Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation

ADHD Predominantly Inattentive Type Clinical Trial

Official title:

Group-Based Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04090983
• Other study ID #: KI-2019-02444
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using a randomized controlled design, standard treatment of group cognitive-behavioral therapy (CBT) according to the Hesslinger protocol is compared to a newly developed group treatment specifically designed for adult patients with ADHD inattentive presentation (ADHD-I) called CBT for ADHD-I (CADDI). Research setting is psychiatric outpatient clinics. Research hypotheses include: 1. The CADDI protocol is more effective than standard treatment in terms of behavioral activation, procrastination, depressive symptoms, functional impairment, and quality of life, 2. Is equally effective in terms of ADHD symptoms, 3. Is more appreciated and tolerable, and 4. Outcome is mediated by mindful awareness. Effects are followed up at 6 and 12 months post treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Principal diagnosis of ADHD inattentive presentation

2. 18 years of age or older

3. If on medication, it needs to be well-established since three months, and

4. Prior psycho-educational intervention

Exclusion Criteria:

1. Intellectual impairment

2. Substance use disorder

3. Difficulties in adherence to medical or other treatment

4. Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or

5. Simultaneous psychological treatment

Related Conditions & MeSH terms

• ADHD Predominantly Inattentive Type
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• Cognitive-behavioral therapy (Hesslinger protocol)
Cognitive-behavioral therapy in a group format focusing on improving symptoms of ADHD, specifically by using skills in counteracting hyperactivity and impulsiveness, and promoting mindful awareness.
• Cognitive-behavioral therapy (CADDI protocol)
Cognitive-behavioral therapy in a group format focusing on improving inattentive symptoms of ADHD, specifically by using skills in organizing, executing, and completing activity, and promoting mindful awareness.

Locations

Country	Name	City	State
Sweden	Psychiatry Centre Södertälje	Södertälje	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Activation for Depression Scale	Total score 0-150; higher scores represent increased activation	14 weeks
Primary	Pure Procrastination Scale	Total score 12-60; higher scores represent more procrastination	14 weeks