NCT03337425

Brief Summary

This pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-Norway. All participants will receive standard treatment during the intervention period. Assessment of client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS), and work participation will be conducted at time of recruitment prior to randomization (T0), pre- (T1), post-treatment (T2), with a 10 week follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

November 2, 2017

Last Update Submit

July 14, 2020

Conditions

Keywords

Psychotherapy, groupAdults

Outcome Measures

Primary Outcomes (2)

  • Change in patient satisfaction

    Measured with a modified version of the Client Satisfaction Questionnaire (CSQ-8). The scale consists of 8 items measured on a scale from 1 to 4. A sum score between 8 and 32 indicate the level of satisfaction with services provided.

    Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

  • Change in general self-efficacy

    Measured with General Self-Efficacy Scale (GSE-6), a short-form measure of self-efficacy. Self-efficacy is regarded as a protective factor in adapting to stress and chronic illness. The scale consists of 6 items, measured on a 4-point scale, with a possible range of 6-24.

    Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

Secondary Outcomes (3)

  • Change in ADHD-related symptoms (ASRS)

    Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

  • Change in ADHD-related symptoms (SCL-9)

    Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

  • Change in ADHD-related quality of life

    Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

Study Arms (2)

psychoeducational groups

EXPERIMENTAL

Psychoeducational group therapy and standard treatment (ADHD treatment as usual)

Behavioral: Psychoeducational group therapyOther: Standard treatment

Waiting list

ACTIVE COMPARATOR

Waiting list and standard treatment (ADHD treatment as usual)

Behavioral: Waiting listOther: Standard treatment

Interventions

The group-based psychoeducational program consists of 10 sessions, run over 10 consecutive weeks. Each session consist of a lecture, given by a recruited expert on the topic of the session (20 minutes) with a following discussion of the topic (45 minutes), facilitated by the course leader. All sessions are organized and led by the course leader, which also includes keeping structure in time, discussion and closing of the session. Psychoeducation comes in addition to standard treatment (ADHD treatment as usual).

psychoeducational groups
Waiting listBEHAVIORAL

Waiting list and standard treatment (ADHD treatment as usual)

Waiting list

Standard treatment consists of diagnostic assessment of ADHD and comorbidity, as well as treatment with medication. In addition, some patients receive cognitive behavioral therapy, although this is not systematically given to every patient. If needed, patients are also offered assistance with regard to economy, housing, education and work. As well as contact with family and network.

Also known as: Treatment as usual
Waiting listpsychoeducational groups

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed ADHD diagnosis
  • speaking a Scandinavian language

You may not qualify if:

  • not able or willing to give informed consent
  • psychosis
  • severe learning difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Levanger Hospital, Nord-Trøndelag Hospital Trust

Levanger, N-T, Norway

Location

Tiller DPS - St. Olavs University Hospital

Trondheim, S-T, 7040, Norway

Location

Related Publications (2)

  • Vaag JR, Lara-Cabrera ML, Hjemdal O, Gjervan B, Torgersen T. Psychoeducational groups versus waitlist in treatment of attention-deficit hyperactivity/impulsivity disorder (ADHD) in adults: a protocol for a pilot randomized waitlist-controlled multicenter trial. Pilot Feasibility Stud. 2019 Jan 23;5:17. doi: 10.1186/s40814-019-0401-1. eCollection 2019.

    PMID: 30693097BACKGROUND
  • Holsbrekken A, Skliarova T, Mandahl A, Saether SG, Lund AGS, Surkovic J, Sondenaa E, Vaag J, Torgersen T, Lara-Cabrera ML. Effects of a psychoeducational group intervention for adults diagnosed with ADHD: a pilot randomized controlled study. BMC Psychiatry. 2025 Oct 14;25(1):983. doi: 10.1186/s12888-025-07452-5.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Waiting ListsTherapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Terje Torgersen, phd

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: a Norwegian multicenter study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 9, 2017

Study Start

November 15, 2017

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations