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| Name | Class |
|---|---|
| University Hospital, Linkoeping | OTHER |
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The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.
Men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. Examples include depressed mood and worry regarding the prognosis and/or cancer recurrence. Psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms.
This study investigates a tailored approach to providing help for men diagnosed with prostate cancer. Participants randomized to the treatment condition will receive an eight week ICBT intervention which is tailored to the problem profile of the participant in question. The treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. Participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. The primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. Participants will be recruited in Sweden with a nationwide recruitment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored ICBT | Experimental | An eight week long ICBT treatment that is tailored to the problem profile of the participant. The treatment is modular, with one module being administered per week of the treatment. |
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| Non-directive support | Active Comparator | The control group will receive weekly support via contact with a therapist, without receiving access to the treatment modules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based cognitive behavioral therapy | Behavioral | An eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Kessler-10 (K10) | Measure of psychological distress. Consists of 10 items. Higher scores indicate greater psychological distress. Scores can range between 10 and 50. | At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Fear of Cancer Recurrence Inventory, short form (FCRI) | Measure of fear of the cancer recurring and/or spreading. Consists of 9 items. Higher scores indicate greater fear/anxiety levels. Scores can range between 0 and 36. | At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire-8 item version (CSQ-8) | Measure of treatment satisfaction. Consists of eight items. Higher scores indicate greater treatment satisfaction. Scores can range between 8 and 32. | Measured after nine weeks of treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerhard Andersson, Ph.D. | Contact | +46-13285840 | gerhard.andersson@liu.se | |
| Anton Käll, Ph.D. | Contact | anton.kall@liu.se |
| Name | Affiliation | Role |
|---|---|---|
| Gerhard Andersson, pHD | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Behavioral Sciences and Learning | Recruiting | Linköping | 58183 | Sweden |
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| Label | URL |
|---|---|
| Website used for the treatment. | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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After recruitment finished, participants will be randomized to either tailored ICBT treatment or a control condition.
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| Non-directive support | Behavioral | Participants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase. |
|
| Generalized Anxiety Disorder-7 item scale (GAD-7) | Measure of symptoms of generalized anxiety disorder. Consists of seven items. Higher scores indicate greater anxiety. Scores can range between 0 and 21. | At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment. |
| Insomnia Severity Index (ISI) | Measure of insomnia and sleep related-difficulties. Consists of seven items. Higher scores indicate greater sleep related-difficulties. Scores can range from 0 to 28. | At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment. |
| Brunnsviken Brief Quality of Life Scale (BBQ) | Measure of quality of life. Consists of 12 items. Higher scores indicate a greater quality of life. Scores can range between 0 and 96. | At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment. |
| The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) | Measure of health-related quality of life. Consists of 30 items and three main subscales which each will serve as an outcome: Global health status, Functional status, and Symptom status. Higher scores indicate a greater health status within the domain. Scores can range between 0 and 100. | At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment. |
| The Illness Cognition Questionnaire (ICQ) | Measure of cognitions about the illness (in this case prostate cancer). Consists of 18 items. Analyzed separately as three subscales: Acceptance, Perceived benefits, and Helplessness. Greater scores indicate greater acceptance, more perceived benefits, and greater helplessness, respectively. Will also be used as mediators in a mediation analysis with the rate of change in subscale sum scores used as mediators. Sum scores for each subscale can range between 6 and 24. | At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment. |
| D001523 |
| Mental Disorders |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |