このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Group CBT for Paternal Perinatal Depression

2026年8月11日 更新者：Ryan Van Lieshout, MD, PhD、McMaster University

Group Cognitive Behavioural Therapy for Paternal Perinatal Depression: A Randomized Controlled Trial

The purpose of the proposed study is to determine the effectiveness of an online, 9-week group cognitive behavioural therapy (CBT) intervention for paternal perinatal depression (PND) in fathers and fathers-to-be. Fathers or fathers-to-be living in Ontario, Canada who have depression symptoms while their partner has been pregnant and/or during the first 18 months of their child's life will be assigned with a 50/50 chance (like flipping a coin) to receive online group CBT in addition to usual care, or to receive usual care only.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

This study will involve a randomized controlled trial (RCT) to determine the effectiveness of a 9-week group CBT intervention added to treatment as usual (TAU) compared to TAU alone for improving paternal perinatal depression symptoms. The primary objective is to determine the effectiveness of the intervention for treating paternal perinatal depression symptoms, and secondary objectives will assess whether the intervention leads to improvements in common comorbidities (anxiety) and complications (parenting stress, social isolation, partner relationship quality, parent-infant attachment, and offspring behaviour) and whether it is cost-effective.

112 participants will be assigned in a 1:1 ratio to the experimental or control group. Participants in both groups will complete online questionnaires and structured telephone interviews at baseline (T1), 9 weeks later (T2 - immediately post-intervention in the experimental group) and 6 months post-enrollment (T3). Those assigned to receive the 9-week CBT group will also be asked questions about their satisfaction with the program and recommendations for improvement.

研究の種類

介入

入学 (推定)

112

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Ryan J Van Lieshout, MD, PhD
  • 電話番号：35123 (905) 522-1155
  • メール：vanlierj@mcmaster.ca

研究場所

  • カナダ
    • Ontario
      • Hamilton、Ontario、カナダ、L8S4L8
        • McMaster University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Non-birthing individuals identifying as fathers-to-be (i.e., have a pregnant partner) or fathers who have an infant <18 months at recruitment
  • Fluent in written/spoken English
  • Have an EPDS score ≥9
  • Live in Ontario

Exclusion Criteria:

  • Free of bipolar, psychotic, borderline personality and current substance use disorders

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
介入なし：コントロール/通常のケア
NO介入グループに無作為化された参加者は、通常どおり治療を受け続けます（標準ケア）。 リソースのリストがメールで送信されます。
実験的：9-Week Group Cognitive Behavioural Therapy Intervention
The experimental group will receive a 9-week group CBT intervention in addition to receiving treatment as usual.
行動：父方の周産期うつ病に対する認知行動療法
認知行動療法（CBT）は、心理療法の一種です（トーク療法）。 毎週のグループセッションは2時間の長さで、週に1回連続で開催されます。 セッションの最初の1時間には、CBTスキルの教育と実践が含まれ、その後、父親の周産期うつ病の参加者に関連するトピックに関する1時間の非構造化された議論が含まれます。 各グループは、Zoomを介してオンラインで配信され、介入マニュアルによってガイドされます。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
時間枠：9 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of perinatal depression (PND). Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PND, ≥13 is consistent with probable PND and changes in scores >4 are accepted as being indicative of clinically significant change.
9 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
時間枠：6 months post enrollment
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PND. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PND, ≥13 is consistent with probable PND and changes in scores >4 are accepted as being indicative of clinically significant change.
6 months post enrollment
Anxiety Symptoms - GAD-7
時間枠：9 weeks
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) will be used to assess anxiety symptoms. The GAD-7 is a 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common comorbidity of PND. Items are scored on a 0-3 point scale with total scores ranging from 0-21. Higher scores indicate more severe anxiety symptoms.
9 weeks
Anxiety Symptoms - GAD-7
時間枠：6 months post enrollment
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) will be used to assess anxiety symptoms. The GAD-7 is a 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common comorbidity of PND. Items are scored on a 0-3 point scale with total scores ranging from 0-21. Higher scores indicate more severe anxiety symptoms.
6 months post enrollment
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
時間枠：9 weeks
A 36-item self-report measure of parenting stress. Items are scored on a 1-5 point scale with total scores ranging from 36-180. Higher scores indicate greater parenting stress.
9 weeks
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
時間枠：6 months post enrollment
A 36-item self-report measure of parenting stress. Items are scored on a 1-5 point scale with total scores ranging from 36-180. Higher scores indicate greater parenting stress.
6 months post enrollment
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
時間枠：9 weeks
A 32-item self-report measure assessing partner relationship quality. Items are rated on a 5-, 6-, or 7-point scale or yes/no response. Total scores range from 0-151, with higher scores indicating better relationship adjustment and quality.
9 weeks
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
時間枠：6 months post enrollment
A 32-item self-report measure assessing partner relationship quality. Items are rated on a 5-, 6-, or 7-point scale or yes/no response. Total scores range from 0-151, with higher scores indicating better relationship adjustment and quality.
6 months post enrollment
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
時間枠：9 weeks
A 25-item self-report measure; each item is scored on a 0-5-point scale. Total scores range from 0-125 with higher scores indicating greater impairment in bonding. Subscales include: Impaired Boding, Rejection and Anger, Infant-Focused Anxiety, Risk of Abuse.
9 weeks
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
時間枠：6 months post enrollment
A 25-item self-report measure; each item is scored on a 0-5-point scale. Total scores range from 0-125 with higher scores indicating greater impairment in bonding. Subscales include: Impaired Boding, Rejection and Anger, Infant-Focused Anxiety, Risk of Abuse.
6 months post enrollment
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
時間枠：9 weeks
A 37 self-report measure. Each item is scored on a 7-point likert scale, with 'does not apply' option available. Mean scores of items responded to are generated for each subscale. Higher scores indicate higher levels of the measured temperament trait. Subscales assessed include Positive Affectivity/Surgency, Negative Emotionality, Orienting/Regulatory Capacity.
9 weeks
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
時間枠：6 months post enrollment
A 37 self-report measure. Each item is scored on a 7-point likert scale, with 'does not apply' option available. Mean scores of items responded to are generated for each subscale. Higher scores indicate higher levels of the measured temperament trait. Subscales assessed include Positive Affectivity/Surgency, Negative Emotionality, Orienting/Regulatory Capacity.
6 months post enrollment
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
時間枠：9 weeks
A 9-item self-report measure assessing depression symptoms. Each item is scored on a 0-3-point scale with total scores ranging from 0-27. Higher scores indicate more severe depressive symptoms.
9 weeks
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
時間枠：6 months post enrollment
A 9-item self-report measure assessing depression symptoms. Each item is scored on a 0-3-point scale with total scores ranging from 0-27. Higher scores indicate more severe depressive symptoms.
6 months post enrollment
Cost-effectiveness - Healthcare Resource Utilization
時間枠：9 weeks
To inform cost-effectiveness analysis, healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period (based on the Canadian Community Health Survey and Service Use and Resources Form). Participants will provide information on all healthcare service and medication use over the trial period.
9 weeks
Cost-effectiveness - Healthcare Resource Utilization
時間枠：6 months post enrollment
To inform cost-effectiveness analysis, healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period (based on the Canadian Community Health Survey and Service Use and Resources Form). Participants will provide information on all healthcare service and medication use over the trial period.
6 months post enrollment
Major Depressive Disorder
時間枠：9 weeks
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
9 weeks
Major Depressive Disorder
時間枠：6 months post enrollment
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
6 months post enrollment
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
時間枠：9 weeks
To inform cost-effectiveness analysis, the EQ-5D-5L will be collected. This is a utility-based health-related quality of life instrument assessing five domains (mobility, self-care, usual activities, pain, depression/anxiety) and will be administered at T1-T3. The Canadian algorithm will be used to convert responses to health utility. QALYs will be calculated by multiplying the health utility for the corresponding time period (i.e., area under the curve approach).
9 weeks
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
時間枠：6 months post enrollment
To inform cost-effectiveness analysis, the EQ-5D-5L will be collected. This is a utility-based health-related quality of life instrument assessing five domains (mobility, self-care, usual activities, pain, depression/anxiety) and will be administered at T1-T3. The Canadian algorithm will be used to convert responses to health utility. QALYs will be calculated by multiplying the health utility for the corresponding time period (i.e., area under the curve approach).
6 months post enrollment

その他の成果指標

結果測定
メジャーの説明
時間枠
Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
時間枠：9 weeks (immediately post treatment in intervention group)
Intervention participants only. Satisfaction with the intervention will be assessed using the eight-item Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of eight items assessing the level of satisfaction with the intervention on a 4-point Likert-type scale, as well as one open-ended question. Responses to the open-ended question will be analyzed using content analysis to inform acceptability of the intervention.
9 weeks (immediately post treatment in intervention group)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

McMaster University

協力者

Ottawa Public Health

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月15日

一次修了 (推定)

2029年12月31日

研究の完了 (推定)

2029年12月31日

試験登録日

最初に提出

2026年8月6日

QC基準を満たした最初の提出物

2026年8月6日

最初の投稿 (実際)

2026年8月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月13日

QC基準を満たした最後の更新が送信されました

2026年8月11日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 20403

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する