Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604845
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
A Comparison of Group Cognitive Behavioural Therapy CBT and Structured Activity Group for Adults With Attention Deficit Hyperactivity Disorder ADHD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-blind Randomised Controlled Trial of Group Cognitive Behavioural Therapy CBT Versus Activity Group Control Condition for Adults With Attention Deficit Hyperactivity Disorder ADHD
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Despite medical treatment many adults with ADHD experience residual symptoms that negatively affect work performance and social life Hence several psychological interventions targeting these symptoms have been developed but the treatment effects are still unclear due to lack of controlled clinical trials
In this single-blind randomised controlled clinical trial we will evaluate the effects of group CBT based on Safrens manual CBT for ADHDMastering Your Adult ADHD Safren SA et al Behav Res Ther 2005 compared to an active control group The control intervention is a manualised activity group that contains the same non-specific therapeutic elements as the treatment but no active CBT components For dose equivalence activity groups will be given with the same same number and length of sessions and the same frequency as the treatment conditions Since therapist experience is known to influence outcomes the activity groups will be held by staff with equivalent training and experience to those giving the treatment groups
Consenting patients assessed eligible for treatment will be randomly assigned to treatment or control group using a standard digital randomisation generator with an allocation of 11 Patients and clinicians rating outcomes will be blind to group assignment
Pre- and post intervention and at 6 months and 12 months follow-up the patients ADHD symptoms symptoms of anxiety and depression and general functioning will be assessed by experienced clinicians and with validated self-rating scales Treatment fidelity and expectation will be compared for the therapy and control groups and adverse events will be registered
An exact power calculation for estimation of sample sizes cannot be performed since effect sizes are not known Based on a previously published studies of Safrens CBT individually administered and general consensus of what is a clinically meaningful improvement in psychological treatments for other psychiatric diagnoses we expect that 60 patients per arm will be sufficient for detection of clinically relevant effect sizes of approximately Cohens d 03-04 A statistician will make a blind Bayesian stop analysis Svensson JE et al J Cereb Blood Flow Metab 2021 for every 20-25 patients and based on the results we can decide to halt the study if sufficient power has been achieved earlier than after 60 patients Full attrition analysis with intention to treat ITT analysis will be performed to investigate and minimize attrition bias
In this single-blind randomised controlled clinical trial we will evaluate the effects of group CBT based on Safrens manual CBT for ADHDMastering Your Adult ADHD Safren SA et al Behav Res Ther 2005 compared to an active control group The control intervention is a manualised activity group that contains the same non-specific therapeutic elements as the treatment but no active CBT components For dose equivalence activity groups will be given with the same same number and length of sessions and the same frequency as the treatment conditions Since therapist experience is known to influence outcomes the activity groups will be held by staff with equivalent training and experience to those giving the treatment groups
Consenting patients assessed eligible for treatment will be randomly assigned to treatment or control group using a standard digital randomisation generator with an allocation of 11 Patients and clinicians rating outcomes will be blind to group assignment
Pre- and post intervention and at 6 months and 12 months follow-up the patients ADHD symptoms symptoms of anxiety and depression and general functioning will be assessed by experienced clinicians and with validated self-rating scales Treatment fidelity and expectation will be compared for the therapy and control groups and adverse events will be registered
An exact power calculation for estimation of sample sizes cannot be performed since effect sizes are not known Based on a previously published studies of Safrens CBT individually administered and general consensus of what is a clinically meaningful improvement in psychological treatments for other psychiatric diagnoses we expect that 60 patients per arm will be sufficient for detection of clinically relevant effect sizes of approximately Cohens d 03-04 A statistician will make a blind Bayesian stop analysis Svensson JE et al J Cereb Blood Flow Metab 2021 for every 20-25 patients and based on the results we can decide to halt the study if sufficient power has been achieved earlier than after 60 patients Full attrition analysis with intention to treat ITT analysis will be performed to investigate and minimize attrition bias
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None