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

ConditionADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Stockholm

About this trial

Many adults with attention deficit hyperactivity disorder (ADHD) experience difficulties with inattention, planning, impulsivity and emotion regulation 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 14 occasions. They will:

* Fill in questionnaires before and after the group intervention, and online after 6, 12 and 24 months * Do an interview with an independent trained clinician about their daily functioning and difficulties related to ADHD symptoms before and after the group intervention, and after 6, 12 and 24 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fulfilling criteria for ADHD

Motivation and practical possibility to participate in the treatment.

Disqualifiers

Ongoing psychosis

Ongoing suicidality/severe self-injury

Intellectual disability

Insufficient Swedish language skills.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group CBT based on DBT-skills training

    Behavioral

    The Swedish version manual of Hesslinger's DBT-based skills training for adults with ADHD. The program includes psychoeducation, skills training and mindfulness exercises and aims to improve ADHD symptoms, especially disorganised and dysfunctional behaviour, emotion dysregulation and impulse control. The skills training group will meet at the clinic weekly for 14 weeks for 2 hours including a break in the middle. The groups are led by two clinicians.

  • Activity group

    Behavioral

    The Activity group is a structured manualised group intervention designed for this as well as prior 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 14 weeks for 2 hours including a break in the middle. The groups are led by two trainers.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group CBT based on DBT-skills trainingExperimental treatment 1 intervention
Group B: Activity groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
2

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.

Time frame
Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months

Secondary outcomes

1

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

CORE-OM is a self-rating questionnaire covering general psychiatric symptoms, well-being and functioning. It has 34 questions about how often the participant experiences a certain symptom, with five response choices ranging from 0 (not at all) to 4 (most or all of the time) points.

Time frame
Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
2

Brunnsviken Brief Quality of Life Inventory (BBQ)

BBQ is a validated brief version of the self-rating Quality of Life Scale, with higher sensitivity to change. It consists of 12 statements and the participant indicates how much they agree with each statement in five response choices ranging from 0 (do not agree at all) to 4 (agree completely).

Time frame
Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
3

Difficulties in Emotion Regulation Scale, brief version (DERS-16)

DERS-16 is a validated brief version of the original 36 item self-assessment measuring clinically relevant difficulties in emotional regulation. DERS-16 consists of 16 questions about how often a statement applies to the participant, with five response choices ranging from 1-5 where 1 is almost never (0-10% of the time) and 5 is almost always (91-100%).

Time frame
Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months

Other outcomes

1

Treatment Credibility questionnaire (TCS)

Swedish version of the TCS for assessment of treatment fidelity and expectation in both participants with ADHD and clinicians administering the CBT and activity groups.

Time frame
After two sessions of CBT/activity group have been administered.
2

Negative Effects Questionnaire (NEQ)

A self-report measure for assessment of adverse events associated with psychological treatment. The 20 item version will be used, and participants rate a statement ranging from 0-4 where 0 is not at alls and 4 is extremely.

Time frame
Between 1-3 months after the last of the 14th weekly intervention session, at one occasion

Sponsors and contacts

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