Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

Support and information + Behavioral activation

Support and information + Systematic exposure with mindfulness training

Support and information + Promotion of health behaviors

Support and information + Behavioral activation + Systematic exposure with mindfulness training

Support and information + Behavioral activation + Promotion of health behaviors

Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors

Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors

Emotional and technical support. Information about the long-term effects of cancer.

Support and information

Behavioral activation with existential themes and emphasis on values and relationships.

Behavioral activation

Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.

Systematic exposure with mindfulness training

An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Promotion of health behaviors

Erland Axelsson, PhD

Negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. Internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. In this factorial pilot study, 48 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address common negative psychological long-term effects of cancer. The aim of this study is to assess the feasibility of the study design and online treatment format. Key feasibility outcomes include interest in the study, patient-reported credibility of the intervention, adherence to the treatment protocol, satisfaction with the treatment, acceptability of the measurement strategy, missing data rates, adverse events, and preliminary efficacy on anxiety, depression, the fear of recurrence, and health-related quality of life.

Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors

Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms

Individual participant data from this pilot study fall under Swedish and European Union data protection and privacy legislation and can therefore not be share in their entirety. Reasonable requests may be directed to the corresponding author, and will be considered on a case-by-case basis.

A key feasibility outcome of this pilot study is the overall experience of study administrators and therapists tasked with the assignment and delivery of treatment variants in accordance with the randomized factorial design. After the main phase, all study administrators and therapists will be asked to rate the feasibility of the planned study design from 0 ("not feasible at all") to 10 ("fully feasible"), which will reported as a mean (SD) and median.

Credibility/Expectancy scale (C/E scale). Theoretical range: 0-50, where a higher score indicates higher credibility/expectancy.

Number of modules initiated, as registered by the clinician.

Number of completed exercises, as based on a short weekly questionnaire tailored to suit each treatment arm, with corresponding questions about the number of days devoted to exposure exercises, days devoted to activity planning, and days devoted to the promotion of health behaviors.

Number of measurements completed at each measurement point after the pre-treatment assessment. Preregistered target: at least 70% non-missing at the post-treatment and follow-up assessments.

Perceived strain caused by the measurement strategy. Preregistered target: at least 75% with a rating below 7 from 0 ("not at all stressful/distressing") to 10 ("extremely stressful/distressing").

The 8-item Client Satisfaction Questionnaire (CSQ-8). Theoretical range: 8-32, where a higher score indicates higher satisfaction.

Likert items pertaining to satisfaction with components.

Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)

20-item Negative Effects Questionnaire (NEQ-20). This will be reported as the proportion of endorsed items in the following subdomains: increase in symptoms, perceived insufficient quality of treatment, dependency, stigma, and hopelessness.

General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)

Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression)

9-item Fear of Cancer Recurrence Inventory (FCRI-9, theoretical range: 0-36, where a higher score indicates a more pronounced fear of cancer recurrence)

36-item Short Form Health Survey (SF-36, scored as a Mental Health Component Score and a Physical Health Component Score according to standard norms, both with a theoretical range of 0-100, where a higher score indicates a higher health-related quality of life)

14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more health anxiety).

Somatic Symptom Scale 8 (SSS-8, theoretical range: 0-32, where a higher score indicates a higher somatic symptom burden). Exploratory secondary analyses will be based on individual items, each scored 0-4.

Body Image Scale (BIS, theoretical range: 0-30, where a higher score indicates a higher level of body image distress).

12-item WHO Disability Assessment Schedule 2.0 (WD2-12, theoretical range: 0-100, where a higher score indicates more disability).

3-item Behavioral Activation for Depression Scale - Activation (BADS-AC-3, theoretical range: 0-18, where a higher score indicates a higher level of behavioral activation).

Symptom Preoccupation Scale (preliminary scale). A higher score indicates higher degree of preoccupation with symptoms. This is to be regarded as an an item pool, and the scale is is under development, which means that the total range cannot be preregistered.

Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ, theoretical range 0-99, where a higher score indicates a higher level of physical activity). If necessary for statistical modeling, the GSLTPAQ will be dichotomized to indicate active (≥24) vs. insufficiently active (\<24).

Based loosely on the Arthritis Self-efficacy Scale. Theoretical range of 0-60, where a higher score indicates a higher level of general health-related self-efficacy.

Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance)

Alcohol Use Disorders Identification Test (AUDIT, theoretical range: 0-40, where a higher score indicates more problematic alcohol use).

Drug Use Disorders Identification Test (DUDIT, theoretical range: 0-44, where a higher score indicates more problematic substance use).

Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors	NCT06046573	Cancer Survivor... Anxiety Depression	Support and inf... Behavioral acti... Systematic expo... Promotion of he...	18 Years -	Karolinska Institutet
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors	NCT06046573	Cancer Survivor... Anxiety Depression	Support and inf... Behavioral acti... Systematic expo... Promotion of he...	18 Years -	Karolinska Institutet

Spots Global Cancer Trial Database for randomized factorial trial