A Comparison of Group Cognitive Behavioural Therapy (CBT) and Structured Activity Group for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT06604845 | Enrolling By Invitation

• 2 other identifiers: EPM Dnr 2024-02227-012023-01505
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Many adults with attention deficit hyperactivity disorder (ADHD) experience difficulties with inattention, planning and impulsivity that impacts work and social life negatively also after treatment with medication. There are various psychological treatments aiming to improve these symptoms, but it is not known if they work or not. The goal of this clinical trial is to evaluate group cognitive behavioural therapy (CBT) for adults with attention deficit hyperactivity disorder (ADHD) in comparison to an active control group consisting of a discussion and activity group. Previous research suggests that group CBT works about equally well as other structured group activities. The main questions the researchers aim to answer are if group CBT work better than activity groups to:

• Improve symptoms of ADHD
• Improve general mental health and life quality
• Improve every-day functioning The researchers also want to learn if group CBT or activity groups work better for some people with ADHD depending on individual characteristics such as
• type of symptoms, age, gender or co-occurring psychiatric diagnoses. The comparison is a manualised structured activity group given at the same number of sessions and same group size. All participants will visit our clinics at 12 occasions. They will:
• Fill in questionnaires before and after the group intervention, and online after 6 and 12 months
• Do cognitive testing before and after the intervention

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Attention Deficit Hyperactivity Disorder (ADHD); Cognitive Behavioral Therapy; Controlled Clinical Trials, Randomized; Adults

Outcome Measures

Primary Outcomes (2)

• Change in Adult ADHD Self-Report Scale (ASRS)

  ASRS is a self-reported symptom questionnaire for adults with ADHD. It has 18 questions about how often the participant experiences a certain symptom, with five response choices ranging from 0 (never) to 4 (very often) points.

  From enrollment to the follow-up 12 months after end of treatment

• Change in Clinical Global Impressions-Severity (CGI-S)

  CGI-S is a 7-point scale where the clinician rate the severity of the patients illness at the time of assessment.

  At enrollment and after 12 weeks at end of treatment

Secondary Outcomes (4)

• Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)

  From enrollment to the follow-up 12 months after end of treatment

• Brunnsviken Brief Quality of Life Inventory (BBQ)

  From enrollment to the follow-up 12 months after end of treatment

• Colour word Interference Test (CWIT)

  At enrollment and after 12 weeks at end of treatment

• Trail Making Test (TMT)

  At enrollment and after 12 weeks at end of treatment

Other Outcomes (1)

• Treatment Credibility questionnaire (TCS)

  At enrollment and after 12 weeks at end of treatment

Study Arms (2)

Group cognitive behavioural therapy

EXPERIMENTAL

Group CBT based on an adapted version of individual CBT for ADHD according to Safren's manual "CBT for ADHD/Mastering Your Adult ADHD".

Behavioral: Group cognitive behavioural therapy (CBT)

Activity group

ACTIVE COMPARATOR

The Activity group is a structured manualised group intervention designed by clinicians and researchers at Sahlgrenska University Hosptial.

Other: Activity group

Interventions

Group cognitive behavioural therapy (CBT) BEHAVIORAL

CBT based on Safren's manual "CBT for ADHD/Mastering Your Adult ADHD"20 adapted for group format. The program includes psychoeducation and cognitive restructuring and aims to improve ADHD symptoms, especially planning, organisation, attention and adaptive thinking. The CBT groups will meet at the clinic weekly for 12 weeks for 2 hours including a break in the middle. The groups are led by two clinicians.

Group cognitive behavioural therapy

Activity group OTHER

The Activity group is a structured manualised group intervention designed for this and planned future studies of psychosocial treatments for adults with ADHD and/or autism. The program includes group discussions, peer-sharing and social every-day life activities. The Activity groups will meet at the clinic weekly for 12 weeks for 2 hours including a break in the middle. The groups are led by two trainers.

Activity group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 20, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)