Long-Term Effects of CBT on Quality of Life in Adults With ADHD

NCT05290311 | Completed DMC

• 1 other identifier: NL79674.018.22
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Background and objective: Although the short-term effects of cognitive behavioural therapy (CBT) in adult patients with ADHD are established, not a lot is known about longer-term effects. To assess the additive value of CBT to pharmacotherapy in the long term, an assessment of ADHD symptoms and quality of life in patients that followed CBT four to eight years ago is done. To understand how CBT impacts quality of life in patients, an assessment of self-efficacy and self-esteem is made. Furthermore, patients will be asked whether they currently still use medicine for ADHD and CBT strategies. To evaluate whether CBT impacts the economic situation of the patient, an assessment of income, occupation status and the housing situation of the patient is done. Study Design: As this is a follow-up, observational cohort study, the same patients from Wettstein et al. (2021) are invited for participation. During February and March, patients are informed via email about the study. Online, patients are asked to provide informed consent and are able to fill in the complete questionnaire. The duration of the questionnaire is 45 minutes and each patient is compensated with a 25 Euro gift card. Outcome variables: ADHD symptoms are measured on the ADHD-RS-IV, quality of life is measured on the AAQoL scale, self-efficacy is measured on the GSES, and self-esteem is measured on the RSES. Medication status, CBT strategy use and data about the socioeconomic status of the patient is asked in multiple choice questions.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

cognitive behavioural therapy; CBT; ADHD; self-esteem; self-efficacy; Rosenberg Self-Esteem Scale; Generalized Self-Efficacy Scale; long term outcomes; ADHD-RS-IV scale; AAQoL scale; socio-economic status; SES; income; occupation; housing situation

Outcome Measures

Primary Outcomes (7)

• Quality of life, measured with the Adult ADHD Quality of life scale (AAQoL)

  Quality of life is measured with the Adult ADHD Quality of life (AAQoL) Scale. Outcome is the mean change in total score from baseline and post-treatment to follow-up assessment. To calculate the total score, the domainscores of the subscales life productivity, relationships and psychological health are turned around. All scores are transverted to a scale of 100 (1 = 0, 2 = 25, 3 = 50, 4 = 75, 5 = 100). All scores are summed up and divided by the amount of items. The maximum score ranges from 0 to 100, with higher scores indicating a better life quality.

  5 to 10 minutes

• ADHD Symptoms, measured with the ADHD-RS-IV scale

  ADHD Symptoms are measured with the ADHD Rating Scale IV (ADHD-RS-IV). Outcome is the mean change in total score from baseline and post-treatment to follow-up assessment per group. Total scores range from 0 to 54, higher scores indicating more symptoms.

  5 to 10 minutes

• Self-Esteem, measured with the Rosenberg Self-Esteem Scale (RSES)

  Self-Esteem is measured with the Rosenberg Self-Esteem Scale. Outcome is the mean total score on the scale per group. Total scores range from 0 to 30 points, with higher scores indicating a higher self-esteem.

  5 minutes

• Self-Efficacy, measured with the Generalized Self-Efficacy Scale (GSES)

  Self-Efficacy is measured with the Generalized Self-Efficacy Scale. Outcome is the mean total score on the scale per group. Total scores range from 10 to 40 points, higher scores indicate high self-efficacy.

  5 minutes

• Medication status, measured with a multiple-choice question

  Medication status of the patient is measured with one multiple choice question. Outcome is the total number of participants currently using medication per group.

  < 5 minutes

• CBT strategy use, measured with a multiple-choice question

  Use of CBT strategies is measured by one multiple choice question. Outcome is the total number of participants currently using each strategy, as well as the average number of strategies used per group.

  5 minutes

• Socioeconomic status

  Socioeconomic status is measured by three open or multiple choice questions, one regarding income, one regarding occupation status and one regarding the housing situation of the patient. Outcome is the average income and the average distribution of the sample in occupation status and housing situation per group.

  5 minutes

Study Arms (2)

COMB

The 'combined' or 'COMB' group received cognitive behavioural therapy next to pharmacotherapy for ADHD in the past. Patients chose themselves whether or not they wanted to receive cognitive behavioural therapy.

Behavioral: cognitive behavioural therapy

PHA

The 'pharmacotherapy' group or 'PHA' received pharmacotherapy for ADHD only in the past. Patients chose themselves whether or not they wanted to receive cognitive behavioural therapy.

Interventions

cognitive behavioural therapy BEHAVIORAL

Cognitive behavioural therapy (CBT) was given according to the protocol of Safren (2004, 2005). Each participant followed one session of 60 minutes per week, for 10 to 16 weeks. Psychotherapists giving CBT had at least a master diploma.

Also known as: Pharmacotherapy

COMB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The gender distribution in the sample is approximately 1:1. All participants should be aged between 18 and 70 years. The estimation is based according to the original sample distribution.

You may qualify if:

• Participants of the study by Wettstein et al. (2021).

You may not qualify if:

• Not applicable as this is a follow-up study.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): collaborator

Study Sites (1)

ADHDcentraal

Amsterdam, North Holland, 1043CB, Netherlands

Location

Related Publications (1)

• Wettstein RKRW, Klabbers Y, Romijn E, Nieuwveen J, Kroesen JC, Wettstein KRM, Dumont GJH. [Cognitive behavioral therapy in combination with pharmacotherapy for adults with ADHD]. Tijdschr Psychiatr. 2021;63(7):550-556. Dutch.

  PMID: 34523707 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral Therapy; Drug Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics

Study Officials

• Glenn Dumont, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 22, 2022
• Study Start: July 13, 2022
• Primary Completion: December 13, 2022
• Study Completion: November 11, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)