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Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder

Primary Purpose

ADHD

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive behavioral therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Over 18 years old of age. Can read and write in Swedish. Have access to a computer, tablet, or smartphone with an Internet connection. Have previously been diagnosed with ADHD. Are studying at a university or college in Sweden or working at least 50% of a full time-employment. Exclusion Criteria: Shows elevated symptoms of depression or risk of suicide, i.e., a total score on the Patient Health Questionnaire - 9 items (PHQ-9; Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001)), > 15 points, or scores > 2 points on question i) concerning suicidality. Has started or changed their medication for any psychiatric diagnosis in the last three months. Exhibits another form of psychiatric diagnosis that requires more specialized care, for example substance abuse syndrome, anorexia nervosa, bipolar disorder, psychotic symptoms, or schizophrenia, as assessed with the MINI (Sheehan et al., 1998).

Sites / Locations

  • Uppsala UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based cognitive behavioral therapy

Wait-list control

Arm Description

Outcomes

Primary Outcome Measures

Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
The AAQoL (Brod et al., 2015; Brod, Johnston, Able, & Swindle, 2006) is a disease-specific quality of life measure for adults with ADHD. The instrument measures quality of life-consequences of ADHD in four domains using and consists of 29 items. The instrument has excellent internal consistency (Cronbach's α = .93 for the overall measure). One example of an item is "In the last two weeks, how hard has it been for you to remember important things?", scored on a five-point Likert-like scale from "Not at all/Never" (1) to "Extremely/Very Often" (5). The scale ranges from 0 to 145.
Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
The AAQoL (Brod et al., 2015; Brod, Johnston, Able, & Swindle, 2006) is a disease-specific quality of life measure for adults with ADHD. The instrument measures quality of life-consequences of ADHD in four domains using and consists of 29 items. The instrument has excellent internal consistency (Cronbach's α = .93 for the overall measure). One example of an item is "In the last two weeks, how hard has it been for you to remember important things?", scored on a five-point Likert-like scale from "Not at all/Never" (1) to "Extremely/Very Often" (5). The scale ranges from 0 to 145.
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
The ASRS is an instrument that measures ADHD-symptoms (Kessler et al., 2005). The instrument consists of 18 items that correspond to the 18 symptom-criteria for ADHD found in the DSM-IV-TR (Association, 2000). Of these 18 questions, six have been identified as most predictive of ADHD-symptoms. The overall range of the entire measure is 0 to 72. However, there are separate items focusing on attention and hyperactivity.
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
The ASRS is an instrument that measures ADHD-symptoms (Kessler et al., 2005). The instrument consists of 18 items that correspond to the 18 symptom-criteria for ADHD found in the DSM-IV-TR (Association, 2000). Of these 18 questions, six have been identified as most predictive of ADHD-symptoms. The overall range of the entire measure is 0 to 72. However, there are separate items focusing on attention and hyperactivity.

Secondary Outcome Measures

Generalized Anxiety Disorder - 7 Items (GAD-7)
The GAD-7 is an instrument that measures anxiety (Spitzer, Kroenke, Williams, & Löwe, 2006). Its internal consistency is excellent (Cronbach's α = .92), and it has good test-retest reliability (IntraClass Correlation = .83; Spitzer et al., 2006). The instrument includes seven items and has a single-factor solution. The score ranges from 0 to 21 points and the items range from 0 ("Not at all") to 3 ("Nearly every day"; Spitzer et al., 2006). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Feeling nervous, anxious, or on edge."
Generalized Anxiety Disorder - 7 Items (GAD-7)
The GAD-7 is an instrument that measures anxiety (Spitzer, Kroenke, Williams, & Löwe, 2006). Its internal consistency is excellent (Cronbach's α = .92), and it has good test-retest reliability (IntraClass Correlation = .83; Spitzer et al., 2006). The instrument includes seven items and has a single-factor solution. The score ranges from 0 to 21 points and the items range from 0 ("Not at all") to 3 ("Nearly every day"; Spitzer et al., 2006). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Feeling nervous, anxious, or on edge."
Patient Health Questionnaire - 9 Items (PHQ-9)
The PHQ-9 is a nine-item instrument measuring depression. It has excellent internal consistency (Cronbach's α = .89) and a good test-retest correlation (r = .84; Kroenke et al., 2001). The instrument has a single-factor solution. The score ranges from 0 to 27 points (Kroenke, Spitzer, & Williams, 2001). Items range from 0 ("Not at all") to 3 ("Nearly every day"). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Little interest or pleasure in doing things."
Patient Health Questionnaire - 9 Items (PHQ-9)
The PHQ-9 is a nine-item instrument measuring depression. It has excellent internal consistency (Cronbach's α = .89) and a good test-retest correlation (r = .84; Kroenke et al., 2001). The instrument has a single-factor solution. The score ranges from 0 to 27 points (Kroenke, Spitzer, & Williams, 2001). Items range from 0 ("Not at all") to 3 ("Nearly every day"). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Little interest or pleasure in doing things."
Perceived Stress scale (PSS)
The PSS is an instrument that evaluates the subjective experience of general stress in various situations and is scored on a five-point Likert-scale 0-4 ("Never" to "Very often"), with seven items being scored in reverse (items 4-7, 9-10, and 13). The PSS includes 14 items in total and has been shown to have good internal consistency (Cronbach's α = .84-.86) as well as good convergent and discriminant validity (Cohen, Kamarck, & Mermelstein, 1983).
Perceived Stress scale (PSS)
The PSS is an instrument that evaluates the subjective experience of general stress in various situations and is scored on a five-point Likert-scale 0-4 ("Never" to "Very often"), with seven items being scored in reverse (items 4-7, 9-10, and 13). The PSS includes 14 items in total and has been shown to have good internal consistency (Cronbach's α = .84-.86) as well as good convergent and discriminant validity (Cohen, Kamarck, & Mermelstein, 1983).
Negative Effects Questionnaire (NEQ)
The NEQ is a 32-item instrument that assesses unwanted and adverse events experienced by patients undergoing psychotherapy (Rozental, Kottorp, Boettcher, Andersson, & Carlbring, 2016; Rozental et al., 2019), e.g., "I experienced more unpleasant feelings". It is comprised of six factors: symptoms, quality, dependency, stigma, hopelessness, and failure. The internal consistency for the full instrument is excellent (Cronbach's α = .95), and is scored on several dimensions; 1) "Did you experience this?" (yes/no), 2) "If yes - here is how negatively it affected me", from 0 ("Not at all") to 4 ("Extremely"), and 3) "Probably caused by" ("The treatment I received" or "Other circumstances").

Full Information

First Posted
December 21, 2022
Last Updated
October 3, 2023
Sponsor
Karolinska Institutet
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT05700539
Brief Title
Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
Official Title
A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder in Sweden
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Attention deficit hyperactivity disorder (ADHD) is a disorder characterized by lack of attention, hyperactivity, and impulsivity. It can have major impact on everyday life and result in negative consequences for one's personal, academic, and work situation. For individuals with symptoms of ADHD, increased levels of anxiety and depression are common, and an overall reduction of quality of life is often present. This study protocol describes a clinical trial of internet-based cognitive behavioral therapy (iCBT), using a randomized controlled study design, with the primary aim to increase quality of life, as well as to reduce symptoms of ADHD, anxiety, depression, and stress. A second aim is to investigate, by qualitative means, what aspects of treatment were perceived as helpful and hindering when it comes to completing iCBT. Two hundred participants with symptoms of ADHD will be included and randomized to two conditions (treatment and wait-list control). The treatment period is comprised of ten weeks, with two mandatory modules and ten modules from which the participants can choose freely. Self-report measures are completed by the participants at baseline and end of treatment, as well as at a six-month follow-up. The treatment is guided by therapists and consists of weekly correspondence with the participants. The study will utilize an intention to treat design, with ANOVAs and Reliable Change Index to evaluate treatment effects. The qualitative part of the project will be interview-based and employ thematic analysis. Lastly, a psychometric evaluation of a common instrument for determining ADHD-symptoms will also be made. The results will hopefully contribute to the evidence base for iCBT for individuals with symptoms of ADHD and help disseminate potentially effective interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-based cognitive behavioral therapy
Arm Type
Experimental
Arm Title
Wait-list control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavioral therapy
Intervention Description
A ten-week treatment based on cognitive behavioral therapy for ADHD, including two mandatory modules and at least four self-selected modules (out of ten available modules). The treatment consists of reading material and exercises to be completed each week.
Primary Outcome Measure Information:
Title
Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
Description
The AAQoL (Brod et al., 2015; Brod, Johnston, Able, & Swindle, 2006) is a disease-specific quality of life measure for adults with ADHD. The instrument measures quality of life-consequences of ADHD in four domains using and consists of 29 items. The instrument has excellent internal consistency (Cronbach's α = .93 for the overall measure). One example of an item is "In the last two weeks, how hard has it been for you to remember important things?", scored on a five-point Likert-like scale from "Not at all/Never" (1) to "Extremely/Very Often" (5). The scale ranges from 0 to 145.
Time Frame
Change in quality of life from baseline to 10 week (i.e., post-treatment)
Title
Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
Description
The AAQoL (Brod et al., 2015; Brod, Johnston, Able, & Swindle, 2006) is a disease-specific quality of life measure for adults with ADHD. The instrument measures quality of life-consequences of ADHD in four domains using and consists of 29 items. The instrument has excellent internal consistency (Cronbach's α = .93 for the overall measure). One example of an item is "In the last two weeks, how hard has it been for you to remember important things?", scored on a five-point Likert-like scale from "Not at all/Never" (1) to "Extremely/Very Often" (5). The scale ranges from 0 to 145.
Time Frame
Change in quality of life from baseline six-month follow-up
Title
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
Description
The ASRS is an instrument that measures ADHD-symptoms (Kessler et al., 2005). The instrument consists of 18 items that correspond to the 18 symptom-criteria for ADHD found in the DSM-IV-TR (Association, 2000). Of these 18 questions, six have been identified as most predictive of ADHD-symptoms. The overall range of the entire measure is 0 to 72. However, there are separate items focusing on attention and hyperactivity.
Time Frame
Change in ADHD symptoms from baseline to 10 week (i.e., post-treatment)
Title
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
Description
The ASRS is an instrument that measures ADHD-symptoms (Kessler et al., 2005). The instrument consists of 18 items that correspond to the 18 symptom-criteria for ADHD found in the DSM-IV-TR (Association, 2000). Of these 18 questions, six have been identified as most predictive of ADHD-symptoms. The overall range of the entire measure is 0 to 72. However, there are separate items focusing on attention and hyperactivity.
Time Frame
Change in ADHD symptoms from baseline to six-month follow-up
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder - 7 Items (GAD-7)
Description
The GAD-7 is an instrument that measures anxiety (Spitzer, Kroenke, Williams, & Löwe, 2006). Its internal consistency is excellent (Cronbach's α = .92), and it has good test-retest reliability (IntraClass Correlation = .83; Spitzer et al., 2006). The instrument includes seven items and has a single-factor solution. The score ranges from 0 to 21 points and the items range from 0 ("Not at all") to 3 ("Nearly every day"; Spitzer et al., 2006). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Feeling nervous, anxious, or on edge."
Time Frame
Change in anxiety symptoms from baseline to 10 week (i.e., post-treatment)
Title
Generalized Anxiety Disorder - 7 Items (GAD-7)
Description
The GAD-7 is an instrument that measures anxiety (Spitzer, Kroenke, Williams, & Löwe, 2006). Its internal consistency is excellent (Cronbach's α = .92), and it has good test-retest reliability (IntraClass Correlation = .83; Spitzer et al., 2006). The instrument includes seven items and has a single-factor solution. The score ranges from 0 to 21 points and the items range from 0 ("Not at all") to 3 ("Nearly every day"; Spitzer et al., 2006). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Feeling nervous, anxious, or on edge."
Time Frame
Change in anxiety symptoms from baseline to six-month follow-up
Title
Patient Health Questionnaire - 9 Items (PHQ-9)
Description
The PHQ-9 is a nine-item instrument measuring depression. It has excellent internal consistency (Cronbach's α = .89) and a good test-retest correlation (r = .84; Kroenke et al., 2001). The instrument has a single-factor solution. The score ranges from 0 to 27 points (Kroenke, Spitzer, & Williams, 2001). Items range from 0 ("Not at all") to 3 ("Nearly every day"). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Little interest or pleasure in doing things."
Time Frame
Change in depressive symptoms from baseline to 10 week (i.e., post-treatment)
Title
Patient Health Questionnaire - 9 Items (PHQ-9)
Description
The PHQ-9 is a nine-item instrument measuring depression. It has excellent internal consistency (Cronbach's α = .89) and a good test-retest correlation (r = .84; Kroenke et al., 2001). The instrument has a single-factor solution. The score ranges from 0 to 27 points (Kroenke, Spitzer, & Williams, 2001). Items range from 0 ("Not at all") to 3 ("Nearly every day"). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Little interest or pleasure in doing things."
Time Frame
Change in depressive symptoms from baseline to six-month follow-up
Title
Perceived Stress scale (PSS)
Description
The PSS is an instrument that evaluates the subjective experience of general stress in various situations and is scored on a five-point Likert-scale 0-4 ("Never" to "Very often"), with seven items being scored in reverse (items 4-7, 9-10, and 13). The PSS includes 14 items in total and has been shown to have good internal consistency (Cronbach's α = .84-.86) as well as good convergent and discriminant validity (Cohen, Kamarck, & Mermelstein, 1983).
Time Frame
Change in stress symptoms from baseline to 10 week (i.e., post-treatment)
Title
Perceived Stress scale (PSS)
Description
The PSS is an instrument that evaluates the subjective experience of general stress in various situations and is scored on a five-point Likert-scale 0-4 ("Never" to "Very often"), with seven items being scored in reverse (items 4-7, 9-10, and 13). The PSS includes 14 items in total and has been shown to have good internal consistency (Cronbach's α = .84-.86) as well as good convergent and discriminant validity (Cohen, Kamarck, & Mermelstein, 1983).
Time Frame
Change in stress symptoms from baseline to six-month follow-up
Title
Negative Effects Questionnaire (NEQ)
Description
The NEQ is a 32-item instrument that assesses unwanted and adverse events experienced by patients undergoing psychotherapy (Rozental, Kottorp, Boettcher, Andersson, & Carlbring, 2016; Rozental et al., 2019), e.g., "I experienced more unpleasant feelings". It is comprised of six factors: symptoms, quality, dependency, stigma, hopelessness, and failure. The internal consistency for the full instrument is excellent (Cronbach's α = .95), and is scored on several dimensions; 1) "Did you experience this?" (yes/no), 2) "If yes - here is how negatively it affected me", from 0 ("Not at all") to 4 ("Extremely"), and 3) "Probably caused by" ("The treatment I received" or "Other circumstances").
Time Frame
Incidence of negative effects of psychological treatment from baseline to post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over 18 years old of age. Can read and write in Swedish. Have access to a computer, tablet, or smartphone with an Internet connection. Have previously been diagnosed with ADHD. Are studying at a university or college in Sweden or working at least 50% of a full time-employment. Exclusion Criteria: Shows elevated symptoms of depression or risk of suicide, i.e., a total score on the Patient Health Questionnaire - 9 items (PHQ-9; Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001)), > 15 points, or scores > 2 points on question i) concerning suicidality. Has started or changed their medication for any psychiatric diagnosis in the last three months. Exhibits another form of psychiatric diagnosis that requires more specialized care, for example substance abuse syndrome, anorexia nervosa, bipolar disorder, psychotic symptoms, or schizophrenia, as assessed with the MINI (Sheehan et al., 1998).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Rozental, PhD
Phone
+46(0)736937948
Email
alexander.rozental@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Buhrman, PhD
Phone
+46(0)733468539
Email
monica.buhrman@psyk.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Forsström, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University
City
Uppsala
ZIP/Postal Code
751 42
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Forsström, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder

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