120202280400	Do you have an unreasonably strong fear for or avoid any of the following: Traveling in a bus, train, or car?	4	N/A
PX120202_Agoraphobia_Public_Place	PX120202280500	Do you have an unreasonably strong fear for or avoid any of the following: Being in a public place like a department store?	4	N/A
PX120202_Agoraphobia_How_Often_Upset	PX120202290100	Please think only of the situation(s) that cause you to have unreasonably strong fears, such as [Insert situations respondent feared from Section 28]. How often do you get very upset in the situation?	4	N/A
PX120202_Agoraphobia_How_Long_Had_Fears	PX120202300100	Please think only of the situation(s) that cause you to have unreasonably strong fears, such as [Insert situations respondent feared from Section 28]. How long have you had any of these fears?	4	N/A
PX120202_Agoraphobia_HowLong_Had_Fears_Months	PX120202300101	Please think only of the situation(s) that cause you to have unreasonably strong fears, such as [Insert situations respondent feared from Section 28]. How long have you had any of these fears?	4	N/A
PX120202_Agoraphobia_Faint_Embarrass	PX120202310100	Please think only of the situation(s) that cause you to have unreasonably strong fears, such as [Insert situations respondent feared from Section 28]. Were you ever afraid that you might faint, lose control, or embarrass yourself in other ways?	4	N/A
PX120202_Agoraphobia_Trapped	PX120202320100	Please think only of the situation(s) that cause you to have unreasonably strong fears, such as [Insert situations respondent feared from Section 28]. Do you worry that you might be trapped without any way to escape?	4	N/A
PX120202_Agoraphobia_No_Help	PX120202330100	Please think only of the situation(s) that cause you to have unreasonably strong fears, such as [Insert situations respondent feared from Section 28]. Do you worry that help might not be available if you needed it?	4	N/A
PX120202_Agoraphobia_Interfere_With_Activities	PX120202340100	Please think only of the situation(s) that cause you to have unreasonably strong fears, such as [Insert situations respondent feared from Section 28]. How much did any of these fears ever interfere with your life or activities?	4	N/A
PX120202_Panic_Attack	PX120202350000	Did you ever have a spell or an attack when all of a sudden you felt frightened, anxious, or very uneasy?	4	N/A
PX120202_Panic_During_Life_Threatening_Situations	PX120202350100	Did any of these attacks occur when you were in a life-threatening situation?	4	N/A
PX120202_Panic_During_Nonlife_Threatening_Situations	PX120202350200	Did any of these attacks occur when you were not in a life-threatening situation?	4	N/A
PX120202_Panic_Number_Attacks	PX120202350300	About how many attacks have you had in your life?	4	N/A
PX120202_Panic_Number_Attacks_Coded	PX120202350301	About how many attacks have you had in your life?	4	N/A
PX120202_Panic_Occurrence_Most_Recent_Attack	PX120202350400	How long ago did you have the most recent attack?	4	N/A
PX120202_Panic_Occurrence_Most_Recent_Attack_Coded	PX120202350401	How long ago did you have the most recent attack?	4	N/A
PX120202_Panic_Occur_Not_Center_Of_Attention	PX120202360000	Did some of your attacks happen in a situation when you were not in danger or not the center of attention?	4	N/A
PX120202_Panic_Specific_Situations	PX120202370000	We already asked about specific situations that cause unreasonably strong fears (heights, elevators, snakes, etc.). When you have sudden anxiety attacks, do they usually occur in specific situations that cause you unreasonably strong fear?	4	N/A
PX120202_Panic_Attack_Random	PX120202370100	Did you ever have an attack when you were not in a situation that usually causes you to have unreasonably strong fears?	4	N/A
PX120202_Panic_Heart_Race	PX120202380100	When you have attacks: Does your heart pound or race?	4	N/A
PX120202_Panic_Chest_Stomach_Pain	PX120202380200	When you have attacks: Do you have tightness, pain, or discomfort in your chest or stomach?	4	N/A
PX120202_Panic_Sweat	PX120202380300	When you have attacks: Do you sweat?	4	N/A
PX120202_Panic_Shake	PX120202380400	When you have attacks: Do you tremble or shake?	4	N/A
PX120202_Panic_Hot_Flashes_Chills	PX120202380500	When you have attacks: Do you have hot flashes or chills?	4	N/A
PX120202_Panic_Things_Seem_Unreal	PX120202380600	When you have attacks: Do you, or things around you, seem unreal?	4	N/A

The Composite International Diagnostic Interview - Short Form (CIDI-SF) was selected to screen a general population for the presence of multiple Anxiety Disorders. It has been used on thousands of subjects in the US and around the world, is available in multiple formats, is easily administered by trained non-clinician interviewers, is well validated and provides screening criteria consistent with the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) and Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).

The Symptom Check List 90 was selected to provide a quantitative measure of anxiety symptoms rather than simply categorical diagnoses. The Symptom Check List 90 was vetted against several other dimensional measures of Anxiety Disorders and ultimately selected because it is easily administered as a self-reported instrument and captures general symptoms of anxiety.

Composite International Diagnostic Index - Short Form:

Kessler, R. C., Andrews, G., Mroczek, D., Ustun, T. B., & Wittchen, H-U. (1998). The World Health Organization Composite International Diagnostic Interview Short Form (CIDI-SF). International Journal of Methods in Psychiatric Research, 7(4), 171-185. (Sections B, C, D, E, F)

Symptom Check List 90:

Derogatis, L. R, Lipman, R. S., & Covi, L. (1973). SCL-90: an outpatient psychiatric rating scale--preliminary report. Psychopharmacology Bulletin, 9(1), 13-28.

The Symptom Check List 90 is published and distributed exclusively by NCS Pearson, Inc and can be obtained through:

Pearson
Attn: Customer Service
P.O. Box 599700
San Antonio, TX
78259

Telephone: 800.627.7271

Email: clinicalcustomersupport@pearson.com

Adult, Senior, Pregnancy

Arabic, Dutch, English, French, Mandarin Chinese, Spanish

Composite International Diagnostic Index - Short Form:

An individual age 18 or older.

Symptom Check List 90:

An individual age 13 and older with a 6th grade reading level.

Composite International Diagnostic Index - Short Form:

The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews*. The interviewer should be trained to prompt respondents further if a "don’t know" response is provided.

* There are multiple modes to administer this question (e.g., pencil and paper and computer-assisted interviews).

Symptom Check List 90:

No training or personnel required for self-administered questionnaire.

Composite International Diagnostic Index - Short Form:

While the source protocol was developed to be administered by a computer-assisted instrument, the PhenX Working Group acknowledges these questions can be administered in a non-computerized format (i.e. pencil and paper instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

Symptom Check List 90:

No equipment needed for self-administered questionnaire.

Standard	Name	ID	Source
Common Data Elements (CDE)	Adult Anxiety Disorder Assessment Score	3075412	CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)	Anx disorders screener adult proto	62716-6	LOINC

American Psychiatric Association (2000). Diagnostic and statistical manual of mental disorders: DSM-IV-TR. Washington, DC: Author.

Costello, E. J., Angold, A., Burns, B. J., Stangl, D. K., Tweed, D. L., Erkanli, A., & Worthman, C. M. (1996). The Great Smoky Mountains Study of Youth. Goals, design, methods, and the prevalence of DSM-III-R disorders. Archives of General Psychiatry, 53, 1129-1136.

Kessler, R. C., Chiu, W. T., Demler, O., & Walters, E. E. (2005). Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 62(6), 617-27.

Nelson, C. B., Kessler, R. C., & Mroczek, D. (Aug 2001). Scoring the World Health Organization’s Composite International Diagnostic Interview Short Form. (CIDI -SF V1.0 Nov 1998).

Self-administered or interviewer-administered questionnaire

None

Requirement Category	Required
Average time of greater than 15 minutes in an unaffected individual	No
Major equipment	No
Specialized requirements for biospecimen collection	No
Specialized training	No

The Expert Review Panel has not reviewed this measure yet.