Fatigue Perpetuating Factors as Mediators of Change in a Cognitive Behavioral Intervention for Targeted Therapy-Related Fatigue in Chronic Myeloid Leukemia: A Pilot Study

2021 ◽  
Author(s):  
Kelly A Hyland ◽  
Ashley M Nelson ◽  
Sarah L Eisel ◽  
Aasha I Hoogland ◽  
Javier Ibarz-Pinilla ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Targeted Therapy ◽  
Chronic Myeloid Leukemia ◽  
Self Efficacy ◽  
Myeloid Leukemia ◽  
Controlled Trial ◽  
Activity Patterns ◽  
Self Report ◽  
Cognitive Behavioral ◽  
Randomized Controlled

Abstract Background Cognitive behavioral therapy for targeted-therapy related fatigue (CBT-TTF) has demonstrated preliminary efficacy in reducing fatigue in patients treated with tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML). Purpose The aim of the current analyses was to explore whether fatigue perpetuating factors (disturbed sleep/wake cycle, dysregulated activity patterns, maladaptive cognitions about fatigue and cancer, insufficient processing of cancer and treatment, inadequate social support and interactions, heightened fear of cancer progression) changed over time in patients receiving CBT-TTF, and whether the effect of CBT-TTF on fatigue was mediated by these factors. Methods Secondary data analyses were conducted from a pilot randomized controlled trial. Patients with CML treated with a TKI who reported moderate to severe fatigue were randomized 2:1 to CBT-TTF delivered via FaceTime for iPad or a waitlist control condition (WLC). Self-report measures of fatigue and fatigue perpetuating factors were obtained before randomization and post-intervention (i.e., approximately 18 weeks later). Mixed model and mediation analyses using bootstrap methods were used. Results A total of 36 participants (CBT-TTF n = 22, WLC n = 14) who had baseline and 18-week follow-up data and attended >5 sessions for CBT-TTF were included. Participants randomized to CBT-TTF reported improvements in activity (mental, physical, social, p’s ≤ .023) and cognitions (helplessness, catastrophizing, focusing on symptoms, self-efficacy, p’s ≤ .003) compared to WLC. Mental activity, social activity, self-efficacy, helplessness, and focusing on symptoms, as well as sleep and insufficient processing (avoidance) mediated the relationship between treatment group and fatigue. Conclusions CBT-TTF appears to improve TKI-related fatigue in CML patients through changes in behavior (sleep, activity patterns) and cognitions about fatigue and cancer. A larger randomized controlled trial is warranted to confirm these findings.

scholarly journals Treating Insomnia with High Risk of Depression Using Therapist-Guided Digital Cognitive, Behavioral, and Circadian Rhythm Support Interventions to Prevent Worsening of Depressive Symptoms: A Randomized Controlled Trial

2021 ◽  
pp. 1-12
Author(s):  
Jeanne Leerssen ◽  
Oti Lakbila-Kamal ◽  
Laura M.S. Dekkers ◽  
Savannah L.C. Ikelaar ◽  
Anne C.W. Albers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Circadian Rhythm ◽  
Depressive Symptoms ◽  
High Risk ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Self Report ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Increased Risk

<b><i>Introduction:</i></b> The global disease burden of major depressive disorder urgently requires prevention in high-risk individuals, such as recently discovered insomnia subtypes. Previous studies targeting insomnia with fully automated eHealth interventions to prevent depression are inconclusive: dropout was high and likely biased, and depressive symptoms in untreated participants on average improved rather than worsened. <b><i>Objective:</i></b> This randomized controlled trial aimed to efficiently prevent the worsening of depressive symptoms by selecting insomnia subtypes at high risk of depression for internet-based circadian rhythm support (CRS), cognitive behavioral therapy for insomnia (CBT-I), or their combination (CBT-I+CRS), with online therapist guidance to promote adherence. <b><i>Methods:</i></b> Participants with an insomnia disorder subtype conveying an increased risk of depression (<i>n</i> = 132) were randomized to no treatment (NT), CRS, CBT-I, or CBT-I+CRS. The Inventory of Depressive Symptomatology – Self Report (IDS-SR) was self-administered at baseline and at four follow-ups spanning 1 year. <b><i>Results:</i></b> Without treatment, depressive symptoms indeed worsened (<i>d</i> = 0.28, <i>p</i> = 0.041) in high-risk insomnia, but not in a reference group with low-risk insomnia. Therapist-guided CBT-I and CBT-I+CRS reduced IDS-SR ratings across all follow-up assessments (respectively, <i>d</i> = –0.80, <i>p</i> = 0.001; <i>d</i> = –0.95, <i>p</i> &#x3c; 0.001). Only CBT-I+CRS reduced the 1-year incidence of clinically meaningful worsening (<i>p</i> = 0.002). Dropout during therapist-guided interventions was very low (8%) compared to previous automated interventions (57–62%). <b><i>Conclusions:</i></b> The findings tentatively suggest that the efficiency of population-wide preventive strategies could benefit from the possibility to select insomnia subtypes at high risk of developing depression for therapist-guided digital CBT-I+CRS. This treatment may provide effective long-term prevention of worsening of depressive symptoms. <b><i>Trial registration:</i></b> the Netherlands Trial Register (NL7359).

scholarly journals A randomized controlled trial comparing peginterferon-α-2a versus observation after stopping tyrosine kinase inhibitor in chronic myeloid leukemia patients with deep molecular response for at least two years

2020 ◽  
Author(s):  
Jew Win Kuan ◽  
Kian Meng Chang ◽  
Chin Lee Phan ◽  
Shu Ping Wong ◽  
Soo Min Lim ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Kinase Inhibitor ◽  
Controlled Trial ◽  
Molecular Response ◽  
Randomized Controlled ◽  
National Medical ◽  
Deep Molecular Response ◽  
Treatment Free Remission

Abstract BackgroundInterferon (IFN) is a logical possibility to increase treatment free remission (TFR) rate in chronic myeloid leukemia (CML). We conducted the first randomized controlled trial comparing the use of pegIFN versus observation in CML patients attempting TFR.MethodsAdult CML patients with stable deep molecular response for ≥ 2 years with ≥ 2 readings of MR4.5 were randomized into two arms -- subcutaneous pegIFN-α-2a starting at 180 µg weekly for a year, followed by observation, or observation.ResultsA total of 30 patients were recruited (pegIFN n = 15, observation n = 15). Median follow-up was 38.1 months (range 15.9–49.4) and 23.8 (1.5–51.0) in pegIFN and observation arm, respectively. A total of 11 patients relapsed (pegIFN n = 4, observation n = 7). The median time of relapse was 13.1 months (range 9.2 to 25.5) and 4.4 (1.2 to 13.6) in pegIFN and observation arm, respectively. Only 8 out of 15 (53%) patients completed 52 doses of pegIFN with mean dose of 43 out of 52 doses (range 20 to 52). Dose of tolerable pegIFN was age dependent.ConclusionPegIFN is a potential consolidative therapy to increase TFR.Trial registration:(1) Malaysia National Medical Research Register (NMRR): NMRR-13-1186-15491. Approved 23rd September 2014, https://www.nmrr.gov.my/fwbLoginPage.jsp(2) ClinicalTrials.gov: NCT02381379. Registered on 24th Feb 2015, https://clinicaltrials.gov/ct2/results?cond=&term=NCT02381379&cntry=&state=&city=&dist=

Randomized controlled trial of telephone-based cognitive-behavioral therapy on parenting self-efficacy and satisfaction

2019 ◽  
Vol 9 (6) ◽  
pp. 1163-1168
Author(s):  
Fei-Wan Ngai ◽  
Paul Wai-Ching Wong ◽  
Ka-Fai Chung ◽  
Kwok-Yin Leung ◽  
Marie Tarrant
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Self Efficacy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Postpartum Women ◽  
Randomized Controlled

Postpartum women who participated in a telephone-based cognitive-behavioral therapy had higher parenting self-efficacy and satisfaction.

scholarly journals A randomized controlled trial comparing peginterferon-α-2a versus observation after stopping tyrosine kinase inhibitor in chronic myeloid leukemia patients with deep molecular response for at least two years

2020 ◽  
Author(s):  
Jew Win Kuan ◽  
Kian Meng Chang ◽  
Chin Lee Phan ◽  
Shu Ping Wong ◽  
Soo Min Lim ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Kinase Inhibitor ◽  
Controlled Trial ◽  
Molecular Response ◽  
Randomized Controlled ◽  
National Medical ◽  
Deep Molecular Response ◽  
Treatment Free Remission

Abstract Background: Interferon (IFN) is a logical possibility to increase treatment free remission (TFR) rate in chronic myeloid leukemia (CML). We conducted the first randomized controlled trial comparing the use of pegIFN versus observation in CML patients attempting TFR. Methods: Adult CML patients with stable deep molecular response for ≥ 2 years with ≥2 readings of MR4.5 were randomized into two arms -- subcutaneous pegIFN-α-2a starting at 180µg weekly for a year, followed by observation, or observation. Results: A total of 30 patients were recruited (pegIFN n=15, observation n=15). Median follow-up was 38.1 months (range 15.9-49.4) and 23.8 (1.5-51.0) in pegIFN and observation arm, respectively. A total of 11 patients relapsed (pegIFN n=4, observation n=7). The median time of relapse was 13.1 months (range 9.2 to 25.5) and 4.4 (1.2 to 13.6) in pegIFN and observation arm, respectively. Only 8 out of 15 (53%) patients completed 52 doses of pegIFN with mean dose of 43 out of 52 doses (range 20 to 52). Dose of tolerable pegIFN was age dependent. Conclusion: PegIFN is a potential consolidative therapy to increase TFR. Trial registration:(1) Malaysia National Medical Research Register (NMRR): NMRR-13-1186-15491. Approved 23rd September 2014, https://www.nmrr.gov.my/fwbLoginPage.jsp(2) ClinicalTrials.gov: NCT02381379. Registered on 24th Feb 2015, https://clinicaltrials.gov/ct2/results?cond=&term=NCT02381379&cntry=&state=&city=&dist=

Preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders: A randomized controlled trial.

2019 ◽  
Vol 87 (6) ◽  
pp. 521-529 ◽  
Author(s):  
Margo de Jonge ◽  
Claudi L. H. Bockting ◽  
Martijn J. Kikkert ◽  
Maarten K. van Dijk ◽  
Digna J. F. van Schaik ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Cognitive Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled

The effect of feedback-informed cognitive behavioral therapy on treatment outcome: A randomized controlled trial.

2020 ◽  
Vol 88 (9) ◽  
pp. 818-828
Author(s):  
Pauline D. Janse ◽  
Kim de Jong ◽  
Carola Veerkamp ◽  
Maarten K. van Dijk ◽  
Giel J. M. Hutschemaekers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Outcome ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled
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