NCT05037903

Brief Summary

This is a qualitative study of participants who have taken part in a randomized controlled trial (RCT) of a new treatment protocol based on cognitive-behavioral therapy for adults with attention deficit/hyperactivity disorder predominantly inattentive presentation. The purpose of the qualitative study is to explore participant perceptions of taking part in the RCT to further develop and improve the new treatment protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

August 31, 2021

Last Update Submit

February 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Qualitative interview data

    Participant responses based on questions posed in an interview

    45-60 minutes

Study Arms (1)

Cognitive-behavioral therapy

EXPERIMENTAL

Cognitive-behavioral therapy, including behavioral exercises and homework assignments.

Behavioral: Cognitive-behavioral therapy

Interventions

Cognitive and behavioral interventions aimed at increasing behavioral activation, and reducing procrastination and inattentive symptoms.

Cognitive-behavioral therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Principal diagnosis of ADHD inattentive presentation
  • years of age or older
  • If on medication, it needs to be well-established since three months, and
  • Prior psycho-educational intervention

You may not qualify if:

  • Intellectual impairment
  • Substance use disorder
  • Difficulties in adherence to medical or other treatment
  • Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or
  • Simultaneous psychological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm Health Care Services, Region Stockholm

Stockholm, Sweden

Location

Related Publications (1)

  • Stralin EE, Sunnhed R, Thorell LB, Lundgren T, Bolte S, Bohman B. "It was very nice to be in a room where everyone had ADD-that's kind of VIP": Exploring clients' perceptions of group CBT for ADHD inattentive presentation. PLoS One. 2024 Jun 21;19(6):e0299060. doi: 10.1371/journal.pone.0299060. eCollection 2024.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Benjamin Bohman

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

July 1, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations