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

ADHD Clinical Trial

Official title:

A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder in Sweden

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700539
• Other study ID #: DF0001
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Alexander Rozental, PhD
• Phone: +46(0)736937948
• Email: alexander.rozental[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: July 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Over 18 years old of age.

2. Can read and write in Swedish.

3. Have access to a computer, tablet, or smartphone with an Internet connection.

4. Have previously been diagnosed with ADHD.

5. Are studying at a university or college in Sweden or working at least 50% of a full time-employment.

Exclusion Criteria:

1. 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.

2. Has started or changed their medication for any psychiatric diagnosis in the last three months.

3. 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).

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• Internet-based cognitive behavioral therapy
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.

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a = .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.	Change in quality of life from baseline to 10 week (i.e., post-treatment)
Primary	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 a = .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.	Change in quality of life from baseline six-month follow-up
Primary	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.	Change in ADHD symptoms from baseline to 10 week (i.e., post-treatment)
Primary	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.	Change in ADHD symptoms from baseline to six-month follow-up
Secondary	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 a = .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."	Change in anxiety symptoms from baseline to 10 week (i.e., post-treatment)
Secondary	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 a = .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."	Change in anxiety symptoms from baseline to six-month follow-up
Secondary	Patient Health Questionnaire - 9 Items (PHQ-9)	The PHQ-9 is a nine-item instrument measuring depression. It has excellent internal consistency (Cronbach's a = .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."	Change in depressive symptoms from baseline to 10 week (i.e., post-treatment)
Secondary	Patient Health Questionnaire - 9 Items (PHQ-9)	The PHQ-9 is a nine-item instrument measuring depression. It has excellent internal consistency (Cronbach's a = .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."	Change in depressive symptoms from baseline to six-month follow-up
Secondary	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 a = .84-.86) as well as good convergent and discriminant validity (Cohen, Kamarck, & Mermelstein, 1983).	Change in stress symptoms from baseline to 10 week (i.e., post-treatment)
Secondary	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 a = .84-.86) as well as good convergent and discriminant validity (Cohen, Kamarck, & Mermelstein, 1983).	Change in stress symptoms from baseline to six-month follow-up
Secondary	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 a = .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").	Incidence of negative effects of psychological treatment from baseline to post-treatment