跳至主要内容
临床试验/NCT05290311
NCT05290311已完成不适用

What Are the Long-Term Effects of Cognitive-Behavioural Therapy on Quality of Life in Adult Patients With ADHD?

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2022年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
155
试验地点
1
主要终点
Quality of life, measured with the Adult ADHD Quality of life scale (AAQoL)

研究概览

简要总结

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.

详细描述

Background of the study:

Cognitive behavioral therapy (CBT) in adult patients with ADHD teaches the patient strategies to compensate for the problems their symptoms produce in daily life. Next to this, CBT achieves to challenge the negative cognitions which patients with ADHD have developed because of their symptoms during lifetime. Research during the previous years has shown that CBT is effective in reducing ADHD symptoms in adult patients. Little research is done about the effects of CBT on quality of life (QoL). The largest study so far assessing QoL in adult patients with ADHD is conducted by Wettstein et al. (2021). The authors compared patients that received CBT next to pharmacotherapy with patients that received pharmacotherapy only on the Adult ADHD Quality of Life (AAQoL) scale. No difference has been found between both groups post-treatment. As CBT teaches strategies that have to be learned and trained over time, it is likely that also effects on QoL might require time to develop. Support for this theory has been found by Cherkasova et al. (2020) that compared CBT-alone with CBT in combination with pharmacotherapy in adult patients with ADHD. While the CBT-only condition scored significantly lower on ADHD-symptom ratings compared to the combination group, these differences became smaller and even insignificant after six months. Other publications report a similar effect for measures of self-esteem and self-efficacy after CBT for ADHD in adults.

Primary Objective:

To identify whether CBT in combination with pharmacotherapy improves the quality of life in adult patients with ADHD four to eight years after treatment. To identify if CBT in addition to pharmacotherapy is associated with increased medication use and by this, symptom control, over time. An attempt is done to understand how CBT works in the long term by measuring self-esteem and self-efficacy in patients that did or did not chose for CBT treatment. To understand the impact of CBT treatment on the economic position of the patient, an estimate of the socioeconomic status will be assessed.

Study Design:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 5 to 10 minutes

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.

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

时间窗: 5 minutes

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.

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

时间窗: 5 minutes

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.

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

时间窗: 5 to 10 minutes

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.

Medication status, measured with a multiple-choice question

时间窗: < 5 minutes

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

CBT strategy use, measured with a multiple-choice question

时间窗: 5 minutes

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.

Socioeconomic status

时间窗: 5 minutes

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.

次要结局

未报告次要终点

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

R.K.R.W. Wettstein

Research Coordinator

Amsterdam UMC, location VUmc

研究点 (1)

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