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A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Emotion Regulation Intervention for ADHD
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years old or older A diagnosis of ADHD Current problems with emotion regulation as indicated with a score above 80 on the Difficulties in Emotion Regulation Scale (DERS) Access to a smartphone Exclusion Criteria: Current self-reported diagnosis of severe psychiatric illness such as ongoing substance abuse or psychosis. High risk of suicidality, as indicated by a) has attempted suicide within the last year, b) has previously attempted suicide and reports suicidal ideation, or c) reports current ideations and has a plan or preferred method. Other ongoing psychological treatment for ADHD or other psychiatric illnesses.

Sites / Locations

  • University of BergenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Emotion regulation Intervention

Arm Description

An 8-week blended intervention targeting emotion dysregulation in ADHD

Outcomes

Primary Outcome Measures

The Credibility and Expectancy Questionnaire (CEQ)
The third item from the The Credibility and Expectancy Questionnaire (CEQ) will be used to assess treatment credibility. The third item states "How confident would you be in recommending this treatment to a friend with similar challenges? The item is rated on a scale from 1 (none at all confident) to 9 (very confident)
Open questions on treatment satisfaction
At the post-intervention assessment, the participants will be asked whether they are likely to continue using the exercises from the intervention in the future and whether they have experienced any adverse events, where the participants will have the option to elaborate in an open text-field. There will also be conducted qualitative interviews with the participants to examine their experiences (positive and negative) with the program.
Treatment adherence
Number of attended group sessions and number of completed homework assignments

Secondary Outcome Measures

Difficulties in Emotion Regulation Scale (DERS)
The measure is a self-report questionnaire that is commonly used to assess emotion dysregulation in clinical populations. The scale includes 36 items rated on a 5-point scale ranging from "Never" (1) to "Almost always" (5), yielding a total score of between 36 - 180, where a higher score indicate a higher degree of emotion dysregulation.
The Adult ADHD Self-Rating Scale (ASRS)
The scale assesses symptoms of inattention (nine items), and symptoms of hyperactivity-impulsivity (nine items) and includes a total of 18 items. The response type consists of a 5-point scale with options "Never" (0), "Rarely" (1), "Sometimes" (2), "Often" (3) or "Very Often" (4) giving the scale a maximum score of 72 for full-scale ASRS and 36 on each of the two subscales of inattention and hyperactivity-impulsivity. A higher score indicate a higher severity in symptoms.
The Adult ADHD Quality of Life Measure (AAQoL)
The measure assesses quality of life during the past two weeks and is specifically developed for adults with ADHD. The scale comprises 29 items rated on a scale from "Not at all/Never" (1) to "Extremely/Very Often" (5), yielding a total score between 0 - 100 points. The scale also included four subscales: life productivity, psychological health, life outlook, and relationships, all yielding a score between 0 - 100 points. A higher score indicates better quality of life.
Hospital Anxiety and Depression Scale (HADS)
The scale examine symptoms of depression and anxiety. The scale consists of 14 items with response options ranging from 0-3, with 3 being the most severe level of symptoms. The scale yields one total score, ranging from 0-42, and one subscale score from depression, and one subscale for anxiety, ranging from 0-21.
The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A)
The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A) is a self-report questionnaire assessing executive functioning in everyday life. The scale consists of 75 items and are rates on a 3-point scale from "Never" (1) to "Often" (3).

Full Information

First Posted
November 21, 2022
Last Updated
December 1, 2022
Sponsor
University of Bergen
Collaborators
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05644028
Brief Title
A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults With ADHD
Official Title
A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bergen
Collaborators
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adults with ADHD.
Detailed Description
Adults with ADHD with co-occurring deficits in emotion regulation are expected to have more severe impairment than those without such deficits in several life domains. Both pharmacological and psychological treatment interventions for adults with ADHD tend to target core symptoms of inattention and hyperactivity, and there are few available interventions targeting emotional symptoms. The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in ADHD. The intervention consists of eight face-to-face group sessions and a companion app to be used by the participants between the sessions for skills training. The investigators seek to recruit between 15 to 20 adults with ADHD to participate in the pilot study. Feasibility outcomes include adherence, treatment satisfaction and treatment credibility. Self-report questionnaires assessing emotion dysregulation, ADHD symptoms, quality of life, anxiety and depression will be used to examine preliminary clinical effects. There will also be conducted qualitative process interviews to examine the participants expectations and experiences with the program. The investigators expect the intervention to be feasible and to find positive preliminary effects. The findings from the study will be of importance for to further improve the intervention for for a future randomized-controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emotion regulation Intervention
Arm Type
Experimental
Arm Description
An 8-week blended intervention targeting emotion dysregulation in ADHD
Intervention Type
Behavioral
Intervention Name(s)
Emotion Regulation Intervention for ADHD
Intervention Description
The intervention will be based on principles from dialectic behavioral therapy. The overall aim of the intervention is to improve emotion regulation skills. The intervention will consist of eight face-to-face group sessions and a digital companion app that the participants can use to practice skills between the sessions. The groups will include mindfulness-based exercises, homework review, introduction to new skills, and peer discussions.
Primary Outcome Measure Information:
Title
The Credibility and Expectancy Questionnaire (CEQ)
Description
The third item from the The Credibility and Expectancy Questionnaire (CEQ) will be used to assess treatment credibility. The third item states "How confident would you be in recommending this treatment to a friend with similar challenges? The item is rated on a scale from 1 (none at all confident) to 9 (very confident)
Time Frame
Up to 12 weeks
Title
Open questions on treatment satisfaction
Description
At the post-intervention assessment, the participants will be asked whether they are likely to continue using the exercises from the intervention in the future and whether they have experienced any adverse events, where the participants will have the option to elaborate in an open text-field. There will also be conducted qualitative interviews with the participants to examine their experiences (positive and negative) with the program.
Time Frame
Up to 12 weeks
Title
Treatment adherence
Description
Number of attended group sessions and number of completed homework assignments
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
The measure is a self-report questionnaire that is commonly used to assess emotion dysregulation in clinical populations. The scale includes 36 items rated on a 5-point scale ranging from "Never" (1) to "Almost always" (5), yielding a total score of between 36 - 180, where a higher score indicate a higher degree of emotion dysregulation.
Time Frame
Up to 12 weeks
Title
The Adult ADHD Self-Rating Scale (ASRS)
Description
The scale assesses symptoms of inattention (nine items), and symptoms of hyperactivity-impulsivity (nine items) and includes a total of 18 items. The response type consists of a 5-point scale with options "Never" (0), "Rarely" (1), "Sometimes" (2), "Often" (3) or "Very Often" (4) giving the scale a maximum score of 72 for full-scale ASRS and 36 on each of the two subscales of inattention and hyperactivity-impulsivity. A higher score indicate a higher severity in symptoms.
Time Frame
Up to 12 weeks
Title
The Adult ADHD Quality of Life Measure (AAQoL)
Description
The measure assesses quality of life during the past two weeks and is specifically developed for adults with ADHD. The scale comprises 29 items rated on a scale from "Not at all/Never" (1) to "Extremely/Very Often" (5), yielding a total score between 0 - 100 points. The scale also included four subscales: life productivity, psychological health, life outlook, and relationships, all yielding a score between 0 - 100 points. A higher score indicates better quality of life.
Time Frame
Up to 12 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The scale examine symptoms of depression and anxiety. The scale consists of 14 items with response options ranging from 0-3, with 3 being the most severe level of symptoms. The scale yields one total score, ranging from 0-42, and one subscale score from depression, and one subscale for anxiety, ranging from 0-21.
Time Frame
Up to 12 weeks
Title
The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A)
Description
The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A) is a self-report questionnaire assessing executive functioning in everyday life. The scale consists of 75 items and are rates on a 3-point scale from "Never" (1) to "Often" (3).
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old or older A diagnosis of ADHD Current problems with emotion regulation as indicated with a score above 80 on the Difficulties in Emotion Regulation Scale (DERS) Access to a smartphone Exclusion Criteria: Current self-reported diagnosis of severe psychiatric illness such as ongoing substance abuse or psychosis. High risk of suicidality, as indicated by a) has attempted suicide within the last year, b) has previously attempted suicide and reports suicidal ideation, or c) reports current ideations and has a plan or preferred method. Other ongoing psychological treatment for ADHD or other psychiatric illnesses.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie Nordby, Cand. Psychol
Phone
45440197
Ext
+47
Email
emilie.nordby@uib.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astri Lundervold, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen
City
Bergen
State/Province
Vestland
ZIP/Postal Code
5019
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Nordby

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults With ADHD

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